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Coronavirus updates February 2021...please add yours.

missy

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"

A photo of the NHS Covid Vaccine Centre in Wembley, London

One standard dose of the AstraZeneca/Oxford COVID-19 vaccine was highly effective against symptomatic disease up to 3 months later, lending support to a prime-boost vaccination strategy, additional analyses of phase III vaccine trial data found.
Vaccine efficacy was 76% (95% CI 59%-86%) from 22 days following the first dose of vaccine to the next dose 90 days later, reported Andrew Pollard, PhD, of the University of Oxford in England, and colleagues.

Moreover, for those who received a second standard dose of vaccine at 12 or more weeks after the first dose, vaccine efficacy was 82.4% (95% CI 62.7%-91.7%).
These results were published on a preprint server for The Lancet and are undergoing peer review at the journal, according to an Oxford press release that called these analyses "exploratory."
England authorized use of the two-dose AstraZeneca/Oxford COVID-19 vaccine in December, but regulators there approved delaying the second dose of COVID-19 vaccine for up to 3 months, which Pollard's group generously referred to as "a policy that has received substantial comment."
Pollard said in the Oxford press release that the new analysis "supports the policy recommendation ... for a 12-week prime-boost interval, as [regulators] look for the optimal approach to roll out, and reassures us that people are protected from 22 days after a single dose of the vaccine."
Researchers analyzed another month of efficacy data based on phase III studies in the U.K. and Brazil and a phase I/II study in the U.K. and South Africa, which included 332 cases of symptomatic COVID-19. They noted this included the subset of British participants who received a half-dose vaccine as their first dose when interim analysis data was reported in December.

Primary endpoint was symptomatic COVID-19 (a positive nucleic acid amplification test plus at least one qualifying symptom) more than 14 days after a booster dose.
In this analysis, 17,177 participants were included, with 8,948 from the U.K., 6,753 from Brazil, and 1,476 from South Africa. Researchers noted there were no additional cases of severe COVID in the vaccinated group, with no cases from 10 days after the first dose of vaccine, versus 22 in the control group.
Overall vaccine efficacy was 66.7% (95% CI 57.4%-74.0%) more than 14 days after the second dose, which included the low-dose/standard dose groups and standard-dose/standard-dose groups. The 76% vaccine efficacy was calculated from the standard-dose/standard-dose group.
A modeled analysis indicated protection did not wane during the initial 3-month period, and antibody levels were maintained during that time.
Pollard and colleagues found vaccine efficacy was 54.9% (95% CI 32.7%-69.7%) at less than 6 weeks, and was supported by data showing binding antibody responses more than two-fold higher after 12 or more weeks versus an interval of less than 6 weeks in adults ages 18-55.

The group also reported analyses exploring transmission. A single standard dose of vaccine reduced PCR-confirmed infection by 67%, and a schedule including two standard doses of the vaccine reduced infection by 49.5% overall, which they added, "may have a substantial impact on transmission by reducing the number of infected individuals in the population."
Oxford researchers expect to report data on new COVID-19 variants in the coming days, the press release said, which likely will be "broadly similar" to other vaccine developers' data.
The AstraZeneca/Oxford vaccine uses a chimpanzee adenovirus vector to deliver SARS-CoV-2 genetic elements encoding spike protein antigens.

Last Updated February 02, 2021

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"
A frosty box of Pfizer-BioNTech COVID-19 vaccine

WASHINGTON -- State public health officials had one message for lawmakers on Tuesday: send us more COVID-19 vaccine.
"Michigan's biggest challenge with the vaccine rollout has been the limited supply of vaccine, lack of predictability regarding vaccine amounts week to week, and the lack of a national strategy until now," said Joneigh Khaldun, MD, MPH, chief medical executive of the Michigan Department of Health and Human Services, at a virtual House Energy & Commerce Health Subcommittee hearing on ways to increase vaccination rates. "Despite this, Michigan has made significant strides ...We have jumped more than 20 spaces in the rankings over the past few weeks as it relates to the proportion of the population vaccinated."

"From the outset, vaccination efforts in Illinois have been limited by vaccine supply and sometimes complicated by inconsistent messages regarding allocations," said Ngozi Ezike, MD, director of the Illinois Department of Public Health. "Operation Warp Speed's promise to Illinois and the nation of a steady cadence of vaccine oftentimes fell short, with reduced or postponed allocations which left Illinois receiving fewer-than-expected doses."
In addition to Khaldun and Ezike, witnesses also included the health state health directors of Colorado, Louisiana, and West Virginia. Committee members were particularly interested in finding out why West Virginia had a relatively high percentage of its residents vaccinated -- 10.8% of West Virginia residents have gotten at least one dose of vaccine, compared with, for example, 6.4% in Illinois, according to CDC data reported by NPR.
Clay Marsh, MD, the state's coronavirus czar, said West Virginia "created a 'team of teams' approach that has been led by the National Guard -- our logistics experts ... As we started to focus and clarify our priorities, we agreed with the [Advisory Committee on Immunization Practices] and were also informed by data from the U.K. and the CDC that demonstrated truly that older patients were the most vulnerable for death and hospitalization ... so we targeted this age group along with the vulnerable populations outlined by the CDC."

State officials also decided not to activate a federal/state pharmacy partnership that used two large pharmacy chains -- CVS and Walgreens -- to distribute the vaccine. "We have 250 pharmacies in West Virginia, half of which are privately owned," he explained. "We started partnering these pharmacies with nursing homes, and we were able to immunize all of our nursing home/assisted living residents before the New Year and we just finished our second dose ... Our goal is to move every vaccine within 5 days into somebody's arm."
Rep. Lori Trahan (D-Mass.) asked Marsh to elaborate on why his state decided not to use the federal pharmacy program. Marsh said state officials asked the leader of West Virginia's long-term care association and a member of the state pharmacy board, who said that the federal program wouldn't work as fast as if they partnered with local pharmacies.
Rep. Tom O'Halleran (D-Ariz.) asked what could be done to address vaccine hesitancy now and in the future. Ezike responded that one idea would be to enlist kids "from a very young age, to talk about the importance of vaccines, and explain the science of vaccines -- explain to youngsters how they don't know about measles and polio because so many diseases have been eradicated by vaccines ... That's infrastructure building that may not give us the full fruits for this pandemic but will help toward the next."

Members also took the opportunity to score some political points. Rep. Frank Pallone (D-N.J.) chair of the full committee, said he disagreed with a comment by Rep. Cathy McMorris Rodgers (R-Wash.) that the vaccination rollout should be best left to the states, noting that earlier in the pandemic, states were competing with one another to procure masks, gloves, and other supplies. "We need a national strategy which is what Biden is trying to accomplish ... I don't think one-size-fits-all works when you have a pandemic of this size ... The fact that President Trump so much stressed that states were on their own and didn't need a national strategy was a huge mistake."

Rep. David McKinley (R-W.Va.) defended the Trump administration. "We've heard a lot of criticisms today of the Trump strategy, but I want to remind people that on September 16, the states were given a 57-page guidance document," he said, holding up a copy. "For people who say there were no plans, that just means that the state didn't create one that works."

"Some states can't get it right," he said, noting that some states have complained they need more vaccine but have only given out 50% of their current supply. In particular, he called out Illinois and Michigan for their low vaccination rates compared with West Virginia's. "Apparently they didn't develop a plan that is flexible enough to work. I'm just concerned about that."

McKinley evinced little sympathy for states complaining that they haven't received enough vaccine. "Complaining about not getting enough vaccine is like complaining about the size of your meal," he said. "You should be grateful to have any food on the table."



Rep. Tim Walberg (R-Mich.) asked Khaldun why lots of doses in Michigan were sitting unused despite the fact that Michigan governor Gretchen Whitmer (D) said the state was ready to administer them. Today, "we're one of the top-tier states when it comes to vaccinating our population," Khaldun responded.

"There were a couple reasons why in the beginning it appeared that Michigan was one of the bottom 10 states ... One of those was actually data not coming into the CDC -- we found more than 30,000 doses we were not getting credit for." In addition, many doses were sitting unused in long-term care facilities, and "we were able to take those out and vaccinate people across the state," she said.

Last Updated February 02, 2021

"
 

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Seems to be good news coming from Israel on the effectiveness of vaccines in reducing transmission.
 

missy

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Seems to be good news coming from Israel on the effectiveness of vaccines in reducing transmission.

Wonderful! Israel was at the forefront in vaccinating their citizens. Very efficient and no nonsense and using their military to make it go quickly and smoothly. Kudos to Israel. We could all take a page from their book re vaccinating.



"

Israel sees vaccination progress against COVID-19​

Israel, which is leading the world in coronavirus vaccinations, is starting to see benefits from its rapid rollout of the vaccine.

Currently, 57.6 percent of its population has been vaccinated, according to the non-profit organization Our World in Data. The vaccination rate is even higher among Israelis ages 60 or older, who were among the first in the country to receive the vaccine.

Last month Clalit, Israel’s largest health service organization, released preliminary data on 200,000 people 60 years or older who were vaccinated, comparing them to 200,000 similar unvaccinated older adults.

The positivity rate dropped 33 percent among those who were vaccinated, 14 days after they received the vaccine. No decline was seen in the unvaccinated.

Maccabi, another Israel healthcare organization, saw an even larger drop, reports The New York Times. Infections decreased by 60 percent among 430,000 people, 13 to 21 days after they received the vaccine.

The data is preliminary and has yet to be published in a peer-reviewed journal, so it should be viewed with some caution.

But Israel’s success offers early clues to what other countries might experience as they ramp up their vaccination efforts.

“It looks like the vaccine in Israel has been really successful,” said Christina Ramirez, PhD, a professor of biostatistics at the UCLA Fielding School of Public Health. “And I think it’ll tell us what we should expect in other countries.”

Late-stage clinical trials have already shown that the Pfizer-BioNTech vaccine has an efficacy of 95 percent against symptomatic infection, and the Moderna-NIAID has an efficacy of 94.1 percent.

Interim data also shows that the Johnson & Johnson vaccine has an efficacy of 66 percent against moderate to severe disease. This study did not look at whether the vaccine prevented mild cases.

Real-world effectiveness of vaccines is often lower than the efficacy seen in clinical trials due to a number of factors.

Israeli researchers plan on doing more in-depth statistical analysis of the data, reports the New York Times. They will likely try to take into account some of these other factors."




And:
 

missy

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And we never learn. People can be so stu***.



"
Coronavirus cases in the U.S. have surged after almost every major holiday of the past year, including Memorial Day, Labor Day, Thanksgiving and Christmas. This weekend brings another major holiday, even if it’s not an official one: Super Bowl Sunday. And there is reason to worry that it will turn into Superspreader Sunday.
Polls show that a significant number of people plan to attend parties. Two separate surveys — one by Seton Hall University and one by the National Retail Federation — found that nearly 30 percent of adults said they would attend a gathering at someone’s home or watch the game at a restaurant or a bar.
If anything, this weekend may be more dangerous than most holidays. Super Bowl parties are usually indoors and can involve more households than a holiday meal. This year’s game is also happening when contagious new variants of the virus have begun to spread.
There is precedent for sporting events leading to outbreaks. Health officials in Los Angeles believe that gatherings to watch playoff games last fall involving the Lakers (who won the N.B.A. title) and Dodgers (who won the World Series) accelerated the virus’s surgein Southern California.
“Crowds of packed fans crammed into outdoor dining patios,” The Los Angeles Times explained last week, noting that gatherings often included unmasked people “chanting, singing or shouting.” The same story quotes Barbara Ferrer, the public health director of Los Angeles County: “Don’t organize a party at home. Don’t go to a Super Bowl party.”
The next several weeks feel especially important. Cases have been falling sharply, and the pace of vaccination — though still maddeningly slow — is picking up. We have reached a potential turning point, when Covid-19 deaths could start declining and never again reach their earlier highs.

"



More vaccine info.
  • AstraZeneca and the University of Oxford released data showing that none of the 12,408 people who had received a vaccine shot died from Covid symptoms or were hospitalized with them. That’s consistent with earlier results for that vaccine, as well as initial results for four other vaccines — from Johnson & Johnson, Moderna, Novavax and Pfizer.
  • Researchers found that the AstraZeneca vaccine also slows the transmission of the virus, underscoring the importance of mass vaccination as a path out of the pandemic.
  • A peer-reviewed study published in The Lancet, a British medical journal, found that Russia’s vaccine, known as Sputnik V, also offered complete protection against serious Covid illnesses. Dr. Angela Rasmussen of Georgetown University called it “great news” and added, “We need more vaccines globally.” (Related: The New Yorker’s Joshua Yaffa and The Times’s Andrew Kramer, who are both based in Moscow, have written about why they got the Sputnik vaccine.)
  • An important caveat: The vaccines’ protection doesn’t kick in immediately. It often takes at least a couple of weeks.
  • The British government said that a variant of the virus first observed there had the potential to make the vaccines less effective. But that’s less alarming than it may sound. For now, the concern is hypothetical: No data shows the vaccines to be ineffective on the British variant. Even if they are less effective, other evidence suggests that modest levels of vaccine protection may almost always be enough to downgrade Covid to an ordinary flu.
  • “Lately, when I talk to reporters, they expect me to be very worried about Covid variants. But I’m not,” Dr. Ellie Murray of the Boston University School of Public Health wrote on Twitter. “Why? Because we know what works to control Covid.” She is more worried about “the lack of action” to promote social distancing, encourage mask wearing and accelerate vaccination, she added.
 

missy

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Finally!



As of February 1, 2021 masks must be worn by passengers on all forms of public transportation (e.g., airplanes, ships, ferries, trains, subways, buses, taxis, ride-shares) traveling into, within, or out of the U.S. (CDC January 29, 2021). Masks are also required while awaiting, boarding, and disembarking from public transportation. Transportation operators, such as crew, drivers, conductors, etc. are also required to wear masks. Masks can be bought or homemade, reusable or disposable, but must fully cover the nose and mouth. Clear panel masks are acceptable to facilitate communication with people who are hearing impaired or who otherwise need to see a speaker's mouth in order to communicate. Medical masks and N95 respirators are also acceptable. In addition to fully covering the nose and mouth, masks should also fulfill the following guidelines:

  • Cloth masks should be made with two or more layers of a breathable fabric that is tightly woven (i.e., fabrics that do not let light pass through when held up to a light source). (See our Top Picks among cloth masks that meet these requirements.) If gaiters are worn, they should have two layers of fabric or be folded to make two layers.
  • Masks should fit snugly but comfortably against the side of the face.
  • Masks should be a solid piece of material without slits, exhalation valves, or punctures.
Scarves, ski masks, turtlenecks pulled over the face, masks made from loosely woven material, and masks with slits, exhalation valves, or punctures are not acceptable.

Face shields and goggles can be worn with masks, but cannot be worn instead of a mask. (See our Top Pick among face shields).

Failure to wear a mask as described above is a violation of federal law and can be enforced by the Transportation Security Administration (TSA) and state and local authorities (TSA 2021). However, there are several exceptions to the requirement: Masks may be removed for brief periods of time when eating, drinking, or taking medication, while communicating with someone who is hearing impaired, when required to verify one's identity, and when requested by a ticket agent or law enforcement officer.

Governments in several European countries have gone a step further, and, in January, mandated the use of masks or respirators documented to provide at least 80 to 95% filtration efficiency in public areas, particularly on public transport and in shops. Respirators in Europe are referred to as filtering facepieces, or FFPs, and are classified as FFP2 (filtering ≥94% of aerosols, total inward leakage <8%) or FFP1 (filtering ≥80% of aerosols, total inward leakage <22%). Austria has the most stringent requirement, requiring FFP2 masks, which provide similar levels of filtration as N95 and KN95 masks.
 

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Covid-19: Third U.S. Vaccine Moves Closer as Johnson & Johnson Seeks F.D.A. Green Light​


Here’s what you need to know:​



Johnson & Johnson applies for emergency authorization for a single-shot vaccine.


A scientist at work at a Johnson & Johnson affiliate in the Netherlands.

A scientist at work at a Johnson & Johnson affiliate in the Netherlands.Credit...Johnson & Johnson, via Associated Press
Johnson & Johnson on Thursday submitted to the Food and Drug Administration an application for emergency authorization for its one-dose coronavirus vaccine, putting the company on track to potentially begin shipping it by early March.
The agency has scheduled a meeting with its outside advisory panel, which will vote on whether the F.D.A. should authorize the vaccine on Feb. 26, according to people familiar with the planning.
That leaves regulators about three weeks to pore over a large and complex application that includes clinical and manufacturing data. A decision on whether to authorize the vaccine could come within days of that meeting.
A similar timeline was used for the review of two-dose vaccines made by Pfizer-BioNTech and Moderna, which were authorized by the F.D.A. in December.
Dr. Paul Stoffels, the company’s chief scientific officer, said in a statement that the application was a “pivotal step toward reducing the burden of disease for people globally and putting an end to the pandemic.” He said Johnson & Johnson was ready to ship the vaccine as soon as the F.D.A. clears it.
Last week, the company announced promising results from its clinical trial, which showed that the vaccine provided strong protection against Covid-19. The trial found it was 85 percent effective in preventing severe disease in all three regions where the vaccine was studied: the United States, Latin America and South Africa. After 28 days, none of the vaccinated participants who developed Covid-19 had to be hospitalized.
But the results came with an ominous note: The vaccine’s efficacy rate was 72 percent in the United States, but only 57 percent in South Africa, where a highly contagious variant of the coronavirus is driving most cases. Preliminary studies have shown that some coronavirus vaccines are less effective against that variant.
There is also still uncertainty about how many doses Johnson & Johnson will be able to provide in the days and months after getting emergency clearance, when the company may have only about seven million ready, according to federal officials familiar with its production. About 30 million doses, made at facilities in the Netherlands and Baltimore, could be available by early April.
The company said on Thursday that it expected to supply the 100 million doses it has promised the U.S. by the end of June.
Noah Weiland

"
 

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COVID-19 Vaccines: We May Not Know Everything, but We Know a Lot​

— Two experts talk vaccine ethics, hesitancy, and prioritization​

by Serena Marshall February 4, 2021

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A screenshot of the Facebook live interview with Brian Williams, MD, and Shannon Firth

As the U.S. undergoes the largest and fastest mass vaccination program in history, there are various ethical considerations that need to be considered. During a Facebook Live event on Jan. 27, Serena Marshall, journalist and host of the "Track the Vax" podcast by MedPage Today and Everyday Health, discussed these issues with John Loike, PhD, a bioethicist and biology professor at Touro College in New York City; and Marty Makary MD, MPH, editor-in-chief at MedPage Today, surgical oncologist and chief of the Johns Hopkins Islet Transplantation Center, professor of health policy and management, and principal investigator on a Robert Wood Johnson Foundation grant for a project to lower healthcare costs.

This exclusive video highlights a debate they had during the interview, regarding the ethical considerations of vaccinating those who have already had the infection, and the one dose versus two dose strategies for allocating limited vaccine supplies.
Click here to watch the entire interview.
Following is a transcript of this part of the interview:

Serena Marshall: I'm Serena Marshall, host of Track the Vax, if you're just joining us, and I'm joined today by two experts, as we wade into ethical considerations of vaccine distribution throughout the U.S. Marty Makary and John Loike, thank you both again for joining us. Now, vaccinating those who have had COVID. Now you both mentioned this in your respective op-eds. You have a different opinion on it: Marty, you said that those who have had the infection should be stepping aside in the vaccine line; John, your position is on the other side of that. So, all right guys, go at it.

John Loike: My point is very simple. While I think that when you've had COVID, we again, must understand what is the nature of your immune response? Everybody is different. If you've had COVID, some people have a great immune response, have very good antibodies, have very good solid toxic T-cells, and are great to wait three months, four months, five months. On the other hand, some individuals who survive and are cured, don't have such a huge immune response. And we have the assets to do that, but they're very expensive so we're not doing that. And I think because of that, I'm assuming that we don't know just because you've had COVID, how immunized you are, and if we could do and get as many people vaccinated as possible -- 'cause I'm a big believer in herd immunity -- in the hundred year history of vaccinations, it really works. And if we can achieve rapid herd immunity at almost any cost, we will make a dramatic termination of this virus.

Marty Makary: I'm curious, John, if you think we should also test those who have been vaccinated to see if in fact they have immunity. Look, I think John's arguments are reasonable. This is the spirit of science here, putting different ideas out and having a civil conversation. I think John made a lot of good points. I would just suggest though that we're learning more and more, even since John's article was written, the U.K. study came out of 6,600 healthcare workers infected with COVID and confirmed to have had been infected and had the antibodies. Less than 1% got reinfected. If you look at the Spanish flu of 1918, there was a study in 2008, for all I know John was one of the co-authors. He's familiar with this study, but they took the survivors of the Spanish flu, eight, almost nine decades later. And they took their blood and they looked at their memory B cells and they were able to produce antibodies to the actual virus of 1918. And so I agree with John. Natural immunity can be powerful and it's not perfect, right? And because it's not perfect, and because it doesn't fit, we haven't done these long, large formal studies. And instead, simply observed that re-infection rates have been low, it hasn't been the solid evidence that you can dig your teeth in to say that natural immunity is 99% effective. It appears to be. And by the way, it may not be with the South African strain or the Brazilian variance. A paper came out I saw published on medRxiv on June 4th, trying to remember where it was from, but they suggested that maybe those viruses are more at risk of reinfecting people previously.

Marshall: Marty, January 4th, just in case our viewers want to go and find it, it was published?
Makary: Yeah, January 4th, on medRxiv.
Marshall: Okay. And that brings me to a really interesting question about these different --
Loike: I think you said it very well Marty, and I know the study with the 6,000 and I'm sure you read the study that came out of Israel, that they looked at those who received the first vaccination and that only reduced the incidence of COVID infectivity by 33%. And, I was surprised that it was so low. I would have thought after the first vaccine dose, that would be much lower. So there's a lot we don't know. But I think that what you're saying is very important.
Marshall: Doesn't a lot of this come down to that exact statement? What we don't know. There's something new we're learning about this virus every day. We have these new strains that are now coming. So is that the overarching question when you are grappling with these ethical considerations? Well, if I don't know whether or not I can get reinfected, should I err on the side of caution and get the vaccine? If I don't know what the long-term impacts of getting infected with the virus are, should I err on the caution and get the vaccine? But we still only have limited vaccine. So it has to come back to who goes first.

Loike: So that's an excellent point. And I just want to say something, I'm sure Marty will respond appropriately as well. And that is that, what we have is a hundred-year history of vaccinations. We may not have a lot of unknowns. We thought we knew a lot about measles and we can see the measles epidemic is re-emerging through '18 to '19. And we understand now why. So the best we can do now is take the information that we have, take our knowledge, and make the best decision that we can make. And we may be wrong, but also recognize an amazing thing that's happened over this last year.
Nowhere in the history have we ever developed vaccines so quickly and so effectively. And that is a tremendous, tremendous, revolution in vaccination. And we should really give credit to all the scientists, the physicians, the governments, who really put all the efforts into it. I mean, normally vaccines take five to 10 years and cost billions of dollars. We did this so quickly. And there's new technology of mRNA vaccination that is not only going to impact pandemics in the future, you're going to see a revolution in how it affects cancer treatments, auto immune disease. I'm sure Marty will expand on that.

Makary: HIV maybe. Yeah, absolutely. Great points, John. Since you brought up the Israel study, it's probably worth noting, I believe the time endpoint was about 30 days, is that right?
Loike: I thought it was two weeks.
Makary: Okay, two weeks. So one topic that I think we're touching on that may be good to address head-on and maybe hear some different perspectives here, if John has a different perspective, is should we be maximizing first doses or give out the second dose? There are hospitals today reserving vaccines for the second dose and denying seniors the vaccine. Okay, they've got a supply and they're told we can't give it to you because they're allocated as second doses for those who got the first dose. I personally believe that we would save more lives if we gave every high risk person a first dose and delay that second dose. Remember this summer, we were saying we just want a vaccine that's at least 50% effective.

Okay, what if I came to you in September and said, "Hey, we just developed a vaccine. It's more than 50% effective. It's about 80% to 90% effective." You'd say, "Well, let's give it to everybody! And you know, it's a single dose and that's how you give it." And then I came to you and said, "Oh, by the way, footnote, if you give it a second time a month later, you'll increase that protection from around 80% to 90% to around 95%." You'd say, "Okay, you know what? Just park that idea. We got to give this thing out to as many people as possible, get as many first doses out to high risk individuals and then work on boosting that protection, that small marginal amounts."
So I think today in America, it is a crime that we are denying people first doses in order to reserve second doses for people at a time when we're severely supply constrained and losing 3,000 Americans per day. My opinion.

Marshall: John, before you respond to that though, I want to ask and throw this question into the mix. There's no data about only one dose. The data that was approved by the FDA was a two-dose regimen. So we don't know how long...
Loike: We do know a lot about one dose.
Marshall: ... from those mRNA vaccines.
Loike: Yes. We do know. It's probably around 60% to 70% effective. So we do know that. And I think what Marty's saying is a very important point. If you do the mathematics, let's say you have a million people. And you have a million doses. If you can only immunize half of that, that's half a million people, right? Who you are going to immunize. And they're going to be 90% effective, so that's 450,000 people. If you give one dose to that million people, you're going to have 70% of those who are going to be immunized. So you have 700,000 who are going to be protected. So what Marty is saying mathematically makes a lot of sense. And personally, as an immunologist, I believe that even with the first dose, you have a lot of immunity and it will last for probably months, maybe even longer. So I ethically have no problem with that.

Marshall: But, to both of you, the FDA authorized on emergency use for these vaccines for a two-dose regimen. That is what the American public heard. There's already huge amounts of vaccine hesitancy across the country. Not anti-vax. Vaccine hesitancy over the concern of the speed and the way these vaccines came to market. So if you switched it to a one dose, couldn't you end up not reaching those vulnerable populations that are in some ways most at need of getting a vaccine?
Makary: I've actually heard people in the medical establishment and the government suggest that we really don't want to be talking about the immunity protection after a single dose, because we need everyone to get a second dose. And I just ethically do not believe that we should withhold information to almost coerce or manipulate people to just get that second dose. People should know their level of protection after one dose and the level of protection after two doses.

Now the reality is, it's not fair for the old guard medical establishment to say, we know two doses work, and we don't have data on one dose. First of all, we don't know anything after 300 days of getting a vaccine. There's zero data, okay? We use logic. We use reason. We talk to immunology experts like John. We have them extrapolate from the experience of a hundred other vaccines. And what we can do is we can make inferences like: Being a week late on your second dose does not really mean you're going to be harmed. There's no harm in delaying that second dose. There might be a slightly marginal different level of risk, exposure. But we can extrapolate. And I think when you see antibodies formed after one dose, we can make logical conclusions about it. And the reality is when the FDA looked at two doses, they didn't consider how severely supply constrained we are. I mean heck, India is almost giving half a dose of a single dose to some people.

I just think we've got to get out of this. And, you know, we talk about diversity by the way in society. How about the diversity and people making the decision about the two dose versus giving one dose out. If an older generation of people stuck on, you can only do what the FDA has studied or has authorized. And they don't want to be more pragmatic, which I think many younger people are more interested in exploring these pragmatic options, but if there's no added harm -- it's impossible to have added harm from one dose versus two doses, right -- why not be practical at a time when 3,000 Americans are dying a day. My opinion.
"
 

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"

Here's Why the U.S. Won't Follow Britain in Delaying Second COVID Vax Dose​

— New AstraZeneca data may ease some concerns -- or not​

by Jennifer Henderson, Enterprise & Investigative Writer, MedPage Today February 4, 2021


A NHS COVID-19 Vaccination Centre Bournemouth sign

As Great Britain continues to stretch out the interval between the first and second doses of the COVID-19 vaccine to 12 weeks, data out Wednesday seem to support doing so -- but concerns remain.
Physicians and public health experts have questioned whether the national strategy of getting as many first doses into arms as quickly as possible -- by extending the time between first and second doses -- is medically and ethically sound. A new study of the AstraZeneca/Oxford vaccine has helped ease the debate, though not entirely.

The study, published as an unreviewed preprint by The Lancet, showed that the AstraZeneca/Oxford vaccine provides sustained protection of 76% during the 12-week interval between first and second doses, the Britain's Department of Health and Social Care announced Wednesday.
However, clinical trials used to authorize the Pfizer/BioNTech and Moderna vaccines didn't examine whether such a lag between first and second doses would have an impact on efficacy.
The Pfizer/BioNTech vaccine was the first authorized for use in the U.K., in early December. Weeks later, British authorities moved to extend the time between first and second doses to 12 weeks -- just after the country identified the novel, more transmissible B.1.1.7 variant that was circulating there. The country's Joint Committee on Vaccination and Immunization supported government officials' decision to delay doses in light of the new variant.
It's a strategy that has continued as the AstraZeneca/Oxford vaccine and the Moderna vaccine were authorized for use in the country.

Initially, the strategy to extend the dosing interval included doing so for individuals who had already consented to and received the first dose of the Pfizer/BioNTech vaccine with the information they would get a second shot 3 weeks later, Helen Salisbury, a general practitioner and honorary senior clinical lecturer at the University of Oxford, told MedPage Today. "That's what we have the data for," she said of the 3-week interval for the Pfizer/BioNTech vaccine.
One of the initial concerns from the physician community surrounded changing the process from what individuals had consented to, and exacerbating a lack of trust some people already hold about vaccines more broadly, Salisbury said.
But the situation has evolved.
The AstraZeneca/Oxford vaccine had another set of timelines built into trialing it, looking at longer gaps between first and second shots, Salisbury noted. And, now, individuals receiving first doses of other vaccines are doing so with the understanding that their second dose will be given 12 weeks later.

If "our best guess" is that the pandemic will end sooner by spacing out doses -- helping to address shortages and vaccinating more people at 76% efficacy rather than fewer people with slightly better protection -- that's likely the right thing to do, Salisbury said. "So far, the data is looking relatively good."
Siu Ping Lam, PhD, director of licensing at Britain's Medicines and Healthcare products Regulatory Agency, also pointed to the latest AstraZeneca/Oxford data.
"The data presented in this pre-print are very reassuring and are consistent with those seen at the time of the approval," he said in a statement provided to MedPage Today. "This data has been submitted to us and, subject to our review, provides further robust evidence to support a 12-week dosing interval for COVID-19 vaccine AstraZeneca. It also shows that, from day 22 to day 90, the first dose of the vaccine has good protection against COVID-19."

However, the U.S. isn't rushing to follow suit.
Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, addressed the U.K.'s strategy of delaying doses during Wednesday's White House COVID-19 Response Team briefing.
"We have heard from studies emanating out of the AstraZeneca platform, that in the U.K. they're talking about the possibility -- since their data seems to show this -- that if you prolong the interval between the first and second dose -- in fact even go with a single dose -- you can get good results," Fauci said during the briefing. "And in fact, the interval between the first and second dose can now be measured in months, according to their own data, and that is actually a favorable response."
"We certainly respect that the U.K. scientists and health officials are going by their data, and letting their own data for their own platform dictate their policy," he continued. "The question is asked often, 'then why don't we do the same thing with our candidates that are now being distributed to people in the United States?' And the response is simple. We also are going very much by the data and the science that has emanated out of very large clinical trials. The Moderna trial -- with 30,000 people -- and the Pfizer trial -- with 44,000 people -- indicate to us that maximum responses are given with a prime followed by a boost within 21 days with Pfizer and 28 days with Moderna."

For people who are unable to get the second dose of the vaccine within those time frames due to special circumstances, the CDC has said that it is okay to receive the boost within four to weeks, Fauci said during the briefing. But that doesn't mean that is the desired dosing schedule.
"We feel strongly that we will go by the science, which has dictated for us the optimal way to get the 94% to 95% response," he added.
Arthur Caplan, PhD, professor of bioethics at NYU Grossman School of Medicine, has also emphasized adhering to available data.
There are questions about guaranteeing there will be enough vaccine for second doses if they are delayed, determining how long protection from the first dose might last, and how new variants change what is known about first doses, Caplan told MedPage Today. He added that one dose may give people a false sense of security -- they may stop masking and social distancing, and that could bring its own challenges.

Veering from available data could have other consequences as well.
Once officials start changing what was promised, that can lead to mistrust, Caplan said.
"It's a version of an experiment," he said of changing vaccine dosing from what was tested in the registration trials. "You have to really treat that, in my mind, as an experiment and get people's informed consent."
There are a lot of ideas about how to vaccinate and protect as many people as possible, Caplan said, including having individuals get a first dose of one vaccine and a second dose of another. But again, he added, it's an experiment. And more vaccines are expected to come online in the coming months.
Salisbury in the U.K. also noted that there are questions that remain, such as whether frontline hospital staff at high risk of occupational exposure should be given both doses within a shorter timeframe than 12 weeks. Additionally, there is limited data on the vaccination of adults ages 80 and up.

As for how variants may contribute to the debate about delayed doses, Salisbury said that it depends on whether many partially vaccinated people end up with mild infections, providing the virus the opportunity to mutate. However, one argument is that more people vaccinated with first doses will contribute to fewer people infected, thwarting the ability of the virus to mutate. "It's a numbers game," she said.
As of Wednesday, CDC data indicated that just over 27 million Americans had received at least one dose of a COVID-19 vaccine, of whom 6.4 million had gotten both doses. Only the Pfizer/BioNTech and Moderna vaccines are available in the U.S.; AstraZeneca's U.S. trial was halted for 7 weeks last fall. Between that and a well-publicized dosing misstep, FDA authorization is not expected until April.

"
 

missy

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Vaccination rate reaches 9% in the USA for at least the first dose. That's something.

And more interesting news thanks to @MamaBee for sharing.




"Just one dose of Pfizer's coronavirus vaccine might be enough to largely protect people from being infected with COVID-19, preliminary research shows."
 

missy

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“ The AstraZeneca/University of Oxford COVID-19 vaccine (AZD1222) proved effective against mild to moderate cases from the so-called U.K. variant, according to data from phase II/III trials.

Vaccine efficacy was 74.9% (95% CI 41.6-88.9) after two doses against symptomatic infection from the B.1.1.7 variant, reported Andrew Pollard, PhD, of University of Oxford in England, and colleagues, writing in a pre-print not yet reviewed by The Lancet.


Cases of the U.K. variant continue to grow in the U.S., and CDC estimates it could be the dominant COVID-19 strain by March. Novavax was previously the only vaccine manufacturer in late-stage clinical trials to share clinical vaccine efficacy data related to the U.K. variant, with 86% efficacy against cases from B.1.1.7, according to a recent press release from the manufacturer. However, researchers here noted, "these are the first published data on the clinical efficacy of a vaccine against SARS-CoV-2 against the novel B.1.1.7 variant compared with non-B.1.1.7 lineages."

University of Oxford sequenced data from 323 swabs in 256 participants from Oct. 1 to Jan. 14. They measured symptomatic COVID (defined as at least one symptom) via nucleic acid amplification test more than 14 days after a second dose of vaccine.

Interestingly, they found virus neutralization activity by vaccine-induced antibodies was 9-fold lower against the B.1.1.7 variant than non-B.1.1.7 variant strains.


"These findings suggest that either lower neutralising antibody titers are sufficient to provide protection or that other mechanisms of immunity may be responsible for protection from disease in vaccinated individuals," the authors wrote.

Vaccine efficacy against non-B.1.1.7 variant strains was 84% (95% CI 70.7-91.4).

Among symptomatic cases where sequencing data were available, there were fewer total cases of the U.K. variant, with non-B.1.1.7 variant strains comprising 86 cases (71.7%). They noted B.1.1.7 variant cases first arose in late November in trial sites in London, but were "an increasing proportion of positive swabs" during December and January.

Researchers also noted this data included part of the subset of participants who received a half-dose of vaccine as their first dose.

One limitation noted by the authors is that sequences from all positive swabs could not be obtained due to "logistical constraints," as well as the possibility of human error during sequencing.

Last Updated February 08, 2021”
 

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“ U.K. Variant Doubling; AZ/Oxford Vax Stumbles in South Africa; Dry Mardi Gras?

According to new research, cases of the U.K. variant in the U.S. could be doubling every 10 days. (CNBC)

South Africa stopped use of the AstraZeneca/Oxford COVID-19 vaccine after preliminary data showed it was less effective against mild and moderate cases of the South African variant. (New York Times)

As of Monday at 8:00 a.m. EST, the unofficial COVID-19 toll in the U.S. reached 27,008,565 cases and 463,482 deaths, up more than 82,000 cases and 22,000 deaths from a week ago.


And the latest CDC data indicate over 59 million COVID-19 vaccine doses have been distributed in the U.S., with over 41 million administered (69%).

Inside the lack of strategy and planning that plagued the Trump administration's ballyhooed "Operation Warp Speed" and its vaccine rollout. (Vanity Fair)

It's not that some healthcare workers don't want the COVID-19 vaccine, they just don't want it right now. (NPR)

A vaccine is great, but researchers shouldn't overlook developing new treatments for COVID-19 either. (Scientific American)

New Orleans will shut bars down for Mardi Gras this year to limit spread of the coronavirus. (New York Post)

Georgia public health department officials seized vaccines at a rural clinic administering the vaccine to teachers, who are not currently in the state's allocated distribution group. (NBC News)

Meanwhile, Massachusetts' vaccine website was so confusing, a software engineer on maternity leave built her own. (WBUR)

NFL commissioner Roger Goodell told President Biden that all 32 NFL owners want to pack their stadiums ... with people getting a COVID-19 vaccine, that is. (Axios)”
 

AprilBaby

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I get Moderna #2 this Thursday but I expect there will be a shot #3 by fall. Hubs is a month short of 65 and very upset he can’t get his shot.
 

Karl_K

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I am hoping the j&j vaccine does not get approved, I will be ticked and likely not accept it if offered because it is remarkably less effective than the other 2 already approved.
After months of screaming follow the science they want us to throw the science out and take a hugely less effective vaccine?
66% vs 92%-95%
Reminds me of the mask lies of the early days.
 

SparklieBug

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The mom of a close friend of ours is in her late 80's, in a care home. Our friends are very strict with COVID protocols, and decided to not take her out of the facility at Christmas, unlike many of the other residents' families. Yup. She contracted COVID a couple weeks ago from some of the other residents or their families, and it prior to any vaccines being available.

Remarkably, it was minor for her and she's recuperated!
 

MMtwo

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I am hoping the j&j vaccine does not get approved, I will be ticked and likely not accept it if offered because it is remarkably less effective than the other 2 already approved.
After months of screaming follow the science they want us to throw the science out and take a hugely less effective vaccine?
66% vs 92%-95%
Reminds me of the mask lies of the early days.

The J&J vaccine is excellent in preventing significant illness though. I get where you are coming from - I would prefer a more effective vaccine too. However...we are playing beat the clock and the J&J vaccine is 85 percent effective at preventing severe illness.

I'm a well-controlled diabetic with hypertension and overweight. My risk (according to this calculator) is normal. In my state, vaccines are going for frontline workers, non-white people prioritized and people over 65. It's going to be a while for me to get this vaccine. Even as a 1b group.
If it will take 6 months to get the Pfizer vaccine, but I can get the J&J in two months....I'll take it! Honestly, it would help my mental health to have SOMETHING available.

 

House Cat

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J&J has shown no hospitalizations and no death. I think a one jab vaccination will be essential in areas where people have difficulty traveling to vaccination sites.
 

missy

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J&J has shown no hospitalizations and no death. I think a one jab vaccination will be essential in areas where people have difficulty traveling to vaccination sites.

One of my friends is waiting to get the J&J vaccine because he prefers the technology involved in it not to mention the one vaccine dose compared to the two necessary for the Pfizer and Moderna (and likely a third for the Moderna Booster in fall but time will tell).
 

missy

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The mom of a close friend of ours is in her late 80's, in a care home. Our friends are very strict with COVID protocols, and decided to not take her out of the facility at Christmas, unlike many of the other residents' families. Yup. She contracted COVID a couple weeks ago from some of the other residents or their families, and it prior to any vaccines being available.

Remarkably, it was minor for her and she's recuperated!

Amazing it was mild for her and glad she is all better now! Thanks for sharing this good news with us!
 

MMtwo

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One of my friends is waiting to get the J&J vaccine because he prefers the technology involved in it not to mention the one vaccine dose compared to the two necessary for the Pfizer and Moderna (and likely a third for the Moderna Booster in fall but time will tell).

Maybe it will have a shorter line. I hope.
 

MMtwo

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One of my friends is waiting to get the J&J vaccine because he prefers the technology involved in it not to mention the one vaccine dose compared to the two necessary for the Pfizer and Moderna (and likely a third for the Moderna Booster in fall but time will tell).

This is a great point. I wonder if I might convince hubby to take a "normal" vaccine. I hope so. He is worried about the "new" vaccines. Also, the side effects on the J&J are less severe.
 

missy

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FYI for those interested in learning more about the Johnson and Johnson vaccine...




How the Johnson & Johnson Vaccine Works​

By Jonathan Corum and Carl ZimmerUpdated Feb. 3, 2021


1-syringe-jnj-450.png

Johnson & Johnson is testing a coronavirus vaccine known as JNJ-78436735 or Ad26.COV2.S. Clinical trials showed that a single dose of the vaccine had an efficacy rate of up to 72 percent.
Janssen Pharmaceutica, a Belgium-based division of Johnson & Johnson, is developing the vaccine in collaboration with Beth Israel Deaconess Medical Center.

A Piece of the Coronavirus​

The SARS-CoV-2 virus is studded with proteins that it uses to enter human cells. These so-called spike proteins make a tempting target for potential vaccines and treatments.

2-virion-600.png

Spikes
Spike
protein
gene
CORONAVIRUS
The Johnson & Johnson vaccine is based on the virus’s genetic instructions for building the spike protein. But unlike the Pfizer-BioNTech and Moderna vaccines, which store the instructions in single-stranded RNA, the Johnson & Johnson vaccine uses double-stranded DNA.

DNA Inside an Adenovirus​

The researchers added the gene for the coronavirus spike protein to another virus called Adenovirus 26. Adenoviruses are common viruses that typically cause colds or flu-like symptoms. The Johnson & Johnson team used a modified adenovirus that can enter cells but can’t replicate inside them or cause illness.


Johnson & Johnson’s vaccine comes out of decades of research on adenovirus-based vaccines. In July, the first one was approved for general use — a vaccine for Ebola, also made by Johnson & Johnson. The company is also running trials on adenovirus-based vaccines for other diseases, including H.I.V. and Zika. Some other coronavirus vaccines are also based on adenoviruses, such as the one developed by the University of Oxford and AstraZeneca using a chimpanzee adenovirus.
Adenovirus-based vaccines for Covid-19 are more rugged than mRNA vaccines from Pfizer and Moderna. DNA is not as fragile as RNA, and the adenovirus’s tough protein coat helps protect the genetic material inside. As a result, the Johnson & Johnson vaccine can be refrigerated for up to three months at 36–46°F (2–8°C).

Entering a Cell​

After the vaccine is injected into a person’s arm, the adenoviruses bump into cells and latch onto proteins on their surface. The cell engulfs the virus in a bubble and pulls it inside. Once inside, the adenovirus escapes from the bubble and travels to the nucleus, the chamber where the cell’s DNA is stored.


The adenovirus pushes its DNA into the nucleus. The adenovirus is engineered so it can’t make copies of itself, but the gene for the coronavirus spike protein can be read by the cell and copied into a molecule called messenger RNA, or mRNA.

Building Spike Proteins​

The mRNA leaves the nucleus, and the cell’s molecules read its sequence and begin assembling spike proteins.


Some of the spike proteins produced by the cell form spikes that migrate to its surface and stick out their tips. The vaccinated cells also break up some of the proteins into fragments, which they present on their surface. These protruding spikes and spike protein fragments can then be recognized by the immune system.
The adenovirus also provokes the immune system by switching on the cell’s alarm systems. The cell sends out warning signals to activate immune cells nearby. By raising this alarm, the Johnson & Johnson vaccine causes the immune system to react more strongly to the spike proteins.

Spotting the Intruder​

When a vaccinated cell dies, the debris contains spike proteins and protein fragments that can then be taken up by a type of immune cell called an antigen-presenting cell.


The cell presents fragments of the spike protein on its surface. When other cells called helper T cells detect these fragments, the helper T cells can raise the alarm and help marshal other immune cells to fight the infection.

Making Antibodies​

Other immune cells, called B cells, may bump into the coronavirus spikes on the surface of vaccinated cells, or free-floating spike protein fragments. A few of the B cells may be able to lock onto the spike proteins. If these B cells are then activated by helper T cells, they will start to proliferate and pour out antibodies that target the spike protein.


Stopping the Virus​

The antibodies can latch onto coronavirus spikes, mark the virus for destruction and prevent infection by blocking the spikes from attaching to other cells.

Killing Infected Cells​

The antigen-presenting cells can also activate another type of immune cell called a killer T cell to seek out and destroy any coronavirus-infected cells that display the spike protein fragments on their surfaces.




Remembering the Virus​

Johnson & Johnson is testing a single dose of the vaccine, unlike the two-dose coronavirus vaccines from Pfizer, Moderna and AstraZeneca. But because Johnson & Johnson’s Phase 3 trial results have not yet been released, researchers don’t know how well the vaccine might work, or how long its protection might last.

9-doses-jnj-600.png

Single dose
If the vaccine is effective, it’s possible that the number of antibodies and killer T cells will drop in the months after vaccination. But the immune system also contains special cells called memory B cells and memory T cells that might retain information about the coronavirus for years or even decades.

Vaccine Timeline​

January, 2020 Johnson & Johnson begins work on a coronavirus vaccine.
March Johnson & Johnson receives $456 million from the United States government to help develop and produce the vaccine.
July A Phase 1/2 trial begins. Unlike the clinical trials for otherleading vaccines, the trial involves one dose, not two.
johnson-syringe-600.jpg

A dose of the Johnson & Johnson vaccine.Michael Ciaglo/Getty Images
August The federal government agrees to pay Johnson & Johnson $1 billion for 100 million doses, if the vaccine is approved.
September Johnson & Johnson launches a Phase 3 trial.
Oct. 8 The European Union reaches a deal to obtain 200 million doses.
Oct. 12 The company pauses its Phase 3 trial to investigate an adverse reaction in a volunteer.
Oct. 23 The trial resumes.
Nov. 16 Johnson & Johnson announces a second Phase 3 trial to observe the effects of two doses of their vaccine, instead of just one.
Dec. 17 Johnson & Johnson announces its Phase 3 trial is fully enrolled, with around 45,000 participants.
January, 2021 Preliminary results from the Phase 3 trial are expected in January. The company is aiming to produce at least a billion doses this year.
Jan. 13 Johnson & Johnson expects to release trial results in as little as two weeks. But the company is falling behind on its original production schedule.
February If trials show the vaccine is effective, the company could apply for emergency use authorization from the Food and Drug Administration in February.

Sources: National Center for Biotechnology Information; Nature; Lynda Coughlan, University of Maryland School of Medicine.

 

SparklieBug

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Amazing it was mild for her and glad she is all better now! Thanks for sharing this good news with us!

Yes! We were braced for the worst and she sailed through, seemingly unscathed.

It’s good to have a little ray of sunshine in these times...
 

Karl_K

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I have been looking into it more and the j&j is likely just fine for someone younger and in good health.
With all my conditions where even a mild case might be fatal I would much prefer one of the more effective vaccines.
I am not as sure now if I would turn down the j&j it would depend on what chance there was of getting something better in a reasonable time.
 

missy

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I have been looking into it more and the j&j is likely just fine for someone younger and in good health.
With all my conditions where even a mild case might be fatal I would much prefer one of the more effective vaccines.
I am not as sure now if I would turn down the j&j it would depend on what chance there was of getting something better in a reasonable time.

I could be wrong, but from what I understand, one could get the J&J and then at a later date get the Pfizer or Moderna when that becomes available to you if it came down to that @Karl_K. I mean, if you have the choice get the Pfizer or Moderna of course but if they only offer you the J&J I would find out if it would be safe to get that and at a later date get one of the other vaccines.

I am surprised you aren't on the priority list right now with your (IIRC) pulmonary issues. :(
 

Karl_K

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I could be wrong, but from what I understand, one could get the J&J and then at a later date get the Pfizer or Moderna when that becomes available to you if it came down to that @Karl_K. I mean, if you have the choice get the Pfizer or Moderna of course but if they only offer you the J&J I would find out if it would be safe to get that and at a later date get one of the other vaccines.

I am surprised you aren't on the priority list right now with your (IIRC) pulmonary issues. :(

yea that may be possible.
In my area the county website is the only way to get on the list right now unless your in a nursing home or get it through work in the medical field or in jail and it lumps mild asthma as the same as more severe issues and is 90% based on age.
Right now the next group in IL starting to get it are incarcerated criminals then they start on everyone else.
 

missy

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Vaccine hunger games. Indeed. :/




"
Vaccine 'Hunger Games'

Americans are crossing state lines to get vaccines, and health officials often don't stand in the way, the New York Times reports.

Given that states have different eligibility rules, patients are making appointments wherever they can get them -- and they're often notified by "vaccine hunter" groups that crowdsource and broadcast appointment availability on social media.



Francisco Garcia, MD, MPH, director of the Pima County Health Department in Tucson, Arizona, told the Times the federal government's lack of coordinated eligibility rules has "created this 'Hunger Games' scenario where people are out there doing everything they can to get to the front of as many lines as they possibly can."

For instance, Chanel Maronge, who lives in Baton Rouge, Louisiana, saw on a Facebook group that she could grab a vaccine appointment across the border in Mississippi.

The 37-year-old school librarian has hypertension, which made her eligible for the vaccine in Mississippi -- but not in her home state. Similarly, her 69-year-old mother was just a year shy of eligibility in Louisiana, but made the cutoff in Mississippi.

Not all states are tracking vaccine recipients' residency, the Times reported. Ohio does, and it found 21,501 shots went to non-residents. In Florida, more than 57,000 non-residents were vaccinated. In the past two weeks, both Kentucky and Washington state updated their requirements so that only state residents or workers (in Kentucky's case, healthcare workers specifically) can receive the vaccine there."


yea that may be possible.
In my area the county website is the only way to get on the list right now unless your in a nursing home or get it through work in the medical field or in jail and it lumps mild asthma as the same as more severe issues and is 90% based on age.
Right now the next group in IL starting to get it are incarcerated criminals then they start on everyone else.

I hope you can get the vaccine you want soon @Karl_K.
 

missy

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"
Nearly 1.5 million Americans are being vaccinated every day against COVID-19. Allergic reactions have led some to question if they should get the vaccine; and scant data from clinical trials for the currently approved vaccines in vulnerable populations means we don't fully know how those with certain conditions will react.



Does that mean those with certain allergies or conditions like HIV, multiple sclerosis, or cancer should pass on the shot? What about those who are pregnant?

Barbara Alexander, MD, infectious disease specialist at Duke University and current president of the Infectious Diseases Society of America, joins us to explore who should get the shot. Later in the podcast, Mark Turrentine, MD, a professor at the Baylor College of Medicine and co-chair of the American College of Obstetricians and Gynecologists (ACOG) COVID-19 OB Expert Work Group, also joins to explain whether the vaccine is safe for pregnant and nursing women.

The following is a transcript of their interviews with "Track the Vax" host Serena Marshall:


Marshall: Dr. Alexander, thank you so much for joining us. We've heard that getting one of these COVID-19 vaccines, especially the second doses, can be painful and even put you out for a few days. It sort of sounds like the effects of the shot are worse than others, perhaps even the flu. Is this just anecdotal or is there some science behind it?



Alexander: I think there is definitely science emerging now; actually, the most recent safety data was reviewed by the Advisory Committee on Immunization Practices. So that's the committee that advises the CDC on vaccine safety and efficacy. They actually reviewed all of the safety data that has been generated so far.

It's true that it seems the second dose is more reactogenic than the first dose. Most symptoms do occur within the first three days after receiving the vaccine and most spontaneously resolve within a couple, three days. The most common side effects seem to be pain, fatigue, headache and myalgias or muscle pains.

Marshall: Why is it the case though for these vaccines? Is it because of their mRNA technology for vaccinations, or is it something to do with the COVID antibody response that they're generating?

Alexander: That's a good question. I don't know that we know absolutely, but I suspect it has more to do with the antibody response. The first vaccine -- most people don't have too much of a reaction, maybe a little bit of soreness at the side of the injection. And it's after that second vaccine that we see most people developing more side effects. And probably that's because after the first dose our bodies began to make an antibody response or an immune response. And when it gets that second dose, the body's really revved up. So then it's really ready to act against the antigen that the vaccine is providing. In that scenario then, what we're getting is an inflammatory response from the body, right.



Marshall: Those kinds of side effects that you mentioned arm pain or fatigue. Those are normal responses. Those are not allergies?

Alexander: That's right. They are not allergies. They're just normal side effects of the vaccine. And we see those in all vaccines that are administered.

Marshall: What would an allergic reaction to this vaccine be?

Alexander: Well, I think that the most important and worrisome allergic reaction that we think about is an immediate allergic reaction or what the scientific term we use is a type one hypersensitivity reaction. And those are usually early onset, like immediately after receiving the vaccine. The majority of these types of reactions occur within 30 minutes of receiving the vaccine.

And the types of reactions that we're talking about here are urticaria or hives, angioedema, which is swelling in the lower layers of the skin and typically it involves the face and tongue and/or throat, and wheezing. If you see one or two of these symptoms in combination with a low blood pressure or fast heart rate, then in that scenario that is anaphylaxis.



Marshall: Anaphylaxis. That's a term we've heard a lot about as these started to roll out and be administered in higher numbers. Is it something that most people should be worried about?

Alexander: Actually, no. When the vaccines were first rolled out there were cases that were reported early on of anaphylaxis and people who had received a vaccine. And it received a lot of attention. It was something that obviously we were very concerned about.

But you know, as we accrued more data we know now that, actually, anaphylaxis is probably not as common as we thought it might be. So again, the safety data is accruing not only from clinical trials, but from the real world.

Based on data that was reported into this vaccine adverse event reporting system, we have data from that system now, and after about 18 million doses of the messenger RNA vaccines being administered, we know the frequency of anaphylaxis is around five cases per a million doses of the Pfizer vaccine and about 2.8 cases per million doses of the Moderna vaccine.



So I think, you know, there were early concerns about anaphylaxis. We've monitored closely for it, but as we've garnered more data and especially in the real world, it seems that the risk of anaphylaxis is much lower than was originally projected.

Marshall: When you look at people who have allergies they see that anaphylaxis number and they might think I have allergic reactions so I shouldn't get the COVID-19 vaccine. If you have a food, pet, environmental allergen, is that an indication that you might qualify for anaphylaxis and should pass on the COVID vaccine?

Alexander: Actually no. You know, people have allergies to a lot of different allergens. Different food products, pet dander, venom to bees, or even latex, none of these are contraindicated or even if you have anaphylaxis to these products, it's safe to get the messenger RNA vaccines.

The only major contraindication to the messenger RNA vaccines is if you've had, again, an immediate allergic reaction, a hypersensitivity response to the first dose of the vaccine or if you've had such a response to a component of the vaccine in the past. And that includes polyethylene glycol, because this component is in both vaccines and some people will react to it.



There is also this other contraindication that is if you have had anaphylaxis to this product called polysorbate, because polysorbate can kind of cross-react with the polyethylene glycol. There's concern that even though polysorbate is not in the vaccines that people who are allergic to it could have an anaphylactic reaction because of the polyethylene glycol in the products.

So again, the only major contraindications and worry about getting these vaccines is if you've had an anaphylactic reaction or hypersensitive reaction to the first dose of the vaccine, a component of the vaccine, including polyethylene glycol, or if you've had a similar reaction to a polysorbate in the past. If you've had this kind of reaction to other vaccines or other injectable therapies, it's not a contraindication, it's just a precaution.

And then if you're going to receive the vaccine, do it in a center that's equipped to immediately treat it in case you did develop anaphylaxis. And that all people with a prior history at an anaphylactic reaction, should be monitored for at least 30 minutes after they received the dose. Again, because 90% of these anaphylactic reactions occur within 30 minutes of getting a dose of the vaccine.



Marshall: Some of the folks that may be joining us might hear this and say: "Well, I don't want to get the vaccine to find out if I have an allergic reaction to it. So, possibly, I am allergic to polyethylene glycol."

If you're allergic to polyethylene glycol, would you already know it or is there something else that it's in that could give you an indication that maybe you are allergic to it? Or are you just one of those people that automatically know what polyethylene glycol is?

Alexander: I think if you've had a reaction to a vaccine or polyethylene glycol in the past, you probably will already know. Again, the chance that you're going to have an anaphylactic reaction is very, very slim. You know, very, very, very, very low. So I would reassure those people. And if they have any concerns, just talk to their doctors.



From a personal standpoint, as an example, I had an anaphylactic reaction as a child to oral penicillin. I had broken my tooth and it had gotten infected. And you know, that was concerning at the time. But, that anaphylactic reaction to that oral antibiotic did not serve as a precaution or contraindication to the vaccine.

And in fact, I received the vaccine and had no problems with it.

Marshall: You mentioned a couple of times how low the risk of anaphylaxis is. It's survivable, even if you do get it. If you were among that small percentage of people that do have an anaphylactic reaction, what are the survival indicators, when it comes down to having that reaction, being treated versus getting COVID.

Alexander: Oh, absolutely. Anaphylaxis is treatable. Basically that's a prompt injection of epinephrine. Most people, if they develop, were to develop signs or symptoms of anaphylaxis would receive the injection of epinephrine and then they would be closely monitored in most centers.


Marshall: Could the version of the vaccine you get dictate how you react to it? We're going to be seeing new versions of vaccines come out so far. We've talked a lot about these mRNA ones because they're the ones that have been released to the public. Looking forward, would we expect to see different reactions and perhaps different contra-indicators for those different styles of vaccines?

Alexander: Absolutely. So we just have to wait and see.

The Johnson & Johnson vaccine, specifically, is using an adenovirus vector. It's a platform that has been used widely in vaccines before that we've used in teenagers, infants and children. So we feel reasonably comfortable with adenovirus vector vaccines. We'll just have to wait and see what the safety data looks like and, importantly, to see what their efficacy data looks like.

But right now, I don't think we have any major concerns about the Johnson & Johnson vector and their type of vaccine.


Marshall: What about those who are immunocompromised or have an autoimmune disease? We're moving through one of the largest mass vaccination campaigns. The hope is to get as many people vaccinated as possible, but besides those that might qualify because they do have a history of anaphylaxis.

Are there groups of people who should not be getting these vaccines because they're contraindicated in other ways?

Alexander: Actually, the bottom line here is that these immunocompromised populations -- so I'm talking about patients living with HIV infection, people with cancer receiving chemotherapy, and/or patients who may have received a solid organ transplant. These populations are receiving immunosuppressive drugs and or chemotherapy, which can weaken their immune system.

And accordingly, they may not have a robust immune response to the vaccine. But, some degree of immunity is better than none. And particularly since these people are at certainly higher risk for severe disease, we are recommending that they get the vaccine



Marshall: We're getting a lot of real world data and that's a good thing. But it's still relevant that there are a lot of these groups, like the immunocompromised, those with autoimmune diseases that we talked about, that weren't included in the original study data. Is that a responsible ask to have these people be vaccinated for something when the original data set didn't include them and we're going by that real-world data?

Alexander: Yeah, I guess, you know, that's a big question. Ethical question. And I think it's a balance between, do we believe that there is any evidence that these vaccines could harm these people versus is there evidence or do we believe that they could benefit these people. Particularly these people who are at risk for developing severe COVID and dying.

And so in those situations, while, you know, it's a balance. We may not have all of the data we want, but if the data points to, they seem to be, and are appearing by all indicators that they are going to be safe; then we might not have all of the data we want yet. But the recommendation is to take these vaccines in the event that they can help prevent severe COVID and potentially save lives.



Often, we won't give certain vaccines to patients with cancer or solid organ transplant patients because the vaccines are alive.

And we worry that even though these vaccines are attenuated that because these people have such weakened immune systems, the vaccine might be able to replicate and cause a problem. But, again, these are not live vaccines. And so we don't have to worry about, you know, an attenuated vaccine, perhaps being able to take off and cause problems even in the immunosuppressed patients.

Initially the clinical trials did exclude patients living with HIV, but all three of the trials, the Moderna, the Pfizer, as well as the Johnson & Johnson study have included patients living with HIV now.

Marshall: Typically wouldn't those vulnerable populations that aren't included in clinical trials be protected through herd immunity? But is that not an option at where we are with the limited number of vaccines, which is why we're encouraging vaccination?


Alexander: Exactly. I think it's going to be a while before we reach herd immunity. Herd immunity we would need to have 70% to 80% -- the actual percentage can be debated. But a high percentage of the country having immunity to SARS-CoV-2. And right now at best estimates, I think we may be 20% to 30% of the population here in the United States with immunity so far.

And so, unfortunately it's impossible to completely put all of these transplant patients, cancer patients, pregnant women into bubbles. Right now, until we can achieve herd immunity the safest thing to do is get these patients vaccinated.

Again, we've not seen any safety signals that these vaccines are not safe in these populations. And we know that some degree of immunity is better than no immunity. And that even a small degree of response to the vaccine may actually prevent these people, if they do contract SARS-CoV-2, from developing severe COVID infection and dying.



So, you know, again, I wish we were near herd immunity status, but we're just not. And so for now, these vaccines do seem to be safe. There's no scientific concerns regarding the safety of these vaccines in these populations. And so we are recommending that these most vulnerable populations get vaccinated.

Marshall: So bottom line, Dr. Alexander, it really sounds like everyone should be vaccinated that there really isn't any contraindications for the majority of people who are looking to receive a vaccine?

Alexander: There are not, and yes, everyone should get a vaccine unless they have one of the major contraindications, which we've talked about, as an immediate allergic reaction and to a prior dose of the vaccine or a component of the vaccine. I would say that for pregnant women a lot of people have debated whether without absolute data: should they get a vaccine or not?


I will say that the CDC and the World Health Organization are slightly different in their recommendations.

Marshall: Dr. Turrentine, explain for us why has been -- what appears to many, a mixed message for moms-to-be.

Turrentine: Even before the COVID-19 vaccine trials pregnant women have traditionally been excluded from clinical trials of new medications and vaccines. In 2013, the National Institutes of Health developed guidelines for protocol design and safety assessment for clinical trials conducted in pregnant women.

And in 2018, the FDA published draft guidance that gave a framework for consideration of inclusion of pregnant women in clinical trials. And the conclusions were that including pregnant and breastfeeding women, it's essential, unless there is some compelling scientific reason to exclude them.

So we had over 73,000 individuals between the two manufacturers trials and you have less than the number of people you can count on your fingers and toes entered into the trial and subsequently became pregnant after receiving the vaccine. So, subsequently, we have this situation where we had these two large placebo-controlled randomized clinical trials with essentially no pregnant women in the trials or women breastfeeding.


So with limited information to guide us, it comes down to expert consensus with mass medical ailments and the interventions we have had good clinical experience with.

And you're going to then get some different compromising approaches. The World Health Organization, actually initially on January the eighth of this year, stated that due to insufficient data they did not recommend the vaccination of pregnant women with the Pfizer COVID-19 vaccine, at that time.

And then on January 27th, again, the World Health Organization came out with a statement on the Moderna messenger RNA COVID-19 vaccine that recommended not getting COVID-19 vaccine unless the woman was at a high risk of exposure. And this led, number one, it led to a lot of confusion on many parts of the world.

Marshall: Women, they're seeing the CDC recommendations that you should trust, have the conversation with your own OB. And they're saying, why is there this disconnect?



Turrentine: Right. So this led to a statement from the U.S. organizations, such as the American College of Obstetricians and Gynecologists, that the COVID-19 vaccines should not be withheld from pregnant individuals who choose to receive it.

And after the publication of that statement, I think it was two days later, the World Health Organization modified its language that there was then no specific reason to believe that they would be any risk that would outweigh the benefits of the vaccination for pregnant women who are at high risk of exposure or have a comorbidity, which adds to their risk of severe disease. So, yet they still state they should be vaccinated only after in consultation with their healthcare provider. I've never been pregnant, but it would, it would confuse me tremendously.

Marshall: There's also mixed messaging within the states. So we talk about the messaging coming from ACOG or the WHO and, you know, how maybe that has been consistent or inconsistent, but even within the states. Depending on where you live, pregnancy is either a contraindication or a comorbidity.



One tells you: "Hey, hold on, maybe you shouldn't get the vaccine." And the other one says: "Hey, we're going to let you skip the line a little bit." So how does that play into all of this confusion?

Turrentine: Well, outstanding question. Hopefully there's nowhere in the U.S. that pregnancy is considered a contraindication. But in October of 2020, just this past fall, the National Academy of Sciences, Engineering and Medicine released a consensus statement that recommended an equitable allocation framework. You have to remember, this was before we knew we were going to have a vaccine that was even effective. So this framework proposed suggestions for the initial period when vaccine demand could exceed supply. So a phased approach was proposed for allocation, benefits by reducing morbidity and mortality caused by the transmission of the COVID-19 disease. So you then, then that begs the question, which groups of individuals should be offered the COVID-19 vaccine first. You also want to minimize the disruption to society and the economy while maintaining your health care resources.



It's a challenging and complex balancing of goals. I mean, there's no instructions to steer us. We do not have experience of a recent pandemic to model after. So, I guess you, with regards to your question, on a personal level I think balancing goals is critical. You need to balance the science, the ethics to have public input and then implementation.

And then, I would also add flexibility to that. And within the national guidelines, state and local jurisdictions should have flexibility to administer the vaccine based on the local epidemiology, their resources and the demand. I mean, the bottom line is we need to give vaccines in arms and that's paramount.

Marshall: So what are you hearing from your patients?

Turrentine: Well, you know, the interesting thing is, there's definitely a lot of initial confusion. There's no question. And the tough part is: we're all looking at the same information. And I think this is the challenge. When you have limited information to guide you for your particular cohorts of patients and you're trying to combat a potentially life threatening disease. So, as someone who's been personally involved with guideline and policy development on a national level, for many years, it's complex.


I can at least feel professional comfort in that the guidelines in the U.S. have been consistent to date. And, you know, we tried to base them on the best evidence we have available to us and hopefully we've reassured our pregnant patients, breastfeeding moms and women contemplating pregnancy that if after some informed decision-making they either choose to obtain a COVID-19 vaccine or not, they feel they've made the right choice.

Marshall: What's your lasting message for those who are either pregnant, considering being pregnant or breastfeeding when it comes to COVID and vaccines? Bottom line, do they get the vaccine?

Turrentine: Bottom line is yes, they should get the vaccine. But what I tell my pregnant patients is first learn everything you can about the COVID-19 disease and the COVID-19 vaccine. COVID disease -- it's dangerous and it's more dangerous for pregnant women.


I mean, COVID patients who are pregnant are five times more likely to end up in the intensive care unit and/or on a ventilator than COVID patients who are not pregnant. And although the absolute risk is low, pregnant individuals are more likely to die of COVID than their non-pregnant peers who are at the same age.

So, the current COVID vaccines have been shown to be 95% effective against COVID infections. And we know that you're not going to get the virus from getting the COVID vaccine.

And as of January the 20th information from the V-Safe app reports a little over 15,000 pregnant women that received the COVID-19 vaccine. So I explained to my pregnant patients: "Yes, we do not have information yet on whether the vaccine works as well in pregnancy as it may in studies of non-pregnant individuals."

So, I guess I then kind of sum it up, as I said, it's all about personal risk.



As someone who cares for pregnant women, the pregnant individual should be given the opportunity to make their own decision as whether they receive the vaccine and barriers should not be put into place to prevent either access or hinder the ability of a pregnant woman to protect themselves from a virus that could be potentially life-threatening.

Last Updated February 10, 2021"
 

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Super_Ideal_Rock
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Am I understanding correctly that it has not been determined that a COVID vaccine prevents transmission and it also hasn’t been proven that it keeps someone vaccinated from catching COVID? In this interview she says “in the event that they prevent COVID”. The WHO said the same in December and Fauci himself said this just last week.

They keep on talking about herd immunity but there won’t be herd immunity if the vaccines don’t prevent transmission of the virus.
 
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