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The meeting was widely seen as a courtesy after the two sides disagreed last week on when a coronavirus vaccine booster might be needed. This led to an unusual setback from the United States Food and Drug Administration and the United States Centers for Disease Control and Prevention, which said fully vaccinated Americans did not need boosters at this time.
“Nothing has really changed,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN’s Chris Cuomo after the meeting.
The virtual meeting on Monday night lasted for an hour as Pfizer presented data. Senior health officials were in attendance including Fauci, CDC Director Dr Rochelle Walensky, National Institutes of Health Director, Dr Francis Collins, US Surgeon General, Dr Vivek Murthy, Acting Commissioner of the FDA, Dr. Janet Woodcock, Assistant Secretary of Health Dr. Rachel Levine and the Scientific Director of the Biden Administration’s Covid-19 Response Team, Dr. David Kessler.
“The CDC and the FDA have said that based on the data we currently know, we don’t need a boost,” Fauci said.
“This is not to say that it will not change. In fact, at some point we may need to give reminders either at all levels or to certain selected groups, such as the elderly or those with dementia. ‘underlying conditions. “
Pfizer called the meeting “productive”.
“We have had a productive meeting with US public health officials on the elements of our research agenda and preliminary recall data in our ongoing trials. Pfizer and the US government both share a sense of urgency to stay ahead of the virus that causes COVID-19. , and we also agree that science will dictate the next steps in the rigorous regulatory process we still 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 our vaccine continues to provide the highest level of protection possible,” the statement said Monday. .
Separately, an HHS spokesperson told CNN the meeting was not unusual.
“Health officials are regularly briefed by manufacturers and others on the latest COVID-19 vaccine data, and today Pfizer offered to brief officials on their latest preliminary data. We appreciate the information they have shared, and officials continue to engage in a rigorous process to determine if, when and for whom a recall might 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 is not based on not exclusively on this data, “added the HHS spokesperson.
“Currently, fully immunized Americans do not need a booster. Available vaccines now offer a very high degree of protection. The administration is prepared for booster doses if and when science demonstrates that ‘they are necessary, and any recommendation from the CDC and the FDA would come after their thorough review process. “
The official added: “Officials will continue to review any new data as it becomes available and keep the public informed.”
Last week, Pfizer sparked an unusually public showdown with the FDA and CDC when it said data showed its vaccine’s effectiveness was waning and boosters would be needed within six months to a year – without providing this data to support the statement.
Pfizer said it would seek emergency use authorization for a recall from the FDA in August. Hours after this announcement, the FDA and CDC released a joint statement saying fully vaccinated Americans did not yet need a Covid-19 vaccine booster.
“The United States is fortunate in having very effective and widely available vaccines for people 12 years of age and older. Fully vaccinated people are protected against serious illness and death, including the variants currently circulating in the world. countries such as Delta, ”they said. mentionned.
Former FDA commissioner and current Pfizer board member Dr Scott Gottlieb told CBS on Sunday that it was Israel’s health ministry’s updated efficacy figures that led Pfizer to ask. an emergency use authorization for a booster dose of its Covid-19 vaccine. .
Israel’s health ministry said in a statement last week that it had seen the effectiveness of Pfizer’s vaccine drop from more than 90% to around 64% as variant B.1.617.2 or Delta spread. .
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