Pfizer is expected to brief top U.S. government health officials in the coming days about the need for a coronavirus vaccine booster shot after an unusually public spat between the pharmaceutical giant and federal officials over whether a third shot will be necessary, according to the company and six people familiar with the plans According to six people familiar with the plans, Pfizer will brief the U.S. government’s top health officials about the need to get a coronavirus vaccine booster shot following an unusually public feud between Pfizer and federal officials regarding whether a third shot is necessary.
Pfizer and BioNTech, a German company, announced that they would seek regulatory approval for a booster in the next few weeks. This is because they believed that people would require a third dose within six to twelve months of receiving their two-shot regimen.
Top U.S. officials aren’t yet certain if boosters are necessary. The Department of Health and Human Services issued a strong rebuttal to the announcements of the companies on Thursday. It stated that Americans who are fully vaccinated don’t need booster shots at this point.
Global anxiety is rising about the spread and spread of the highly transmissible delta strain, which has now become the most common strain in the United States. This is due to ongoing concerns about vaccine hesitancy, and fairness in potentially giving Americans a third shot while much of the rest of the world has no access to vaccines.
Pfizer publicly cited Israeli data showing that the vaccine is still effective in preventing serious illnesses and hospitalizations from the delta variant, but less so for milder cases. Pfizer is most concerned about whether boosters are necessary for the elderly or most vulnerable.
Pfizer claimed it had its own data that showed that immunity to the coronavirus decreases over time in people who have been vaccinated, especially in elderly persons. However, some scientists and health officials cautioned that they only have seen the data. The FDA will receive the data.
The briefing will include Anthony S. Fauci (President Biden’s chief medical advisor and director of National Institute of Allergy and Infectious Diseases); Francis S. Collins (director of the National Institutes of Health); Rochelle Walensky (director of the Centers for Disease Control and Prevention); Janet Woodcock (acting commissioner for Food and Drug Administration); David Kessler (chief science officer for covid-19 response); and Vivek H.murthy, the surgeon-general. It is unclear who will be there. Although the meeting is set for Monday, it could change.
People familiar with the meeting and those who spoke out about booster shots discussed the topic under the condition that they remain anonymous as they are not permitted to discuss it publicly. Numerous companies regularly briefed U.S. officials about their findings and data throughout vaccine trials.
Pfizer will present to the U.S. officials a briefing about the need to boost similar to that they gave to Europeans last Wednesday.
HHS and FDA declined comment. Pfizer representatives confirmed the meeting, but declined to give details.
Although Pfizer was not mentioned in the HHS statement, it stated that boosters would be determined by a scientific-based and rigorous process led by FDA, CDC and NIH. According to the statement, data from drug companies will only partially inform the decision. The statement highlighted that all current data show that fully vaccinated individuals are protected from severe illnesses, even the most difficult variants.
Officials from the United States stated that they haven’t seen any convincing data that boosters are needed. They wait to see if Pfizer has additional or new data that supports their claims. Two officials said that while there is concern about boosters impacting vaccine hesitancy and that they were not the primary issue in deciding whether to recommend some Americans get a third shot, that was not the main issue.
Fauci said Friday to CNN that Albert Bourla, CEO of Pfizer, called Fauci to apologize for failing to alert the U.S. government about its plans to request authorization for a third shot.
Two senior officials in the administration said that while they believe it is appropriate to recommend boosters for the elderly or the most vulnerable (e.g., those with immunocompromised), there will be a public process to do so.