(Reuters) – Novavax Inc’s COVID-19 vaccine was 96% effective in preventing cases caused by the original version of the coronavirus in a late-stage trial conducted in the UK, the company said on Thursday, getting one step closer to regulation. approval.
There were no cases of serious illness or death among those who received the vaccine, the company said, in a sign that it could halt the worst effects of the new variants that have emerged.
The vaccine was 86% effective in protecting against the most contagious virus variant first discovered and now prevalent in the UK, for a combined 90% effectiveness rate overall based on infection data from both versions of the coronavirus.
Novavax shares rose 22% in after-hours trading to $ 229. They were trading below $ 10 on January 21, 2020, when the company announced that it was developing a coronavirus vaccine.
In a smaller trial conducted in South Africa, where volunteers were primarily exposed to another newer and more contagious variant that was widely circulating there and spread throughout the world, the Novavax vaccine was 55% effective, based on people without HIV, but it still completely prevented serious diseases. .
Novavax medical director Filip Dubovsky said the performance in South Africa suggests there may still be reasons to use it in areas where the South African variant is dominant.
Novavax is also developing new formulations of its vaccine to protect against emerging variants and plans to begin clinical trials of these injections in the second quarter of this year.
The results of the final analysis of the UK trial were largely in line with interim data published in January.
The company expects to use the data to submit it for regulatory clearance in various countries. It is unclear when he will seek authorization from the United States or if regulators will require him to complete an ongoing trial in the United States.
Novavax expects data from a 30,000-person trial in the United States and Mexico in early April.
Dubovsky said Novavax still plans to apply for clearance from UK regulators early in the second quarter of 2021.
The UK trial, which recruited more than 15,000 people aged 18 to 84, evaluated the efficacy of the vaccine during a period with high transmission of the now widely circulating UK variant of the virus.
The effectiveness of the injection in the South African trial was reduced to around 49% when the analysis included data from HIV positive participants.
The vaccine could be licensed for use in the United States as early as May if US regulators decide that the UK data is sufficient to make a decision. It could take a couple more months if they insist on looking at the US trial data first, its chief executive told Reuters earlier this month.
“Ultimately, they have to decide whether the data that we can bring to the table is adequate or whether they would rather wait for the data from our US study,” Dubovsky said Thursday.
Novavax’s vaccine production plants should be fully operational by April, executives said in an investor call in March. The drugmaker expects to have tens of millions of doses in stock and ready to ship to the United States when it receives authorization, CEO Stanley Erck told Reuters.
Novavax plans to produce its two-shot vaccine at eight manufacturing locations, including the Serum Institute of India.
If licensed, it would follow three COVID-19 vaccines previously approved for use in Britain by Pfizer and its BioNTech partner, Moderna Inc and the AstraZeneca injection developed with the University of Oxford.
The Maryland-based company has received $ 1.6 billion from the United States government in funding for the vaccine trial and to secure 100 million doses.
Reporting by Dania Nadeem in Bengaluru and Carl O’Donnell in New York; Editing by Bill Berkrot and Lisa Shumaker