Novavax says COVID-19 vaccine is 89% effective in a trial 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 trial in the UK and was almost as effective in protecting against the variant most highly contagious discovery in the UK, according to a preliminary analysis.

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

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

Novavax is already stockpiling vaccines at six operational manufacturing sites and said it expects a total of eight plants in seven countries to produce at a rate of 2 billion doses a year, including those at India’s Serum Institute.

The company in a conference call said it was provisional data and executives said they expect it to be two to three months before they are ready to apply for authorization from regulators.

The trial in the UK, which registered 15,000 people aged between 18 and 84, is expected to take place in Britain, the European Union and other countries.

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

Call executives said the company was discussing with the U.S. Food and Drug Administration whether data from the United Kingdom and South Africa was sufficient to apply for emergency use authorization from the United States. USA.

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

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

“WE HAVE BEEN MISSED”

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

“It’s not statistically different. The vaccine basically works well in the predominant strain circulating in the United Kingdom, 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 matched expectations and that he was concerned that people were focusing too much on the poor effectiveness shown in South Africa.

“We broke down because we saw the numbers of Moderna and Pfizer. I know people will be alarmed, but the 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 elude antibody protection in laboratory studies by Moderna and Pfizer / BioNTech.

Novavax said it has begun manufacturing new versions of its vaccine to protect itself from emerging virus variants in early January and hopes to select the ideal candidates for a boost 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 is also underway in the United States and Mexico that began in December. The company has received $ 1.6 billion from the U.S. government in funding for vaccine testing and for 100 million doses.

It has also received at least $ 388 million in support of the Coalition for Epidemic Preparedness Innovation (CEPI), a group based in Norway with the support of 14 governments, the Bill and Melinda Gates Foundation and the British 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 inactivated cold 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 the company’s proprietary Matrix-M adjuvant that is used to increase its effectiveness.