(Reuters) – Novavax Inc.’s COVID-19 vaccine has been 96% effective in preventing cases caused by the original version of the coronavirus in a late-stage trial in the United Kingdom, the company said on Thursday, moving it one step further. close 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 more serious 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 United Kingdom, for a combined efficacy rate of 90%, based on data from infections of 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 study in South Africa – in which volunteers were exposed primarily to another newer, more contagious variant that is widely circulated and spread around the world – the Novavax vaccine was effective with 55 %, based on people without HIV, but still fully prevented severe diseases.
Novavax medical director Filip Dubovsky said the performance in South Africa suggests there could be another case for its use 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 testing of these photographs in the second quarter of this year.
The results of the final analysis of the UK study were largely in line with provisional data published in January.
The company expects to use the data to send it to the regulatory authority in different countries. It is unclear when he will apply for US authorization or whether regulators will ask him to complete an ongoing lawsuit in the US.
Novavax expects data from a trial of 30,000 people in the United States and Mexico by early April.
Dubovsky said Novavax intends to seek authorization from the UK regulators in the early second quarter of 2021.
The UK study, which enrolled more than 15,000 people between the ages of 18 and 84, assessed the vaccine’s effectiveness in a period of high transmission of the now widely circulating virus variant in the UK.
The effectiveness of the shooting in the South African study decreased to about 49% when the analysis included data from HIV-positive participants.
The vaccine could be disposed of for use in the United States in May if US regulators decide that data from the UK is sufficient to make a decision. It could take several more months if he insists on seeing data from the US trial for the first time, his chief executive 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 prefer to wait for the data from our US study,” Dubovsky said on Thursday.
Novavax vaccine production facilities should be fully operational by April, executives said in a March investor call. 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 production sites, including the Indian Serum Institute.
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 in conjunction with Oxford University.
The Maryland-based company received $ 1.6 billion from the US government to fund the vaccine study and provide 100 million doses.
Reporting by Dania Nadeem in Bengaluru and Carl O’Donnell in New York; Editing by Bill Berkrot and Lisa Shumaker