Novavax, Inc. announced that it would delay seeking approval for its COVID-19 vaccine due to hold-ups in completing preparations to mass-produce the drug. “The manufacturing part has been the most work that we have to do,” Stanley Erck, Novavax chief executive, said in an interview Thursday. “Hopefully October for the FDA, but we don’t have a date picked.”
The Novavax vaccine has several advantages over other approved vaccines. It can be stored at normal refrigerator temperatures, a boon for getting the vaccine to third-world countries. The vaccine only needs one dose instead of the two doses required for full effectiveness with the Moderna and Pfizer vaccines.
The company has delayed its plans to request authorization several times as it has worked to validate its manufacturing processes and generate data from manufacturing partners needed to demonstrate to regulators that production meets standards. It also faced challenges ramping up its production capabilities amid raw-material shortages.
The company on Thursday released new data showing that a single booster shot of its vaccine administered six months after an initial two-dose regimen elicits a 4.6-fold increase in antibodies. It said the booster performs well against the Delta variant. Studies are under way to see if it can be used as a booster for other Covid-19 vaccines.
The vaccine’s efficacy is good — 90.4 percent in clinical trials. And it may offer longer — perhaps even permanent — immunity.
The Novavax vaccine works more like traditional vaccines, mimicking the coronavirus to elicit an immune response.
Novavax’s vaccine contains proteins resembling the “spike” proteins found on the surface of the coronavirus and are supposed to trigger an immune response to the virus once injected.
Novavax manufactures the proteins in insect cells.
The vaccine also contains an adjuvant, a substance designed to enhance immune responses. Novavax’s adjuvant is derived from the bark of an evergreen tree native to Chile.
The pharmaceutical war against COVID is in its infancy. Vaccines, as well as anti-virals and other therapies, will come online over the next several years, giving doctors a range of options to fight the disease. Eventually, very few people will contract or die from the coronavirus.
Until then, we need all the weapons we can get.