U.S. federal health agencies and the maker of one of the most popular COVID vaccines are publicly at odds over whether fully vaccinated people will soon need a third booster shot.
Pfizer announced Thursday it will seek Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) in August for a third dose of its COVID-19 vaccine. The drugmaker predicted those who have been fully vaccinated will need a booster shot within six to 12 months of receiving their second dose of the Pfizer vaccine.
But hours later, the U.S. Department of Health and Human Services (HHS) issued a joint statement by the FDA and Centers for Disease and Control and Prevention (CDC) saying, “Americans who have been fully vaccinated do not need a booster shot at this time.”
The statement did not explicitly mention Pfizer, but said “a science-based, rigorous process” headed by the CDC, FDA and the National Institutes of Health would determine when or whether boosters were necessary.
According to the HHS statement:
“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.”
In a statement to CNN Friday, the World Health Organization said:
“We don’t know whether booster vaccines will be needed to maintain protection against COVID-19 until additional data is collected,” adding, “limited data [is] available on how long the protection from current doses lasts, and whether an additional booster dose would be beneficial and for whom.”
Scientists “applauded the statement” from HHS, The Washington Post reported, saying boosters were not imminent and the science isn’t clear on if or when they will be needed.
“My opinion right now … is that current vaccination seems to be largely ‘holding,’” said E. John Wherry, an immunologist at the University of Pennsylvania’s Perelman School of Medicine. “But the companies seem to suggest their continued follow-up of their trial patients shows concerning levels of waning of immunity. Not much of these data from the companies are publicly available yet. I agree we need as much independent data and assessment as possible on this topic.”
John P. Moore, professor of microbiology and immunology at Weill Cornell Medicine, said:
“No one is saying we’ll never need a booster, but to say we need it now and give the public the impression the vaccines are failing and something needs to be done as a matter of urgency. … The time isn’t now. The decisions that are going to be made will be made by federal agencies.”
The HHS statement followed recommendations made June 23 by the CDC’s Advisory Committee on Immunization and Practices (ACIP). Members of the ACIP COVID-19 working group said they would recommend booster shots only if there were a demonstrated decline in efficacy — not just a waning antibody response.
Boosters may be recommended if there’s a variant that’s able to evade the vaccines, according to slides presented by Dr. Sara Oliver, a medical epidemiologist with the CDC’s National Center for Immunization and Respiratory Diseases.
Dr. Sharon Frey, ACIP member and clinical director of the Center for Vaccine Development at Saint Louis University Medical School, said:
“I would have to agree with the interpretation of the working group in the sense that there’s no data to support recommendations to support boosters at this time. There’s no evidence against declining protection at this time.”
