In this photo, a silhouette of a man holding a medical syringe and vial is displayed in front of the Novavax logo on a screen.
Cézary Kowalski | Light flare | Getty Images
Independent advisers from the Centers for Disease Control and Prevention on Tuesday recommended Novavax’s two-dose Covid-19 vaccine as the primary series for adults, one of the last steps before pharmacies can start giving the shots.
The CDC committee voted unanimously to recommend the vaccine for people ages 18 and older after reviewing the safety and effectiveness of the vaccines in an hour-long public meeting on Tuesday. CDC Director Dr. Rochelle Walensky could give the go-ahead for vaccinations to begin as early as this week.
Novavax stock rose 12% after the CDC panel recommendation.
Walensky’s endorsement will complete a two-year journey for Novavax, one of the first entrants in the US race to produce a vaccine to protect against Covid-19. The small Maryland biotech company received $1.8 billion in taxpayer money from Operation Warp Speed, but struggled to set up its manufacturing base and eventually fell behind Pfizer and Moderna.
Novavax’s vaccine will enter the United States at a time when more than three-quarters of American adults, 77%, are now fully immunized with Pfizer, Moderna and, to a much lesser extent, Johnson & Johnson injections, data shows. from the CDC.
US health officials and Novavax executives said the vaccine would provide another option for people who don’t want to take Pfizer and Moderna’s vaccines. Between 26 and 37 million adults are still unvaccinated in the United States, according to CDC data, but it’s unclear how many of those people will choose to take Novavax’s vaccine.
The Biden administration has obtained 3.2 million doses of the vaccine from Novavax so far, according to the Department of Health and Human Services.
“Novavax’s primary target population will be the 10% to 13% of those who are unvaccinated,” said Dr. Oliver Brooks, committee member and chief medical officer of Watts HealthCare Corporation in Los Angeles.
“I understand that we’re really focusing on this population in hopes that maybe this protein subunit vaccine will move them from unvaccinated to vaccinated,” Brooks said.
Efficiency and safety
Novavax injections were 90% effective in preventing disease overall and 100% effective in preventing severe disease when the alpha variant of Covid was dominant, according to clinical trial data. The company has not released data on the actual effectiveness of its shots against omicron and its sub-variants.
But Novavax’s vaccine appears to produce a strong immune response against omicron and its subvariants, which would suggest it is effective against the variant. The company’s immune response data against omicron impressed members of the Food and Drug Administration’s vaccine committee last month.
The FDA, in a fact sheet for health care providers, warned that Novavax’s vaccine appears to carry a risk of heart inflammation called myocarditis. FDA officials reported four cases of myocarditis and pericarditis — swelling of a membrane surrounding the heart — from the Novavax clinical trial in young men ages 16 to 28.
Pfizer and Moderna injections also pose a high risk of myocarditis for adolescents and young men after the second dose. The CDC has found that Covid infection carries a greater risk of heart inflammation than vaccination with Pfizer or Moderna injections. Myocarditis is usually caused by viral infections.
Novavax’s vaccine uses a different platform than Pfizer’s and Moderna’s vaccines. The Novavax vaccine is based on protein technology already used in HPV and hepatitis B vaccines.
The company produces inactive copies of the virus’ spike protein by inserting genetic code into an insect virus that infects the cells of moths. Spike copies are harvested and purified from these cells for his vaccine.
The spike protein is the mechanism used by the virus to invade human cells. The spike copies in the vaccine prime the body’s immune system to produce antibodies that prevent the virus from invading human cells. Novavax’s vaccine also contains an additional ingredient, called an adjuvant, derived from the bark of a South American tree to produce a broader immune response to fight off the virus.
Pfizer and Moderna’s vaccine, on the other hand, uses messenger RNA technology. Their injections deliver messenger RNA to human cells, which then produce inactive copies of the spike protein to generate an immune response to fight off the virus. Vaccines from Pfizer and Moderna are the first mRNA vaccines to receive FDA approval.
Novavax shots are also stored at normal refrigerator temperatures, while Pfizer and Moderna shots require sub-zero cold.
Although the FDA has repeatedly cleared vaccines from Pfizer and Moderna as safe and effective vaccines for all age groups in the United States, health officials have struggled to convince millions of skeptics to get vaccinated.
Change of vaccine in the fall
The United States plans to modify vaccines to target the more transmissible BA.4 or BA.5 omicron subvariants, which are now dominant, ahead of a vaccination campaign scheduled for the fall. Covid vaccines are less effective at preventing omicron infection due to the variant’s many mutations, but they still generally protect against serious disease.
U.S. health officials believe that modifying vaccine formulations to target omicron variants as well as the original strain that emerged in Wuhan, China, in 2019 will provide longer-lasting protection against the virus this fall.
Novavax’s vaccine, like all currently licensed Covid vaccines, is based on the original strain of the virus that first emerged in China. Like Pfizer and Moderna, Novavax is developing vaccines that target the omicron variant, but company executives said it’s unclear whether they should roll out an updated vaccine because the company’s current vaccine triggers a broad immune response against the variant.
The CDC and FDA have not approved mixing and matching Novavax’s vaccine with Pfizer’s and Moderna’s injections as a booster. Novavax has announced its intention to ask the FDA to authorize a booster injection of its vaccine.
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