As the more transmissible Omicron variant threatens to disrupt daily life in the country well into the winter and as school districts in Democratic-led states scale back efforts to mandate students get vaccine to not get ahead of regulators, the decisions come.
The FDA needed to quickly adapt to the evolving virus that causes Covid-19 and use the best available science to make informed decisions, according to acting FDA Commissioner Janet Woodcock. With the current wave of the omicron variant, it's critical that we continue to take effective, life-saving preventative measures such as primary vaccination and boosters, mask wearing and social distancing in order to effectively fight Covid-19.
The CEO and co-founder of BioNTech said that it was important to offer all eligible individuals a booster in the current situation.
According to news reports, the advisory committee on vaccines is expected to make a decision on whether to recommend the shots for the youngest teens this week. The meeting is scheduled for Wednesday.
The FDA and CDC expanded booster access to 16- and 17-year-olds due to Omicron's rapid rise.
Increasing the number of teenagers in school in January may increase their protection against Covid as winter weather makes most Americans indoors, where the coronaviruses can spread more easily. The way Omicron has spread across the country has convinced some experts that the widespread boosting strategy is a good idea.
Concerns about exposing otherwise healthy young people to myocarditis, an inflammatory heart condition and rare side effect of the messenger RNA vaccines like Pfizer's, have prompted some medical experts to urge caution in permitting additional doses for children with scant safety data. Teens and adults under the age of 30 are most at risk of developing the condition.
The FDA believes that the risk of myocarditis after a booster dose is a third of that after the second dose in the primary series, and that the three-week interval between first and second shots along with the biological markers in older male teens may contribute to their risk.
The risk of myocarditis with third doses in the 12- to-15-year age range is likely to be quite acceptable given the potential benefits, and the idea here is that we are willing to use data to look at it closely and make inferences in this case.
The emergency use authorization update was based on published and unpublished studies and real-world evidence from Israel, which has been boosting teenage citizens for months.
Israeli teens have been given over five million booster doses after their primary series. More than 6,300 teens ages 12 to 15 who received a booster when eligibility was expanded have no reported cases of myocarditis or pericarditis.
It is difficult to identify a rare side effect in a few thousand subjects in a clinical trial.
Marks pointed to the spike in Omicron cases over the holidays as the reason why the FDA didn't convene its vaccine advisory committee.
He said it made sense to move as quickly as possible.
A booster dose for children with conditions like diabetes or obese should be made available to them, according to a member of the advisory committee.
He said that more antibodies is better. Every parent will have to decide if she believes the benefit of a booster dose in a perfectly healthy child who doesn't have asthma. She has to decide if the benefit outweighs the risk.
Paul Offit, director of the Vaccine Education Center at the Children's Hospital of Philadelphia, said that a booster shot will protect you from mild illness caused by Omicron for three to four months.
He said that boosting is not going to have a big impact on the Pandemic because it is a disease of the unvaccinated. I feel like we've given up on the unvaccinated.
