The meeting was largely seen as a courtesy after the two sides disagreed last week about when a booster shot for the coronavirus vaccine might be needed. That led to an unusual withdrawal from the US Food and Drug Administration and the US Centers for Disease Control and Prevention, which said fully vaccinated Americans don’t need boosters at this time.
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Monday night’s virtual meeting lasted an hour as Pfizer presented data. Top health officials attended, 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 we know now, we don’t need a boost,” Fauci said.
“That doesn’t mean that won’t change. Maybe at some point we need to give boosters, either across the board or to certain select groups, such as the elderly or people with underlying conditions.”
Pfizer called the meeting “productive.”
“We had a productive meeting with U.S. public health officials about the elements of our research program and preliminary booster data in our ongoing investigations. Both Pfizer and the U.S. government share a sense of urgency to stay ahead of the virus that causes COVID-19, and we also agree that the scientific data will dictate the next steps in the rigorous regulatory process we always follow,” the company said in a statement.
Pfizer said it would “publish more definitive data in a peer-reviewed journal and continue to work with regulatory authorities to ensure that our vaccine continues to provide the highest possible level of protection,” the statement said on Monday.
Separately, an HHS spokesperson told CNN that the encounter was not unusual.
“Health officials are routinely informed by manufacturers and others about the latest data on COVID-19 vaccines, and today Pfizer offered to update officials with their latest preliminary data. We appreciate the information they have shared, and officials continue to engage with a science-based rigorous process to consider whether, when and for whom a booster may be needed,” the spokesperson said.
“As the CDC and FDA said last week, this process takes into account lab data, clinical trial data, and cohort data — which may include data from specific drug companies, but don’t rely solely on that data,” the HHS spokesperson added.
“Right now, fully vaccinated Americans do not need a booster injection. The vaccines that are available now offer a very high level of protection. The administration is prepared for booster doses as and when science shows they are needed, and any recommendation from CDC and FDA would come after their thorough review process.”
The official added: “Officials will continue to review new data as it becomes available and will keep the public informed.”
Last week, Pfizer began an unusually public showdown with the FDA and CDC when it said data showed its vaccine’s effectiveness was declining 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 FDA approval to use a booster 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 individuals 12 years of age and older. Fully vaccinated people are protected from serious illness and death, including those currently circulating in the country such as Delta,” they say. said.
On Sunday, Dr. Scott Gottlieb, former FDA commissioner and current board member at Pfizer, told CBS that it was updated efficacy numbers from the Israeli Ministry of Health that prompted Pfizer to request emergency use approval for a booster dose of its Covid-19 vaccine.
Israel’s health ministry said in a statement last week that it had seen the efficacy of Pfizer’s vaccine drop from more than 90% to about 64% as the B.1,617.2 or Delta variant spread.
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