By Ludwig Burger and Patricia Weiss
FRANKFURT (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 (N:PFE), GlaxoSmithKline (L:GSK) and AstraZeneca (L:AZN), 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 (O:SVA) 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 (O:BNTX).
"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 (N:JNJ), Merck & Co (N:MRK), Moderna (O:MRNA), Novavax (O:NVAX) and Sanofi (PA:SASY).
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.