US FDA authorizes Pfizer/BioNTech and Moderna’s updated Covid shots for Omicron variant

US FDA authorizes Pfizer/BioNTech and Moderna’s updated Covid shots for Omicron variant
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The US Food and Drug Administration (FDA) has authorized updated Covid-19 vaccines from Pfizer/BioNTech and Moderna that target the recently circulating Omicron variant of the coronavirus. This move paves the way for the launch of a fall vaccination campaign later this week. However, a third shot made by Novavax is still under review by the FDA.

Pfizer and Moderna have stated that their updated vaccines, which target the XBB.1.5 subvariant of the virus, are expected to be available for most people in the United States in the coming days. The FDA has approved these shots for people aged 12 and above, and has authorized emergency use for children aged 6 months through 11 years.

Dr. Peter Marks, a top FDA scientist, said that the updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. He encouraged eligible individuals to consider getting vaccinated.

An endorsement from CDC Director Mandy Cohen, expected in the coming days, should clear the way for the new shots. Cohen has stated that she expects the vaccines to roll out in September.

The FDA authorization comes as the new EG.5 subvariant of Omicron, nicknamed Eris, has rapidly spread in the United States and other countries. Concerns have also been raised about the highly mutated BA.2.86 subvariant detected in several countries.

Last week, Pfizer and Moderna reported that their updated Covid-19 vaccines generated strong responses in testing against the BA.2.86 subvariant. Novavax is still evaluating the effectiveness of its vaccine against this subvariant.

Novavax’s Chief Executive, John Jacobs, said that the company anticipates US authorization of its vaccine in the near term. The company has produced tens of millions of doses and has signed contracts for broad distribution across the country.

Novavax’s protein-based vaccine is based on older technology compared to the messenger RNA vaccines. The company still plans to present at Tuesday’s CDC advisory panel meeting and does not believe that an additional meeting will be required for CDC approval once the vaccine is authorized.

While the demand for Covid vaccines has dropped sharply, the US government has ended the COVID public health emergency declaration and handed over the responsibility for vaccinations to the private sector. COVID vaccines will still be free for most Americans with health insurance coverage, and the government is working on a program to provide the vaccines for free to people without insurance.

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TIS Staff

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