Pfizer scheduled to discuss vaccine booster with U.S. officials

Pfizer says it plans to meet with top U.S. health officials Monday to discuss the drugmaker’s request for federal authorization of a third dose of its COVID-19 vaccine as President Joe Biden’s chief medical adviser 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 and other officials Monday, days after Pfizer asserted that booster shots would be needed within 12 months.

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 to their second dose months earlier—evidence it believes supports the need for a booster.

On Sunday, Dr. Anthony Fauci didn’t 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 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.

Currently only about 48% of the U.S. population is fully vaccinated. Some parts of the country have far lower immunization rates, and in those places the delta variant is surging. Last week, Dr. Rochelle Walensky, the CDC director, said that’s leading to “two truths”—highly immunized swaths of America are getting back to normal while hospitalizations 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 hospitalizations, and he was dismayed by efforts to block making vaccinations more accessible, such as Biden’s suggestion of door-to-door outreach.

Gov. Asa Hutchinson, R-Ark., agreed Sunday that there is a vaccine resistance in Southern and rural states like his because “you have that more conservative approach, skepticism 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.

Rep. Adam Kinzinger, R-Ill., 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.”

Fauci appeared on CNN’s “State of the Union,” ABC’s “This Week” and CBS’ “Face the Nation”; Hutchinson spoke on ABC, and Kinzinger was on CNN.

The debate about a booster shot comes as global anxiety rises about the spread of the highly transmissible delta variant, which has become the most prevalent strain in the United States.

Pfizer has publicly cited data from Israel showing that its vaccine remains effective against the delta variant in preventing hospitalizations and serious illness but has declining effectiveness at preventing milder cases. The company is most focused on whether boosters are needed for the elderly and most vulnerable.

Pfizer said it has its own data showing that immunity against the coronavirus declines in vaccinated people over time, particularly in the elderly, but some scientists and health officials have cautioned that only the company has seen that data so far. The company will share the data with the FDA.

Those invited to the upcoming briefing include Anthony S. Fauci, President Biden’s chief medical adviser and director of the 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 the Food and Drug Administration; David Kessler, chief science officer for the covid-19 response; and Vivek Murthy, the surgeon general. It is not yet clear who will attend. The meeting is scheduled for Monday, though that could change.

U.S. officials said they have not seen persuasive data clearly indicating boosters will be needed and are waiting to see whether Pfizer will have new or additional data that makes a compelling case. There is also concern that discussion of boosters could impact vaccine hesitancy, though two officials stressed that was not the main issue in deciding whether to recommend that some Americans receive a third shot.

Fauci told CNN on Friday that Pfizer CEO Albert Bourla called him to apologize for not alerting the U.S. government that it planned to seek authorization for a third shot of its vaccine.

Several senior health officials said they think it will probably be appropriate to recommend boosters for the elderly and the most vulnerable, such as those who are immunocompromised, but stressed there will be a public process to make such an evaluation, according to two senior administration officials.

An advisory panel to the CDC, called the Advisory Committee on Immunization Practices, will evaluate Pfizer’s data if the FDA authorizes Pfizer’s booster shot and recommend who should receive it, as the panel has done for several other health decisions related to coronavirus vaccines.

That panel heard a detailed presentation last month on what is known about the need for boosters and the questions that will need to be answered as authorities assess whether the United States is going to need additional doses in the future. Among the questions: Will boosters be needed, and if so, are they needed for everyone, or only in specific populations? What is the optimal timing, and can they be given as a “mixed dose,” or do they need to be matched with the original series of shots?

The FDA and the CDC advisory group will require data on safety, the immune response generated by boosters and public health, said Sara Oliver, a CDC official who is part of the advisory committee’s COVID-19 work group.

The work group recommended that booster doses begin only after evidence of declining vaccine effectiveness against illnesses and signs that variants substantially affected vaccine protection. Oliver said there were no data to support recommendations for booster doses at the moment but that CDC is continuing to monitor vaccine effectiveness and the risk of variants.

Top health officials are still trying to understand the clinical significance of declining immunity in older people who have been vaccinated and whether that justifies administering a third shot.

Pfizer officials have begun to worry that data out of Israel showing declining effectiveness could cause some people to believe its vaccine is not effective. They have also grown concerned there could be outbreaks in nursing homes and among other vulnerable populations as the delta variant surges in the United States, and have worried about waiting too long to administer boosters, according to a person familiar with some of the discussions.

Receiving an emergency authorization from the FDA, and then a recommendation from the Advisory Committee on Immunization Practices, would probably take months. Pfizer officials are anxious that the process will take too long if U.S. officials do not take action soon.

Some scientists and health experts have said Pfizer stands to benefit financially from the administration of booster shots and said the company sparked confusion with its Thursday announcement.

All the pharmaceutical companies involved in making coronavirus vaccines are working on formulating and testing booster shots to prepare for the possibility that immunity fades or a new variant capable of totally escaping vaccines emerges, steps that experts agree are prudent and wise.

Some other countries have already laid out plans to begin administering booster shots. In the United Kingdom, the National Health Service has outlined plans for booster shots to begin in September, targeted first to groups that include people who are immunosuppressed, people older than 70 and front-line health-care workers. Eventually, its boosters will be offered to people older than 50 and adults at high risk. Israeli health officials are still considering whether to offer booster shots.