FDA approves ‘updated boosters’ to fight COVID-19 omicron variants

Federal health leaders hope physicians will join the chorus advocating for people to get COVID-19 booster shots to protect against a possible fall surge of the virus.

U.S. Food and Drug Administration (FDA) on Aug. 31 amended its emergency use authorizations for bivalent COVID-19 vaccines by Moderna and Pfizer-BioNTech for use as booster doses for people at least two months after their primary or booster vaccinations. The bivalent vaccines contain two messenger RNA (mRNA) components, one to fight the omicron variants BA.4 and BA.5 joined with the original strain of SARS-CoV-2.

The current COVID-19 surge is waning, but models predict another peaking around Dec. 1, when people are spending more time indoors, FDA Commissioner Robert M. Califf, MD, told reporters in an online press conference held Aug. 31. He was joined by Peter Marks, MD, PhD, FDA’s director biologics evaluation and research.

“I want to make clear that these updated boosters present us with an opportunity to get ahead of the next predicated wave of COVID-19,” Califf said. “These updated boosters are critical in helping protect teens and adults from the most serious outcomes of COVID-19 caused by the currently circulating variant.”

They spoke on the same day new government figures showed U.S. life expectancy from birth dropped again in 2021, to an average of 76.1 years, with COVID-19 and the opioid epidemic major factors. Citing the U.S. Centers for Disease Control and Prevention, Califf said data show people up to date on their COVID-19 vaccines have lower risk of death.

“As a clinician then I urge all individuals to consider receiving a booster and encourage other practitioners to speak to their patients about the importance of these boosters,” he said.

What is the evidence?

Reporters’ questions dealt largely with recommendations on timing and the available evidence, or paucity of it, for what FDA is calling the “updated boosters.”

FDA’s announcement of the booster authorizations included data supporting the EUAs. In the online discussion, Califf bristled at the suggestion the regulators relied only on animal studies to revise the EUAs.

Several factors make the public health experts “highly confident” in the EUAs, Marks said.

• FDA and other researchers have a lot of clinical experience with mRNA vaccines since the original vaccines have been given to more than 200 million people in the United States.
• The new bivalent vaccines with the EUA, are “quite similar” to the vaccine combining the original virus strain’s mRNA with mRNA from the BA.1 omicron variant, and studied by the manufacturers.
• Data exists from nonclinical studies of the vaccines with the new EUAs.
• FDA researchers have extensive past experience with strain changes made without clinical studies, in making annual strain changes for influenza vaccines.

It’s fair for people to raise questions, Califf said, but the EUAs represent “the best consensus that we have among the experts.”

“It’s just painful to see people dying unnecessarily when there’s a free treatment that would prevent their death and you know, as a cardiologist in my career, I spent my career trying to save lives,” Califf said. “This is much more clear than anything I’ve ever seen.”

Long COVID

Apart from details about the new vaccines, Califf and Marks emphasized the importance of getting vaccinated or boosted.

For the updated boosters, data on effects in children are expected in coming months, Marks said. Some critics say the latest vaccination campaign should focus on older adults most at risk, he said.

But long COVID is real and it affects millions of people, including those in their 20s and 30s, Marks said. Califf noted when he was young, he felt invincible like other young people may feel.

“And again, I’d emphasize we’re not talking about trivial things here,” Califf said. “We’re talking about prevention of death and hospitalization as an outcome. It’s just me but I’ll also tell you I’m turning 71 next month, I will be at the front of the line at the pharmacy getting my vaccination. I’m very confident about this.”

Ages for boosters

The Moderna COVID-19 vaccine, bivalent, is authorized for use as a single booster dose in individuals 18 years of age and older. The Pfizer-BioNTech COVID-19 vaccine, bivalent, is authorized for use as a single booster dose in individuals 12 years of age and older.

With the approval, the monovalent mRNA COVID-19 vaccines are no longer authorized as booster doses for those aged aged 18 years and older for the Moderna shots and for people aged 12 years and older for the Pfizer-BioNTech vaccine. But they will remain in use as the primary vaccines for anyone aged 6 months or older, and the Pfizer-BioNTech vaccine remains authorized for a single booster dose for patients 5 through 11 years of age, at least five months after completing a primary series with the Pfizer-BioNTech COVID-19 vaccine.