CDC Endorses Novavax’s COVID Vaccine for Adults

July 20, 2022 – American adults who haven’t yet gotten vaccinated against COVID-19 should consider a new option from Novavax, which is a more traditional type of vaccine, federal health officials said Tuesday.

The FDA authorized the Novavax shot as the country’s first protein vaccine against COVID-19 last week, and the CDC gave its endorsement on Tuesday.

“If you have been waiting for a COVID-19 vaccine built on a different technology than those previously available, now is the time to join the millions of Americans who have been vaccinated,” Rochelle Walensky, MD, the CDC director, said in a statement.

She supported the CDC Advisory Committee on Immunization Practices’ recommendation that the Novavax vaccine be used as another option for ages 18 and older. It will be available in coming weeks, the CDC said.

“With COVID-19 cases on the rise again across parts of the country, vaccination is critical to help protect against the complications of severe COVID-19 disease,” Walensky said.

Protein subunit vaccines, like the Novavax shot, combine harmless proteins from the COVID-19 virus with another ingredient called adjuvant, which helps the immune system respond to the virus in the future, the CDC said. Vaccines with protein subunits have been used for more than 30 years in the U.S., beginning with the first licensed hepatitis B vaccine. Other protein subunit vaccines in the U.S. include shots for the flu, whooping cough, and shingles.

Nearly 90% of adults in the U.S. have received their first COVID-19 vaccine dose, and 77% have received two doses, according to the latest CDC data. About 51% of adults have received a booster dose.

An estimated 26 million to 37 million adults remain unvaccinated and haven’t received a single dose, according to The Associated Press. The Novavax vaccine is intended for that group.

“We really need to focus on that population,” Oliver Brooks, MD, one of the members of the CDC’s vaccine advisory panel and past president of the National Medical Association, said Tuesday.

Health officials hope the shot “will change them over from being unvaccinated to vaccinated,” he said.

Large studies in the U.S., Mexico, and Britain found that two doses of the Novavax vaccine were safe and about 90% effective at preventing COVID-19 that has symptoms, the AP reported. When the Delta variant emerged last year, Novavax said a booster dose increased antibodies as well.

The reactions to the vaccine were mild, the AP reported, including arm pain and fatigue. Regulators warned of the rare risk of heart inflammation, which has also been documented with the Pfizer and Moderna vaccines in teen boys and young men.

Manufacturing problems have delayed the Novavax vaccine, which means the shot was studied before the Omicron variant emerged. It’s not clear how well the vaccine protects against the latest subvariants.

At the same time, Novavax announced this month that lab studies show two doses create cross-protective antibodies against Omicron, including the BA.5 subvariant dominant in the U.S. right now. The company is testing updated shots to fight the new Omicron subvariants, with the aim of releasing a booster dose later this year.

The Novavax shot is approved for use in Europe, Canada, Australia, South Korea, and other countries, the AP reported. Many countries also allow booster doses, and 2 weeks ago, European regulators authorized the shots for ages 12 and older.

The U.S. has purchased 3.2 million doses of the vaccine so far. Distribution is expected to begin soon, and the shots should be available in the next few weeks.

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