FDA Says What on COVID-19 Shots?

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Some Americans cannot receive another COVID-19 vaccine dose, U.S. regulators said on April 18, as they made sweeping changes to the vaccine system.

The U.S. Food and Drug Administration (FDA) announced the changes, including replacing the old Pfizer and Moderna vaccines with updated bivalent shots that had previously only been available as boosters.

Regulators are also scaling back the number of recommended doses for most individuals, including people who haven’t received a shot.

Key changes include:

Most unvaccinated Americans are still being encouraged to get a COVID-19 vaccine but only need a single dose of a bivalent, the FDA said. The exception is young children. Children aged 6 months through 5 years can receive two doses of Moderna’s bivalent while those aged 6 months through 4 years can get three doses of Pfizer’s bivalent.
Americans who have received a primary series of a COVID-19 vaccine and one of the bivalent boosters still cannot get an additional dose, unless they’re in certain groups.
Any individual 65 years old or older can receive a bivalent dose, even if they’ve already received one, provided four months or more has elapsed since their last shot.
People aged 5 and older and deemed immune compromised can get another bivalent at least two months after their last shot, even if it was a bivalent, and can get additional doses “at the discretion of, and at intervals determined by, their healthcare provider.”
Little Data to Support Bivalents
The FDA authorized the original vaccines in late 2020 based on clinical trial efficacy data. The original vaccines targeted the Wuhan virus strain, which hasn’t circulated since 2020.

The updated bivalents target the Wuhan strain and the BA.4 and BA.5 subvariants of the Omicron strain. The subvariants were displaced in 2022.

Regulators authorized the bivalents as boosters in 2022 despite no clinical trial data being available. In letters formally announcing the bivalents as replacing the old vaccines, the FDA made clear that scientists aren’t sure whether the bivalents protect against COVID-19.

“Based on the totality of the scientific evidence available, FDA concluded that it is reasonable to believe that Pfizer-BioNTech COVID‑19 Vaccine, Bivalent may be effective in individuals 6 months of age and older for the prevention of COVID-19,” the letter to Pfizer states. The same language was used for Moderna’s shot.

Most of the data supporting Pfizer’s expanded authorization comes from the old vaccines and a bivalent that has never been used in the United States. The only trial data for the available bivalent showed that children had higher levels of neutralizing antibodies when they received a bivalent. Antibodies are thought to protect against COVID-19.

No clinical trial data for Moderna’s shot was cited, and no efficacy data was cited for either vaccine.

Dr. Peter Marks, a top FDA vaccine official, claimed in a briefing that “the available data continue [to] demonstrate that vaccines prevent all serious outcomes from COVID-19, including hospitalization and death.” It’s not clear which data he was citing, and the FDA did not respond to a request for comment.

The FDA cited a single observational study in its letter to Pfizer. English researchers reported in The Lancet that vaccination with an old vaccine in addition to previous infection provided strong protection against symptomatic COVID-19 through March 2022. Other research has found that prior infection alone is as good as or better than vaccination.

Other observational studies have found the updated vaccines provide transient protection against hospitalization and poor protection against infection.

Seroprevalence data indicates a majority of Americans have recovered from COVID-19, the FDA noted. That’s an important acknowledgement, Dr. Monica Gandhi, a professor of medicine at the University of California–San Francisco, told The Epoch Times in an email.

Gandhi said she agrees that only the elderly and immune suppressed should receive another dose, as opposed to the entire population. Dr. Harvey Risch, professor emeritus of epidemiology at the Yale School of Public Health, said that he sees the vaccines as largely unnecessary.

“The current vaccines are out-of-date, any new ones will be out-of-date by the time they are generally available, and mostly everybody already has SARS-CoV-2 antibodies anyway,” Risch told The Epoch Times via email. “At this point, the vaccines are thus not generally useful products for serving a public health function.”

Change Made to Boost Uptake
Uptake of the vaccines was high after they were authorized, but has dropped considerably since. Just 16.7 percent of the U.S. population has received a bivalent shot, compared to 69.4 percent who received a primary series of the old vaccine.

FDA officials said the changes announced on April 18 were made to simplify the vaccine composition, reduce the complexity of the available doses, and increase uptake.

“This approach will help us achieve higher vaccination coverage across the country,” Marks told reporters. “If anything comes out of this action, we’re hoping that it can encourage people who have not received the bivalent booster to go out and consider getting one.”

The newly rolled out system is for the spring, as officials are planning to meet over the summer to discuss a fall regimen. They plan to adapt COVID-19 vaccines to the influenza model, updating strains in the vaccines each year.

Advisers to the agency backed the pivot to bivalents in a January discussion. Some said they favor updating the strains in the future.

Correction: A previous version of this article incorrectly spelled Dr. Gandhi’s name. The Epoch Times regrets the error.