J&J and Moderna vaccine boosters in FDA pipeline and pending approval

With early COVID-19 vaccine recipients now receiving a third Pfizer booster shot and a one-half dose of the Moderna vaccine awaiting FDA approval as a booster, the U.S. Food & Drug Administration (FDA) vaccine advisory group has approved a booster dose of Johnson & Johnson (J&J) vaccine for all Americans 18 years old and older who received a single dose.

The group’s decision is nonbinding, and FDA officials will make the final decision, paving the way for Center for Disease Control and Prevention vaccine advisors to hold their recommendation discussions, slated for late October. In February the FDA granted the J&J vaccine emergency use authorization (EUA) as a single-dose product.

Unlike the booster recommendation for the two mRNA vaccines (Moderna and Pfizer-BioNTech), which targets those at highest risk, the J&J booster recommendation includes anyone who got the J&J vaccine. The booster should be given at least two months after the primary, or initial dose. About 14 million doses of the vaccine have been given in the United States.

During the group’s discussions, members said the vaccine should be considered a two-dose product, which got pushback from the Johnson & Johnson. Many experts consider the one-dose primary series as one of the vaccine’s strengths, which makes it easier to deliver, especially in hard-to-reach populations.