In a statement published hours after Pfizer signaled its intention to file for emergency use authorization for a COVID-19 booster shot, the FDA and Centers for Disease Control and Prevention (CDC) said fully vaccinated Americans "do not need" an extra dose at this time. The health agencies said the U.S. "is fortunate to have highly effective vaccines that are widely available" to eligible populations.
"People who are fully vaccinated are protected from severe disease and death, including from the variants currently circulating in the country such as Delta," the statement said. "People who are not vaccinated remain at risk. Virtually all COVID-19 hospitalizations and deaths are among those who are unvaccinated."
The agencies, echoing federal officials, urged Americans who have not yet received their shot to do so "as soon as possible."
Data regarding vaccine effectiveness against the Delta variant, particularly in recipients who received the one-shot Johnson & Johnson jab, has in part fueled the booster debate. However, health officials have stressed that fully vaccinated individuals have a high degree of protection, and that the true risk is for unvaccinated populations.
"Americans who have been fully vaccinated do not need a booster shot at this time," the agencies stated in Thursday. "FDA, CDC and NIH are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary. This process takes into account laboratory data, clinical trial data, and cohort data – which can include data from specific pharmaceutical companies, but does not rely on those data exclusively. We continue to review any new data as it becomes available and will keep the public informed. We are prepared for booster doses if and when the science demonstrates that they are needed."
Pfizer had announced Thursday that it would seek EUA for a booster in August. Dr. Mikael Dolsten, a Pfizer executive, told the Associated Press that early data indicated a booster saw antibody levels jump five- to tenfold following the third dose compared to the second dose given months earlier.
Even if the FDA did grant Pfizer’s booster EUA, health authorities would have to decide whether they’re really needed, Dr. William Schaffner, a vaccine expert at Vanderbilt University Medical Center, told the Associated Press, adding that it would be a "huge effort" while the country is still wrangling with getting enough first doses into people.