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With the US in hand, BioNTech's CEO is searching for extra vaccine manufacturing

© Reuters. Ugur Sahin, CEO and co-founder of the German biotech company BioNTech, is interviewed by journalists in Marburg

By Michael Erman

NEW YORK (Reuters) – The CEO of German BioNTech SE (NASDAQ 🙂 said the biggest challenge for him and his partner Pfizer Inc (NYSE 🙂 will now that the COVID-19 vaccine has been approved for use in the United States, will be scaling up production to meet high demand.

"We have to solve the challenge in manufacturing," said Ugur Sahin in an interview with Reuters. "It's very clear that more cans are needed. And we're dealing with this question – how to make more cans."

The companies have announced that they will produce up to 1.3 billion doses of the vaccine over the next year.

The US Food and Drug Administration approved the vaccine for emergency use on Friday after the UK became the first country to start using the vaccine outside of clinical trials earlier this week.

Sahin expects the companies to receive conditional approval from the European Medicines Agency by the end of the month and start rolling out vaccines in European countries early next year.

One possibility to increase the supply is to start up the BioNTech plant purchased by Novartis AG in Marburg earlier than planned with a dose of 750 million doses per year.

BioNTech had announced that the vaccine would be manufactured there in the first half of 2021, and Sahin said they are working on getting it up and running on an accelerated timeline.

"The basic plan provides for 1.3 billion doses," said Sahin. "And we're working on an expanded plan. I can't tell you at the moment what is possible and how much we can scale up, but we'll try to do that significantly."

In the United States of around 330 million people, vaccine supply will initially be limited. The US government has ordered 100 million doses of the two-dose vaccine and may negotiate more.

Pfizer board member and former FDA commissioner Scott Gottlieb said in an interview with CNBC that the company had offered to sell more cans to the US last month but was turned down.

In the data released this week, Pfizer and BioNTech said their vaccine gave recipients some protection even before the second shot. About 12 days after the first shot, some effectiveness appeared to be evident.

Sahin said he was surprised by the data: "We know that the immune response is greatly enhanced after the second dose."

He said the companies had not yet decided whether to evaluate a single-dose version of the vaccine.

"This will be a discussion that we will certainly have with our Pfizer partners," he said.

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