WASHINGTON – The FDA said Wednesday that it is grappling with the question of when recipients of Johnson & Johnson’s single-dose COVID-19 vaccine will need another dose in six or two months.
In an online review, FDA scientists did not come to a firm conclusion, citing flaws in J&J data, including little information on protection against the extra-infectious delta variant of the coronavirus.
The review is taking place ahead of Thursday and Friday meetings when an FDA advisory panel will recommend whether J&J and Moderna booster doses should be maintained. This is part of the government’s vaccine review process: next week the FDA will make a final decision on approving these boosters, and then the Centers for Disease Control and Prevention will discuss who should actually get them.
Health authorities say all vaccines used in the U.S. continue to provide robust protection against serious illness or death from COVID-19. But amid signs that protection against milder infections may be chilling, the government has already approved booster doses of Pfizer vaccine for certain people starting six months after their last vaccination.
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Seeking a uniform recommendation, Moderna also asked the FDA to withdraw the booster dose after six months. But J&J complicated this decision by offering a second shoot for a period of two to six months.
FDA reviewers wrote that the study on the two-month booster plan suggests “there may be benefits,” but points to only a small number of people who instead got another shot six months later.
Overall, the J&J vaccine “continues to provide protection against severe illness and death from COVID-19,” the FDA reviewers concluded. But the data on its effectiveness is “consistently less” than on the protection seen with the shots of Pfizer and Moderna.
For its part, J&J has filed data with the FDA from a real study showing that its vaccine remains approximately 80% effective against US hospitalizations.
J&J’s single-use vaccine was expected due to its single-use formulation. But its deployment was thwarted by a number of issues, including manufacturing problems and some rare but serious side effects, including thrombotic disorders and a neurological reaction called Guillain-Barré syndrome. In both cases, regulators decided that the benefits of vaccination outweighed these risks.
Rival drug manufacturers Pfizer and Moderna have provided the vast majority of COVID-19 vaccines in the United States. More than 170 million Americans have been fully vaccinated with the two-dose vaccines from these companies, while less than 15 million Americans have received the J&J vaccine.
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