The Centers for Disease Control and Prevention on Wednesday advisable Novavax‘s Covid boosters for adults within the U.S., including for individuals who received Pfizer, Moderna or Johnson & Johnson’s shots as their primary series.
The Food and Drug Administration, in a factsheet for healthcare providers, said adults ages 18 and older can receive Novavax as their third dose six months after completion of the first series of a U.S. authorized Covid vaccine.
The CDC gave the ultimate go ahead for pharmacies to begin administering the Novavax boosters just hours after the FDA had authorized the shots. Dr. Evelyn Twentyman, a CDC official, announced the Novavax advice during a gathering of the agency’s independent vaccine experts Wednesday afternoon.
The CDC advisable Novavax’s boosters with no debate or vote from its independent experts.
The authorization of Novavax’s booster could significantly increase the role that its shot plays in U.S. vaccination efforts. Up until now, Novavax’s vaccine was only authorized as a two-dose primary series, which limited its market because so many individuals were already immunized with Pfizer or Moderna. Tens of 1000’s of individuals have been immunized against Covid with Novavax’s shots compared with greater than 200 million who’ve received other vaccines within the U.S.
The corporate’s shares jumped by almost 6% in morning trading but were flat by noon.
The FDA’s decision to permit individuals who received two doses of Pfizer or Moderna to receive Novavax as their third shot means tens of millions of more people can get the Maryland biotech company’s vaccine.
“In accordance with CDC data, almost 50 percent of adults who received their primary series have yet to receive their first booster dose. Offering one other vaccine alternative may help increase COVID-19 booster vaccination rates for these adults,” Novavax CEO Stanley Erck said in an announcement Wednesday.
Only 35,300 people have received Novavax’s shots as a primary series to this point within the U.S., based on data from the CDC. By comparison, some 372.5 million Pfizer shots, 235.8 million Moderna doses and 18.9 million Johnson & Johnson shots have been administered across the U.S. to this point.
But allowing for mixing and matching opens Novavax’s market as much as roughly the 100 million adults within the US who’ve accomplished their primary series but not received a primary booster dose.
The FDA’s authorization of Novavax’s boosters comes as tens of millions of Americans have already received Pfizer’s and Moderna’s recent bivalent shots that concentrate on the dominant omicron BA.5 subvariant and the unique strain of Covid that first emerged in Wuhan, China in 2019.
U.S. health officials imagine Pfizer and Moderna’s updated boosters will provide stronger protection against infection and disease this winter than the primary generation of vaccines because they aim omicron BA.5, which is causing most infections right away.
Novavax’s newly authorized booster was developed against the unique strain of Covid but the corporate believes its protein technology provides durable protection across different variants of the virus. Novavax’s shots depend on more conventional technology utilized in other vaccines for many years reasonably than the newer messenger RNA platform utilized by Pfizer and Moderna.
Novavax said its booster doses triggered robust antibodies against omicron BA.1, BA.2 and the dominant BA.5 subvariant in studies that observed adults who received the third shot 8 to 11 months after receiving their Novavax primary series.
The booster dose also induced an immune response in participants who received Moderna, Pfizer and Johnson & Johnson as their primary series, based on the corporate.
Dr. Filip Dubovsky, Novavax’s chief medical officer, said the corporate believes its shots will provide durable protection whilst the virus continues to evolve.
“We expect we’ve got a product that has a broad immune response, so we’re not going to be chasing the virus every time a recent a recent variant crops up. That should be proven but that is our hypothesis,” Dubovsky said.
Essentially the most common unwanted side effects of Novavax’s vaccine are pain on the injection site, fatigue, headache, muscle pain, nausea and vomiting, based on the Centers for Disease Control and Prevention.
The FDA, in a fact sheet for health-care providers, has warned that Novavax’s primary series appears to hold a risk of heart inflammation called myocarditis. Pfizer’s and Moderna’s shots also carry an elevated risk of myocarditis primarily in young men and adolescent boys after the second dose.
A study from the CDC last spring found that Covid infection carries the next risk of myocarditis than Pfizer or Moderna vaccination.
Novavax has not presented real-world efficacy data on how its shots perform against BA.5, some of the immune evasive variants of Covid yet. Pfizer and Moderna also do not need real-world data on how their recent boosters perform against BA.5.
Novavax was one in all the unique participants within the U.S. race to develop a vaccine in 2020 and received $1.8 billion in taxpayer money, but fell behind Pfizer and Moderna since it had difficulties getting its manufacturing in place.
The FDA authorized Novavax’s two-dose primary series over the summer within the hope that people who find themselves skeptical of Pfizer’s and Moderna’s shots could be more willing to get immunized with the Novavax version. People ages 12 and older are eligible for Novavax’s primary series, while people 18 and over can now get its booster shot.
Individuals who received Novavax’s vaccine as their primary series are also eligible for Pfizer and BioNTech’s or Moderna’s recent omicron booster.