With COVID-19 a fading worry and no longer a national or state emergency, the Food and Drug Administration made significant changes Tuesday in its vaccine authorization, eliminating the original formula, shifting to mostly 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 was 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 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.
The new guidance was eagerly anticipated by Dr. Bob Wachter, who chairs the University of California-San Francisco’s medical department. A recent New England Journal of Medicine study convinced him that people his age would benefit from another booster.
“As a healthy 65 year old, I’ve been on the fence about getting another boost before fall, particularly in setting of fairly low case rates,” Wachter tweeted April 13, before the FDA’s approval. “These results — a significant drop in efficacy vs. severe infection by 6 months — will push me to get another boost now if FDA approves it.”
But the FDA overhaul 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 authorizes COVID-19 vaccine boosters only for those age 75 or older, those living in elder care homes or those age 5 and up with weakened immunity. Canada allows boosters for those age 5 and up. Germany recommends boosters for those age 12 and up.
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.
But that’s largely because most people by now have been vaccinated, infected or both, and reported trend lines at the CDC for infections, hospitalizations and deaths are all heading downward. Deaths nationally have fallen from more than 500 a day in January to fewer than 200 a day.
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, a variant that spreads super easily but hasn’t proven as virulent as earlier strains, 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 protect from 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.”