FDA approves improved version of Novavax's COVID-19 vaccine

A medical professional administers the vaccine. Photo courtesy of Novavax.

1 week agoThe FDA approved updated versions for Pfizer/BioNTech and Moderna's mRAN. Available At some pharmacies.

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

“COVID-19 vaccines have had an enormous positive impact on public health, and vaccination remains the most effective way to prevent COVID-19,” said Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research. stated in a news release“COVID-19 remains a very real risk for many people and we encourage individuals to consider getting the most current COVID-19 vaccine when eligible.”

“Today's authorization provides a new COVID-19 vaccine option that meets the FDA's standards of safety, effectiveness and manufacturing quality required for emergency use authorization.”

Anyone aged 12 or older who has never received a COVID-19 vaccine is eligible to receive two doses of the Novavax vaccine, three weeks apart.

People who have received only one dose of any manufacturer's vaccine will be allowed to receive the first dose – three weeks after the last dose in the case of Novavax and at least two months after the last dose in the case of the other two companies.

June 5An FDA advisory committee has recommended updating the COVID-19 vaccine formulation.

“Today's approval enables Novavax to launch an improved version of our COVID-19 vaccine in prefilled syringes in the United States, and we have worked hard to make the vaccine available to consumers at thousands of locations across the country,” said John C. Jacobs, president and chief executive officer. stated in a news release.

The FDA has said the vaccine will need to be evaluated annually, similar to seasonal flu vaccines, with the last update due in September 2023.

Earlier this month, the Department of Health and Human Services announced a national campaign to increase public awareness about common respiratory viruses and available vaccines. Health officials said they hope the campaign, called “Reduce Risk, Increase Action,” will reduce severe illness from influenza, COVID-19 and respiratory syncytial virus in high-risk populations and curb the spread of the viruses in the United States.

KP.3.1.1 was the predominant strain, accounting for 31% to 43% of clinical specimens in the two weeks ending August 17, an increase from 20% to 30% in the two weeks ending August 3. According to the CDC:.

“COVID-19 activity is increasing across the country, with many regions continuing to increase and others beginning to show signs of declining,” it said. The CDC reported Friday..

The CDC is no longer tracking cases, but is looking at SARS-CoV-2 levels in wastewater and limited data from hospitals and states, which is currently difficult to track because most people are testing themselves at home and the results are not reported to state health departments.

The CDC's latest case update on May 11, 2023, puts the number of infected people at over 103 million and the death toll at over 1.1 million.

According to the CDC, levels of the virus in wastewater are at “very high” levels nationwide. dataIt was the hottest summer temperature recorded in the U.S. since July 2022. A map of the U.S., last updated Thursday, lists the different levels.

The only state with a “low” level is Michigan. All other states have “high” or “very high” levels, but no data is available for Arizona, North Dakota, Utah, Guam or the U.S. Virgin Islands.

About 22.5% of U.S. adults have received the latest round of vaccinations since they began last fall. According to the CDC in May.

The FDA issued an emergency use authorization for the Pfizer-BioNTech vaccine on December 11, 2020, and an emergency use authorization for the Moderna vaccine on December 18, 2020 for people aged 18 and older.

Novavax was approved for people aged 18 and older on June 7, 2022.