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CHICAGO: Novavax said Thursday (Jan 28) that its coronavirus vaccine was 89.3 percent effective at preventing COVID-19 in a UK trial, and was almost as effective at protecting against the most highly contagious variant first discovered in the UK. , according to a preliminary analysis.
A mid-stage trial of the vaccine in South Africa, where a potent variant of the virus is common, showed 60% effectiveness among people who did not have HIV.
Novavax shares rose 34 percent after trading hours following the release of test results on the same day that the United States reported its first cases of the South African variant.
Novavax is already stockpiling vaccines at six operational manufacturing locations, and said it expects a total of eight plants in seven countries to produce at a rate of 2 billion doses per year, including the Serum Institute of India.
The company said in a conference call that it was provisional data and executives said they wait two to three months before they are ready to apply for authorization with regulators.
READ: Pfizer-BioNTech says COVID-19 vaccine works against UK and South African virus mutations
The UK 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. About 27 percent of the people in the trial are over 65.
The approval of the Novavax vaccine would be very welcome in Europe, as it struggles with the short supply of vaccines after Pfizer-BioNTech and AstraZeneca administered fewer doses than expected.
Executives on the call said the company was discussing with the US Food and Drug Administration whether data from the UK and South Africa was sufficient to request US emergency use authorization.
The UK study was carried out while the most transmissible UK variant was in circulation. Preliminary analysis suggests that the vaccine was 85.6 percent effective against this mutation, the US company announced in its press release. It did not provide detailed data.
In the UK trial, the vaccine’s efficacy was close to that of Pfizer’s two licensed vaccines with BioNTech and Moderna, whose two-dose regimens were both about 95 percent effective in preventing COVID-19 in clinical trials. .
READ: South Korea in talks to secure 40 million doses of Novavax COVID-19 vaccine
“WE HAVE LOST”
John Moore, a professor of microbiology and immunology at Weill Cornell Medical College in New York, said the data from Novavax UK is essential as are the results from the Pfizer and Moderna vaccines.
“It is not statistically different. The vaccine basically works well in the predominant strain circulating in the UK, which means it is equally effective in the US,” he said.
Dr. Amesh Adalja, an infectious disease expert at the Johns Hopkins Center for Health Security, said the results were in line with hopes and he was concerned that people were focusing too much on the weaker efficacy shown in South Africa.
“We have spoiled ourselves because we have seen the numbers from Moderna and Pfizer. I know people are going to be alarmed, but the 60 percent efficacy against the new variant is acceptable,” he said, noting that the Drug Administration US Foods initially said it would approve a vaccine that was at least 50 percent effective.
READ: Moderna Says Vaccine Effective Against COVID-19 Variants; testing an additional booster for the South African strain
The South African variant has been shown to evade antibody protection in laboratory studies by Moderna and Pfizer-BioNTech.
Novavax said it began making new versions of its vaccine to protect against emerging virus variants in early January and hopes 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.
Also underway is a 30,000-person trial in the United States and Mexico that began in December. The company has received $ 1.6 billion from the United States government in funding for the vaccine trial and for 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 Wellcome Trust of Great Britain. .
The vaccines licensed so far have been based on newer technology platforms, such as the messenger RNA technology used by Moderna and Pfizer-BioNTech, or the inactivated cold virus platforms used by the University of Oxford / 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 used to increase its effectiveness.
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