(Reuters) – Novavax Inc’s COVID-19 vaccine was 96% effective in preventing cases caused by the original version of the coronavirus in a final phase trial in the UK, the company said on Thursday, approaching one more step to regulatory 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 virus variant first discovered and now prevalent in the UK. It was approximately 90% effective overall, combining data from infected people with both versions of the coronavirus.
Shares of Novavax jumped 22% after trading at $ 229. They were trading 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 primarily exposed to another newer, contagious variant circulating and spreading around the world, the Novavax vaccine was only 55% effective, but it still totally prevented serious illness and death.
The results of the final analysis of the UK trial mainly coincided with the provisional data published in January.
The company hopes to use the data to send it to regulatory clearance in several countries. It is unclear when he will seek U.S. authorization or whether regulators will force him to complete an ongoing trial in the United States.
The UK trial, which enrolled more than 15,000 people aged 18 to 84, assessed the vaccine’s effectiveness over a period with high transmission of the now widely circulating UK virus variant.
The effectiveness of the shot in the South African trial decreased by about 49% when the analysis included data from HIV-positive participants.
Novavax began an ongoing submission of its vaccine data to the UK Medicines and Health Products Regulatory Agency (MHRA) in mid-January, which should help speed up the approval process.
The vaccine could be phased out for use in the United States as early as May if U.S. regulators decide the UK data is sufficient to make a decision. It could take a couple more months if they insist on seeing data from the US trial for the first time, his executive told Reuters earlier this month. [L2N2KZ2X6]
Novavax vaccine production plants are expected to be fully operational by April, executives said in an investor call in March. The drug maker expects to have tens of millions of doses stored 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 sites, including the Serum Institute of India.
If authorized, three COVID-19 vaccines previously approved for use in Britain by Pfizer and its partner BioNTech, Moderna Inc and the AstraZeneca trait developed with Oxford University would follow.
The final results of the Novavax trial provide more hope as daily deaths from COVID-19 increase in Britain, probably caused by the UK variant.
Report by Dania Nadeem in Bengaluru; Edited by Caroline Humer and Bill Berkrot