Nine COVID-19 vaccine makers sign safety pledge

Nine leading US and European vaccine developers pledged 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 US 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).

“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.”

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 per cent, 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.