CDC and FDA clear Novavax vaccine as a first COVID booster for adults

U.S. regulators on Wednesday granted emergency use authorization for the COVID-19 vaccine made by Novavax to be used as a booster.

The shot can now be administered to people 18 and older who received the Novavax, Pfizer, Moderna, or Johnson & Johnson vaccines as their primary series, at least six months after the completion of those initial doses, according to the Food and Drug Administration.The Novavax booster, however, should not be given to those who have already been boosted with one or more booster doses of the other approved vaccines, the agency said in a fact sheet for health care providers.

“There was no justification provided for that,” said Dr. Monica Gandhi, an infectious disease doctor and professor of medicine at the University of California, San Francisco, about the FDA decision to only allow the Novavax vaccine as a first booster.

“It doesn't make sense to me because we’re already into fall of 2022 and many people have gotten their first booster and are on their second or even third [booster dose]. ... Since the data shows the increased antibodies against the circulating variants, it makes sense for people to get boosted with this even if they’ve had one or two before. So I don’t see any point in that,” Gandhi added.

But Gandhi told Yahoo News the approval of the Novavax booster shot is still a "big deal" because it gives the American people another vaccine option. Up until now, U.S. regulators had only authorized the shot as a two-dose primary series.

“Just giving people choices is really, I think important for public health,” Gandhi said.

The Centers for Disease Control and Prevention said the Novavax booster is an option for some people who may be unable to receive an mRNA vaccine such Pfizer’s or Moderna’s because of an allergy to a component of these shots, or because of “a history of a severe allergic reaction (such as anaphylaxis) after a previous dose of an mRNA COVID-19 vaccine, or a lack of availability of an mRNA vaccine.”

About 50% of Americans who have received their primary series and are eligible for a booster have not yet received one according to the CDC. Boosters, health experts have said, are essential to keep people protected against severe outcomes of COVID-19.

"Offering another vaccine choice may help increase COVID-19 booster vaccination rates for these adults," said Novavax CEO Stanley Erck in a statement.

The Novavax vaccine uses an older and more conventional technology called recombinant protein, which has been used for decades in other vaccines targeting influenza, shingles, human papillomavirus (HPV) and hepatitis B.

The mRNA vaccines, such as those manufactured by Pfizer and Moderna, on the other hand, rely on messenger RNA – a newer technology that instructs human cells to produce copies of the COVID-19’s spike protein, which is the part of the virus that helps it attach to cells.

Even though the mRNA vaccines have gone through rigorous clinical trials and have been proven to be some of the safest inoculations ever, with billions of doses administered globally, many Americans have been skeptical about the shots. Now that the Novavax vaccine has been approved for use as a primary series and as a booster, health experts hope that those who are unvaccinated against the coronavirus will consider this option.

In clinical trials, two doses of the Novavax vaccine were found to be 90% effective against symptomatic infection and 100% protective against severe disease. Even though the shots were designed to target the original strain of the coronavirus, the company that developed the vaccine recently said data from studies in adults and adolescents showed that the Novavax booster dose produced strong antibodies against several Omicron variants, including BA.1, BA.2 and BA.5.

Health experts have said the nation could encounter a surge of COVID-19 as winter approaches and have urged everyone to stay up to date with their COVID-19 vaccination, including receiving the new bivalent boosters developed by Pfizer and Moderna that target the BA.4 and BA.5 Omicron subvariants. The BA.5 subvariant continues to dominate infections, accounting for about 68% of cases in the United States, according to the latest CDC data.

Wednesday's authorization of the Novavax booster comes just a week after both the FDA and the CDC also OK'd the new Omicron boosters for Americans as young as 5.

Separately, on Thursday, the CDC's Advisory Committee on Immunization Practices voted to include the COVID-19 vaccine on the list of routine immunizations that are recommended for children as young as 6 months old and all adults.

In making this decision, the panel of experts said that since the coronavirus is something everyone will have to learn to live with, recommending the vaccination for children was wise. This, however, doesn't mean that the CDC will make the COVID-19 shots mandatory for kids to attend school, as Fox News host Tucker Carlson suggested in a tweet Wednesday. According to the agency and multiple health officials, the CDC does not have the authority to require students to get the vaccine, because the decision is left up to states and local jurisdictions, the Washington Post reported.

The significance of Thursday’s vote means that the agency would be recommending that the COVID-19 vaccine be added to the 2023 list of regular vaccinations against common infectious diseases such as the flu, measles mumps and rubella and polio.