Novavax expects Omicron-targeting vaccine by fourth quarter

The vaccine is currently under FDA review

Vaccine-maker Novavax said it expects to be in a position to provide an Omicron-containing vaccine in the fourth quarter of 2022. 

In a statement, Novavax wrote that it is awaiting emergency use authorization for its prototype COVID-19 vaccine, noting that clinical data demonstrate it offers immune responses against variants like the Omicron BA.4/5. 

"Novavax is already well underway in our variant program and will accelerate our focus on Omicron BA.4/5, as recommended by FDA in their guidance on June 30th.  We expect to have additional preclinical data on Omicron BA.4/5 in the late summer or fall, and expect to be in a position to provide an Omicron-containing vaccine in Q4 of this year," it said. 

A Food and Drug Administration (FDA) advisory panel recommended Novavax's shot for emergency use authorization at the beginning of June. 

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Novavax COVID vaccines in India

In this image provided by the Serum Institute of India, vials of freshly manufactured Novavax COVID-19 vaccines wait to be labeled in 2022, in Pune, India.  (Serum Institute of India for Novavax via AP / AP Newsroom)

At the end of last month, the agency said it had advised manufacturers to update their COVID-19 vaccines to add an Omicron BA.4/5 spike protein component to current vaccine composition, "so that the modified vaccines can potentially be used starting in early to mid-fall 2022."

"As we expect this coming year to be a transitional period when this modified booster vaccine may be introduced, we have not advised manufacturers to change the vaccine for primary vaccination, since a primary series with the FDA-authorized and approved COVID-19 vaccines provides a base of protection against serious outcomes of COVID-19 caused by circulating strains of SARS-CoV-2," it explained. 

A trial of a Novavax vaccine in the Philippines

This Wednesday, Oct. 7, 2020 file photo shows a vial of the Phase 3 Novavax coronavirus vaccine ready for use in a trial at St. George's University hospital in London. (AP Photo/Alastair Grant, File / AP Newsroom)

Some health officials hope that Novavax may appeal more to the millions of Americans who remain unvaccinated. 

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Novavax is a protein vaccine, a more traditional kind of shot than mRNA vaccines, and would be a top choice for boosters, regardless of which kind of vaccines Americans got first. 

The Nuvaxvoid vaccine from Novavax

FILE PHOTO: Four vials with the "Nuvaxovid" COVID-19 vaccine from Novavax are pictured in Saabruecken, Germany, February 26, 2022.  (REUTERS/Frank Simon/File Photo / Reuters)

Protein vaccines have been used for years to prevent hepatitis B, shingles and other diseases.

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The most widely used vaccines in the U.S. are made by Pfizer and Moderna, which use mRNA to deliver genetic instructions for immune system to produce its own copies of the spike protein that is found on the surface of the virus that causes COVID-19. 

FOX Business' Paul Best and The Associated Press contributed to this report.