FDA delays action on youngster vaccines
Advisory panel meeting rescheduled pending results from 3-shot dose study. CDC study shows protection from boosters weakens after 3-4 months. New monoclonal antibody cleared to treat omicron.
At least three major updates today, on children’s vaccines, treatments for omicron, and booster shot protection.
Vaccines for kids under 5
I was expecting to share a summary of the data on the Pfizer COVID-19 vaccine for children 6 months - 4 years today, but the FDA surprised many of us by abruptly postponing next week’s advisory panel review of this data. Instead, the committee will meet March 3.
Previously, Pfizer said that a two-dose regimen for young children appeared to be safe but was not sufficiently effective against COVID-19, so it was continuing its clinical study to test whether a three-dose regimen worked better.
Among other things, this delay means that children under 5 won’t have any COVID-19 vaccination options until March - at the earliest.
Booster protection wanes
Multiple studies from the CDC out this week reinforce confidence that the vaccines remain safe and largely effective. However, one large study found that protection against severe disease dropped considerably over time among people who had received booster doses. The efficacy remains higher than vaccines against many other illnesses, however, so they still appear to work.
But the numbers are concerning: “Among recipients of 3 doses, (vaccine efficacy) against COVID-19–associated hospitalizations declined from 91% among those vaccinated within the past 2 months to 78% among those vaccinated ≥4 months earlier (p<0.001).”
Effectiveness at preventing illness needing emergency treatment was lower — 66% in the third and fourth month and estimated at 31% five months or later. Note that this data was based on emergency department visits, so it doesn’t separate patients who had other or underlying medical conditions.
For a somewhat different interpretation, here’s the CDC news release.
Related news: The Johnson & Johnson vaccine has an overall efficacy of about 60% and the protection lasts six months or longer, according to a paper in the New England Journal of Medicine reporting the final results of the J&J clinical trials. In the United States, efficacy was closer to 70%, and the one-shot J&J vaccine was 75% effective and preventing severe illness or death from the delta variant.
FDA clears new monoclonal antibody
The FDA Friday gave emergency use authorization for bebtelovimab, a monoclonal antibody made by Lilly, for the treatment of mild to moderate COVID-19 in high-risk adults and children.
Useful
The CDC published a tool to calculate ventilation needed to prevent the spread of COVID-19.
Protecting ourselves
Several states and communities are dropping mask requirements and other prevention strategies, instead, they are relying on individuals to take their own actions. They also are acting before the CDC has published updated guidance on mask use. No doubt CDC experts feel burned after prematurely lifting masking guidance right before the delta wave last year.
My own opinion is that relaxing some of the “mandates” is reasonable in communities that have achieved such a high level of vaccination that they have few new hospitalizations or deaths from COVID-19 and a small number of vulnerable people. But relaxing requirements for people to get vaccinated seems counterproductive, especially since the USA’s horrifying death toll (over 914,000 deaths to-date,) is directly related to the refusal of millions to get vaccinated.
As the omicron wave subsides, the pandemic is not over. There is real concern about a new subvariant already spreading in the USA. And, in Asia, where COVID-19 precautions appeared to be taken very seriously, new surges occurred across the continent after Lunar New Year celebrations.
Based on current circumstances, the CDC estimates that the USA will record as many as 978,000 deaths by March 15. Those who remain unvaccinated are 15 times more likely to die.
