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WASHINGTON, January 28American biotech firm Novavax said Thursday that its two-shot Covid-19 vaccine showed an overall efficacy of 89.3 percent in a major Phase 3 clinical trial in Britain, and remained highly effective against an identified variant for the first time there.
But the positive news was partially offset by other results that showed it offered significantly less protection against a highly communicable variant of the coronavirus first identified in South Africa, which is spreading rapidly around the world.
Novavax said it began work on new vaccines against emerging strains in early January and hopes to select ideal candidates in the next few days and then begin clinical trials in the second quarter of the year.
“NVX-CoV2373 has the potential to play an important role in solving this global public health crisis,” said the company’s president and CEO, Stanley Erck, using the Novavax name for the vaccine.
“We look forward to working with our partners, collaborators, researchers and regulators around the world to make the vaccine available as quickly as possible.”
British Prime Minister Boris Johnson tweeted that the results were “good news.”
“Our drug regulator will now evaluate the vaccine, which will be manufactured in Teesside. If approved, we have 60 million doses on request, ”he added.
The vaccine was one of six candidates backed by a US government project formerly known as Operation Warp Speed, which has brought the company $ 1.75 billion. It is also being tested in a trial in the United States and Mexico, which has recruited 16,000 of the 30,000 participants.
Unlike the Pfizer, Moderna and AstraZeneca vaccines, which deliver the genetic instructions that cause human cells to create a key virus protein, Novavax injection injects the proteins directly into the body to elicit an immune response.
‘Still pretty good’ against B.1.351
The British trial involved 15,000 people between the ages of 18 and 84, including 27 percent who were over 65.
The first interim analysis was based on 62 cases, of which 56 cases of Covid-19 were observed in the placebo group versus six cases among people who received NVX-CoV2373.
The company’s preliminary analysis indicated that the variant first identified in Britain, B.1.1.7, was detected in more than 50 percent of confirmed cases.
Efficacy per strain was calculated at 95.6 percent versus the original Covid strain and 85.6 percent versus B.1.1.7.
But the level of protection was lower in a smaller mid-stage trial in South Africa.
This study recruited just over 4,400 patients from September to mid-January, during which time the B.1.351 variant, which contains critical mutations throughout the spike protein of the virus, was rapidly spreading across the country.
The overall efficacy was 49.4 percent in this trial, but the figure rose to 60 percent among the 94 percent of the trial participants who were HIV negative.
Worryingly, Novavax said that about a third of the participants in the South African trial had previously been infected with the original form of the virus, while subsequent infections during the study were largely from the variant.
Amesh Adalja, a physician and principal investigator at the Johns Hopkins Center for Health Safety, told AFP that it was important to keep the decline in efficacy in perspective and that the vaccine remained a success.
“Sixty percent against the variant is still pretty good,” he said. “Clearly, the Novavax vaccine prevented a serious disease that really matters most in the end.”
J&J later?
The studies are the first to evaluate the performance of a Covid-19 vaccine against the UK and South African variants in the real world.
Pfizer and Moderna have previously said that their vaccines are still effective against the variants, but their studies were based on laboratory research.
The United States said Thursday that it had found its first two cases of variant B.1.351 on US soil, raising concerns that it could reignite the national infection rate, which is currently in decline.
Novavax’s announcement puts pressure on another vaccine maker, Johnson & Johnson, which is expected to announce the results of its phase 3 trial next week. – AFP
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