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Biotechs, Pharmas Vow Not to Rush Covid-19 Vaccines

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(Ewa Urban, Pixabay)

8 Sept. 2020. In a joint statement today, CEOs of nine companies promised to follow the highest ethical and scientific standards in development and testing of their Covid-19 vaccines. Taking part in the statement are biotechnology enterprises BioNTech, Moderna, and Novavax, and drug makers AstraZeneca, GlaxoSmithKline, Johnson & Johnson, Merck, Pfizer, and Sanofi.

The statement, released through BusinessWire, is an apparent response to actions and comments made by the U.S. Food and Drug Administration in late August, reportedly from political pressure by the White House. On 23 August, FDA gave an emergency use authorization, or EUA, for convalescent plasma as a treatment for confirmed or suspected infections in hospitalized Covid-19 patients. President Trump called it “a historic breakthrough” that day at the White House, with FDA commissioner Stephen Hahn looking on. Ten days later, a panel convened by National Institutes of Health updated its treatment guidelines for Covid-19, saying current data do not support recommending convalescent plasma as a therapy for Covid-19 infections.

On 30 August, Hahn told the Financial Times (paid subscription required) that the agency would consider issuing an EUA for a Covid-19 vaccine before completion of late-stage trials, if supported by the data. Those reports generated harsh criticism in industry newsletters and on social media.

In today’s statement the company CEOs pledged, “to make clear our on-going commitment to developing and testing potential vaccines for Covid-19 in accordance with high ethical standards and sound scientific principles.” The companies also promised to follow FDA’s own guidance requiring that “scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.”

Moreover, the statement committed the companies to seek “approval or emergency use authorization 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 FDA.” Phase 3 clinical studies are the large-scale, randomized, late-stage trials noted earlier.

In addition, the companies promised to “ensure a sufficient supply and range of vaccine options, including those suitable for global access.” This part of the statement refers to the companies’ participation in international programs, such as the Covid-19 Vaccine Global Access, or Covax facility backed by World Health Organization, European Union, and non-government organizations to provide worldwide equitable access to Covid-19 vaccines, once they’re approved. Nine vaccines backed by Coalition for Epidemic Preparedness Innovations, or CEPI, are part of Covax. On 1 September., the U.S. announced it would not take part in Covax.

As reported by Science & Enterprise on 1 September, AstraZeneca issued its own statement to “adhere to the highest scientific and clinical standards” in its Covid-19 vaccine development. That statement noted …

We are moving quickly but without cutting corners, and regulators have clear and stringent efficacy and safety standards for the approval of any new medicine, and that includes this potential Covid-19 vaccine. We will remain true to our values as we continue our efforts to bring this vaccine broadly and equitably to billions of people around world.

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Disclosure: The author owns shares in Pfizer and Johnson & Johnson.

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