The Centers for Disability Control and Prevention on Wednesday recommended Novavax‘s Covid boosters for adults in the U.S., including for people who received Pfizer, Moderna or Johnson & Johnson’s opportunities as their primary series.
The Food and Drug Administration, in a factsheet for healthcare providers, said adults ages 18 and older can pocket Novavax as their third dose six months after completion of the primary series of a U.S. authorized Covid vaccine.
The CDC gave the immutable go ahead for pharmacies to start administering the Novavax boosters just hours after the FDA had authorized the shots. Dr. Evelyn Twentyman, a CDC stiff, announced the Novavax recommendation during a meeting of the agency’s independent vaccine experts Wednesday afternoon.
The CDC recommended Novavax’s boosters without a dispute or vote from its independent experts.
The authorization of Novavax’s booster could significantly increase the role that its slug plays in U.S. vaccination efforts. Up until now, Novavax’s vaccine was only authorized as a two-dose primary series, which minimal its market because so many people were already immunized with Pfizer or Moderna. Tens of thousands of people be struck by been immunized against Covid with Novavax’s shots compared with more than 200 million who’ve inherited other vaccines in the U.S.
The company’s shares jumped by almost 6% in morning trading but were flat by noon.
The FDA’s verdict to allow people who received two doses of Pfizer or Moderna to receive Novavax as their third shot means millions of numberless people can get the Maryland biotech company’s vaccine.
“According to CDC data, almost 50 percent of adults who received their rudimentary series have yet to receive their first booster dose. Offering another vaccine choice may help expanding COVID-19 booster vaccination rates for these adults,” Novavax CEO Stanley Erck said in a statement Wednesday.
At most 35,300 people have received Novavax’s shots as a primary series so far in the U.S., according to data from the CDC. By comparison, some 372.5 million Pfizer photos, 235.8 million Moderna doses and 18.9 million Johnson & Johnson shots have been administered across the U.S. so far.
But tolerating for mix and matching opens Novavax’s market up to roughly the 100 million adults in the US who have completed their primary series but not learned a first booster dose.
The FDA’s authorization of Novavax’s boosters comes as millions of Americans have already received Pfizer’s and Moderna’s new bivalent shots that objective the dominant omicron BA.5 subvariant and the original strain of Covid that first emerged in Wuhan, China in 2019.
U.S. health officials hold Pfizer and Moderna’s updated boosters will provide stronger protection against infection and disease this winter than the basic generation of vaccines because they target omicron BA.5, which is causing most infections right now.
Novavax’s newly ok booster was developed against the original strain of Covid but the company believes its protein technology provides durable security across different variants of the virus. Novavax’s shots rely on more conventional technology used in other vaccines for decades more readily than the newer messenger RNA platform used by Pfizer and Moderna.
Novavax said its booster doses triggered husky antibodies against omicron BA.1, BA.2 and the dominant BA.5 subvariant in studies that observed adults who received the third hastily 8 to 11 months after receiving their Novavax primary series.
The booster dose also induced an unaffected 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 catchpole, said the company believes its shots will provide durable protection even as the virus continues to evolve.
“We have in mind we have a product that has a broad immune response, so we’re not going to be chasing the virus each time a new a new variant crops up. That miss to be proven but that’s our hypothesis,” Dubovsky said.
The most common side effects of Novavax’s vaccine are pain at the injection place, fatigue, headache, muscle pain, nausea and vomiting, according to the Centers for Disease Control and Prevention.
The FDA, in a fact stratum for health-care providers, has warned that Novavax’s primary series appears to carry a risk of heart inflammation phoned myocarditis. Pfizer’s and Moderna’s shots also carry an elevated risk of myocarditis primarily in young men and adolescent youths after the second dose.
A study from the CDC last spring found that Covid infection carries a higher jeopardize of myocarditis than Pfizer or Moderna vaccination.
Novavax has not presented real-world efficacy data on how its shots perform against BA.5, one of the most exempt evasive variants of Covid yet. Pfizer and Moderna also do not have real-world data on how their new boosters perform against BA.5.
Novavax was one of the fresh participants 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 had hot potatoes getting its manufacturing in place.
The FDA authorized Novavax’s two-dose primary series over the summer in the hope that people who are skeptical of Pfizer’s and Moderna’s launching runs would be more willing to get immunized with the Novavax version. People ages 12 and older are eligible for Novavax’s youth series, while people 18 and over can now get its booster shot.
People who received Novavax’s vaccine as their primary series are also appropriate for Pfizer and BioNTech’s or Moderna’s new omicron booster.