Coronavirus Updates May 2024

[missy]

The side effects of Covid Vaccines
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‘I’m not real’​

Let me start with a disclaimer: The subject of today’s newsletter will make some readers uncomfortable. It makes me a little uncomfortable.

The Times has just published an article about Americans who believe they suffered serious side effects from a Covid vaccine. More than 13,000 of them have filed vaccine-injury claims with the federal government.

My colleague Apoorva Mandavilli tells some of their stories in the article, including those of several people who work in medicine and science:

Ilka Warshawsky, a 58-year-old pathologist, said she lost all hearing in her right ear shortly after receiving a Covid booster shot. Dr. Gregory Poland, 68 — no less than the editor in chief of Vaccine, a scientific journal — said that a loud whooshing sound in his ears had accompanied every moment since his first Covid shot. Shaun Barcavage, 54, a nurse practitioner in New York City, has experienced a ringing sound in his ears, a racing heart and pain in his eyes, mouth and genitals for more than three years. “I can’t get the government to help me,” Barcavage said. “I am told I’m not real.”

This subject is uncomfortable because it feeds into false stories about the Covid vaccines that many Americans have come to believe — namely, that the vaccines are ineffective or have side effects that exceed their benefits. Robert F. Kennedy Jr., the independent presidential candidate, has promoted these stories, as have some Republican politicians and conservative media figures. “The scale of misinformation,” Dr. Joshua Sharfstein of Johns Hopkins University told Apoorva, “is staggering.”

So let me be clear:


The benefits of the Covid vaccines have far outweighed the downsides, according to a voluminous amount of data and scientific studies from around the world. In the U.S. alone, the vaccines have saved at least several hundred thousand lives and perhaps more than one million, studies estimate. Rates of death, hospitalization and serious illness have all been much higher among the unvaccinated than the vaccinated.




Not only are the vaccines’ benefits enormous, but the true toll of the side effects may be lower than the perceived toll: Experts told Apoorva that some people who believe Covid vaccines have harmed them are probably wrong about the cause of their problems.

How so? Human beings suffer mysterious medical ailments all the time. If you happened to begin experiencing one in the weeks after receiving a vaccine, you might blame the shot, too, even if it were a coincidence. So far, federal officials have approved less than 2 percent of the Covid vaccine injury-compensation claims they have reviewed.

Still, some ailments almost certainly do stem from the vaccines. The C.D.C. says some people are allergic (as is the case with any vaccine). Both the C.D.C. and researchers in Israel — which has better medical tracking than the U.S. — have concluded that the vaccines contributed to heart inflammation, especially in young men and boys. Officials in Hong Kong — another place with good health care data — have concluded that the vaccines caused severe shingles in about seven vaccine recipients per million.

Honesty and trust​

These side effects are worthy of attention for two main reasons.

First, people who are suffering deserve recognition — and the lack of it can be infuriating. Dr. Janet Woodcock, a former F.D.A. commissioner, told The Times that she regretted not doing more to respond to people who blame the vaccines for harming them while she was in office. “I believe their suffering should be acknowledged, that they have real problems, and they should be taken seriously,” Woodcock said.

The second reason is that public health depends on public trust, and public trust in turn depends on honesty. During the pandemic, as I’ve written in the past, government officials and academic experts sometimes made the mistake of deciding that Americans couldn’t handle the truth.

Instead, experts emphasized evidence that was convenient to their recommendations and buried inconvenient facts. They exaggerated the risk of outdoor Covid transmission, the virus’s danger to children and the benefits of mask mandates, among other things. The goal may have been admirable — fighting a deadly virus — but the strategy backfired. Many people ended up confused, wondering what the truth was.

The overall picture​

Here’s my best attempt to summarize the full truth about the Covid vaccines:

They are overwhelmingly safe and effective. They have saved millions of lives and prevented untold misery around the world. They’re so valuable that elderly people and those with underlying health conditions should be vigilant about getting booster shots when they’re eligible. For most children, on the other hand, booster shots seem to have only modest benefits, which is why many countries don’t recommend them.

And, yes, a small fraction of people will experience significant side effects from the vaccines. Eventually, scientific research may be able to better understand and reduce those side effects — which is more reason to pay attention to them.

Overall, Covid vaccines are probably the most beneficial medical breakthrough in years, if not decades.

Thousands Believe Covid Vaccines Harmed Them. Is Anyone Listening?

All vaccines have at least occasional side effects. But people who say they were injured by Covid vaccines believe their cases have been ignored.

www.nytimes.com

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[missy]

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A Covid-19 update​

More data is sunsetting, new low in hospitalizations (!), and the upcoming fall vaccine formula.​

KATELYN JETELINA

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It’s been a while since a Covid-19 update. Some major developments are coming down the pipeline. Here is an attempt to keep you updated, even if it’s not making headlines.

Hospitalization reporting is sunsetting.​

During the Covid-19 emergency, the U.S. scrambled to get a national view of severe disease quickly due to our fragmented healthcare system. We eventually created a national hospitalization reporting system where hospitals were required to report capacity, Covid-19 hospitalizations, and more.
This was an enormous step because it led to visibility and, thus, action. This system could be used for many things today and in the future (cough, cough, H5N1). Preparedness is the name of the game; we cannot slip back into the cycle of panic and neglect.
Unfortunately, this hospital reporting requirement is sunsetting today (April 30). Sunsetting means a few things:

• Hospitals will voluntarily send data. Given that hospitals hated sending Covid-19 hospitalization data in the first place, I assume that many will stop.
• We will rely heavily on our older system, which is suboptimal. In pre-pandemic times CDC created a hospital surveillance system called RESP-NET for flu and other diseases. This system is great but only collects data from about 10% of hospitals, mostly from urban areas. So, this data shows an incomplete and sometimes biased picture. Take this winter, for example, where RESP-NET (the older system) showed flu hospitalizations higher than Covid-19;however, this was not the case when looking at data from the newer, more complete reporting system.

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Data Sources: CDC; Annotated by YLE

• HHS is not giving up the fight. In a welcome development, the Department of Health and Human Services (HHS) has proposed a new rule requiring hospitals to report data outside of an emergency. The new rule’s proposed start date of October 1.

HHS is asking for public comment starting May 2, particularly whether you think this new rule is important. (My humble opinon: It’s an essential system that will protect the health and safety of our communities.) I’ll alert you once it’s open. Your comments will really make a difference.

Covid-19 is at a new low, with variants on the horizon.​

Covid-19 in wastewater is at very low levels at this time, which is a welcome reprieve after this respiratory season. This means the probability that Covid-19 is hanging around at a party or daycare is very low.

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SARS-CoV-2 Wastewater (Source: CDC)
With it, hospitalizations are at the lowest point since the beginning of the pandemic. What a beauty to see!

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Source: CDC; Annotated by YLE
SARS-Cov-2 continues to mutate. The next variant on deck is what scientists call “FLiRT,” shorthand for two mutations on the spike protein. Think of these as the children of JN.1.
Will this cause an infection wave? There are many similarities between FLiRT and JN.1—which took over this winter—so this certainly won’t cause a tsunami and probably not even a wave. Maybe a wavelet, depending on how much immunity our communities have. A smaller summer wave would follow a pattern we’re seeing, where each summer wave gets smaller and smaller over time. (See figure above.)

Many of you are asking whether you should get your spring Covid-19 vaccine. My thoughts are on a previous YLE post here, but basically, if you’re over 65 and high risk (i.e., in a nursing home, or have comorbidities), I would. I would also get this sooner rather than later. You don’t want to get your spring vaccine too late, because a fall vaccine will be coming in a few months. We want these spread apart as much as possible.

WHO recommended a vaccine formula for fall. FDA will decide May 16.​

WHO recommended a JN.1 formula for the upcoming fall Covid-19 vaccine. Their spring recommendation (including for flu) is an effort to get the global players (i.e., countries and manufacturers) on the same page.
JN.1 is the most recent Covid-19 variant that spread this past winter. Many scientists (including myself) are disappointed because this means we are following the virus instead of getting ahead of it.
The FDA will decide the U.S. vaccine formula plan on May 16. They will likely follow WHO, especially since Novavax has already tested this formula in anticipation of the fall rollout. Protein-based vaccines need a much longer development runway than mRNA vaccines.
I’ll share Cliff’s notes from the May meeting.

Bottom line​

Things should be quiet on the Covid-19 front for now. I hope you get to enjoy those graduations and summer vacations!



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[missy]

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Bloomberg - Are you a robot?

Long Covid and your gut​

As Covid cases go, Marilyn Stebbins’ was a memorable one. She was the first in Yolo County, California, reported to have the virus in early March 2020. It was severe, requiring a week-long hospitalization, including supplemental oxygen in an intensive-care unit. And it was oddly persistent. While Stebbins, then a 58-year-old academic pharmacist and ultra distance runner, was probably infected in mid-February, she was still intermittently testing positive on nasal PCR swabs well into May. Diarrhea and other gastrointestinal symptoms lingered for six months, while her gut function took about two years to normalize, she said. “It was the weirdest thing,” Stebbins told me. “It was like I just couldn’t put any weight on if I tried.” Over four years later, scientists are starting to connect the dots between prolonged SARS-CoV-2 infections, long-term gastrointestinal problems, disturbances of intestine-dwelling microbes and long Covid symptoms. Though evidence is still emerging and incomplete, it’s clear that the coronavirus can be difficult to shake. In a study published last month, researchers in China analyzed surgical specimens and other tissue samples from 225 patients in Beijing who had mild Covid at the end of 2022, when the omicron variant ripped across the country. Most of the patients had been vaccinated multiple times. The study found vestiges of SARS-CoV-2 in blood and multiple organs — including the liver, stomach, and brain — for up to four months after infection. Importantly, patients were over five times more likely to report long Covid symptoms if they were persistently harboring viral material. Doctors at the University of California, San Francisco, who began studying the coronavirus’s aftereffects in early 2020, detected viral remnants in bloodup to 14 months later in Covid patients. The researchers also found traces of the virus — including active particles, in some cases — in patients’ connective tissue, where immune cells are located. They suspect that it could be a source of the immune activation and dysregulation plaguing some long Covid patients. More research is needed to understand how the persistence of viral fragments is contributing to long Covid symptoms and if that’s behind the increased risk of heart attack and stroke that patients experience a year or more after a SARS-CoV-2 infection, according to Michael Peluso, an infectious disease researcher at UCSF. Peluso and colleagues are studying whether monoclonal antibodies or antiviral drugs can remove the virus and relieve long Covid symptoms. Researchers in Hong Kong showed last year that twice-daily ingestion of a liquid laden with billions of “friendly” microbes and nutrients improves the gut microbiome and can alleviate multiple long Covid symptoms. “There is a lot more work to be done, but I feel like we are making progress in really understanding the long-term consequences of this infection,” Peluso said. —Jason Gale "

 

[missy]

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COVID Vaccines and New-Onset Seizures: New Data​

Eve Bender
May 08, 2024





There is no association between the SARS-CoV-2 vaccine and the risk for new-onset seizure, data from a new meta-analysis of six randomized, placebo-controlled clinical trials (RCTs) showed.

Results of the pooled analysis that included 63,500 individuals vaccinated with SARS-CoV-2 and 55,000 who received a placebo vaccine showed there was no significant difference between the two groups with respect to new-onset seizures at 28- or 43-day follow-up.

Regarding new-onset seizures in the general population, there was no statistically significant difference in risk for seizure incidence among vaccinated individuals vs placebo recipients, according to our meta-analysis, the investigators, led by Ali Rafati, MD, MPH, Iran University of Medical Sciences in Tehran, Iran, wrote.


The findings were published online on April 29 in JAMA Neurology.

Mixed Results
Results from previous research have been mixed regarding the link between the SARS-CoV-2 vaccination and new-onset seizures, with some showing an association.

To learn more about the possible association between the vaccines and new-onset seizures, the researchers conducted a literature review and identified six RCTs that measured adverse events following SARS-CoV-2 vaccinations (including messenger RNA, viral vector, and inactivated virus) vs placebo or other vaccines.


While five of the studies defined new-onset seizures according to the Medical Dictionary for Regulatory Activities, trial investigators in the sixth RCT assessed and determined new-onset seizures in participants.

Participants received two vaccinations 28 days apart in five RCTs and only one vaccine in the sixth trial.

The research team searched the data for new-onset seizure in the 28 days following one or both COVID vaccinations.


No link found
After comparing the incidence of new-onset seizure between the 63,500 vaccine (nine new-onset seizures, 0.014%) and 55,000 placebo recipients (one new-onset seizure, 0.002%), investigators found no significant difference between the two groups (odds ratio [OR], 2.70; 95% CI, 0.76-9.57; P = .12)

Investigators also sliced the data several ways to see if it would yield different results. When they analyzed data by vaccine platform (viral vector) and age group (children), they didn't observe significant differences in new-onset data.

The researchers also searched for data beyond the month following the injection to encompass the entire blinded phase, so they analyzed the results of three RCTs that reported adverse events up to 162 days after the vaccine.

After pooling the results from the three studies, investigators found no statistical difference between the vaccine and placebo groups in terms of the new-onset seizure (OR, 2.31; 95% CI, 0.86%-3.23; P > .99)

Study limitations included the missing information on vaccine doses or risk factors for the development of seizures. Also, the RCTs included in the meta-analysis were conducted at different times, so the SARS-CoV-2 vaccines may have differed in their composition and efficacy.

"The global vaccination drive against SARS-CoV-2 has been a monumental effort in combating the pandemic. SARS-CoV-2 vaccinations that are now available appear safe and appropriate," the authors wrote.

There were no study funding sources or disclosures reported.

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[missy]

COVID's surprising role in the surge of food recalls | MDLinx

Various products, from nuts to ground beef, have been recalled due to contamination concerns with pathogens like Listeria, Salmonella, and E. coli.

www.mdlinx.com