With COVID-19 a fading worry, the Food and Drug Administration made significant changes Tuesday in its vaccine authorization, eliminating the original formula, shifting to favor a single dose of the updated shot and allowing new boosters for older and sicker people.
Dr. Peter Marks, who directs the FDA’s Center for Biologics Evaluation and Research, said the idea is to streamline COVID-19 vaccine guidance as the country transitions to managing the virus as an endemic or ever-present concern while spurring interest in the shots, particularly among those who are most vulnerable.
“COVID-19 continues to be a very real risk for many people,” Marks said in a statement. “The available data continue to demonstrate that vaccines prevent the most serious outcomes of COVID-19, which are severe illness, hospitalization, and death.”
The FDA’s changes are:
- The original COVID shots are no longer authorized in the U.S. That’s the Pfizer and Moderna COVID-19 messenger-RNA vaccines based on the original strain of the SARS-CoV-2 virus that emerged in Wuhan, China, in late 2019 and were given as a two-dose primary series starting in December 2020. That strain has long been replaced by a series of variants, including the current omicron.
- One shot gets you caught up. Most people who haven’t yet had a shot of the updated “bivalent” vaccine based on both the Wuhan and more recent omicron strains can now receive a single dose. That includes the 30% of Americans who didn’t get vaccinated with the two-shot primary series of the original vaccine. Children 6 months to 5 years old who are unvaccinated or who had the original vaccine can receive multiple doses of the bivalent vaccine for kids.
- Older and vulnerable adults can get another booster. If you are 65 or older and already had a dose of the bivalent vaccine, you can now get a second booster of that shot after at least four months. Those with compromised immunity who had a dose of the bivalent vaccine also may receive another shot after at least two months, and additional doses at the discretion of their doctor. Most other people who already had the bivalent shot are not eligible for another.
The bivalent boosters could become available later this week after the Centers for Disease Control and Prevention weighs in with its recommendation, which could come as early as Wednesday.
Dr. Bob Wachter, who chairs the University of California-San Francisco’s medical department, said “the FDA made a reasonable call, and it’s also reasonable to offer it to people without pushing it too hard.”
Another booster after six months should offer some short-lived protection against infection and boost protection against severe infection, which he said has waned by about half after the initial booster. He’ll urge his 87-year-old mother to get the booster, and he and his wife in their mid-60s will get it because “there is a decent chance of benefit and next-to-no risk,” but he’s fine with his 30-something kids putting it off.
“For people at low risk of a bad outcome,” Wachter said, “the additional benefit of another boost may not be worth it. For those at higher risk, it probably is.”
But the FDA’s announcement left other medical experts with questions about who besides those at high risk still needs a booster.
Dr. Paul A. Offit, director of the Vaccine Education Center at Children’s Hospital Of Philadelphia, co-inventor of a rotavirus vaccine and a member of the FDA’s vaccine advisory panel, said the good news is prior infection or vaccination still provides durable protection against severe illness from current omicron strains.
But Offit hasn’t seen convincing evidence additional doses will significantly boost protection for those who aren’t old or chronically ill.
“We’re the only country in this world that recommends a booster dose for everyone over 6 months of age,” Offit said in an interview Tuesday. “I’ve had three doses of the vaccine and an infection. I’m not going to get a booster, and I’m older than 65.”
The United Kingdom, for example, offers a seasonal COVID-19 vaccine booster if you’re age 75 or older, living in elder care homes or for those 5 and up with weakened immunity. Germany recommends a booster at 12 and up, or 5 and up with health conditions, but a second dose only for 60 and older, health workers and those with weak immunity.
Only 17% in the U.S. have had the updated bivalent booster, with the highest uptake among people 65 and older, at 43%. Among other age groups only one in five or fewer have had the bivalent booster.
The virus does continue to mutate. One new strain that the World Health Organization has been monitoring is the XBB.1.16, dubbed “Arcturus,” which has spread in India and other parts of the world and seems to cause conjunctivitis, or red and itchy eyes, in young people. That variant is now about 7% of U.S. cases, which mostly are XBB.1.5.
But all circulating strains remain in the omicron family that first emerged in November 2021, against which people’s protection against severe illness has held up, Offit said.
Marks said the FDA plans to convene its vaccine expert panel in June to discuss a possible update to the strain composition of the COVID-19 vaccines for the fall, much like it does each year for influenza shots. But Offit isn’t convinced a new formula is needed.
The omicron strains that the current bivalent booster was tailored to combat already are long gone, he said, yet the vaccines still protect against severe disease and death, unlike with the flu, where a mismatch to the circulating strain provides little protection at all.
“I think most people don’t fear this disease anymore. Right now it’s pretty reasonable to not fear this disease,” Offit said. “I’m a vaccine advocate, I’m for vaccines, but I’m not for them if it’s not clear I need them.”
