Sumary of FDA remains skeptical about booster shots despite new Pfizer data suggesting efficacy declines:
- The U.S. Food and Drug Administration (FDA) remains skeptical of COVID-19 vaccine booster shots ahead of an advisory committee meeting on Friday despite Pfizer-BioNTech releasing new data suggesting the need for them.
- The Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet at the end of the week to discuss data on potential third doses.
- Members will vote on whether or not booster doses are safe and effective and if they should be approved for all Americans.
- New data from Pfizer published on Wednesday suggests that efficacy of the regular two-dose regimen declines from 96.2 percent to 83.7 percent after six months, but that a booster dose increased immune responses.
- Documents ahead of an FDA advisory committee about COVID-19 vaccine booster shots were published on Wednesday.
- At the time, Pfizer said its early data suggested people who received booster doses between six and 12 months after their final dose had high levels of protection.
- The company filed for emergency use authorization for booster doses in late August and submitted data, made public on Wednesday.
- emerging data suggest that vaccine protection may wane approximately six to eight months following the second dose, and evidence is building to suggest that administration of booster doses of COVID-19 mRNA vaccines is potentially an urgent emerging public health issue,’ the authors wrote.