COVID vaccines

At the start of year four of the pandemic — year three of the Covid vaccination program — the FDA is trying to chart a future path.

The J&J vaccine was the product of a bold — and ultimately ill-fated — move by the company to try to produce a Covid vaccine that could be given in a single dose. [benched](https://www.statnews.com/2021/12/16/cdc-advisory-panel-concerned-about-rare-side-effects-tied-to-jj-vaccine-gives-preferential-nod-to-mrna-shots/) the J&J vaccine, saying it should only be given to people who cannot or will not take one of the other vaccines, which at the time were the messenger RNA vaccines made by Pfizer and Moderna. The answer, according to data presented by Heather Scobie of the CDC, is that older people are most likely to be hospitalized and to die, but that there is also an increase in the number of hospitalizations of infants who have not yet been vaccinated. (The Moderna vaccine is given as a two-dose regimen for young children.) The FDA documents released before the meeting did not include a justification for why Pfizer’s three-dose pediatric vaccine could now be given as a two-dose series. Those who received the bivalent booster are also less likely to die from Covid than those who have received only the primary vaccine series — that is, the original two doses. Remember: As part of its effort to simplify the Covid vaccine administration schedule, the FDA is proposing that all young children get two doses of vaccine. going to be setting Covid vaccine update policy for the world, effectively, if it entrenches a system of choosing new strains for the vaccine every June for use in the fall? Importantly, it used a BA.1 booster, not the BA.4/BA.5 booster that was used in the U.S. In documents the FDA made public before the meeting, it proposed choosing new vaccine strains in June for a vaccine campaign that would begin in September. Instead of one vaccine for first timers, containing only a single strain of the virus, and another for people being boosted, which has been updated with a more recent strain, would it be okay to have a single product to fill both functions? For example, the idea that everyone might need an annual Covid booster will not earn a unanimous “yea” vote out of this expert panel. The 19% of people who haven’t had a single dose of Covid vaccine are unlikely to roll up their sleeves.

The Vaccines and Related Biological Products Advisory Committee meets Thursday to consider how to update guidelines for COVID-19 booster shots.

Flu is typically less lethal in years when the match between the virus and the vaccine is good. The FDA is proposing a committee that would recommend variants for annual vaccines, typically in June. With the flu, an expert panel meets every spring to pick four strains to target with that fall's vaccine. The Masimo Foundation does not provide editorial input. BA.4 is virtually gone and the original virus hasn't been seen for more than a year. Just since Halloween, the dominant variant in the United States has A similar process exists to address new, particularly dangerous flu strains. BA.5 was the prevailing variant in the U.S. last summer when FDA chose the composition of the shot, though it Giving everyone the same type of shot will simplify the options. "That's the hope. Carlos del Rio, president of the Infectious Disease Society of America, on Tuesday during a call with media.

A panel of independent experts that advises the US Food and Drug Administration on its vaccine decisions will hold a full day of meetings Thursday to ...

It continues to update its evaluations with new data, but the agency said that it seems to be a statistical fluke and that no changes to vaccination recommendations are warranted at this time. The CDC and the FDA said this month that they had detected a potential safety signal with the Pfizer boosters. The idea is that most people would be urged to get an updated Covid-19 shot once a year, the same way they do for influenza. [Sign up here to get The Results Are In with Dr. So the FDA’s advisers are expected to vote Thursday on whether the US should be offering just one type of Covid-19 shot for both the primary and booster doses. So last year, in consultation with its vaccine advisers, the FDA decided that it was time to update the vaccines.

Documents released earlier this week compared the agency's desired approach to the annual flu immunization effort. As it stands now, anyone getting a Covid shot ...

What is the effectiveness of the vaccine in the face of these variants? They will also hear from the National Institutes of Health on the development of next-generation vaccines. The FDA isn’t obligated to follow their recommendations, but it typically does. Not long after the booster shots were rolled out in September, new variants were on the rise. “I don’t think that we can chase after every new variant that comes along because the virus is changing so much,” said committee member Stanley Perlman, professor of immunology at the University of Iowa who sits on the FDA panel. The message has come through loud and clear that Americans have already had enough of frequent Covid shots.