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

CHICAGO (Reuters) – Novavax Inc said on Thursday that its coronavirus vaccine was 89.3% effective in preventing COVID-19 in a study in the UK and was just as effective in protecting against the more severe variant. first found in the UK, according to a preliminary analysis.

An intermediate study of the vaccine in South Africa, where a new disturbing variant of the virus is common, showed an efficiency of 60% among people who did not have HIV.

Novavax shares increased 34% in trading hours after the publication of the results of the trial on the same day that the United States reported the first cases of the South African variant.

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

The company said in a conference call that these were interim data, and executives said it expects two to three months to elapse before they are ready to seek authorization from regulators.

The UK trial, which enrolled 15,000 people between the ages of 18 and 84, is expected to be used to apply for use in the UK, the European Union and other countries.

Approval of the Novavax vaccine would be most welcome in Europe, as it is fighting a small amount of vaccine after Pfizer / BioNTech and AstraZeneca Plc administered fewer doses than expected.

The directors of the appeal said that the company is discussing with the US Food and Drug Administration whether the data from the UK and South Africa were sufficient to apply for US emergency use authorization.

The study in the UK took place as the more transmissible version in the UK circulated. Preliminary analysis suggests that the vaccine was 85.6% effective against this mutation, the US company said in a press release. He did not provide detailed data.

In the UK study, the effectiveness of the vaccine 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 WANTED”

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

“It’s not a different statistic. The vaccine basically works in the predominant strain circulating in the UK, which means it is likely to be just as 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 that he was worried that people would focus too much on the poorer effectiveness shown in South Africa.

“We pampered ourselves because we saw the Moderna and Pfizer numbers. I know people will be alarmed, but the 60% effectiveness of the new variant is acceptable, “he said, noting that the FDA initially said it would approve a vaccine that would be at least 50 percent effective.

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

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

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

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

Authorized vaccines have so far relied on newer technology platforms, such as RNA messenger 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 Flublok seasonal flu vaccine. The Novavax vaccine works with Matrix-M’s patented adjuvant, which is used to increase its effectiveness.