(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 company said, in a sign that it could stop 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 is now prevalent in the UK, with an overall combined 90% efficacy rate based on data of infections of both versions of the coronavirus.
Novavax shares jumped 22% in out-of-hours trading to $ 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 exposed primarily to another newer and more contagious variant circulating and spreading around the world, the Novavax vaccine was 55% effective, based on people without HIV, but still fully prevented serious illness. .
Novavax chief medical officer Filip Dubovsky said the action in South Africa suggests there may still be a case for using it in areas where the South African variant is dominant.
Novavax is also developing new formulations of its vaccine to protect itself from emerging variants and plans to begin clinical trials of these vaccines in the second quarter of this year.
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.
Novavax expects data from a trial of 30,000 people in the United States and Mexico in early April.
Dubovsky said Novavax still plans to seek permission from UK regulators in the early second quarter of 2021.
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.
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.
“Ultimately, they have to decide if the data we can provide in the table is adequate or if they prefer to wait for the data from our study in the US,” Dubovsky said Thursday.
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 Maryland-based company has received $ 1.6 billion from the U.S. government in funding for the vaccine trial and to secure 100 million doses.
Report by Dania Nadeem in Bengaluru and Carl O’Donnell in New York; Edited by Bill Berkrot and Lisa Shumaker