U.S. CDC Advisers Back Novavax COVID Vaccine For Adults

Advisers to the U.S. Centers for Disease Control and Prevention (CDC) on Tuesday voted unanimously to recommend use of Novavax Inc's COVID-19 vaccine for individuals aged 18 and above.

The shot has been endorsed by the CDC's Advisory Committee on Immunization Practices (ACIP). CDC Director Rochelle Walensky still needs to sign off on the recommendations before the vaccine can be made available in the United States.

The U.S. government has secured 3.2 million Novavax vaccine doses. Novavax said in an emailed statement on Tuesday that the FDA had cleared the first lot of its doses for release, and it expects to ship doses for the U.S. government to distribute in the coming days.

The vaccine was authorized by the U.S. Food and Drug Administration last week as a two-dose primary vaccination series, becoming the fourth COVID shot to be authorized for use in adults in the United States.

Novavax hopes its protein-based shot can reach wider acceptance among vaccine skeptics, because it uses an older technology than the messenger RNA vaccines. Protein-based vaccines have been used for decades to combat diseases including hepatitis B and influenza.

More than 77% of U.S. adults have been fully vaccinated with shots from Moderna Inc, Pfizer-BioNTech, or Johnson & Johnson.

With the Novavax shots, "we really need to focus on that population with the hope that (the new shot) will change them over from being unvaccinated," Dr Oliver Brooke, one of the ACIP voting members said.

In a 30,000 participant clinical trial conducted before the emergence of the vaccine-evasive Omicron variant, the two-dose vaccine was around 90% effective at preventing illness from COVID.

In July, Novavax said the vaccine shows broad immune response to currently circulating variants, including Omicron subvariants BA.4/5.

Serum Institute of India, company's manufacturing partner, received FDA approval last week to export the vaccine to the country.

The Novavax shot has been available in Europe since December, but there has not been significant demand for it there. More than 13 million doses of the vaccine have been distributed around the EU, but only around 250,000 doses of the vaccine have been administered there.

Last week, the European Medicines Agency identified severe allergic reactions as potential side effects of the shot while the U.S. product label warns against administering the shot to people with a history of allergic reactions to any components of the shot.

Novavax has been testing updated vaccine based on the first BA.1 Omicron variant and expects it to be available by the fourth quarter.

The company has also accelerated development of shots to protect against the BA.4 and BA.5 subvariants and expects additional preclinical data on such in late summer or fall.