FDA announces key meetings on kid Covid-19 vaccines, Moderna and J&J boosters
The meetings set up a rough timeline for a slate of FDA decisions that could help the country avoid a damaging winter surge — and ultimately help bring the pandemic to an end. The FDA advisory committee meeting is normally the final step before the agency issues a formal decision on authorizing or approving a shot. While FDA is not bound by its advisory committee’s decisions, it normally follows them.
Background: Booster shots have been a contentious topic among President Joe Biden’s top health advisers and health experts outside of the government. In August, top administration health officials endorsed a plan to roll boosters out to most adults starting in late September. FDA and the Centers for Disease Control and Prevention ultimately authorized a more limited booster plan for the Pfizer vaccine after objections from their staff, their external advisory committees and other health experts.
Now, leaders of the administration’s Covid-19 response are debating what the goal of booster shots should be. Some feel that the additional shots for all will be necessary to avoid surges in cases through the chilly fall and winter months, as people head indoors and gather for holidays. Others argue that because boosters won’t protect everyone from mild to moderate Covid-19, they should only be given to those like the elderly whose protection from serious illness and death is waning over time, based on currently available data.
Many scientists also view vaccinating children as a key step to ending the pandemic, especially with school districts around the country back to in-person instruction this academic year. On Friday, California Gov. Gavin Newsom announced that he would mandate that all students receive a vaccine as soon as they are fully approved by FDA.
“We know from our vast experience with other pediatric vaccines that children are not small adults, and we will conduct a comprehensive evaluation of clinical trial data submitted in support of the safety and effectiveness of the vaccine used in a younger pediatric population,” said Janet Woodcock, FDA’s acting commissioner, in a statement.
What’s next: The advisory committee meetings will be held Oct. 14, Oct. 15 and Oct. 26. FDA will post its relevant regulatory analyses two days before each meeting.
