pfizer to meet with u s on boosters which officials say arent needed now
pfizer to meet with u s on boosters which officials say arent needed now

Pfizer to Meet With U.S. on Boosters, Which Officials Say Aren’t Needed Now

Representatives of Pfizer are expected to meet with top U.S. scientists on Monday to make a case for eventual federal authorization of coronavirus vaccine booster shots, even as top health officials say the extra doses are not necessary at this time, according to two White House officials.

Pfizer and its German partner BioNTech announced last week that they were developing a version of their coronavirus vaccine that targets Delta, a highly contagious variant, and reported promising results from studies of people who received a third dose of the original vaccine. The companies said in a news release that booster doses may be needed to fend off virus variants.

The data are not yet published or peer-reviewed, but the companies said that they would submit results to the Food and Drug Administration for eventual authorization of booster shots — an announcement that caught the Biden administration by surprise. Dr. Anthony S. Fauci, President Biden’s top medical adviser for the pandemic, later told Wolf Blitzer of CNN that the Pfizer’s chief executive, Albert Bourla, called him to apologize for not giving Dr. Fauci a “heads up” about the recommendation.

In an unusual joint statement issued Thursday evening, hours after the Pfizer announcement, the F.D.A. and the Centers for Disease Control and Prevention pushed back.

“Americans who have been fully vaccinated do not need a booster shot at this time,” the statement said, adding, “We are prepared for booster doses if and when the science demonstrates that they are needed.”

The clash between the companies and the Biden administration, however muted, prompted Biden officials to invite Pfizer representatives to present their data to the White House, according to one of the officials, both of whom are not authorized to speak publicly.

The attendees will be a who’s who of government doctors: Dr. Fauci; Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention; Dr. Francis Collins, director of the National Institutes of Health; Dr. Vivek Murthy, the Surgeon General; Dr. Rachel Levine, the assistant secretary for health; Dr. Janet Woodcock, the acting F.D.A commissioner; and Dr. David Kessler, a former F.D.A. commissioner who is heading the Biden administration’s vaccine distribution effort, among others.

Officials from Pfizer did not immediately respond to a request for comment.

Dr. Fauci said Sunday that there was no evidence at this point that booster shots were needed for either Pfizer-BioNTech or Moderna vaccines, which require two doses, or the one-dose Johnson and Johnson vaccine.

“Right now, given the data and the information we have, we do not need to give people a third shot, a boost,” Dr. Fauci said on CNN’s “State of the Union,” though he added, “There are studies being done now ongoing as we speak about looking at the feasibility about if and when we should be boosting people.”

At least one outside infectious disease expert, Dr. Carlos Del Rio of Emory University, criticized Pfizer-BioNTech for creating confusion and staging a “publicity stunt.” He also complained about Monday’s meeting being conducted in private instead of by the C.D.C.’s advisory committee on vaccine practices, known as A.C.I.P., which will ultimately make a recommendation on whether booster shots are necessary.

“I want to see the data and I think they should present it in an A.C.I.P. session,” Dr. Del Rio said, adding, “It’s very inappropriate of the company to, first of all, announce that we’re doing this, second to say we need a booster where there’s no evidence for that.”

Since the onset of the pandemic, Pfizer-BioNTech have pursued a “get to market first” strategy in manufacturing and marketing their coronavirus vaccine.

The companies did not take federal money or participate in Operation Warp Speed, former President Donald J. Trump’s fast-track vaccine initiative. They were the not only the first to win F.D.A. authorization for their coronavirus vaccine, the first to use novel mRNA technology, but also the first to gain authorization for their vaccine’s use in adolescents.

The strategy has “paid off as handsomely as anyone could ask for,” said Steve Brozak, president of WBB Securities, a research investment bank focused on biotechnology.

Slightly more than two-thirds of American adults — 67.6 percent — have had at least one Covid-19 shot, according to the C.D.C. That figure falls short of the Biden administration’s goals; the president had hoped to have 70 percent of adults at least partially vaccinated by July 4.

Still, the national vaccination campaign has made clear that the vaccine succeeds at preventing disease, and studies suggest that vaccines remain effective against the Delta variant. Outbreaks are occurring in areas with low rates of vaccination, and the national caseload has ticked up recently; according to a New York Times database.

With so many people still hesitant, persuading people to get booster shots may be tough. “At this point the most important booster we need is to get people vaccinated,” Dr. Del Rio said.

World Health Organization officials emphasized on Monday the importance of prioritizing resources for global vaccine production and distribution over the development of boosters in light of the stark gap between vaccination programs in different countries.

“It’s not to say one or the other, it’s putting things in a crisis in order,” said Dr. Michael Ryan, the executive director of the W.H.O. Health Emergencies Program, in reference to addressing what the organization calls a two-tier pandemic.

Lauren McCarthy contributed reporting.