FDA advisory committee recommends a monovalent COVID booster

Hello again to a monovalent COVID-19 vaccine. Goodbye to the bivalent shot.

That was the message Thursday from an FDA advisory committee, which decided unanimously that COVID vaccines this fall should not provide coverage against the original, wild-type coronavirus and that protection only is needed against an XBB strain.

Aside from the 21-0 vote, there was little agreement on many of the other matters discussed by the Vaccines and Related Biological Products Advisory Committee, which gave no clear-cut recommendations on when shots should be provided and who should get them.

Those questions are likely to be answered next Friday when the Centers for Disease Control and Prevention (CDC) hold their advisory committee meeting. Additionally, the FDA will decide whether to accept yesterday’s advisory committee recommendation.

During Thursday’s meeting, representatives from vaccine manufacturers said they could have vaccines ready within the next few months. Pfizer said it could be ready to launch by the end of next month. Moderna expects its updated doses to be ready for shipment by the end of the summer.

Novavax, the lone company providing non-mRNA vaccines in the United States, will have its shot ready “during the fall vaccination campaign,” it said in a release.

Vaccines provided by the companies will be tweaked to defend specifically against the XBB.1.5 subvariant and will provide protection against the other circulating subvariants.

“Novavax data showed that its XBB.1.5 COVID vaccine candidate induced functional immune responses for XBB.1.5, XBB.1.16 and XBB.2.3 variants, indicating a broad response that could potentially be applicable for forward-drift variants,” the company said in its statement.

The advisory committee recommendation is consistent with a directive last month from the World Health Organization, which has recommended that new COVID-19 boosters target XBB subvariants.

Also noted during the advisory committee meeting was that it is possible that the FDA would return to a bivalent COVID vaccine in the future and that most recent COVID deaths have been among those older than 75.

There also is considerable uncertainty that fall is the best time for booster shots. Over the last three years, the virus has shown little seasonality.