Bronze medal winner? Novavax reports vaccine 89% effective in Phase 3 trials

And that’s just the average efficacy for the latest COVID-19 candidate to ready itself for an emergency-use authorization. According to a report from Novavax, their UK Phase 3 trials demonstrate a very robust response against the original forms of the virus (95.6%) and the UK variant (85.6%).

The news on the response to the South Africa variant isn’t nearly as good, however:

Biotech firm Novavax said Thursday that its coronavirus vaccine was more than 89% effective in protecting against Covid-19 in its phase three clinical trial conducted in the United Kingdom.

The results were based on 62 confirmed Covid-19 infections among the trial’s 15,000 participants. The company said 56 cases were observed in the placebo group versus six cases observed in the group that received its vaccine. That resulted in an estimated vaccine efficacy of 89.3%, it said. …

The study also found that the vaccine appeared to be 85.6% effective against the U.K. variant, also known as B.1.1.7. A separate phase two study in South Africa showed that the vaccine isn’t nearly as effective against a new strain ravaging that country.

The shot was still considered effective in protecting against the virus, but at an efficacy rate of just 49.4% among 44 Covid-19 cases in South Africa, where 90% of the cases contain the troubling new variant, the company said.

If the data passes peer review, it could allow Novavax to join other vaccines from Pfizer and Moderna for an EUA for immediate use. AstraZeneca still has not yet been granted an EUA in the US but is already being used in the UK. It may take until spring before the FDA can get the data from AstraZeneca for the EUA process.

Like AstraZeneca and Moderna, Novavax was one of the Operation Warp Speed grant recipients, with 100 million Novavax doses reserved for use in the US. There still may be a question as to whether the UK Phase 3 trial data will be accepted by the FDA, as the scope of the study might not have been sufficient.  Novavax launched a parallel Phase 3 study late last month here and in Mexico, but it’s likely to at least attempt some sort of application based on this data, if for no other reason than to fill the gap left by AstraZeneca’s delay and to get in around the same time as the upcoming Johnson & Johnson candidate.

Even the relatively disappointing results in South Africa weren’t all bad, either:

Some of the people in the South African trial had previously been infected with COVID-19 and were reinfected with the B.1.351 variant, suggesting that previous infection may not protect against the variant as well as vaccination with the Novavax vaccine, the company said.

“The 60% reduced risk against COVID-19 illness in vaccinated individuals in South Africans underscores the value of this vaccine to prevent illness from the highly worrisome variant currently circulating in South Africa, and which is spreading globally,” professor Shabir Maddi, executive director of the Vaccines and Infectious Diseases Analytics Research Unit (VIDA) at Wits, and principal investigator of the South African trial, said in a prepared statement.

“This is the first COVID-19 vaccine for which we now have objective evidence that it protects against the variant dominating in South Africa,” he said.

The Novavax vaccine appears to be a different type than the mRNA vaccines from Pfizer and Moderna and the viral-vector vaccine from AstraZeneca. At least from these descriptions, Novavax is a protein subunit vaccine that doesn’t involve RNA or an attenuated virus for immune response. That should make it, like the Pfizer and Moderna vaccines, a better choice for immune-suppressed recipients. According to the chart at this site, it’s also not developed from embryonic stem cells, although those were used in testing the vaccine at some point.

It’s a great piece of news if the data holds up. Next up will be the single-shot J&J vaccine, the testing data for which the FDA expects to get in the next week or so. It should be a nose-to-nose race for the bronze medal, but fourth place will still be a finish in the money.