Pfizer says it plans to meet with top United States health officials on Monday to discuss the drugmaker’s request for federal authorisation of a third dose of its COVID-19 vaccine, as President Joe Biden’s chief medical adviser Anthony Fauci acknowledged that “it is entirely conceivable, maybe likely” that booster shots will be needed.
The company said it was scheduled to have the meeting with the Food and Drug Administration (FDA) and other officials on Monday, days after Pfizer asserted that booster shots would be needed within 12 months.
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Pfizer’s Dr Mikael Dolsten told The Associated Press last week that early data from the company’s booster study suggests people’s antibody levels jump five to 10-fold after a third dose, compared with their second dose months earlier – evidence it believes supports the need for a booster.
On Sunday, Fauci did not rule out the possibility but said it was too soon for the government to recommend another shot. He said the Centers for Disease Control and Prevention (CDC) and the FDA did the right thing last week by pushing back against Pfizer’s assertion with their statement that they did not view booster shots as necessary “at this time”.
Fauci said clinical studies and laboratory data have yet to fully bear out the need for a booster to the current two-shot Pfizer and Moderna vaccines or the one-shot Johnson & Johnson regimen.
“Right now, given the data and the information we have, we do not need to give people a third shot,” he said. “That doesn’t mean we stop there … There are studies being done now, ongoing as we speak, about looking at the feasibility about if and when we should be boosting people.”
He said it was quite possible in the coming months “as data evolves” that the government may urge a booster based on such factors as age and underlying medical conditions.
“Certainly it is entirely conceivable, maybe likely at some time, we will need a boost,″ Fauci said.
Other leading vaccine experts questioned Pfizer’s rationale and said that more data was needed to justify a booster, especially as many countries struggle to administer the initial vaccine doses needed to protect their citizens.
“It’s disappointing that with such a complicated decision they took such a unilateral approach,” Larry Corey, a virologist at Seattle’s Fred Hutchinson Cancer Research Center who is overseeing US-government backed COVID-19 vaccine trials, told Reuters news agency.
Monday’s planned meeting between Pfizer and US health officials was first reported by The Washington Post.
Currently only about 48 percent of the US population is fully vaccinated. Some parts of the country have far lower immunisation rates, and in those places, the Delta variant is surging.
Last week, Rochelle Walensky, the CDC director, said that is leading to “two truths”: highly immunised swaths of the US are getting back to normal, while hospitalisations are rising in other places.
Fauci said it was inexplicable that some Americans are so resistant to getting a vaccine when scientific data show how effective it is in staving off COVID-19 infections and hospitalisations, and he was dismayed by efforts to block making vaccinations more accessible, such as Biden’s suggestion of door-to-door outreach.
Governor Asa Hutchinson of Arkansas agreed on Sunday that there is vaccine resistance in southern and rural states like his because “you have that more conservative approach, scepticism about government”.
Describing his efforts to boost vaccinations in his state, which is seeing rising infections, Hutchinson said “no one wants an agent knocking on a door,” but “we do want those that do not have access otherwise to make sure they know about it”.
The grassroots component of the federal vaccination campaign has been in operation since April, when supplies of shots began outpacing demand. It was outlined and funded by Congress in the $1.9 trillion COVID-19 relief bill passed in March and overwhelmingly is carried out by local officials and private-sector workers and volunteers.
Republican representative Adam Kinzinger from Illinois blasted opposition to vaccination efforts from some GOP lawmakers as “absolute insanity”. He said House Republican leader Kevin McCarthy of California and others in the party need to speak out against “these absolute clown politicians playing on your vaccine fears for their own selfish gain”.