In addition to the offerings from Pfizer, Moderna, and Johnson & Johnson, a fourth vaccine may be approved in the next month or two. Novavax has completed its phase 3 clinical trials which will be reviewed by the FDA, after which, the company will be able to request emergency approval for distribution. The initial results certainly sound promising. The company is reporting efficacy rates nearly as high as those seen with Pfizer and Moderna, along with a 100% effectiveness in preventing moderate to severe effects from COVID. In addition, this vaccine can be stored at normal refrigerator temperatures and it doesn’t employ some of the new technology that has led to doubt among some of the vaccine-hesitant population. (NBC News)
The Maryland-based biotech company Novavax reported Monday that its experimental Covid-19 vaccine is safe and 100 percent effective against moderate to severe disease.
The results are from the company’s Phase 3 clinical trials conducted in the U.S. and Mexico. The company has already completed a Phase 3 trial in the U.K., but the U.S. trial results are required to apply for emergency use authorization in this country.
Novavax said in a statement that it plans to apply to the Food and Drug Administration for authorization in the third quarter. That would add a fourth vaccine to the U.S. arsenal.
It’s not entirely clear why Novavax took nearly six months longer than both Pfizer and Moderna to finish development and make it through the clinical trials. They were also part of Operation Warp Speed so they had federal funding available to allow them to do so as rapidly as possible. But it’s possible that the process takes longer when you’re creating a vaccine using the “old school” method.
As the company spokesperson explained, Novavax doesn’t employ the messenger RNA (mRNA) technology used by Pfizer and Moderna. This vaccine just introduces the “spike protein” from the novel coronavirus directly into the patient’s bloodstream. This is the same method traditionally used when developing flu vaccines. So some of the people who remain unsure about the mRNA technology that’s already being deployed might feel a bit more comfortable with Novavax.
Of course, that depends entirely on whether or not this new vaccine will be made available in the United States. As the linked NBC News article reports, nobody is exactly sure where Novavax will fit in the overall vaccination strategy in America. We are already on track to have enough doses for everyone in the country using the three vaccines that have already been approved. There is going to be a high demand for vaccines globally for some time to come, but if they’re not needed at home, the eventual shipments of Novavax may wind up going overseas.
If that turns out to be the case, Novavax will likely prove far more useful in underdeveloped areas. Pfizer and Moderna are very fragile and have to be stored at very low temperatures. But this new vaccine can be shipped in standard refrigeration trucks and stored at distribution pods without requiring special, low-temperature freezers.
Getting back to the clinical trial results, the details make this new dose look pretty much on par with both Pfizer and Moderna. The treatment was 90% effective overall and 93% effective against the most common variants of the virus seen in the United States. Among the small number of patients who did contract the virus after being vaccinated, 100% of them only experienced what was classified as “mild” symptoms, with none seeing moderate to severe symptoms.
To be honest, if I were the person in charge of this operation, I’d probably consider shipping more of the Johnson & Johnson doses to other countries and stocking up on the Novavax vaccine to replace them. Whether you’re talking about transportability, overall efficacy, or concerns over mRNA technology, this one is sounding like the best of all possible worlds.