BioNTech founders warn of vaccine supply gaps

The German biotech startup has led the vaccine race but its shot has been slow to arrive in the European Union due to relatively slow approval from the bloc’s health regulator and the small size of the order placed by Brussels.

The delays have caused consternation in Germany, where some regions had to temporarily close vaccination centres days after the launch of an inoculation drive on Dec. 27.

“At the moment it doesn’t look good – a hole is appearing because there’s a lack of other approved vaccines and we have to fill the gap with our own vaccine,” BioNTech CEO Ugur Sahin told news weekly Spiegel in an interview.

A shot from Moderna is expected to be cleared by the European Medicines Agency (EMA) on Jan. 6.

German Health Minister Jens Spahn has urged the EMA to also quickly approve a vaccine developed by Oxford University and AstraZeneca that Britain cleared this week. The EU timeline for that treatment remains uncertain.

Sahin said the BioNTech/Pfizer vaccine, which uses messenger RNA to instruct the human immune system to fight the coronavirus, should be able to cope with a variant first detected in Britain that appears to be more contagious.

“We are testing whether our vaccine can also neutralise this variant, and will soon know more,” he said.

Asked about coping with a strong mutation, he said it would be possible to tweak the vaccine as required within six weeks – though such new treatments might require additional regulatory approvals.

Sahin founded BioNTech with his wife, Oezlem Tuereci, who is the company’s chief medical officer. Both faulted the EU’s decision to spread orders in the expectation that more vaccines would be quickly approved.

The United States ordered 600 million doses of the BioNTech/Pfizer vaccine in July, while the EU waited until November to place an order of half that size.

“At some point it became clear that it would not be possible to deliver so quickly,” Tuereci told Spiegel. “By then it was already too late to place follow-on orders.”

BioNTech hopes to launch a new production line in Marburg, Germany, in February that could produce 250 million doses in the first half of the year, said Sahin.

Talks are under way with contract manufacturers on boosting output and there should be greater clarity by the end of January, he added.

Sahin also said BioNTech would make its vaccine, which requires storage at around minus 70 Celsius (minus 94 Fahrenheit), easier to handle. A next-generation vaccine that would keep at higher temperatures could be ready by late summer.

REUTERS