Between April and August 2020, Operation Warp Speed (OWS) selected six companies for funding to expedite development and production of vaccines against COVID-19. The companies included Moderna, Johnson & Johnson, AstraZeneca-University of Oxford, Novavax, Merck-IAVI, and Sanofi-GlaxoSmithKline. OWS also placed an advance-purchase order with Pfizer-BioNTech. The investments have provided good returns so far with the Pfizer-BioNTech, Moderna, and Johnson & Johnson receiving FDA Emergency-Use Authorization in December and Johnson & Johnson’s getting the green light at the end of February.

The remaining four companies have seen mixed success. Merck-IAVI terminated development of its two vaccines in January for lack of efficacy in early trials. Sanofi-GlaxoSmithKline announced in December that it would delay its vaccine’s release until late 2021 because it generated insufficient immune response in older individuals and needed to be reworked.

That leaves AstraZeneca-Oxford and Novavax still in the running. AstraZeneca-Oxford had been on pace to win early authorization with its phase II/III clinical trial providing initial results in mid-November, but questions about the dosage, efficacy in older people, and analysis stalled the process in the U.S. Overall, the vaccine demonstrated 66% efficacy, far lower than the already approved vaccines, but still better than the baseline of 50% established by the FDA.

AstraZeneca launched a new trial of nearly 30,000 people in the U.S. in December. Data from that study will likely not be ready for FDA review until April. The vaccine has already gained approval in the U.K., Australia, Canada, and Europe.

Novavax’s two-dose vaccine showed an efficacy of 89.3% overall in reports released in late January. It was 96% effective against the variant that dominated the globe in 2020 and 86% against the U.K. variant, B.1.1.7. The company’s CEO, Stanley Erck, said that the FDA could approve it as early as May, if regulators use data from Novavax’s U.K. study of 15,000 people. If the agency waits for data from the 30,000-participant U.S. trial, that could push clearance back until perhaps July. Erck added that the company will have tens of millions or even one hundred million shots available when it receives authorization.

The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.

« Click here to return to COVID-19 Update.