UPDATE 2 BioNTech founders warn of vaccine gaps – Spiegel

* CEO Sahin cannot fully cover the lack of other vaccines

* Say the test of BioNTech / Pfizer vaccine on the British COVID variant

* Can adjust the vaccine for strong mutations within six weeks

* BioNTech may have easier storage vaccine by summer (add BioNTech comments on EU talks)

BioNTech is partnering with Pfizer, a partner, to boost the production of their COVID-19 vaccine, warn the founders and warn that there will be gaps until other vaccines are rolled out.

The German biotech launch led the vaccine contest, but the shot was slow to arrive in the European Union due to the relatively late approval of the block’s health regulator and the small size of the order placed by Brussels.

The delays in the introduction of the home-made vaccine caused a stir in Germany, where some regions had to strike within a few days of the start of the vaccination.

“At the moment it does not look good – there is a gap because other approved vaccines are missing and we have to fill the gap with our own vaccine,” BioNTech CEO Ugur Sahin told the weekly Spiegel.

Sahin founded BioNTech with his wife, Oezlem Tuereci, who is the medical head of the company. Both blamed 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 BioNTech / Pfizer shot in July, while the EU waited until November to order half the size.

“At some point, it became clear that it would not be as fast as possible to deliver,” Tuereci told Spiegel. “Then it was too late to place follow-up orders.”

Following the publication of the interview, BioNTech said it was in talks with Brussels about promoting production

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

NEW PRODUCTION

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

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

Health Minister Jens Spahn said on Twitter that German authorities would do everything possible to make a quick start possible in Marburg.

The federal government, which supported BioNTech with 375 million euros ($ 458 million) in funding, opposed opposition leaders’ calls to accelerate production of its vaccine by issuing mandatory licenses to other drugmakers.

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

Spahn also appealed to the EMA to quickly approve the Oxford-AstraZeneca shot cleared by Britain. The EU timeline for treatment remains uncertain.

The vaccine was approved for emergency use by the Indian drug regulator on Friday, two sources with knowledge of this told Reuters.

VIRAL VARIANT

Sahin said the BioNTech / Pfizer vaccine, which uses messenger RNA to direct the human immune system to fight the coronavirus, could handle a new, more contagious variant first detected in Britain.

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

Asked about dealing with a strong mutation, he said it is possible to adjust the vaccine within six weeks, although such new treatments require additional regulatory approvals.

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

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