© Reuters. FILE PHOTO: A nurse holds a vial of the Pfizer / BioNTech COVID-19 vaccine at Coventry University Hospital
By Douglas Busvine
BERLIN (Reuters) – BioNTech works closely with the partner Pfizer (NYSE 🙂 in an effort to kickstart production of their COVID-19 vaccine, the founders said, warning that there would be supply gaps until other vaccines were introduced.
The German biotech startup has led the vaccine race, but its shot came slowly into the European Union due to the relatively late approval from the bloc's health authority and the small size of the order placed by Brussels.
The delays in introducing the home-grown vaccine have caused dismay in Germany, where some regions have had to stop vaccination within days of a vaccination campaign.
"At the moment it is not looking good – there is a hole because there is a lack of other approved vaccines and we have to fill the gap with our own vaccine," Ugur Sahin, CEO of BioNTech, told the weekly newspaper Spiegel.
Sahin founded BioNTech with his wife Oezlem Tuereci, the company's Chief Medical Officer. Both objected to the EU's decision to disseminate orders, expecting more vaccines to be approved quickly.
The US ordered 600 million cans of the BioNTech / Pfizer shot in July while the EU waited until November to place an order in half that size.
"At some point it became clear that it would not be possible to deliver so quickly," Tuereci told Spiegel. "At this point it was already too late to place follow-up orders."
After the interview was published, BioNTech said it was in talks with Brussels about increasing production
"We are in productive talks with the European Commission about how we can make more of our vaccine in Europe for Europe," said a spokeswoman.
BioNTech hopes to open a new production line in Marburg ahead of schedule in February that has the potential to produce 250 million cans in the first half of 2021, Sahin said.
Talks with contract manufacturers are also ongoing and should be more clarified by the end of January, he added.
Health Minister Jens Spahn said on Twitter that the German authorities would do everything to enable a quick start in Marburg.
The federal government, which has supported BioNTech with 375 million euros, has opposed the demands of opposition leaders to speed up the production of their vaccine by granting compulsory licenses to other drug manufacturers.
Another vaccine out Moderna (NASDAQ 🙂 is expected to be approved by the European Medicines Agency (EMA) on January 6th.
Spahn has also asked the EMA to swiftly approve the Oxford-AstraZeneca University's UK-approved shot. The EU timetable for this treatment remains uncertain.
This vaccine was approved for emergency use by the Indian Medicines Agency on Friday, two sources with knowledge of the matter told Reuters.
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 new, contagious variant first discovered in the UK .
"We are testing whether our vaccine can also neutralize this variant and will soon know more," he said.
When asked how to manage a strong mutation, he said it was possible to tweak the vaccine as needed within six weeks – although such new treatments may require additional regulatory approvals.
Sahin also said BioNTech would make its vaccine easier to handle, which must be stored at around minus 70 degrees Celsius, adding that a next-generation vaccine could be ready by late summer.