(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 vaccine was also around 86% effective in protecting against the most contagious variant of the virus first discovered and now prevalent in the UK. It was about 90% effective overall, combining data from people infected with both versions of the coronavirus.
Novavax shares rose 22% after hours 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 only 55% effective, but still prevented by complete serious illness and death.
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.
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.
Novavax started a continuous submission of its vaccine data to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in mid-January, which should help speed up the approval process.
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. [L2N2KZ2X6]
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 final results of Novavax’s trial provide more hope as daily deaths from COVID-19 in Britain rise, likely driven by the UK variant.
Report from Dania Nadeem in Bengaluru; Editing by Caroline Humer and Bill Berkrot