Novavax Inc.’s coronavirus (COVID-19) vaccine was 96% effective in preventing cases caused by the original version of coronavirus in a late-stage trial conducted in the United Kingdom, the company said on Thursday, one step closer to regulatory approval Is moving forward. .
There were no cases of serious illness or deaths among those receiving the vaccine.
The vaccine was about 86% effective at protecting against the more infectious virus variants discovered earlier and is now prevalent in the UK, about 90% overall, combining data from people infected with both versions of the coronovirus.
Novavax shares jumped 22% after trading from 22% to $ 229. They were trading below $ 10 on January 21, 2020, when the company announced that it was developing a coronavirus virus vaccine.
In a small trial conducted in South Africa – where volunteers were primarily exposed to another new, more infectious form, which was widespread and spreading around the world – the Novavax vaccine was only 55% Was effective but still prevented serious illness and death altogether.
The results of the UK trial’s final analysis were largely in line with interim data released in January. The company hopes to use the data to submit to regulatory authority in various countries. It is unclear whether it will seek US authorization or if regulators will require it to carry out ongoing testing in the United States.
The UK trial, which enrolled more than 15,000 people between the ages of 18 and 84, assessed the efficacy of the vaccine with high transmission of the UK virus variant which is now widely circulating.
The effectiveness of the shot in the South Africa trial decreased to approximately 49% when the analysis included data from HIV-positive participants.
Novavax began a rolling submission of its vaccine data to the Medicines and Healthcare Products Regulatory Agency (MHRA) of the UK in mid-January, which would help speed up the approval process.
The vaccine may be approved for use in the United States as of May if US regulators decide that the UK data is sufficient to make a decision. It may take him a few months to insist on looking at the figures before the US trial, its chief executive told Reuters earlier this month.
Officials said Novavax’s vaccine production plant should be fully operational by April. CEO Stanley Erk told Reuters that the drugmaker expects tens of millions of stockpiles and ships to be ready in the United States.
Novavax plans to produce its two-shot vaccine at eight manufacturing locations, including the Serum Institute of India. If authorized, it will follow three COVID-19 vaccines developed in the UK with Oxford University from Pfizer and partners BioNTech, Moderna Inc and AstraZeneca Schott. The final results of the Novavax trial provide further anticipation as to the possibility of daily COVID-19 deaths in the UK, possibly driven by the UK version.
.
Leave a Reply