9 COVID-19 vaccine developers pledge to uphold testing rigour, scientific standards

*Assure the global world of integrity of scientific process as they work towards potential global regulatory filings and approvals of first COVID-19 vaccines ─Report

Isola Moses | ConsumerConnect

As the global community awaits the conclusions of ongoing research, and eventual production and release of vaccines against the disruptive Coronavirus disease (COVID-19), nine leading European and United States (US) vaccine developers have assured consumers to uphold scientific standards their experimental immunisations will be held against in the race to contain the pandemic.

The companies, including Pfizer (PFE.N), GlaxoSmithKline (GSK.L) and AstraZeneca (AZN.L), in a statement Tuesday, September 8, 2020, 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.

Other signatories to the pledge were Johnson & Johnson (JNJ.N), Merck & Co (MRK.N), Moderna (MRNA.O), Novavax (NVAX.O), Sanofi (SASY.PA) and BioNTech (BNTX.O).

The drug manufacturing companies stated that 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.”

Their 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.

It is recalled that the Head of US Food and Drug Administration (FDA) in August said COVID-19 vaccines might 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.

The pronouncement was said to have prompted a call for caution from the World Health Organisation (WHO).

Though vaccine 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.

In an instance similar to Head of FDA’s recent pronouncement on the country’s readiness to release a vaccine, the Head of China’s Sinovac Biotech (SVA.O) said most of its employees and their families had 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, however, did not sign the statement, report said.

On their promise to ensure safety and efficacy of their vaccines when released, co-signatory Ugur Sahin, Chief Executive of Pfizer’s German partner BioNTech, said: “We want it to be known that also in the current situation we are not willing to compromise safety and efficacy.

“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.

Nonetheless, the nine companies said they would follow established guidance from expert regulatory authorities such as the FDA.

It is also noted that 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%, 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.

Source Link: 9 COVID-19 Vaccine Developers Pledge To Uphold Testing Rigour, Scientific Standards https://consumerconnectng.com/5925/2020/09/9-covid-19-vaccine-developers-pledge-to-uphold-testing-rigour-scientific-standards/