Novavax provides first expected vaccine trial data with testing against COVID variants


Washington – US biotech firm Novavax said its two-shot COVID-19 vaccine appeared on Thursday as a whole Efficacy of 89.3% It was highly effective in a major phase 3 clinical trial in the UK and against a variant previously identified. But positive news was offset to some extent by other results, which showed that it provided less protection against the highly communicable version Coronavirus First identified in South Africa.

Like the UK strain, the variant previously found in South Africa is now spreading rapidly around the world, and earlier cases have been confirmed in the US In recent weeks, concern has been expressed that vaccines developed worldwide are less Can be effective especially the South Africa version, and Novavax test results appear to confirm some level of resistance, with both the company and an external health expert optimistic about the level of protection provided against the new strains Were.

“NVX-CoV2373 has the potential to play an important role in resolving this global public health crisis,” said Stanley Erk, president and CEO of the company, using Novavax’s name for the vaccine. “We want to continue working with our partners, collaborators, investigators and regulators worldwide to make the vaccine available as soon as possible.”

British Prime Minister Boris Johnson tweeted that the results were “good news”, saying that Britain’s drug regulators would now assess the vaccine for possible approval.

The vaccine was one of six candidates to be named by a US government project known as Operation Operation Speed, which provided $ 1.75 billion to the Maryland-based company. It is also being tested in a trial in the US and Mexico, in which about 16,000 out of 30,000 participants have been recruited so far.

Unlike Pfizer, Moderna and AstraZeneca vaccines, which give genetic instructions that make human cells an important protein of the virus, the Novavax shot injects the protein directly into the body to evoke an immune response.

“Very good” vs South Africa tension

The British trial involved 15,000 people between the ages of 18 and 84, including 27% who were over 65 years of age. The first interim analysis was based on 62 cases of confirmed COVID-19 in participants, of which 56 cases were seen in the placebo group vs. Six cases in people receiving the vaccine.

A preliminary analysis of the company indicated that the first identified variant in the UK, called B.1.1.7, was confirmed in more than 50% of cases. Novavax said the results showed that their vaccine was 95.6% effective against the original COVID-19 strain, and 85.6% against the UK version.

But a small, mid-stage trial conducted in South Africa had a low level of protection. That study enrolled just over 4,400 patients from September to mid-January, during which time the type B.1.351, which has significant changes with the virus’s spike protein, was spreading rapidly in the country.

Overall efficacy in this trial was 49.4%, but the figure increased to 60% among 94% of trial participants who were HIV-negative.

What is of concern is that Novavax stated that one third of the participants in the South Africa trial were originally infected with the virus, while the infections during the study were largely variants.


Concern over South African COVID version

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South African researchers told CBS News that the results came just days after new tensions surfaced in the country Highly resistant to antibodies Among those infected with the original strain of the virus in blood samples, it was first detected in late 2019 in Wuhan, China. That research left scientists concerned that previous infections may confer little immunity to the new South Africa variant, and the potential efficacy of vaccines.

Amesh Adalja, a doctor and senior scholar at the Johns Hopkins Center for Health Security, however, told AFP that maintaining low efficacy in perspective was important, and the vaccine was still a success.

“Sixty percent against the version is still very good,” he said. “Clearly, the Novavax vaccine prevented serious illness, which really matters the most.”

Professor Shabbir Madhi, who runs the South African trial, said on Thursday evening that Novavax’s results were something “he didn’t even think about in a dream” when he saw how the first wave of COVID infection with the original strain had worsened natural immunity Edition in South Africa.

NovaWax CEO Erk said the initial efficacy results from the South Africa trial were “above people’s expectations.”

Studies in the UK and South Africa first assessed the performance of the COVID-19 vaccine against both the UK and South Africa in real-world trials.

Modern has said earlier that its Vaccine must remain “effective” Both are against new, highly infectious variants, but the study it cited was based on laboratory research, not real-world testing against human infection.

Pfizer is also Laboratory results reported There is a suggestion that its vaccine would prove effective against the UK version, but no data has yet come up to test against the prevalent strain in South Africa.

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