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 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.
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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)
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