The meetings set a rough timeline for a number of FDA decisions that could help the country avoid a harmful winter surge – and ultimately help end the pandemic. The FDA advisory committee meeting is usually the final step before the agency makes a formal decision to approve or approve a shot. While the FDA is not bound by the decisions of its advisory committee, it usually follows them.
Background: Booster shots are a controversial topic among President Joe Biden’s top health advisors and health professionals outside of government. In August, senior administration health officials endorsed a plan to provide boosters to most adults by the end of September. The FDA and Centers for Disease Control and Prevention eventually approved a more limited booster plan for the Pfizer vaccine, following objections from their staff, their external advisory boards, and other health professionals.
Now leaders of the government’s Covid-19 response are discussing what should be the target of booster shots. Some believe that the extra shots are necessary for everyone to avoid surges in the cold fall and winter months when people go inside and gather for vacation. Others argue that boosters do not all protect against mild to moderate Covid-19 and therefore should only be given to the elderly, such as the elderly, whose protection from serious illness and death wears off over time, based on currently available data.
Many scholars also view vaccinating children as an important step in ending the pandemic, especially as school districts across the country are back to face-to-face teaching this school year. On Friday, California Governor Gavin Newsom announced that he would order that all students receive a vaccine once they are fully approved by the FDA.
“We know from our long experience with other pediatric vaccines that children are not little adults and we will conduct a full assessment of the clinical trial data provided to support the vaccine’s safety and effectiveness in a younger pediatric population,” said Janet Woodcock , acting commissioner of the FDA, in a statement.
What’s next: The Advisory Committee meetings will be held on October 14th, October 15th and October 26th. The FDA will publish its relevant regulatory analyzes two days before each meeting.