* CEO Sahin says can't fully cover lack of other vaccines
* Says testing BioNTech/Pfizer vaccine on UK COVID variant
* Could tweak vaccine for strong mutations in six weeks
* BioNTech may have more easily storable vaccine by summer
(Adds BioNTech comment on talks with EU)
By Douglas Busvine
BERLIN, Jan 1 (Reuters) - BioNTech is working
flat out with partner Pfizer to boost production of
their COVID-19 vaccine, its founders said, warning there would
be gaps in supply until other vaccines were rolled out.
The German biotech startup has led the vaccine race but its
shot has been slow to arrive in the European Union because of
relatively late approval from the bloc's health regulator and
the small size of the order placed by Brussels.
The delays in rolling out the home-grown vaccine have caused
consternation in Germany, where some regions had to halt
vaccinations within days of starting an inoculation drive.
"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.
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 approved quickly.
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 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."
After publication of the interview, BioNTech said it was in
talks with Brussels on boosting output
“We are in productive discussions with the European
Commission on how to make more of our vaccine in Europe, for
Europe," a spokeswoman said.
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, said Sahin.
Talks are also under way 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 enable a swift start
in Marburg.
The federal government, which has backed BioNTech with 375
million euros ($458 million) in funding, has resisted calls from
opposition leaders to speed production of its vaccine by issuing
compulsory licences to other drugmakers.
Another vaccine from Moderna is expected to be
cleared by the European Medicines Agency (EMA) on Jan. 6.
Spahn has also urged the EMA to quickly approve the Oxford
University-AstraZeneca shot cleared by Britain. The EU
timeline for that treatment remains uncertain.
That vaccine was approved by India's drug regulator on
Friday for emergency use, two sources with knowledge of the
matter 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 cope with a new, more contagious
variant first detected in Britain.
"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 also said BioNTech would make its vaccine, which
requires storage at about minus 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)