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FDA Urged to Publish Follow-up Studies on COVID Vaccine Safety Signals
In July 2021, the U.S. Food and Drug Administration (FDA) quietly disclosed findings of a potential increase in four types of serious adverse events in elderly people who had had Pfizer’s COVID-19 vaccine: acute myocardial infarction, disseminated intravascular coagulation, immune thrombocytopenia and pulmonary embolism. Little detail was provided, such as the magnitude of the increased potential risk, and no press release or other alert was sent to doctors or the public. The FDA promised it would “share further updates and information with the public as they become available.”
Eighteen days later, the FDA published a study planning document (or protocol) outlining a follow-up epidemiological study intended to investigate the matter more thoroughly. This recondite technical document disclosed the unadjusted relative risk ratio estimates originally found for the four serious adverse events, which ranged from 42% to 91% increased risk. (Neither absolute risk increases nor confidence intervals were provided.)
More than a year later, however, the status and results of the follow-up study are unknown. The agency has not published a press release, or notified doctors or published the findings by preprint or the scientific literature or updated the vaccine’s product label.
“To keep this information from the scientific community and prevent us from analyzing it ourselves, is irresponsible. It presumes that these organizations are perfect and cannot benefit from independent scrutiny,” says Joseph Fraiman, an emergency medicine physician in New Orleans, who recently carried out a reanalysis of serious adverse events in Pfizer’s and Moderna’s randomized trials.
Patients Died From COVID Drug Treatment at Two California Hospitals, Suits Allege
Two women have filed lawsuits alleging their husbands died from negligence at Inland Empire hospitals after doctors prescribed remdesivir to treat COVID-19 and then failed to tell them about the dangerous side effects of the anti-viral drug.
The lawsuits, filed last month in state court against Kaiser Permanente Riverside Medical Center and Redlands Community Hospital and several of their physicians, allege doctors engaged in fraud by prescribing each of the men remdesivir without their knowledge or consent. Doctors also allegedly failed to explain that the drug is ineffective in treating COVID-19, is toxic to kidneys and can cause death, the complaints say.
The World Health Organization issued a recommendation in November 2020 against the use of remdesivir regardless of disease severity, saying there is no evidence the drug improves survival or shortens recovery.
Additionally, the National Institutes of Health said individuals with kidney impairment or failure may experience liver or kidney toxicity due to the release of sulfobutylether beta-cyclodextrin sodium contained in remdesivir.
Seniors Becoming Less Interested in Getting COVID Vaccine Boosters
Older Americans are most likely to have received the initial COVID-19 vaccines but their interest in boosters appears to be declining. According to the CDC, about 71% of seniors received the first recommended booster, but only 44% received the second.
And a Kaiser Family Foundation survey published last month found only 8% of seniors said they had received the updated bivalent booster which became available in September, though almost half said they planned to.
Yet a significant number of seniors said they hadn’t heard about the newest booster and didn’t know it was recommended for them.
Extremely Low Booster Rates Suggest NYC Area Has No COVID Cares Left to Give
The updated COVID-19 booster vaccines don’t seem to be at the forefront of people’s minds — even as the autumn surge creeps toward the U.S. It’s hard even to find how many people are taking the shots.
As of Monday morning, neither the COVID-19 dashboards for New York City nor New Jersey were displaying the numbers of bivalent boosters, which are designed to fight newer coronavirus variants. That’s despite the bivalents becoming the go-to booster for anyone over the age of 12 nearly two months ago, on Sept. 2.
This data is valuable because it can help convey how much general interest there is in the shots — and what areas might be at-risk as new variants emerge. Its absence also speaks to a larger trend of people not really knowing if they should care about COVID-19 anymore, health experts said.
Cory Franklin: The Key to Unlocking the Mysteries of COVID Is Understanding Immunity
Among the many medical puzzles about COVID-19 that continue to confound experts: Why does one spouse contract COVID-19 while in many cases the other does not? Why does the African continent have far fewer COVID-19 cases and deaths per capita than the other continents? Why does Singapore have more COVID-19 cases per capita than the U.S. but less than one-tenth the per capita death rate? What protects you better from future COVID-19 infection, previous infection or vaccination?
The real key to demystifying the COVID-19 pandemic is immunity — explaining why some individuals are able to resist infection, while others are susceptible and still others are especially vulnerable. Unfortunately, even our best immunologists have little more than a rudimentary understanding of how immunity in COVID-19 works.
Immunity is basically how the body defends itself from germs, and it is a complicated phenomenon. We are born with certain types of immunity, we acquire some immunity through vaccination and some is developed through exposure to various infectious agents.
One theory about why Africa has been relatively protected from COVID-19 is the outdoor population’s greater exposure to germs — the so-called hygiene hypothesis. The lower mortality from COVID-19 in East Asia may be the result of contact with earlier COVID-19-related coronaviruses in these countries, which would have conferred some protective immunity.
First on CNN: Most People Feel Socially Connected as COVID Precautions Ease, but Many Still Need Support, Survey Finds
Lots of research has been done on links between loneliness, social connection, health and well-being, but a new international survey by the analytics firm Gallup and Facebook’s parent company, Meta, aims to shed some light on exactly how connected people feel and how they connect with others.
They found that most people around the world feel a sense of social connection as COVID-19 precautions ease, but many still need support or help from others — and the factors that drive feelings of connection vary by country.
The report is a glimpse into how people have adapted to pandemic-related changes, said Telli Davoodi, a senior social science researcher at Gallup and lead researcher on the project.
A majority of respondents in each country said they felt “very” or “fairly” emotionally connected to others, especially in Egypt, where nearly 9 out of 10 people said they felt connected. Sense of connection was lowest in Brazil (53%), while the U.S. landed in the middle (75%). However, at least a third of respondents in each country said that they had needed support or help from someone “often” or “sometimes” in the previous month.
Stay Fit & Your COVID Shot May Work Even Better
U.S. News & World Report reported:
The more often you work out, the more effective your COVID-19 vaccination will be, a new study suggests. Fully vaccinated folks who clocked high weekly levels of physical activity were nearly three times less likely to land in the hospital with COVID, compared to those who got the jab but didn’t exercise often, researchers found.
Participants were placed in three different physical activity categories — high, medium or low — based on the average weekly amount they worked out during the two years prior to the start of the study. The research team then tracked the outcomes of those who contracted COVID.
High-level exercisers who got more than 150 minutes of physical activity every week were 86% less likely to have a case of COVID contracted following their vaccination land them in the hospital, researchers found. Likewise, people who averaged 60 to 149 minutes of physical activity weekly — the medium category — had a 72% reduced risk of hospitalization from COVID.
But the vaccine was only 60% effective in those with the lowest levels of exercise, under 60 minutes a week, researchers found. It’s not clear why physical activity might enhance COVID vaccination, the researchers wrote.
COVID Vaccine Study Links Side Effects With Greater Antibody Response
People who reported experiencing side effects to the Pfizer/BioNTech and Moderna COVID-19 vaccines such as fever, chills or muscle pain tended to have a greater antibody response following vaccination, according to new research.
Having such symptoms after vaccination is associated with greater antibody responses compared with having only pain or rash at the injection site or no symptoms at all, suggests the paper published Friday in the journal JAMA Network Open.
