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Pfizer officials informed U.S. health officials on Monday of preliminary data regarding the need for a third injection of the company’s COVID-19 vaccine, but the Biden administration said its position had not changed according to which a booster injection was not currently required.
The meeting comes after Pfizer made some waves last week when it said it would seek approval from the Food and Drug Administration (FDA) for a third injection of its COVID-19 vaccine. The FDA and the Centers for Disease Control and Prevention (CDC) pushed back hours later in a rare joint statement saying a recall was not needed at this time.
On Monday, Pfizer officials informed health officials in the Biden administration of preliminary data, which is not public, that the company used to determine that a recall is necessary.
But a spokesperson for the Department of Health and Human Services (HHS) said following the meeting that there were no short-term changes in government guidance and that a recall was not currently not needed.
“We appreciate the information they have shared, and officials continue to embark on a rigorous, science-based process to determine if, when and for whom a recall might be needed,” the HHS spokesperson said. .
“At this time, Americans who are fully vaccinated do not need a booster,” the spokesperson added. “The vaccines available now offer a very high degree of protection. The administration is prepared for the booster doses if and when science shows they are necessary, and any recommendation from the CDC and FDA would come after their process of boostering. officials will continue to review any new data as it becomes available and keep the public informed. “
Administration officials have stressed that while Pfizer’s data may be part of the decision of whether a recall is ultimately necessary, they will consider a range of evidence in making the decision.
Yet U.S. officials are not saying booster shots will never be needed, just that there is no evidence yet that they are currently needed.
Pfizer said in a statement that the meeting was “productive” and that it would publish “more definitive data” in a peer-reviewed journal in the future.
“We have had a productive meeting with US public health officials on elements of our research agenda and preliminary recall data in our ongoing trials,” Pfizer said. “Pfizer and the US government share a sense of urgency to stay ahead of the virus that causes COVID-19, and we also agree that the science will dictate the next steps in the rigorous regulatory process we still follow.”
World Health Organization officials rejected Pfizer’s call for booster injections earlier on Monday, saying vulnerable people around the world are still waiting for their first two injections and should be the priority before residents of the rich countries only receive a third injection.
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