(Reuters) – Novavax Inc’s COVID-19 vaccine was 96% effective in preventing cases caused by the original version of the coronavirus at a late-stage investigation in the UK, the company said Thursday, giving it a step closer to regulation. approval.
There were no cases of serious illness or deaths among those who received the vaccine, the company said, as a sign that it could stop the worse effects of new variants.
The vaccine was 86% effective in protecting against the more contagious virus variant first discovered and now common in the UK, for a combined effectiveness rate of 90% overall based on infection data from both versions of the vaccine. coronavirus.
Novavax shares rose 22% in non-business hours trading to $ 229. They traded below $ 10 on January 21, 2020, when the company announced it was developing a coronavirus vaccine.
In a smaller trial conducted in South Africa – where volunteers were mainly exposed to another newer, more contagious variant that is widely circulating there and spreading around the world – the Novavax vaccine was 55% effective, based on people without HIV, but still completely prevent serious diseases.
Filip Dubovsky, Novavax’s Chief Medical Officer, said the performance in South Africa suggests there may still be a reason to use it in areas where the South African variety is dominant.
Novavax is also developing new formulations of its vaccine to protect against emerging variants and plans to initiate clinical trials of these injections in the second quarter of this year.
The results of the final analysis of the UK trial were largely consistent with the interim data released in January.
The company expects to use the data to submit for legal authorization in various countries. It’s not clear when it will seek US approval or require regulators to complete an ongoing process in the United States.
Novavax expects data from a trial with 30,000 people in the United States and Mexico in early April.
Dubovsky said Novavax still plans to file an application with UK regulators early in the second quarter of 2021.
The UK study, which enrolled more than 15,000 people aged 18 to 84, assessed the vaccine’s efficacy over a period of high transmission of the UK virus variant now widely circulating.
The effectiveness of the shot in the South African trial fell to about 49% when the analysis included data from HIV-positive participants.
The vaccine could be approved for use in the United States in May if US regulators decide the UK data is sufficient to make a decision. It could take a few more months if they insist on seeing data from the U.S. trial for the first time, the CEO told Reuters earlier this month.
“Ultimately, they have to decide whether the data we can bring to the table is adequate or whether they would rather wait for data from our US study,” Dubovsky said Thursday.
Novavax’s vaccine manufacturing facilities should all be fully functional by April, executives said during an investor call in March. The drug company expects to have tens of millions of doses in stock and ready to ship in the United States when it receives approval, CEO Stanley Erck told Reuters.
Novavax plans to manufacture its dual vaccine at eight manufacturing sites, including the Serum Institute of India.
If authorized, it would follow three COVID-19 vaccines previously approved for use in the UK by Pfizer and partner BioNTech, Moderna Inc and the AstraZeneca shot developed with the University of Oxford.
The Maryland-based company has received $ 1.6 billion from the US government to fund 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