Novavax says COVID-19 vaccine is 89% effective in UK trial, less in South Africa, stocks jump

CHICAGO (Reuters) – Novavax Inc said on Thursday that its coronavirus vaccine was 89.3% effective at preventing COVID-19 in a trial conducted in the UK, and was nearly as effective at protecting against the more highly contagious variant it was first discovered in the UK, according to a preliminary analysis.

A mid-stage trial of the vaccine in South Africa, where a disturbing new variant of the virus is common, showed 60% effectiveness in people who did not have HIV.

Shares of Novavax rose 34% in non-business hours trading following the release of the test results on the same day that the United States reported the first cases of the South African variant.

Novavax is already laying vaccines at six manufacturing sites and said it expects a total of eight plants in seven countries to produce 2 billion doses per year, including from the Serum Institute of India.

The company noted during a conference call that this was interim data and executives said they expect it to take two to three months to be ready to apply for authorization from regulators.

The UK trial, which involved 15,000 people ages 18 to 84, is expected to be used in Great Britain, the European Union and other countries.

Approval of the Novavax vaccine would be very welcome in Europe as it grapples with a meager vaccine supply after Pfizer / BioNTech and AstraZeneca Plc deliver fewer doses than hoped for.

Leaders on the call said the company was discussing with the U.S. Food and Drug Administration whether the data from the UK and South Africa was sufficient to apply for a U.S. emergency use clearance.

The UK study took place when the more transmissible UK variant was circulating. The preliminary analysis suggests the vaccine was 85.6% effective against this mutation, the US company announced in its press release. It did not provide detailed data.

In the UK study, the effectiveness of the vaccine was close to that of Pfizer Inc’s two authorized vaccines with BioNTech SE and Moderna Inc, whose two-dose regimens were both approximately 95% effective in preventing COVID-19 in clinical trials .

‘WE HAVE GLOBALS’

John Moore, professor of microbiology and immunology at Weill Cornell Medical College in New York, said the Novavax UK data is essentially the same as the results from Pfizer and Moderna.

“It’s no different statistically. The vaccine works in principle well in the predominant strain circulating in the UK, which means it will likely be equally effective in the United States, ”he said.

Dr. Amesh Adalja, an infectious disease expert at the Johns Hopkins Center for Health Security, said the results were in line with expectations and he was concerned that people would focus too much on the weaker effectiveness found in South Africa is displayed.

“We are spoiled because we saw the songs from Moderna and Pfizer. I know people will be alarmed, but 60% efficacy against the new variant is acceptable, ”he said, noting that the FDA initially said it would approve a vaccine that was at least 50% effective.

Laboratory studies by Moderna and Pfizer / BioNTech have shown that the South African variant bypasses antibody protection.

Novavax said it started making new versions of its vaccine to protect against emerging virus variants in early January and expects to select ideal candidates for a booster in the coming days. The company said it plans to begin clinical testing of these new vaccines in the second quarter of this year.

A trial of 30,000 individuals in the United States and Mexico that began in December is also underway. The company has received $ 1.6 billion from the US government in funding for the vaccine trial and 100 million doses.

It has also received at least $ 388 million in support from the Coalition for Epidemic Preparedness Innovation (CEPI), a Norway-based group backed by 14 governments, the Bill and Melinda Gates Foundation, and the UK Wellcome Trust.

So far, authorized vaccines have been based on newer technology platforms, such as the messenger RNA technology used by Moderna and Pfizer / BioNTech, or inactivated cold virus platforms used by Oxford University / AstraZeneca and CanSino Biologics.

Novavax is a more conventional protein-based vaccine, an approach similar to Sanofi’s to make its Flublok seasonal flu vaccine. The Novavax vaccine works with the company’s proprietary Matrix-M adjuvant, which is used to increase efficacy.