For people who received Pfizer's or Moderna's shots as their primary series, the FDA has approved Novavax's Covid boosters.
The authorization of Novavax's booster could increase the role that its shot plays in the U.S. The market for Novavax's vaccine was limited because so many people had already received Pfizer of Moderna.
After completing the primary series of any U.S. authorized Covid vaccine, adults 18 and older can receive a third dose of Novavax.
More people will be able to get the Novavax vaccine because of the FDA decision to allow people who received two doses of Pfizer or Moderna to get their third shot. The final approval from the Centers for Disease Control and Prevention is needed before Novavax's booster can be given to patients.
Almost half of adults who received their primary series have yet to receive their first booster dose. Stanley Erck, CEO of Novavax, said in a statement Wednesday that offering another vaccine choice may increase the number of COVID-19 booster vaccinations.
The FDA gave the go-ahead for Novavax's shares to rise.
According to the CDC, only 35,300 people have received Novavax's shots as a primary series. More than 400 million Pfizer, Moderna, and Johnson & Johnson shots have been administered in the US so far.
Up to 100 million adults in the US who have completed their primary series but not received a first booster dose can now use Novavax.
Millions of Americans have already received Pfizer's and Moderna's new bivalent shots that target the dominant omicron BA.5 sub variant and the original strain of Covid that first emerged in China in 2019.
According to U.S. health officials, Pfizer and Moderna's updated boosters will give better protection against infections this winter than the first generation of vaccines because they target omicron BA.5.
Novavax has an authorized booster that protects against the original strain of Covid, but the company believes it has the ability to protect against other versions of the virus. Pfizer and Moderna use a newer messenger RNA platform for their vaccines, but Novavax uses more traditional technology.
Adults who received the third shot 8 to 11 months after receiving their Novavax primary series had robust antibodies against omicron BA.1, BA.2 and the dominant BA.5 subvariant, according to Novavax.
According to the company, the immune response in participants who received Moderna, Pfizer and Johnson & Johnson as their primary series was caused by the booster dose.
Even though the virus continues to evolve, the company believes its shots will provide durable protection.
We think we have a product that has a broad immune response so we won't be chasing the virus every time a new variant crops up. Our hypothesis is that that needs to be proven.
Pain at the injection site is one of the most common side effects of Novavax.
Novavax's primary series appears to carry an increased risk of heart inflammation called myocarditis.
According to a study done by the CDC, Covid has a higher risk of myocarditis than Pfizer or Moderna.
Novavax doesn't have real-world efficacy data on how its shots perform against BA.5. Pfizer and Moderna don't have data on how their new boosters perform.
Novavax was one of the original participants in the U.S. race to develop a vaccine in 2020 but fell behind Pfizer and Moderna due to difficulties getting its manufacturing in place.
The FDA authorized Novavax's two-dose primary series in the hopes that people who are skeptical of Pfizer's and Moderna's shots would be more willing to get immunizations with the Novavax version. Novavax has a primary series for people ages 12 and older and a booster series for people 18 and over.
The omicron booster is available to people who received Novavax's vaccine as their primary series. People who received Novavax's primary series have not been given Moderna's shots.
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