The Covid-19 vaccine at Novavax Inc was 96% effective in preventing cases caused by the original version of the coronavirus in a late test conducted in the United Kingdom, the company said Thursday. move a step closer to regulatory agreement.
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 new crop changes.
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The vaccine was 86% effective in protecting against the more susceptible virus that was first discovered and is now common in the United Kingdom, for an overall 90% effectiveness based on data from human infections. two versions of the coronavirus.
Novavax shares jumped 22% in after-hours trading to $ 229. They traded below $ 10 on Jan. 21, 2020, when the company announced that they were developing a coronavirus vaccine.
In a smaller trial conducted in South Africa – where volunteers were relatively newer, more infectious who were widely circulating there and spreading around the world – the Novavax vaccine was 55% effective, based on people without HIV, but still prevented serious illness. .
Novavax Chief Medical Officer Filip Dubovsky said the performance in South Africa suggests there may still be a case for its use in areas where South Africa’s diversity is controlled.
Novavax is also developing new formulas of its vaccine to protect against emerging changes and plans to begin clinical trials on these strains in the second quarter of this year.
Results from the final UK test were largely in line with interim data released in January.
The company plans to use the data to apply for regulatory approval in different countries. It is unclear when it will seek U.S. approval or whether regulators will seek to complete an ongoing test in the United States.
Novavax expects data from a 30,000-person trial in the United States and Mexico by early April.
Dubovsky said Novavax still plans to file for approval from UK regulators early in the second quarter of 2021.
The UK trial, which enrolled more than 15,000 people aged 18 to 84, evaluated the effectiveness of the vaccine at a time when the high spread of the UK virus is now widely circulated.
The effectiveness of the picture in the South African trial fell to about 49% when the analysis included data from HIV-positive participants.
The vaccine could be cleared for use in the United States as early as May if U.S. regulators decide that UK data is sufficient to make a decision. It could take a month or two longer if they ask him to see data from the U.S. test first, his boss told Reuters earlier this month.
“Ultimately, they have to decide whether the data we can bring to the table is relevant or whether they would prefer to wait for data from our U.S. study,” Dubovsky said Thursday.
Novavax vaccine fruit plants should be fully operational by April, officials said in an investor call in March. The drug dealer expects tens of millions of doses to be collected and ready for disposal in the United States when licensed, Chief Stanley Erck told Reuters.
Novavax plans to carry out its dual-vaccine vaccine at eight manufacturing sites, including the Serum Institute of India.
If authorized, it would follow three previously approved COVID-19 vaccines for use in Britain from Pfizer and its BioNTech partner, Moderna Inc and the AstraZeneca model developed by Oxford University.
The Maryland-based company has received $ 1.6 billion from the U.S. government in funding for the vaccine trial and to receive 100 million doses.
This story was published from a wire group group with no text changes. Only the headline has changed.