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

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

A trial in the middle of the vaccine in South Africa, where a disturbing new variant of the virus is common, has shown 60% effectiveness among people who do not have HIV.

Novavax shares rose 34% in trading after hours of announcing trial results on the same day as the United States reported its first cases of the South African variant.

Novavax is already taking up the vaccine at six factory premises and says it expects to produce a total of eight plants in seven countries at 2 billion doses per year, including the Serum Institute of India.

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

The British trial, which enrolled 15,000 people aged 18 to 84, is expected to be used to apply for use in Britain, the European Union and other countries.

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

Executives said the company spoke to the U.S. Food and Drug Administration about data from the United Kingdom and South Africa to adequately apply for U.S. emergency permits.

The British study took place when the more transferable British variant was in circulation. According to the preliminary analysis, the vaccine was 85.6% effective against this mutation, the US company announced in its news release. It did not provide detailed data.

In the UK trial, the efficacy of the vaccine was close to that of the two authorized vaccines from Pfizer Inc with BioNTech SE and Moderna Inc, the two doses of which were approximately 95% effective in preventing COVID-19 in clinical trials.

“WE DID”

John Moore, a 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 does not differ statistically. “The vaccine actually works well in the predominant strain circulating in the UK, which means it will probably be just as effective in the United States,” he said.

Dr. Amesh Adalja, an infectious disease expert at the Johns Hopkins Center for Health Safety, said the results were in line with hope, and that he was concerned that people would focus too much on the poorer efficiencies shown in South Africa.

‘We were spoiled because we saw the Moderna and Pfizer numbers. I know people will be worried, but the 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.

The South African variant has been shown to avoid antibody protection in laboratory studies by Moderna and Pfizer / BioNTech.

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

A trial of 30,000 people in the United States and Mexico that began in December is also underway. The company received $ 1.6 billion from the U.S. government for the vaccination for 100 million doses.

It also received at least $ 388 million in support from the Coalition for Epidemic Preparedness Innovation (CEPI), a Norwegian group supported by 14 governments, the Bill and Melinda Gates Foundation, and the British Wellcome Trust.

Authorized vaccines have so far 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 the University of Oxford / AstraZeneca and CanSino Biologics.

Novavaxs is a more conventional protein-based vaccine, an approach similar to the one Sanofi used to make the seasonal flu vaccine against Flublok. The Novavax vaccine works with the company’s own Matrix-M additive used to increase its effectiveness.