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* Companies pledge to uphold integrity of scientific process
* Debate about speed of development has become heated
* Mass testing with control groups are needed - statement
(Adds industry comment, background)
By Ludwig Burger, Patricia Weiss and Caroline Copley
FRANKFURT, Sept 8 (Reuters) - Nine leading U.S. and European
vaccine developers pledged on Tuesday to uphold the scientific
standards their experimental immunisations will be held against
in the global race to contain the coronavirus pandemic.
The companies, including Pfizer, GlaxoSmithKline
and AstraZeneca, issued what they called a
"historic pledge" after a rise in concern that safety and
efficacy standards might slip in the rush to find a vaccine.
The companies said in a statement they would "uphold the
integrity of the scientific process as they work towards
potential global regulatory filings and approvals of the first
COVID-19 vaccines".
The other signatories were Johnson & Johnson, Merck
& Co, Moderna, Novavax, Sanofi
and BioNTech.
The promise to play by established rules underlines a highly
politicised debate over what action is needed to rein in
COVID-19 quickly and to jumpstart global business and trade.
The head of the U.S. Food and Drug Administration (FDA) said
last month COVID-19 vaccines may not necessarily need to
complete Phase Three clinical trials - large-scale testing
intended to demonstrate safety and efficacy - as long as
officials are convinced the benefits outweigh the risks.
This prompted a call for caution from the World Health
Organization (WHO).
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 criticise a lack of testing.
The head of China's Sinovac Biotech has 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.
Chinese companies or institutions, which are involved in
several leading vaccine projects, did not sign the statement.
PROMISE ON SAFETY AND EFFICACY
"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, 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."
BioNTech and Pfizer could unveil pivotal trial data as early
as October, potentially placing them at the centre of bitter
U.S. politics before the Nov. 3 presidential
election.
President Donald Trump has said it is possible the United
States will have a vaccine before the election. His Democratic
rival, Kamala Harris, has said she would not take his word alone
on any potential coronavirus vaccine.
The nine companies said they would 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 said there must be statistical certainty of
95%, in some cases higher, and that a positive reading on
efficacy does not come just from random variations but reflects
the underlying workings of the compound.
The development race has intensified safety concerns about
an inoculation, polls have shown.
Western regulators have said they would not cut corners but
rather prioritise the review workload and allow for development
steps in parallel that would normally be handled consecutively.
Sahin declined to comment on regulators specifically or on
what events prompted the joint statement.
The chief executive of German vaccine developer Leukocare,
which did not sign the pledge, was more forthright.
"What Russia did - and maybe also there are tendencies in
the U.S. to push the approval of a vaccine which has not been
sufficiently developed in clinic – bears a huge risk," said CEO
Michael Scholl.
"My biggest fear is that we will approve vaccines that are
not safe and that will have a negative impact on the concept of
vaccinations in general."
Leukocare is working with Italy’s ReiThera and Belgium’s
Univercells to produce a COVID-19 vaccine currently in phase I
testing.
(Reporting by Ludwig Burger, Patricia Weiss in Frankfurt and
Caroline Copley in Berlin; Editing by Susan Fenton and Timothy
Heritage)
