Last checked at 
* If all goes well, approval seen mid-Dec
* BioNTech CEO says market will welcome up to 8 vaccines
* CEO says working on more temperature resistant formulation
(Adds details on competitive setting, new formulation)
By Ludwig Burger and Patricia Weiss
FRANKFURT, Nov 18 (Reuters) - U.S. and European regulators
could approve Pfizer and BioNTech's
experimental COVID-19 vaccine as early as mid-December, the
German firm's chief executive said on Wednesday, following the
release of positive trial results.
Speaking to Reuters TV, Chief Executive Ugur Sahin said if
all goes well, the U.S. Food and Drug Administration could grant
emergency-use approval towards the end of the first half of
December or early in the second half.
Conditional approval in the European Union could be achieved
in the second half of December, he added.
"It will depend on the requests that we will receive and
whether all the conditions are met," he said.
Earlier on Wednesday, the partners unveiled trial results
showing their shot had a 95% efficacy rate across different age
groups and no serious side effects, a major milestone in the
race to end the pandemic.
Sahin said that any coronavirus vaccine that clears
regulatory hurdles over the next few months will be lapped up by
health systems around the world regardless of its relative
merits as demand will far outstrip supply.
"I don't really expect a competitive situation over the
first nine months because every dose of approved vaccine that
anyone can supply is welcome and will likely be used."
Moderna Inc on Monday released preliminary data for
its vaccine, showing 94.5% effectiveness. AstraZeneca,
working on a vaccine with Oxford University, is expected to
release results from its mass trial before year-end.
"The first five to eight companies (to win approval) will
not stand in each other's way... I assume it won't be before
mid-2021 that each vaccine will have to distinguish itself with
a specific profile," said Sahin.
He added that BioNTech and Pfizer were working on a refined
formulation of the vaccine that will not require ultra-cold
storage for easier handling in developing countries.
The more robust version would likely be launched during the
second half of next year, he said.
For now BioNTech's vaccine must be stored and transported at
-70C though it can be kept in a normal fridge for up to five
days, or up to 15 days in a thermal shipping box.
(Reporting by Ludwig Burger, Patricia Weiss and Tilman
Blasshofer; Editing by Jan Harvey and Aurora Ellis)
