Western Coronavirus Vaccine Producers Pledge to Uphold Testing Rigor

FRANKFURT, KOMPAS.com – Nine top American and European coronavirus vaccine producers pledged to uphold rigorous scientific standards amid a hurried global race to find a cure.

The pledge was made Tuesday and comes as experimental immunizations of a coronavirus vaccine intensify.

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 politicized debate over what action is needed to quickly rein in the spread of the deadly disease and to jumpstart global business and trade.

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The head of the US Food and Drug Administration (FDA) said last month that the normal approval process may be bypassed for a coronavirus 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 coronavirus 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 program.

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"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 center of bitter US presidential politics ahead of the November 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.