Novavax takes protein-based Covid-19 vaccine overseas, asking for an approval in the UK
Just after an onslaught of manufacturing issues last week and submitting their Covid-19 vaccine to the WHO for review last month, Novavax is going across the sea and taking its protein-based Covid-19 vaccine up with the crown.
The company filed for marketing authorization approval with the MHRA in the UK, Novavax said this morning in a statement.
As for a submission to the FDA, Novavax said that they plan to have the application in by year’s end. The Maryland biotech has delayed filing with the FDA several times, sparking criticism from analysts as credibility has worn thin.
The biotech had received close to $1.6 billion last year from the feds for its work on the vaccine, as the Trump administration pledged to buy 100 million doses in Operation Warp Speed.
Shares of Novavax $NVAX rose about 8% to $146.30 over the day.
The request in the UK for a go-ahead is based on data from close to 45,000 patients in Phase III trials.
Novavax and its manufacturing partner in India — the Serum Institute — have already filed for authorization in India, Indonesia and the Philippines, and requested an emergency use listing with WHO.
Through that arrangement, Novavax and Serum are expected to deliver more than a billion doses — but that is only possible if Novavax gets all its manufacturing issues squared away.
Just last week, news broke that production problems at a facility in Maryland could lead to a shortage of as many as 1 billion doses.
The company has run into trouble with the purity of its vaccine, with the biotech having trouble proving it can consistently produce a shot up to agency’s standards, and it has caused significant delays in the rollout to low- and middle-income countries. This follows several delays at Novavax that has put executives on the defensive.
According to sources who spoke with Politico, purity levels in the vaccine have hovered at around 70%. And because lower purity levels raise the chance of having contaminants or unnecessary substances in the vaccine, that can disrupt plans to get vaccine supplies more broadly distributed.