FDA Clears Moderna, J&J Boosters and Backs Vaccine Mixing (2)

Oct. 20, 2021, 10:59 PM

The U.S. Food and Drug Administration cleared a path for millions more Americans to receive Covid-19 vaccine booster shots, as the nation looks to bolster its defenses and prevent another virus surge.

The agency said in a statement on Wednesday that Moderna Inc. vaccine recipients 65 and over can receive a third shot, as can adults 18 and up who are at high risk of severe Covid or with frequent institutional or occupational exposure to the virus that causes the disease.

Additionally, all J&J recipients 18 and older are eligible for a booster shot at least two months after receiving their first dose.

The agency also allowed each of the available Covid vaccines to be used as a booster dose for eligible individuals following completion of a primary vaccination with a different vaccine.

WATCH: The U.S. Food and Drug Administration said Moderna Inc. vaccine recipients 65 and over can receive a third shot, and Johnson & Johnson recipients 18 and older are eligible for a booster shot at least two months after receiving their first dose.
(Source: Bloomberg)

The moves will mean the U.S. has a bigger toolkit to try to limit a potential winter virus rebound. The summer’s delta-variant fueled spike in infections helped increase urgency to make boosters available, and health officials across the U.S. are eager to forestall a rebound in cases that could cripple hospitals and disrupt work and school this winter.

FDA officials indicated they would also move quickly to expand eligibility for booster shots as more data become available or if breakthrough cases start to rise in younger adults.

“We will not hesitate to drop this age range as we see that that benefit clearly outweighs the risk,” said Peter Marks, the head of the agency’s Center for Biologics Evaluation and Research, during a media briefing following the announcement.

The clearances came after a panel of expert advisers to the FDA unanimously backed the Moderna and J&J booster regimens in two days of meetings last week. Regulators have now signed off on boosters for all three coronavirus vaccines available in the U.S.

Last month, the FDA said people 65 and over and others who are at heightened risk of severe Covid were eligible for a booster dose of the vaccine developed by Pfizer Inc. and BioNTech SE.

Moderna shares climbed 0.8% in after-hours trading in New York, while J&J shares gained 0.4% and Pfizer shares rose 0.2%. U.S.-traded shares of Germany-based BioNTech gained 0.9%.

Smaller Dose

The Moderna booster shot authorized by the FDA is half the dose that is given in the initial two-shot series, and it should be given at least six months after the initial inoculation, regulators said.

The FDA said that a single booster dose of the Pfizer vaccine may be given at least 6 months after completing the primary series to people 18 to 64 with frequent institutional or occupational exposure to the coronavirus.

In permitting mixing and matching, the FDA is allowing J&J vaccine recipients to receive an additional dose of any cleared vaccine after two months. Likewise, recipients of Moderna and Pfizer who are eligible for a booster would receive their booster, including J&J’s shot, at least six months after their initial immunization regimen.

Marks said during the call with reporters that different combinations produce different antibody levels in the short term, but it isn’t clear what that means in terms of actual long-term protection.

Seen as a convenient, effective alternative to two-shot messenger RNA vaccines, J&J’s single-shot immunization has seen far less use in the U.S., in part because it isn’t as effective. The drugmaker has also experienced manufacturing problems that limited the shot’s distribution.

The decision to allow mixing will create greater flexibility and is beneficial to global public health, Paul Stoffels, J&J’s chief scientific officer, said in a statement.

Before the Moderna and J&J booster shots can be administered, the Centers for Disease Control and Prevention’s Advisory Panel on Immunization Practices will make further recommendations about who should receive them. The panel is scheduled to discuss boosters on Thursday.

The next big milestone for the U.S. immunization effort looms next week, when the FDA advisory panel is expected to weigh Pfizer’s proposed Covid vaccine for children ages 5 to 11. If authorized, it could begin to roll out to pediatricians’ offices and drugstores as soon as next month.

(Updates with comment from FDA officials beginning in seventh paragraph)

--With assistance from Jeannie Baumann and Riley Griffin.

To contact the reporter on this story:
Robert Langreth in New York at rlangreth@bloomberg.net

To contact the editors responsible for this story:
Timothy Annett at tannett@bloomberg.net

John Lauerman

© 2021 Bloomberg L.P. All rights reserved. Used with permission.

To read more articles log in.

Learn more about a Bloomberg Law subscription.