September 9, 2020, 04.06 PM

"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.

Read also: Trump Administration to Pay Big Bucks for Pfizer’s Covid-19 Vaccine

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 percent, 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.

Read also: Indonesia Eyes Partnership with Bill and Melinda Gates Foundation on Covid-19 Vaccine

Sahin said inclusion in the pledge broadly reflected a significant vaccine market share or a leading position in coronavirus vaccine development.

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