The Food and Drug Administration has approved Novavax‘s Covid boosters for adults in the US, including people who received the Pfizer or Moderna shots as their primary series.
Approval for Novavax’s booster vaccine could greatly increase the role its injection plays in the U.S. vaccination effort. Previously, Novavax’s vaccine was only approved as a two-dose primary series, which limited its market because so many people had already been immunized with Moderna’s Pfizer.
The FDA said in a factsheet for healthcare providers that adults ages 18 and older can receive Novavax as a third dose six months after completion of the primary series of a US-approved Covid vaccine.
The FDA’s decision to give Novavax as a third shot to people who have received two doses of Pfizer or Moderna means millions more people can get the Maryland-based biotech’s vaccine. The Centers for Disease Control and Prevention is yet to provide final approval before pharmacies can begin administering the Novavax booster.
“According to CDC data, nearly 50 percent of adults who have received their primary series of vaccines have yet to receive their first booster dose. Offering a different vaccine choice may help increase COVID-19 booster rates for these adults,” Novavax CEO Stanley Erck said in a statement Wednesday.
Shares of Novavax rose 2.8% after FDA approval in late morning trading.
Only 35,300 people in the United States have received Novavax recordings as their primary series, according to CDC data. For comparison: around 372.5 million Pfizer shots, 235.8 million Modern cans and 18.9 million Johnson&Johnson So far, shots have been administered throughout the United States.
But the mix-and-match option opens Novavax’s market to about 100 million US adults who have completed their primary series but have not received their first booster dose.
The FDA’s approval of the Novavax boosters comes as millions of Americans have already received the new bivalent vaccines from Pfizer and Moderna, targeting the dominant subvariant Omicron BA.5 and the original Covid strain, which was first seen in Wuhan, China, showed up.
US health officials believe that this winter’s updated boosters from Pfizer and Moderna will provide stronger protection against infection and disease than the first-generation vaccines because they target Omicron BA.5, which currently causes most infections.
Novavax’s newly approved booster was developed against the original Covid strain, but the company believes its protein technology offers durable protection across different variants of the virus. Novavax’s injections are based on more conventional technologies used in other vaccines for decades, rather than the newer messenger RNA platform used by Pfizer and Moderna.
Novavax said its booster doses elicited robust antibodies against Omicron BA.1, BA.2 and the dominant BA.5 subvariant in studies that followed adults who received the third vaccination 8 to 11 months after receiving their Novavax primary series .
The booster dose also elicited an immune response in participants who received Moderna, Pfizer and Johnson & Johnson as their primary series, according to the company.
dr Filip Dubovsky, Novavax’s chief medical officer, said the company believes its vaccines will provide lasting protection even as the virus continues to evolve.
“We believe we have a product that has a broad immune response, so we’re not going to be chasing the virus every time a new variant emerges. That needs to be proven, but that’s our hypothesis,” Dubovsky said.
The most common side effects of the Novavax vaccine, according to the Centers for Disease Control and Prevention, are pain at the injection site, fatigue, headache, muscle aches, nausea, and vomiting.
The FDA has warned in a health care provider factsheet that the primary line of Novavax appears to pose a risk of a heart infection called myocarditis. The Pfizer and Moderna syringes also carry an increased risk of myocarditis, especially in young men and adolescent boys after the second dose.
A study by the CDC last spring found that a Covid infection carries a higher risk of myocarditis than a Pfizer or Moderna vaccine.
Novavax has not presented real-world efficacy data on how its shots are performing against BA.5, one of the most immune-avoidable variants of Covid to date. Pfizer and Moderna also don’t have any real data on how their new boosters compare to BA.5.
Novavax was one of the original entrants in the U.S. race to develop a vaccine in 2020 and received $1.8 billion in taxpayer money, but fell behind Pfizer and Moderna because it struggled to ramp up its production.
The FDA approved Novavax’s two-dose primary series over the summer in hopes that people who are skeptical about Pfizer and Moderna’s shots would be more willing to use them to immunize themselves Novavax Execution. Those aged 12 and over are eligible for the primary series of Novavax, while those aged 18 and over can now receive the booster shot.
Individuals who received Novavax’s vaccine as a primary series are also eligible for Pfizer and BioNTech’s new Omicron booster. The recordings of Moderna have not yet been released to buff people who received the primary series from Novavax.