WASHINGTON – Pfizer and BioNTech asked federal regulators Tuesday to approve their coronavirus booster vaccination for anyone ages 18 and older, a move that would likely call any adult in America into question for an additional injection.
The Food and Drug Administration is expected to approve the motion, possibly before Thanksgiving and well before Christmas trips and gatherings. The prospect that all 181 million fully vaccinated adults in the country will have access to additional vaccinations is a turning point in two months, as an FDA advisory council. recommended overwhelmingly against Pfizer-BioNTech’s motion to allow booster vaccinations for all adult recipients of this vaccine.
At the time, several committee members expressed doubts as to whether young, healthy people need boosters. But the Biden government has been keen to offer extra shots since August when President Biden announced that “the best way to protect ourselves” is to give every adult a booster shot.
Mr Biden originally wanted Americans to start the refresher in late September, but the start of the campaign was delayed after regulators insisted they needed more time to review the safety and effectiveness data. Some global public health experts said it was better to focus on getting initial vaccinations in poorer countries with low vaccination rates than distributing extra vaccinations here so quickly.
If regulators approve Pfizer’s motion, President Biden will have honored his promise to offer a booster shot to every adult – though the choice for many would be limited to Pfizer’s vaccine.
Currently, only those 65 years of age and older and adults at special risk due to illness or where they live or work can receive booster injections if they have first received Pfizer-BioNTech or Moderna’s vaccine. The FDA has approved boosters for all Johnson & Johnson recipients because this vaccine offers less protection. People can choose which of the three vaccines they want for their additional vaccination.
Almost 25 million Americans have received boosters to date, including people with immunodeficiency who were eligible in August. That’s about 14 percent of people fully vaccinated, a number that could rise sharply if all other adults are eligible for a Pfizer BioNTech booster. While the entitlement categories are quite broad, it is estimated that at least 30 to 40 percent of vaccinated adults are still excluded.
Moderna is expected to file its own application with the FDA shortly to expand eligibility for its booster. Some experts predict the agency may approve wider use of Moderna’s booster but may exclude young men amid concerns about a rare disease related to the vaccine that appears to affect them disproportionately. The condition known as myocarditis is inflammation of the heart muscle.
Some countries in Europe have already approved booster syringes for all adults; Israel offers them to everyone aged 12 and over. On Tuesday, Canadian officials approved a booster dose of the Pfizer BioNTech vaccine for anyone over the age of 18.
In the United States, experts are divided over the need for a booster vaccination for the entire population. Many say the vaccines continue to offer robust protection against serious illness and hospitalization, especially for younger people with no previous illnesses.
There is virtually unanimous agreement that vaccinating the roughly 60 million Americans over the age of 11 who have not even received their first vaccination should remain the government’s top priority.
For younger, healthy people, the benefits of a booster injection will be marginal, according to Dr. Eric Rubin, FDA Advisory Board member and Associate Professor of Immunology at Harvard TH Chan School of Public Health.
Even so, some leading experts argue that the case for booster shots has grown stronger. Dr. Nahid Bhadelia, director of the Boston University Center for Emerging Infectious Diseases Policy and Research, said “there is now some stronger data” than in September when the FDA adviser rejected Pfizer’s original proposal.
She added, “I think the boosters now look like they could help prevent serious illnesses in a lot more people than we thought before.”
Dr. Rubin said he was reassured by the fact that when Israel began vaccinating young people, “really didn’t see any significant safety signals.”
Earlier this month, Dr. Anthony S. Fauci, the federal government’s foremost infectious disease expert, said the latest data from Israel shows its aggressive booster campaign has limited serious illness, hospitalization and death rates there. He called the results “pretty dramatic”.
Federal officials have been closely monitoring the Israeli experience because the vaccination campaign has got off to a quick start and the country has a nationalized health system that allows for easier monitoring of results than the United States.
An Israeli study published in The Lancet in late October compared about 730,000 people who received a booster dose in August or September with people who had received only two doses of the Pfizer BioNTech vaccine at least five months earlier. The study included recipients aged 12 and over; the average age was 52 years.
Compared to recipients with two doses, recipients with a booster had a 93 percent lower risk of hospitalization, a 92 percent lower risk of serious illness, and an 81 percent lower risk of death, the study found. The boosted recipients were examined between a week and almost two months after their third dose.
Pfizer and BioNTech said their request was based on data from a clinical trial in the US and elsewhere that included more than 10,000 volunteers. They said the third injection counteracted the vaccine’s diminishing effectiveness over time. After the third vaccination, the vaccine’s effectiveness against symptomatic diseases was up to 95 percent, they said.
The FDA has the power to change Pfizer-BioNTech’s current emergency approval and is not expected to convene its advisory panel again. Dr. Rubin said he was okay with that.
“The FDA has a keen sense of what the panel was concerned about and they are now in a good position to make their own judgment,” he said.
Moderna could follow suit with a request similar to Pfizer’s. However, obtaining approval can be more complicated due to concerns about rare cases of myocarditis, especially in men under 30 who have received two doses of Moderna’s vaccine. Similar concerns have been expressed about the Pfizer BioNTech vaccine, but to a lesser extent.
If regulators approve Pfizer’s application, it would, to some extent, only officially condone what health officials say they are already occurring frequently. Many Americans seem to get a booster shot whether or not they are officially eligible, so sticking to complicated claim categories may be pointless, some officials said.
“A move like this – if backed by the data I haven’t seen – is an acknowledgment of that reality,” said Dr. Nirav D. Shah, Maine’s Chief Health Officer and President of the Association of State and Area Health Officials.
“Provided the data shows the boost is worth it, this is a good move,” he said.