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Top biopharma CEOs sign COVID-19 vaccine safety pledge

Leaders promise to uphold rigorous safety and efficacy protocols

The chief executive officers of a number of top companies working on COVID-19 vaccines issued a joint pledge yesterday, promising to uphold rigorous safety and efficacy protocols during and after the clinical development of their respective candidates.

The pledge was co-signed by the CEOs of nine pharma and biotech companies, including the leaders of AstraZeneca, Johnson & Johnson, Merck, Moderna and Novavax as well as Pfizer and BioNTech, and Sanofi and GlaxoSmithKline, the companies that are leading joint vaccine projects respectively, and stated:

'Following guidance from expert regulatory authorities such as the FDA regarding the development of COVID-19 vaccines, consistent with existing standards and practices, and in the interest of public health, we pledge to:

  • Always make the safety and well-being of vaccinated individuals our top priority
  • Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigour of manufacturing processes
  • Only submit for approval or emergency use authorisation after demonstrating safety and efficacy through a phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as the FDA
  • Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.'

The pledge follows concerns that the speed at which vaccines are currently being developed for COVID-19 could come with a cost – namely less rigorous safety and efficacy checks.

These concerns were exacerbated by comments made by US president Donald Trump that a vaccine for the novel coronavirus, SARS-CoV-2, could be available in just a few months.

“Under Operation Warp Speed we’re producing a vaccine in record time. This is a vaccine that we’re going to have very soon – by the end of the year, but much sooner than that, perhaps,” said Trump.

The crucial need for ensuring the safety of any potential vaccine has been further highlighted by the recent news that AstraZeneca has put its coronavirus vaccine clinical trials on hold, after one participant experienced serious side effects. While the nature of the illness was not disclosed, the patient is expected to recover.

Article by
Lucy Parsons

9th September 2020

From: Research



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