Washington: The Covid-19 vaccine from Novavax Inc. may be allowed to be used in the United States as soon as possible if US regulators allow it to be used based on data from the British company’s experience, which may be completed “in the coming weeks,” the CEO said Monday. .
However, CEO Stanley Erk added that talks with the FDA are continuing and the agency may ask Novavax to provide data from its US trial, which could take an additional two months to complete, delaying the US clearance until midsummer. .
Novavax shares retreated 5.6% at $ 226.85 in extended trading, after initially rallying after the release of their quarterly results.
Shares are up nearly 2,400% from $ 9.82 on January 21, 2020, when the company announced it was developing a vaccine against the Coronavirus.
Initial data from its UK trial released in January showed that the vaccine is approximately 96% effective against the original version of the coronavirus and about 86% effective against the widely spread variant that was first detected in Britain.
Erk said Novavax could already manufacture its shots at scale and would be able to store tens of millions of doses and be ready for shipment in the US when it receives the mandate.
“It’s going to be great – Erk said in an interview.
Novavax promised to deliver 110 million doses to the US government by the end of the third quarter. That could happen as early as July, Erk said.
Novavax head of research Gregory Glenn said on a conference call after the company announced the quarterly results that Novavax’s vaccine plants should be fully operational by April.
“In April, May and June, we must finish filling and finalizing the product before regulatory approvals,” Glenn said.
In late January, Erk said he expects Novavax will take several weeks to present trial data in the UK to regulators in the UK, Europe and elsewhere. Novavax could produce up to 150 million doses per month by May or June, he added in January in an interview.
The Novavax injection, if allowed, will add to the vaccine options for the millions of Americans waiting to be immunized against the Coronavirus.
The Johnson & Johnson single-dose vaccine on Saturday became the third to win a United States license for emergency use (USA). Vaccines produced by Pfizer Inc with its partner BioNTech and Moderna Inc were awarded EUAs in December.
The Novavax vaccine is a two-dose system like Pfizer and Moderna, but is easier to ship as it can be stored at fridge temperatures, rather than freezing.
Novavax promised to deliver doses to the United States after the Trump administration gave it $ 1.6 billion to help fund research, development and production of a Covid-19 vaccine.
Novavax completed enrollment for its 30,000-subject US trial in February.