US, European COVID vaccine developers pledge to uphold testing rigour

FRANKFURT: Nine leading US and European vaccine developers pledged on Tuesday 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).
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 criticise a lack of testing.
The head of China’s Sinovac Biotech has 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. Chinese companies or institutions, which are involved in several leading vaccine projects, did not sign the statement.

PROMISE ON SAFETY
AND EFFICACY
“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.”
BioNTech and Pfizer could unveil pivotal trial data as early as October, potentially placing them at the centre of bitter US politics before the November 3 presidential election.
President Donald Trump has said it is possible the United States will have a vaccine before the election. His Democratic rival, Kamala Harris, has said she would not take his word alone on any potential coronavirus vaccine. 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.
— Reuters