Experts urge single vaccine formula for all

Recommendation by FDA experts would retire the original COVID shot with updated formula

The original COVID-19 vaccine formula introduced in December 2020 should be retired and replaced entirely with the updated mix tailored to recent virus variants, an FDA expert panel has urged in a unanimous vote.

The Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee was asked to consider whether to recommend a single vaccine composition for all situations, the socalled bivalent formula based both on the original virus strain and the more recent omicron BA.4/5 strains.

“This isn't only a convenience thing to increase the number of people vaccinated, which is extremely important,” said Dr. Hayley Gans, pediatrics professor at Stanford University Medical Center, during Thursday's panel discussion. “But also I think moving toward the strains that are circulating is important.”

But the coronavirus's ever-evolving mutations make that difficult. Even the strains the updated booster shot was designed to protect against are rapidly vanishing. The Centers for Disease Control and Prevention indicates that the omicron BA.4 variant is no longer circulating and that BA.5 only represents about 2% of cases nationally, edged out by XBB.1.15, which now accounts for about half of infections.

“I do think it's important to get closer to the circulating strains,” said Dr. Paul Offit, a pediatrics professor at Children's Hospital of Philadelphia.

It was unclear how soon the FDA might put the committee's recommendation into action.

The move comes as a succession of omicron variants of the virus that causes COVID-19 continues to infect the vaccinated, boosted and unvaccinated, but hospitalizations and deaths haven't soared as they did in past winter waves of infection since the virus emerged three years ago, in early 2020.

Last year, the FDA experts urged new booster shots based on both the original virus strain that emerged in Wuhan, China, and some of the newer omicron virus variants, known as BA.4 and BA.5.

But that updated formula was only recommended for boosters to goose the immune response for the already vaccinated. Those who had not been vaccinated had to get the original vaccine, based on a now-extinct strain. Health officials said the original vaccine still showed strong protection against severe illness.

Experts have said low vaccination rates since then suggest the strategy wasn't popular. Currently, 61% of Americans and 75% of Californians have had the primary, twodose COVID-19 vaccination. But only 15% nationally and 18% in California have had the single, updated booster shot unveiled last fall.

Others on the panel questioned the need for vaccines to combat infections that don't produce symptoms.

“You can certainly make the argument an asymptomatic infection is desirable,” said Dr. Cody Meissner, a pediatrics professor at Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire, adding it will “act as its own boost.”

“We certainly want to stop the virus from circulating,” Meissner said. “But that's probably not going to be possible. The virus is always going to mutate and evolve and find ways to avoid the immunity humans build up.”

During the open comment period, several people told the panel they had suffered severe side effects from the vaccines and felt the agency was downplaying the risks.

Angie Bluford, who said she's a 49-year-old mother from Wilmington, North Carolina, said she got the Moderna vaccine in April 2021 “to protect my family,” thinking she was “doing the right thing,” and that she felt ill the next day, with headaches, shortness of breath and other symptoms.

“My body is a shell of what it once was,” she said. “Please hear us and help us.”

Dr. Tom Shimabukuro of the CDC's immunization safety office said the agency has robust safety monitoring systems in place and is aware of the reports, but that none has risen to a level that would warrant a change in the vaccine and booster recommendations.

He added that the CDC is still investigating indications of a possible elevated stroke risk in older people that appeared in one of several safety monitoring networks and not others.

“The public and the medical community should be confident that the government has systems in place to rapidly detect safety problems,” Shimabukuro said. “We are aware of these reports of people experiencing long-lasting health problems following COVID vaccination. No specific medical causes for the symptoms have been found. We will continue to monitor the safety of these vaccines.”

The panel concluded with discussions about future vaccine and booster schedules and dosages but made no recommendations.