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COVID Vaccine by Novavax is Approved

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This week, the CDC followed the recommendation of the FDA and endorsed the use of the Novavax COVID vaccine for primary series prevention in adults ages 18 and older. The FDA now will release this vaccine under emergency use authorization.

Novavax is the first COVID protein subunit vaccine that the CDC and the FDA have approved for use in the United States. Protein subunit vaccines contain harmless pieces (proteins) of the COVID virus alongside another ingredient called an adjuvant that helps the immune system respond to the virus. Good clinical research has demonstrated the safety and effectiveness of the Novavax COVID vaccine at preventing the most severe outcomes.

Vaccines using protein subunits have been used for more than 30 years in the United States, beginning with the first licensed hepatitis B vaccine. Other protein subunit vaccines in the US today include those to protect against influenza, shingles, and whooping cough. This is a very different technology than the dominant Pfizer and Moderna COVID vaccines that deliver genetic instructions for the body to produce its own copies of the spike protein. The lesser-used Johnson & Johnson vaccine uses a harmless cold virus to deliver spike-making instructions.

The Novavax COVID vaccine is for adults ages 18 and older, delivered as a two-dose primary series, three weeks apart. This recommendation is for all adults, including those who are moderately or severely immunocompromised. The FDA is evaluating it for those as young as the age of 12. Novavax also has submitted data to the FDA on booster doses of their vaccine, including "mix-and-match" use in people who'd earlier received Pfizer or Moderna shots.

Typical vaccine reactions for the Novavax vaccine were mild, including arm pain and fatigue. The FDA did warn about the possibility of a rare risk, heart inflammation, a reaction that also has been seen rarely with the Pfizer and Moderna vaccines.

Fitting Novavax into the overall vaccine strategy for the country is important. The CDC recommends everyone ages 6 months and older get vaccinated against COVID, and that everyone ages 5 years and older get a COVID booster, as they are eligible. The Novavax vaccine will provide a new option for people who have avoided vaccination with gene-based messenger RNA vaccines made by Moderna Inc. and Pfizer. COVID vaccines used in the U.S. continue to be highly effective in reducing the risk of severe disease, hospitalization, and death, including against the now dominant circulating Omicron subvariants.

Federal and authorities are planning for a fall booster campaign using Pfizer and Moderna shots that better target omicron subtypes — and Novavax also has begun testing updated shots. The release of vaccines this summer include options for all persons down to the age of 6 months, so children have the ability to be vaccinated before school starts.

All Americans should be aware of protection options this summer and into the fall, so that there are as many people protected from serious respiratory infections as the winter disease season arrives.

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