Novavax trials COVID-19 #vaccine in South Africa
Novavax Inc said its coronavirus vaccine was 89.3% effective in trials. Preliminary evidence suggests that serum is almost as effective against a new strain found in the UK..
An interim vaccine trial in South Africa, where an alarming new strain of the virus is prevalent, has been shown to be 60% effective in people who do not have HIV.
Novavax shares jump 34% during trading after results were published.
The company is already stockpiling the vaccine at six active manufacturing sites and expects a total of eight plants in seven countries to produce about 2 billion doses of vaccine per year..
Executives expect to be ready to apply for regulatory approval in two to three months..
UK trial data, involving 15,000 people aged 18 to 84, will be used to apply for the drug in the UK, EU and other countries.
Approval of Novavax vaccine would come in handy in Europe as the region suffers from poor supplies after Pfizer / BioNTech and AstraZeneca provided fewer doses than expected.
Novavax executives are discussing with the US Food and Drug Administration (FDA) whether there will be enough data from the UK and South Africa to apply for a serum approval emergencies in the USA.
In a British study, the vaccine was close to the effectiveness of two other drugs from Pfizer and Moderna, whose trials showed a 95% chance of preventing Covid-19..
John moore, Professor of Microbiology and Immunology at Weill Cornell College of Medicine in New York, said the Novavax UK data is essentially the same as the results of Pfizer and Moderna.
«There is no statistical difference. The vaccine fights well against the strain circulating in the UK, which means it is likely to be equally effective in the US.», – he said.
Doctor Amesh adalya, an infectious disease expert at the Johns Hopkins Center for Medical Research, said the results were in line with expectations. However, he is concerned that people will place too much emphasis on the weaker efficacy shown in South Africa..
«We are too spoiled by the high performance of Moderna and Pfizer. This may not sound very convincing, but trust me, 60% effective against a new strain – this is a normal option», – he said, recalling that the FDA originally said it would approve a vaccine that is at least 50% effective.
Novavax announced the start of development of new versions of its vaccine to protect against mutated virus variants in early January. The company plans to begin clinical trials of these drugs in the second quarter..
Recall that Novavax received $ 1.6 billion from the US government to fund trials and create 100 million doses.
She also received at least $ 388 million in support from the coalition. «For Epidemic Preparedness Innovation (CEPI)», a Norwegian-based group supported by 14 governments, Bill and Melinda gates, as well as the British Wellcome Trust.
Approved vaccines have so far been based on new technology platforms such as Moderna messenger RNA technology and Pfizer / BioNTech.
Novavax is a more traditional protein-based vaccine, with an approach similar to that used by Sanofi to make its seasonal Flublok influenza vaccine..