9 biopharmaceutical companies including Massachusetts-based Moderna sign COVID-19 vaccine safety pledge as White House pushes for rapid development timeline

As the Trump administration pushes for the rapid development of a vaccine against the coronavirus, the leaders of nine biopharmaceutical companies have signed a safety pledge, assuring the public that high scientific and ethical standards will be met when developing any COVID-19 vaccination.

The CEOs who signed the pledge include the heads of three companies that are in the midst of large-scale third-phase clinical trials of coronavirus vaccine development in the United States.

Vaccine developers include Cambridge, Massachusetts-based biotechnology company Moderna, Inc., UK drugmaker AstraZeneca, and New York-based pharmaceutical company Pfizer.

The other signatories to the pledge were BioNTech, Novavax, Sanofi, GlaxoSmithKline, Johnson & Johnson and Merck.

Collectively, the nine companies have developed more than 70 vaccines to help eradicate some of the world’s “most complex and deadly public health threats”, highlighting their experience in “clinical development and regulatory rigor,” the pledge says. .

“We, the undersigned biopharmaceutical companies, wish to clearly state our continued commitment to develop and test potential COVID-19 vaccines in accordance with high ethical standards and sound scientific principles,” the companies pledge states.

As part of their commitment, the companies pledged to make the safety and well-being of those vaccinated a top priority and to adhere to high standards for the conduct of clinical trials and manufacturing processes.

They also committed to only submitting vaccines for approval or authorization for emergency use after demonstrating safety and efficacy through a phase 3 clinical study and worked to ensure an adequate supply of vaccines and a range of options for global use.

All potential coronavirus vaccines, the companies noted, are being reviewed and determined by expert regulatory bodies around the world, such as the United States Food and Drug Administration, and the FDA has set “clear directions” for the development and authorization of these vaccines.

The agency’s criteria are based on medical principles required to prove the safety of potential COVID-19 vaccines, according to the biopharmaceutical companies.

“Specifically, the agency requires that scientific evidence for regulatory approval come from high-quality, randomized, observer-blind clinical trials, pending appropriately designed studies with significant numbers. participants in diverse populations, ”the companies wrote. in their commitment.

The announcement of the pledge comes as the White House continues to tell the public to expect a vaccine by the end of fall.

The Centers for Disease Control and Prevention sent documents to officials in all 50 states as well as five major cities on August 27, telling them millions of doses of the COVID -19 vaccine could be available by late October or early November 2020 , The New York Times first reported.

On the same day, President Donald Trump said in his address to the Republican National Convention that a vaccine could be developed before the end of 2020, according to the Times report.

The newspaper pointed out in its reporting that there were concerns that the Trump administration was trying to speed up the distribution of a vaccine before election day on November 3.

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