UPDATE The founders of 2-BioNTech warn of gaps in vaccine supply – Spiegel

* CEO Sahin says the lack of other vaccines cannot fully cover

* Says BioNTech / Pfizer vaccine testing on UK COVID variant

* Can adapt vaccine for strong mutations within 6 weeks

* BioNTech may have an easier to keep vaccine by summer (adds BioNTech note on talks with EU)

BERLIN, Jan. 1 (Reuters) – BioNTech is hard at work with partner Pfizer to boost production of their COVID-19 vaccine, the founders said.

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

The delays in the rollout of the home-grown vaccine have caused consternation in Germany, where some regions had to stop vaccinations within days of starting a vaccination drive.

“Things don’t look good at the moment – a gap is emerging because there is a lack of other approved vaccines and we need to fill the gap with our own vaccine,” BioNTech CEO Ugur Sahin told news weekly Spiegel.

Sahin founded BioNTech with his wife, Oezlem Tuereci, the company’s chief medical officer. Both were guilty of the EU’s decision to distribute orders in the expectation that more vaccines would be approved soon.

The United States ordered 600 million doses of the BioNTech / Pfizer shot in July, while the EU waited until November to place an order half the 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-up orders.”

After publishing the interview, BioNTech said it was in talks with Brussels about boosting output

“We are in productive discussions with the European Commission on how to make more of our vaccine in Europe, for Europe,” said a spokeswoman.

NEW PRODUCTION

BioNTech hopes to launch a new production line in Marburg, Germany, ahead of schedule in February, with the potential to produce 250 million doses in the first half of 2021, Sahin said.

Discussions are also underway with contract manufacturers and there should be more clarity by the end of January, he added.

Health Minister Jens Spahn said on Twitter that the German authorities would do everything they could to enable a quick start in Marburg.

The federal government, which backed BioNTech with $ 375 million ($ 458 million) in funding, has resisted calls from opposition leaders to speed up production of its vaccine by issuing compulsory licenses to other drug manufacturers.

Another vaccine from Moderna is expected to be approved by the European Medicines Agency (EMA) on January 6.

Spahn has also urged the EMA to quickly approve the Oxford University-AstraZeneca shot, approved by Great Britain. The EU timetable for that treatment remains uncertain.

That vaccine was approved by the Indian drug regulator for emergency use on Friday, two knowledgeable sources told Reuters.

VIRAL VARIANT

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

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

When asked about how to deal with a strong mutation, he said it would be possible to modify the vaccine as needed within six weeks – although such new treatments may require additional regulatory approvals.

Sahin also said BioNTech would make its vaccine, which should be stored at about minus 70 degrees Celsius (minus 94 Fahrenheit), easier to handle, adding that a next-generation vaccine could be ready by the end of the summer. (Reporting by Douglas Busvine Editing by John Stonestreet and David Goodman)

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