FDA advisers approve Novavax covid vaccine: shot

Dr. Stephen Wallace, who leads global external relations strategies for the COVID-19 prevention network at the Fred Hutchinson Cancer Research Center in Seattle, received his second injection from Dr. Tia Babu during the Novavax Vaccine Phase 3 clinical trial in February 2021.

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Dr. Stephen Wallace, who leads global external relations strategies for the COVID-19 prevention network at the Fred Hutchinson Cancer Research Center in Seattle, received his second injection from Dr. Tia Babu during the Novavax Vaccine Phase 3 clinical trial in February 2021.

Karen Dusi / Getty Images

In a 21-0 vote with a break, Food and Drug Administration advisers have recommended that the agency approve Novavax’s two-dose vaccine against COVID-19.

In a statement to the committee before the vote, Dr. Peter Marks, the FDA’s top vaccine official, said, “We are talking about providing another option for those who would not otherwise be vaccinated.”

During the panel discussion, Dr. Eric Rubin, Editor-in-Chief New England Journal of Medicine, The data for the NovaVax vaccine look a lot like the mRNA vaccine developed by Moderna and Pfizer-BioNTech.

By the same regulatory criteria, he said, recommending approval is “not such a difficult decision now.” However, he said he was disappointed that there was no further data on how the Novavax vaccine performed against current forms of the coronavirus. “We’re seeing effectiveness against strains that no longer exist,” he said.

An FDA summary found that the Novavax covid vaccine has 90% efficacy in protecting humans against mild, moderate and severe diseases. The main study the agency used to evaluate the effectiveness of the Novavax vaccine included about 30,000 patients in the United States and Mexico. But data collection was completed by the end of September 2021, a few months before the omicron was detected in the United States.

The Novavax vaccine uses a copy of the SARS-CoV-2 spike protein to instruct body cells to make proteins instead of snippets of genetic code, which induce an immune response. Both methods have been shown to be successful against COVID-19.

There is some evidence that the Novavax vaccine can cause a rare heart attack that sometimes occurs in people who receive another COVID-19 vaccine. Problems have also been reported with the mRNA vaccine. But the committee concluded that the benefits of the Novavax vaccine outweigh the risks.

The FDA usually follows the recommendations of its advisers but is not obliged to do so.

If the agency approves the Novavax vaccine, the final step before launching it would be an approval by the Centers for Disease Control and Prevention.

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