FDA approves Novavax's updated COVID-19 vaccine

Aug. 31 (UPI) -- A third COVID-19 vaccine will be available shortly as Novavax joins Pfizer/BioNTech and Moderna in targeting variants that are now circulating.

The U.S. Food and Drug Administration on Friday authorized the updated version of the protein-based Novavax Covid-19 vaccine for use in people 12 and older.

One week ago , the FDA approved the updated versions for Pfizer/BioNTech and Moderna, an mRAN. They are now available in some pharmacies.

All these vaccines include a monovalent, or single, component that corresponds to the Omicron variant JN.1 strain of SARS-CoV-2.

"The COVID-19 vaccines have had a tremendous positive impact on public health and vaccination continues to be the most effective method for COVID-19 prevention," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a news release . "COVID-19 continues to be a very real risk for many people, and we encourage individuals to consider getting an updated COVID-19 vaccine when eligible.

"Today's authorization provides an additional COVID-19 vaccine option that meets the FDA's standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization."

Individuals 12 years of age and older who have never been vaccinated with any COVID-19 vaccine are eligible to receive two doses three weeks apart of Novavax.

One dose is allowed for those who have been vaccinated only with one dose of any of the manufacturers' doses. For Novavax, it is three weeks after the last dose and for the two others it is at least two months.

On June 5 , an FDA advisory panel recommended updating the formula for COVID-19 vaccines.

"Today's authorization enables Novavax to launch our updated COVID-19 vaccine in the U.S. in pre-filled syringes, and we have worked hard to ensure consumers have access in thousands of locations nationwide," President and Chief Executive Officer John C. Jacobs said in a news release .

The FDA says vaccines will need to be assessed annually, like for seasonal influenza vaccines. The last update was in September 2023.

Earlier this month, Health and Human Services announced a national campaign to increase public awareness of common respiratory viruses and available vaccines. Health officials said they hope the campaign, called "Risk Less. Do More," will reduce serious illnesses from the flu, COVID-19, and respiratory syncytial viruses in high-risk populations, as well as limit the spread of the virus in the United States.

KP.3.1.1 was the dominant strain and accounts for between 31% and 43% of clinical specimens for two weeks ending Aug. 17 compared with 20% to 30% for the two-week period ending Aug. 3, according to the CDC .

"COVID-19 activity is elevated nationally, with continued increases in many areas and early signs of decline in others," the CDC reported on Friday .

The CDC no longer tracks cases but examines SARS-CoV-2 levels in sewage, and limited data from hospitals and states. Cases now are hard to track because most people get tests at home and the results are not reported to state health agencies.

In the last cases update from the CDC on May 11, 2023, there were more than 103 million infections with more than 1.1 million deaths.

Levels of the virus measured in wastewater are at "very high" levels nationally, according to CDC data , sparking the highest summer peak in the United States since July 2022. A map of the United States, last updated Thursday, lists different levels.

The only "low" level is in Michigan. Everywhere else is "high" or "very high" though no data was from obtained from Arizona, North Dakota, Utah as well as Guam and U.S. Virgin Islands.

About 22.5% of U.S. adults received the latest round of shots that rolled out last fall, according to the CDC in May .

The FDA issued Emergency Use Authorization for the Pfizer-BioNTech vaccine on Dec. 11, 2020, and for the Moderna vaccine on Dec. 18, 2020 for those 18 and older.

Novavax was approved June 7, 2022 for those 18 and older.