Yearly COVID shot may be needed as virus becomes ‘new normal,’ FDA officials say
A yearly COVID-19 shot may be needed — just as flu shots are recommended each year — as living with the virus becomes the “new normal,” according to Food and Drug Administration officials.
“It will likely circulate globally for the foreseeable future, taking its place alongside other common respiratory viruses such as influenza,” three FDA officials wrote in an article published to the peer-reviewed journal JAMA on May 2.
As a result, “society is moving toward a new normal that may well include annual COVID-19 vaccination alongside seasonal influenza vaccination.”
The article’s authors include Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research; Dr. Janet Woodcock, the FDA’s principal deputy commissioner; and Dr. Robert Califf, the commissioner of food and drugs.
They wrote that an update to the COVID-19 vaccines’ makeup will be considered and likely discussed each year by the FDA’s Vaccines and Related Biological Products Advisory Committee given how the virus is likely to continually spread.
“By summer, decisions will need to be made for the 2022-2023 season about who should be eligible for vaccination with additional boosters and regarding vaccine composition,” the officials wrote.
This means that the composition of vaccines available in the U.S. might be adjusted soon.
To “benefit” people of all ages against COVID-19 and its variants, a first potential update to COVID-19 vaccines will need to be decided ahead of fall and winter based on the variants circulating, according to Marks, Woodcock and Califf.
“This is because the variant(s) covered by the vaccine may have an important influence on both the extent and duration of protection against a future SARS-CoV-2 variant(s) that may circulate,” they wrote.
Currently, the omicron variant and its subvariants — including BA.2 and BA.2.12.1 — dominate U.S. cases as of the week ending April 30, according to Centers for Disease Control and Prevention data estimates.
“In the event of a major fall or winter wave, a vaccine with optimal variant coverage might facilitate significant reductions in lost productivity and health care utilization from both acute and chronic complications of COVID-19,” the FDA officials said.
The FDA’s vaccine advisory committee recently met, and it was agreed that a “single vaccine composition used by all manufacturers was desirable,” according to the article, adding that clinical data would be considered beforehand.
Marks, Woodcock and Califf emphasized that the current vaccines to date are “reasonably good at protecting severe outcomes” when it comes to sickness but an update to them may achieve better protection against variants.
Three potential risks for the US
The FDA officials mentioned three potential factors that might put the U.S. population at risk for COVID-19 during fall and winter, especially for unvaccinated individuals, in the article.
They include “(1) waning immunity from prior vaccine or prior infection, (2) further evolution of SARS-CoV-2, and (3) seasonality of respiratory virus infection, waves of which are generally more severe in the fall to winter months when individuals move their activities indoors,” Marks, Woodcock and Califf wrote.
Their paper comes as COVID-19 deaths in the U.S. have nearly reached 1 million as of May 5, according to Johns Hopkins University. In the past 28 days, more than 12,000 people in the U.S. have died.
New cases increased by roughly 25% nationwide as of April 27 compared to the prior week’s average, according to the CDC.
This story was originally published May 5, 2022 at 2:05 PM with the headline "Yearly COVID shot may be needed as virus becomes ‘new normal,’ FDA officials say."
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