Novavax COVID-19 Vaccine Demonstrates 89.3% Efficacy in UK Phase 3 Trial

[PeteS in CA]

Novavax COVID-19 Vaccine Demonstrates 89.3% Efficacy in UK Phase 3 Trial

https://ir.novavax.com/news-releases/news-release-details/novavax-covid-19-vaccine-demonstrates-893-efficacy-uk-phase-3

GAITHERSBURG, Md., Jan. 28, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that NVX-CoV2373, its protein-based COVID-19 vaccine candidate, met the primary endpoint, with a vaccine efficacy of 89.3%, in its Phase 3 clinical trial conducted in the United Kingdom (UK). The study assessed efficacy during a period with high transmission and with a new UK variant strain of the virus emerging and circulating widely. It was conducted in partnership with the UK Government’s Vaccines Taskforce. Novavax also announced successful results of its Phase 2b study conducted in South Africa.

“With today’s results from our UK Phase 3 and South Africa Phase 2b clinical trials, we have now reported data on our COVID-19 vaccine from Phase 1, 2 and 3 trials involving over 20,000 participants. In addition, our PREVENT-19 US and Mexico clinical trial has randomized over 16,000 participants toward our enrollment goal of 30,000. NVX-CoV2373 is the first vaccine to demonstrate not only high clinical efficacy against COVID-19 but also significant clinical efficacy against both the rapidly emerging UK and South Africa variants,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “NVX-CoV2373 has the potential to play an important role in solving this global public health crisis. We look forward to continuing to work with our partners, collaborators, investigators and regulators around the world to make the vaccine available as quickly as possible.”

NVX-CoV2373 contains a full-length, prefusion spike protein made using Novavax’ recombinant nanoparticle technology and the company’s proprietary saponin-based Matrix-M™ adjuvant. The purified protein is encoded by the genetic sequence of the SARS-CoV-2 spike (S) protein and is produced in insect cells. It can neither cause COVID-19 nor can it replicate, is stable at 2°C to 8°C (refrigerated) and is shipped in a ready-to-use liquid formulation that permits distribution using existing vaccine supply chain channels.

I don't see a date for requesting FDA EUA evaluation but that is probably imminent. Novavax is not very "talkative" in issuing press releases, but they received a DoD vaccine contract in early June, and substantial R & D funding and a conditional 100M-dose purchase contract in early July.

Though no EUA application date was announced, this looks to be coming down a bit earlier than I guesstimated, not that I mind being wrong. Because the vaccine storage requirement is far more Third-World-Friendly than Pfizer's or Moderna's, philanthropic geopolitics may play in to when/if Novavax applies for FDA EUA.

[jmyrlefuller]

I see J&J is reporting 85% on it's one-shot vaccine, too.

[PeteS in CA]

I see J&J is reporting 85% on it's one-shot vaccine, too.

IIRC, J&J's storage requirements are basically Third-World-Friendly. So with AstraZeneca, Novavx, and J&J all Third-World-Friendly Melinda-Gates-Grade guilt-trippers should STFU. Should, but too ignorant to know they are wrong.

J&J also has a Phase III two-dose test underway, to see whether a second dose improves efficacy. I wonder whether Pfizer and/or Moderna have considered doing the reverse, a single-dose test to see if efficacy would be reduced.