One of the unexpected successes of the Covid-19 vaccine race, Novavax is set to complete registration of its trial in the United States in record time, bringing it even closer to order fulfillment to inoculate 50 million Americans.
The 30-year-old biotech – which has never succeeded in bringing a drug to market – has almost recruited all 30,000 participants in its US trial, which began in late December, according to its chief executive, Stanley Erck.
Novavax suffered a setback with its manufacturing that meant the trial started six to eight weeks later than expected, but it caught up when participants rushed to join the trial at 115 sites in the United States and Mexico.
The Novavax jab could be the fourth to receive emergency use authorization in the United States for Covid-19. Vaccines from BioNTech / Pfizer and Moderna have already received emergency approval, while the regulator’s vaccine advisory group is due to meet to discuss Johnson & Johnson’s vaccine at the end of the month.
And Erck said Novavax could jump on rivals in the race for approval as the U.S. Food and Drug Administration plans to clear its use based on previously published UK trial data.
“Nothing has materialized yet, but it is likely that they will take a very close look at it,” Erck told the Financial Times.
The UK trial concluded that the two-stroke regime was 89% effective. It was 95.6% effective against the original strain of Sars CoV-2 and 85.6% against B.1.1.7, the variant first discovered in the UK.
The FDA has rejected a request to review UK trial data in the case of AstraZeneca, ordering the company to complete trials in the United States before considering an emergency use authorization in the United States, according to people familiar with the matter. Some experts have questioned how the AstraZeneca trials in the UK were constructed, while the Novavax studies were in line with the FDA guidelines.
The UK is still likely to be the first country to approve Novavax’s vaccine, after data which Boris Johnson, the Prime Minister, called “good news”. Erck said he expected many other countries to follow the UK “very, very quickly”.
In the UK, Novavax received money from the central government working group on vaccines, and in the US it received $ 1.6 billion to ramp up manufacturing, one of the biggest awards of the Trump administration’s Operation Warp Speed.
Novavax shares have climbed more than 4,000% in the past year, reflecting how the coronavirus has transformed his fortunes. The company has tried to manufacture vaccines for pandemic influenza and other coronaviruses such as Sars and Mers, but has never gone as far as approval.
Over the past six months, it has grown from 150 employees to 700 and has had to expand its manufacturing significantly as it prepares to fulfill government orders, including 100 million doses in the US and 60 million in the UK. -United.
“We currently have commercial scale manufacturing at eight different factories in seven countries,” Erck said. “A year ago we had none.”
UK trial data showed Novavax’s vaccine was less effective against the strain that originated in South Africa, and the company said it was preparing for a trial of a booster or a new vaccine targeting several strains.
Erck said the company has already started studying a reformulated vaccine in primates and plans to start a human trial around the start of the second trimester.