Pfizer executives briefed US federal health officials Monday about why they believe a third booster shot of its vaccine will be needed.The meeting was largely seen as a courtesy after the two sides disagreed last week on when a booster shot for the coronavirus vaccine might be necessary. That led to unusual pushback from the US Food and Drug Administration and US Centers for Disease Control and Prevention, which said fully vaccinated Americans don’t need boosters right now. The virtual meeting Monday evening lasted for an hour as Pfizer presented data.
Top health officials were present, including Fauci, CDC Director Dr. Rochelle Walensky, Director of the National Institutes of Health Dr. Francis Collins, US Surgeon General Dr. Vivek Murthy, Acting FDA Commissioner Dr. Janet Woodcock, Assistant Secretary for Health Dr. Rachel Levine and Chief Science Officer of the Biden administration’s Covid-19 response team Dr. David Kessler.”The CDC and the FDA said that based on the data that we know right now, we don’t need a boost,” Fauci said.”That doesn’t mean that that won’t change. We might need, as a matter of fact, at some time to give boosters either across the board or to certain select groups, such as the elderly or those with underlying conditions.”Pfizer called the meeting “productive.”
“We had a productive meeting with U.S. public health officials on the elements of our research program and the preliminary booster data in our ongoing trials. Both Pfizer and the U.S. government share a sense of urgency in staying ahead of the virus that causes COVID-19, and we also agree that the scientific data will dictate next steps in the rigorous regulatory process that we always follow,” the company said in a statement.Pfizer said it would be publishing “more definitive data in a peer-reviewed journal and continuing to work with regulatory authorities to ensure that our vaccine continues to offer the highest degree of protection possible,” according to Monday’s statement.Separately, a HHS spokesperson told CNN the meeting was not unusual.”Health officials are routinely briefed by manufacturers and others on the latest data on COVID-19 vaccines, and today Pfizer offered to brief officials on their latest preliminary data.
We appreciate the information they shared, and officials continue to engage in a science-based rigorous process to consider whether, when, or for whom a booster might be necessary,” the spokesperson said. “As CDC and FDA said last week, 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,” the HHS spokesperson added.”At this time, fully vaccinated Americansdo not need a booster shot. The vaccines available now offer a very high degree of protection. The administration is prepared for booster doses if and when the science demonstrates that they are needed, and any recommendation by CDC and FDA would come after their thorough review process.
“Pfizer says it's time for a Covid booster; FDA and CDC say not so fast Pfizer says it’s time for a Covid booster; FDA and CDC say not so fastThe official added, “Officials will continue to review any new data as it becomes available and will keep the public informed.”Last week, Pfizer set off an unusually public confrontation with the FDA and CDC when it said data showed the efficacy of its vaccine was waning and boosters would be needed within six months to a year — without providing that data to back up the statement.Pfizer said it would seek emergency use authorization for a booster from the FDA in August. Hours after that announcement, FDA and CDC issued a joint statement saying that fully vaccinated Americans do not yet need a Covid-19 vaccine booster.
“The United States is fortunate to have highly effective vaccines that are widely available for those aged 12 and up. People are protected from severe disease and death, including from the variants in the country such as Delta,” they said.