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

CHICAGO (Reuters) – Novavax Inc. said on Thursday that its coronavirus vaccine was 89.3% effective in preventing COVID-19 in a UK study, and was almost as effective in protecting against the variant most highly contagious discovery for the first time in the UK, according to a preliminary analysis.

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

Novavax’s shares rose 34% in after-hours trading after the test results were released on the same day that the United States reported its first cases of the South African variant.

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

The company in a conference call noted that it was provisional data and executives said they expect it to take two to three months before they are ready to request authorization from regulators.

The UK study, which involved 15,000 people between the ages of 18 and 84, is expected to be used for enrollment in Britain, the European Union and other countries.

The approval of the Novavax vaccine would be very welcome in Europe, as it struggles with the scarce supply of vaccine after Pfizer / BioNTech and AstraZeneca Plc administered fewer doses than expected.

Executives on the call said the company was discussing with the U.S. Food and Drug Administration whether data from the UK and South Africa were sufficient to apply for emergency use authorization in the U.S.

The UK study occurred when the most transmissible UK variant was in circulation. The preliminary analysis suggests that the vaccine was 85.6% effective against this mutation, the American company announced in its press release. It did not provide detailed data.

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

‘WE HAVE BEEN Pampered’

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

“It is not statistically different. The vaccine basically works well on the predominant strain in circulation in the United Kingdom, which means it is likely to be equally effective in the United States, ”he said.

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

“We were spoiled because we saw the numbers for Moderna and Pfizer. I know that people will be alarmed, but 60% effectiveness 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 started producing new versions of its vaccine to protect against emerging variants of the virus in early January and hopes to select ideal candidates for a boost in the coming days. The company said it plans to start clinical testing 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 United States government in funding for the vaccine test and for 100 million doses.

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

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

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