Cezary Kowalski Lightrocket | Getty Images Independent advisers to the Centers for Disease Control and Prevention recommended Novavax’s two-dose Covid-19 vaccine as the main line for adults on Tuesday, one of the final steps before pharmacies begin dispensing the shots. The CDC panel voted unanimously to recommend the vaccine for people 18 and older after reviewing the vaccines’ safety and effectiveness during an hours-long public meeting Tuesday. CDC Director Dr. Rochelle Walensky, could give the go-ahead for vaccinations to begin as soon as this week. Novavax stock rose 12% after the CDC panel’s recommendation. Walensky’s approval would cap 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 build its manufacturing base and ultimately fell behind Pfizer and Moderna. Novavax’s vaccine will enter the U.S. at a time when more than three-quarters of U.S. adults, 77 percent, are now fully vaccinated with Pfizer, Moderna, and to a much lesser extent Johnson & Johnson vaccines, according to CDC data . U.S. health officials and Novavax executives said the vaccine would provide another option for people who don’t want to get Pfizer and Moderna shots. Anywhere from 26 million to 37 million adults are still unvaccinated in the U.S., according to CDC data, but it’s unclear how many of those people will choose to get Novavax’s shot. The Biden administration has so far secured 3.2 million doses of the Novavax vaccine, according to the Department of Health and Human Services. “The main target population for Novavax will be the 10% to 13% of those who have not been vaccinated,” said Dr. Oliver Brooks, board member and chief medical officer at Watts HealthCare Corporation in Los Angeles. “My understanding is that we’re really focused on that population with the hope that maybe this protein subunit vaccine will switch them from unvaccinated to vaccinated,” Brooks said.
Efficiency and safety
Novavax’s vaccines were 90% effective at preventing disease overall and 100% effective at preventing severe disease when the alpha variant of Covid was predominant, 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 the micron 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 newsletter for health care providers warned that the Novavax vaccine appears to carry a risk of heart inflammation called myocarditis. FDA officials cited four cases of myocarditis and pericarditis — swelling of a membrane surrounding the heart — from the clinical trial of Novavax in young men ages 16 to 28. The Pfizer and Moderna vaccines also carry an increased risk of myocarditis for adolescent boys and young men after the second dose. The CDC found that getting infected with Covid carries a greater risk of heart inflammation than getting vaccinated with Pfizer or Moderna vaccines. Myocarditis is usually caused by viral infections.
Different technology
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 moth cells. Spike copies are harvested and purified from these cells for his vaccine. The spike protein is the mechanism the virus uses to invade human cells. Copies of the vaccine prepare the body’s immune system to produce antibodies that prevent the virus from invading human cells. Novavax’s vaccine also has an additional ingredient, called an adjuvant, that comes from the bark of a South American tree to produce a broader immune response to fight the virus. Pfizer and Moderna’s vaccine, in contrast, use messenger RNA technology. Their shots deliver messenger RNA to human cells, which then produce inactive copies of the spike protein to mount an immune response to fight the virus. Pfizer and Moderna’s vaccines are the first mRNA vaccines to receive FDA approval. Novavax shots are also stored at normal refrigerator temperatures, while Pfizer and Moderna shots require subzero temperatures. Although the FDA has repeatedly approved Pfizer’s and Moderna’s vaccines as safe and effective for every age group in the US, health officials have struggled to convince millions of skeptics to get the shots.
Autumn vaccine change
The US plans to modify vaccines to target the more contagious BA.4 or BA.5 omicron subvariants, which are now predominant, ahead of an expected fall vaccination campaign. Covid vaccines are less effective at preventing omicron infection due to the many mutations of the variant, but still generally protect against serious disease. US health officials believe changing the vaccine formula to target micron variants as well as the original strain that emerged in Wuhan, China in 2019 will provide more durable protection against the virus this fall. Novavax’s vaccine, like every currently approved Covid vaccine, is based on the original strain of the virus that first appeared in China. Like Pfizer and Moderna, Novavax is developing vaccines that target the Omicron variant, but company executives said it’s not clear they need to release an updated vaccine because the company’s current vaccine triggers a broad immune response against the variant. CDC and FDA have not approved mixing and matching Novavax vaccine with Pfizer and Moderna vaccines as a booster. Novavax said it plans to ask the FDA to approve a booster shot of its vaccine.
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