A vaccine advisory panel voted Thursday to recommend that a wide swath of Americans should be offered Covid-19 vaccine booster shots, given at least six months after their second vaccination.
The Advisory Committee on Immunization Practices, or ACIP, recommended by a 15 to 0 vote that adults 65 and older should be offered booster jabs and by a vote of 13-2 that a booster dose should be offered to individuals 50-64 with underlying health conditions.
In a separate vote, the panel left the door open to 18- to 49-year-olds with underlying medical conditions obtaining a booster shot, based on an assessment of “benefit and risk,” a phrase traditionally meant to suggest a conversation between individuals and their health care providers.
The committee voted against recommending a booster to anyone 18-64 who is in an occupational or institutional setting where burden of Covid-19 infection and risk of transmission is high. A vote in favor would have cleared the way for all health care workers to get an additional dose of vaccine.
Rochelle Walensky, director of the Centers for Disease Control and Prevention, must sign off on the recommendation. She is expected to do so on Thursday, opening the door for the booster shot program to begin soon, potentially in the week that the Biden administration had set as its target.
Based on the ACIP’s recommendation, many adults will soon be able to get a Covid vaccine booster, though only people who received the Pfizer and BioNTech vaccine as their primary series are eligible to receive a booster. Nearly 100 million people in the United States have received two doses of the Pfizer vaccine.
Late Wednesday, the Food and Drug Administration issued an emergency use authorization for the Pfizer booster shot for people 65 years of age and older and a wide array of people who are at higher risk of severe Covid because of health conditions or because they have “frequent and unavoidable exposure” to the SARS-CoV-2 virus in institutional or occupational settings.
A number of ACIP members questioned whether the committee could recommend that people who received the Moderna or Johnson & Johnson vaccine should be allowed to seek a Pfizer booster. But the FDA said it had no data on which to conclude getting a third shot of another vaccine would be as effective as a third shot of one’s original vaccine.
Peter Marks, director of FDA’s vaccines division, told the committee FDA understands the frustration about not being able to give boosters at this point to people who did not get the Pfizer vaccine. The agency is working with manufacturers and will try to fill this gap as quickly as possible, he said.
While most members of the committee supported the use of boosters, several raised concerns that this step won’t fix the country’s Covid problem. Keipp Talbot, a vaccine researcher from Vanderbilt University, said hospitals are full of people with Covid-19 who aren’t vaccinated and boosting fully vaccinated people won’t change that.
“I feel like we’re putting lipstick on hogs,” she said. “This is not going to solve the pandemic.”
Thursday’s ACIP vote punctuates a rocky five-week period in which the Biden administration found itself at odds with many in the scientific community — and those who value drug and vaccine approvals playing out according to regulatory pathways.
Rather than asking the FDA and the CDC to advise it on whether it was time to make booster shots available to Americans, the administration announced a booster shot campaign would begin the week of Sept. 20. The announcement was made before any booster shots had been authorized for use — and before two of the three manufacturers had even filed an application to the FDA for approval of a booster.
Whether most fully vaccinated people need a booster shot at this point remains a point of heated debate. While data from Israel — one of the first countries to rapidly vaccinate a large portion of its population — suggests the Pfizer vaccine’s ability to protect against serious disease subsides within months, many questions remain about the interpretation of those data. And as Israel only used the Pfizer vaccine, the country’s experience tells the world nothing about other vaccines in use.
The FDA’s vaccine advisory committee, the Vaccines and Related Biological Products Advisory Committee, or VRBPAC for short, voted at a meeting last Friday not to recommend boosters for everyone 16 years of age and older who had received the Pfizer vaccine. Instead, it recommended a smaller group of individuals be offered boosters — people 65 and older and people at high risk of severe disease.
Pfizer had applied for approval of a booster that would be offered to anyone aged 16 and older, to be given six months after the second dose of vaccine.
In crafting the emergency use authorization for the Pfizer booster, the FDA used the vagueness of the VRBPAC vote to greatly increase the number of people eligible for a booster shot.
In addition to adults 65 and older, anyone 18 years of age or older who is at high risk of severe Covid because of a health condition or because their work puts them at high risk of being exposed to the SARS-CoV-2 virus can get a booster. That means people who are pregnant, have diabetes, are obese, or have a range of medical conditions like high blood pressure are eligible. Likewise health workers, teachers, day care workers, people who work in grocery stores, or who live or work in homeless shelters and prisons can receive a booster.
As interpreted by the CDC, it would also include people who live with people who are immunocompromised. Studies have shown that immunocompromised people often are not protected by two doses; in August, FDA extended the authorizations for the Pfizer and Moderna vaccines to allow severely immunocompromised people to get a booster dose. But even with a third dose, some have limited vaccine-induced protection.
There is a fair amount of overlap among these groups. Regardless, these groups could total as more than 100 million Americans — though only the portion of them who received the Pfizer vaccine will be eligible for a booster at this time.
One group that did not make the cut was 16 and 17 year olds. Pfizer’s application included no data to support the safety of giving 16 and 17 year olds a booster and members of VRBPAC objected strongly to their inclusion without safety data. In the end, the FDA did not include them.