By Ludwig Burger and Patricia Weiss
FRANKFURT, Sept 8 (Reuters) - Nine leading U.S. and European
vaccine developers pledged on Tuesday to uphold the scientific
standards that their experimental immunisations will be held
against, amid a hurried global race to contain the pandemic.
The companies, including Pfizer, GlaxoSmithKline
and AstraZeneca, in a joint statement made a
"historic pledge... to uphold the integrity of the scientific
process as they work towards potential global regulatory filings
and approvals of the first COVID-19 vaccines".
The unusual move to promise to play by well-established
rules underlines a highly politicised debate over what action is
needed to quickly rein in the spread of the deadly disease and
to jumpstart global business and trade.
The head of the U.S. Food and Drug Administration (FDA) said
last month that the normal approval process may be bypassed for
a COVID-19 vaccine as long as officials were convinced the
benefits outweigh the risks, prompting a call for caution from
the World Health Organisation.
Developers globally have yet to produce large-scale trial
data showing actual infections in participants, yet Russia
granted approval to a COVID-19 vaccine last month, prompting
some Western experts to criticize a lack of testing.
The head of China's Sinovac Biotech said most of its
employees and their families have already taken an experimental
vaccine developed by the Chinese firm under the country's
emergency-use programme.
"We want it to be known that also in the current situation
we are not willing to compromise safety and efficacy," said
co-signatory Ugur Sahin, the chief executive of Pfizer's German
partner BioNTech.
"Apart from the pressure and the hope for a vaccine to be
available as fast as possible, there is also a lot of
uncertainty among people that some development steps may be
omitted here," he added.
BioNTech and Pfizer have raised the prospect of unveiling
pivotal trial data in October, potentially placing it at the
centre of bitter U.S. presidential politics ahead of the Nov. 3
election.
According to the statement, the nine companies pledge to
follow established guidance from expert regulatory authorities
such as the FDA.
Among other hurdles, approval must be based on large,
diverse clinical trials with comparative groups that do not
receive the vaccine in question. Participants and those working
on the trial must not know which group they belong to, according
to the pledge.
BioNTech's Sahin added there must be statistical certainty
of 95%, in some cases higher, that a positive reading on
efficacy does not just come from random variations but reflects
the underlying workings of the compound.
The list of co-signatories is completed by Johnson & Johnson
, Merck & Co, Moderna, Novavax
and Sanofi.
Sahin said inclusion in the pledge broadly reflected a
significant vaccines market share or a leading position in
coronavirus vaccine development.
The frenetic development race has intensified safety
concerns about an inoculation, polls have shown.
Western regulators have stressed they would not cut corners
but rather prioritise the review workload and allow for
development steps in parallel that would normally be handled
consecutively.
(Reporting by Ludwig Burger and Patricia Weiss; Editing by
Susan Fenton)
Glaxosmithkline (GSK)
Astrazeneca (AZN)
