FDA Split on When or if J&J Vaccine Recipients Need Booster

The Food and Drug Administration (FDA) is split on whether and when recipients of the one-dose Johnson & Johnson COVID-19 vaccine may need a booster dose, the Associated Press reported.

Scientists who conducted an online review of the shot said that there were lapses in the data provided by J&J as well as little information on the booster's effectiveness against the highly contagious Delta variant.

The shaky evaluation comes ahead of discussions Thursday and Friday when an FDA advisory panel is scheduled to convene and ultimately recommend whether or not the Moderna and J&J vaccines need a booster dose. If it does recommend a booster for J&J, the agency will also need to decide whether recipients should get the shot two months or six months after initial vaccination.

If the FDA does give the go-ahead for the booster shots, more guidelines on their distribution will have to be laid out when they arrive at the next step in the governmental vaccine review process. The Centers for Disease Control and Prevention (CDC) will have to decide who among the U.S. population should receive them, the AP reported.

For more reporting from the Associated Press, see below.

FDA Weighs J&J Booster
The Food and Drug Administration said Wednesday that it is wrestling with whether and when recipients of the single-shot Johnson & Johnson COVID-19 vaccine need another dose — at six months or as early as two months. A pharmacist holds a vial of the Johnson & Johnson COVID-19 vaccine at a hospital in Bay Shore, N.Y. Janssen Pharmaceuticals is a division of Johnson & Johnson on Wednesday, March 3, 2021. Mark Lennihan/AP Photo

Health authorities say all the vaccines used in the U.S. continue to provide strong protection against severe disease or death from COVID-19. But amid signs that protection against milder infections may be waning, the government already has cleared booster doses of the Pfizer vaccine for certain people starting at six months after their last shot.

Aiming for uniform recommendations, Moderna likewise asked the FDA to clear its booster dose at six months. But J&J complicated the decision by proposing a second shot over a range of two to six months.

FDA reviewers wrote that a study of the two-month booster plan suggests "there may be a benefit," while pointing to only small numbers of people who got another shot at six months instead.

Overall, the J&J vaccine "still affords protection against severe COVID-19 disease and death," the FDA's reviewers concluded. But data about its effectiveness "are consistently less" than the protection seen with Pfizer and Moderna shots.

For its part, J&J filed data with the FDA from a real-world study showing its vaccine remains about 80 percent effective against hospitalizations in the U.S.

J&J's single-dose vaccine was highly anticipated for its one-and-done formulation. But its rollout was hurt by a series of troubles including manufacturing problems and some rare but serious side effects including a blood clot disorder and a neurological reaction called Guillain-Barre syndrome. In both cases, regulators decided the shot's benefits outweighed those risks.

Rival drugmakers Pfizer and Moderna have provided the vast majority of U.S. COVID-19 vaccines. More than 170 million Americans have been fully vaccinated with those companies' two-dose shots while less than 15 million Americans got the J&J shot.

J&J Vaccine Distribution
The Food and Drug Administration is split on whether and when recipients of the one-dose Johnson & Johnson COVID-19 vaccine may need a booster dose. Above, home base primary care pharmacist Erin Emonds fills five syringes with the Johnson & Johnson Covid-19 Janssen Vaccine for use in at-home vaccinations at the U.S. Department of Veterans Affairs' VA Boston Healthcare System's Jamaica Plain Medical Center in Boston, Massachusetts on March 4, 2021. Joseph Prezioso/AFP via Getty Images