Novavax vaccine 96% effective against the original coronavirus, 86% against the British variant in the British trial

(Reuters) – The COVID-19 vaccine from Novavax Inc was 96% effective in preventing cases caused by the original version of the coronavirus in a late-stage trial conducted in the United Kingdom, the company said Thursday and it moved a step closer to regulatory legislation. approval.

There were no cases of serious illnesses or deaths among those who received the vaccine, the company said in a sign that it could stop the worse effects of new variants that have emerged.

The vaccine was 86% effective in protecting against the more contagious virus variant first discovered in the UK and now widely used, for a combined 90% efficacy rate, based on data from infections of both versions of the coronavirus.

Novavax shares rose 22% in the post-trade to $ 229. They traded below $ 10 on January 21, 2020, when the company announced that they were developing a coronavirus vaccine.

In a smaller trial conducted in South Africa – where volunteers were mainly exposed to a new, more contagious variant that was widespread and spread around the world – the Novavax vaccine was 55% effective, based on humans without HIV, but still prevented serious diseases.

Novipax chief medical officer Filip Dubovsky said the performance in South Africa indicated that there could still be a case for using it in areas where the South African variant dominated.

Novavax is also developing new formulations of its vaccine to protect against emerging variants, and plans to launch clinical trials in the second quarter of this year.

The results of the final analysis of the British trial are in line with the interim data released in January.

The company expects to use the data to submit to different countries for regulatory authorization. It is not clear when this will require US permission or regulators will require it 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 to take place in early April.

Dubovsky said Novavax still intends to submit authorization to UK regulators early in the second quarter of 2021.

The British trial, which included more than 15,000 people aged 18 to 84, assessed the effectiveness of the vaccine during a period of high transmission of the British virus variant that is now widespread.

The effectiveness of the shot in the South African experiment decreased to about 49% when the data of HIV-positive participants were included in the analysis.

The vaccine could be cleared 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 several months longer if they insist on first seeing data from the US trial, its chief executive told Reuters earlier this month.

“Ultimately, they must decide whether the data we can bring to the table is sufficient and whether they prefer to wait for the data from our U.S. study,” Dubovsky said Thursday.

Novavax’s vaccine production plants should all be fully functional by April, executives said in an investor call in March. The drugmaker expects tens of millions of doses to be stored in the United States and ready to ship when it receives authorization, CEO Stanley Erck told Reuters.

Novavax plans to produce its two-vaccine at eight manufacturing sites, including the Serum Institute of India.

If approved, it will 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 collaboration with the University of Oxford.

The Maryland company has received $ 1.6 billion from the U.S. government to fund the vaccine trial and to secure 100 million doses.