US regulators will no longer approve Covid booster shots for healthy adults and children without new studies, adding a costly requirement for drugmakers, though they will still be available for millions of high-risk Americans.
Food and Drug Administration Commissioner Marty Makary and Vinay Prasad, who leads the agency’s vaccine division, outlined the approach they intend to take with updated versions of the immunizations in an article published Tuesday in the New England Journal of Medicine.
The agency’s willingness to continue making the shots available for high-risk people with a wide range of health conditions was a relief to the industry, which feared a wave of restrictions from President Donald Trump’s political appointees who questioned the vaccines. Investors were buoyed as the new policy doesn’t require the costly trials for older adults who are more likely to get vaccinated.
Moderna Inc.’s shares rose 6.1% as of 2:51 p.m. in New York. Pfizer Inc. gained 1.9% and Novavax Inc. fell 1.6%.
Jefferies analyst Michael Yee said the announcement “actually eases some investor concern.” Bloomberg Intelligence analyst Sam Fazeli added that the FDA guidance “may be a silver lining” for Covid vaccine makers because it could increase use of the shots given how many people are considered high risk.
Covid vaccination rates have been in decline, with just 23% of US adults getting the latest booster, according to the Centers for Disease Control and Prevention.
The article also offered a favorable take on how the agency’s leaders are thinking broadly about vaccines, even as their boss, Health and Human Services Secretary Robert F. Kennedy Jr., has criticized the shots. Makary and Prasad praised them in general, and immunizations for measles specifically, amid an ongoing outbreak that’s led to more than 1,000 infections and three deaths this year.
Required Research
Typically with seasonal vaccines like the flu, drugmakers are able to introduce new formulas designed to match the mutating virus based on simple tests that show they generate a strong immune response. These faster reviews follow initial approvals based on rigorous trials proving the shots are safe and reduce the risk of infection and death.
Going forward, the FDA expects drugmakers to do full studies before it approves updated immunizations for those six months to 64 years old without health issues that put them at high risk, Makary and Prasad wrote. Shots for the elderly and those with health risks, a group they say encompasses between 100 million and 200 million Americans, will be cleared using the current approach that doesn’t require extensive studies.
Companies likely won’t need to do new trials every year, Prasad said during an FDA town hall on Tuesday. Rather, he said they will probably be needed when “the virus really changes.”
“We have an obligation every few years — or however long that may be — to generate credible evidence for the American people, to clarify that we know where we stand,” Prasad said.
The rigorous trials, which involve testing against a placebo, are typically considered unethical when a vaccine already exists because it involves withholding proven protection and potentially exposing people to preventable illness. Manufacturers have also worried that it may be difficult to do comprehensive studies in time to make shots available when a new strain begins circulating.
The range of high-risk conditions that will allow for vaccine use without additional studies is broad, including people who are obese and have mental health conditions like depression, the FDA officials wrote.
It’s unclear if drug companies would do the trials to get broader approval. Moderna and Novavax didn’t immediately respond to requests for comment. Pfizer is evaluating the new policy and is having ongoing discussions with the agency, a spokesperson said. The company believes “broad vaccination programs are an essential tool for helping to prevent COVID-19-associated hospitalizations and severe disease, including death,” the spokesman said.
New Direction
Changes in who gets Covid vaccinations have been looming for some time. While the shots currently are recommended for everyone aged six months and older, a group of CDC advisers is debating whether they should only be offered to high-risk children and adults. Such a move would make it even less attractive for companies to do the additional studies.
The FDA is changing its approach in part because the benefits of repeat Covid shots — particularly among low-risk people who may have already gotten boosters or been infected by the virus multiple times — is uncertain, Makary and Prasad wrote.
The FDA’s new policy “represents a balance of regulatory flexibility and a commitment to gold-standard science,” they said. “The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk.”
The FDA has already started to limit who can get Covid shots. Last week the agency gave full approval to a Covid vaccine from Novavax, but for a narrower group that includes adults 65 and older and those ages 12-to-64 who have at least one underlying condition. The agency also required the company to conduct additional safety trials, including evaluating the risk of myocarditis, or inflammation of the heart muscle.
Moderna, meanwhile, is currently awaiting an FDA decision on a new version of its Covid vaccine. The article didn’t address the company’s situation. –BLOOMBERG
The post US will no longer approve Covid boosters for healthy kids, adults without new trials appeared first on The Malaysian Reserve.
