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US approves Novavax’s COVID-19 vaccine

Novavax’s COVID-19 vaccine. (Photo: AP)

The above recommendation was put forward in a 21-0 vote and one abstention.

Before the vote, Dr Peter Marks, the top vaccine official for the US Food and Drug Administration (FDA), said: “We approve (Novavax vaccine) to provide another option for vaccine-eligible people.

During the FDA panel discussion, Dr. Eric Rubin, editor-in-chief of the New England Journal of Medicine, said that data on vaccine against COVID-19 of Novavax is similar to that of the mRNA vaccine produced by Moderna and Pfizer-BioNTech.

According to the criteria for licensing a COVID-19 vaccine, Rubin confirmed, “it’s not difficult to make a decision now” when proposing licensing. However, Rubin said, there is currently no further data on how the Novavax vaccine works against current variants of the SARS-CoV-2 virus.

The US licensed Novavax's COVID-19 vaccine - Photo 1.

An FDA summary shows that Novavax’s COVID-19 vaccine is 90% effective in protecting against mild, moderate, and severe illness. The main study that the agency used to evaluate the effectiveness of the Novavax vaccine was conducted with about 30,000 patients in the United States and Mexico. However, data collection ended at the end of September 2021, several months before the Omicron variant was detected in the US.

The Novavax vaccine uses lab-produced copies of mutant proteins of the SARS-CoV-2 virus, not genetic code that instructs the body’s cells to make proteins that promote an immune response. In fact, both approaches have been effective against COVID-19.

There is some evidence that the Novavax vaccine can cause a rare heart attack, which has also occurred in a small number of people receiving other COVID-19 vaccines. This problem has also been noted with mRNA vaccines. However, the FDA committee concluded that the benefits of the Novavax vaccine outweigh the risks.

After this agency licensed, the Novavax vaccine could be put on the market after the US Centers for Disease Control and Prevention (CDC) confirmed it.

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