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As Political Pressure Mounts, COVID-19 Vaccine Developers Pledge To Put Safety First

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As Political Pressure Mounts, COVID-19 Vaccine Developers Pledge To Put Safety First

Against the backdrop of pressure to expeditiously bring out a coronavirus vaccine as quickly as possible, biopharma companies working on vaccine candidates said as a group Tuesday that safety comes first.

The CEOs of nine biopharma companies that are among the frontrunners in the COVID-19 vaccine race released a signed pledge Tuesday that underlined their commitment to make the safety and well-being of vaccinated individuals their "top priority" in the development and testing process.

The signatories of the pledge include the CEOs of:

AstraZeneca plc (NYSE: AZN)

BioNTech SE – ADR (NASDAQ: BNTX)

Pfizer Inc. (NYSE: PFE)

Moderna Inc (NASDAQ: MRNA)

Merck & Co., Inc. (NYSE: MRK)

Johnson & Johnson (NYSE: JNJ)

Novavax, Inc. (NASDAQ: NVAX)

Sanofi SA (NASDAQ: SNY)

GlaxoSmithKline plc (NYSE: GSK)

The CEOs committed to adhere to high "scientific and ethical standards" in conducting clinical trials and manufacturing; to apply for emergency use authorization only after safety and efficacy are demonstrated through a large scale Phase 3 study done in accordance with the requirements of regulatory agencies; and work to ensure a sufficient vaccine supply.

"We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved," the CEOs said in the statement.

The industry's collective stance comes close on the heels of U.S. President Donald Trump pressuring the FDA into giving emergency use authorization to plasma therapy to treat COVID-19, the disease caused by SARS-CoV-2.

This is despite scientists and researchers expressing doubts regarding the therapy's efficacy in countering the virus.

See also: The Week Ahead In Biotech: Focus On Mallinckrodt FDA Decision, Conference Presentations

Trump Confident About Vaccine: Trump, who has seen his approval ratings slump ahead of the Nov. 3 election, has been vocal about pursuing an expedited vaccine timeline.

"We remain on track to deliver a vaccine before the end of the year and maybe even before Nov. 1. We think we can probably have it sometime during the month of October," Trump said in a Labor Day weekend press briefing.

Pfizer's CEO suggested that results from the final stage of clinical trials of a vaccine program conducted in partnership with Germany's BioNTech could be out soon, probably next month, Trump said in the statement.

"We have some really great companies. They're all doing very well. They're all in final stages, and I think you're going to see results that are shockingly good." 

Democrats Skeptical: Trump's Democratic challenger Joe Biden has expressed doubts over whether Trump will heed the advice of scientists and follow a transparent process.

"He has said so many things that aren't true I am worried that if we do have a really good vaccine people are going to be reluctant to take it," Biden said Monday.

Biden's running mate Kamala Harris has echoed a similar sentiment.

"I will say that I would not trust Donald Trump and it would have to be a credible source of information that talks about the efficacy and the reliability of whatever he's talking about," Harris said in an interview with CNN.

Related Link: Attention Biotech Investors: Mark Your Calendar For September PDUFA Dates

 

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