Biopharma CEOs pledge safety first for COVID vaccine amid political pressure

The race for a COVID-19 vaccine will prioritize safety, science and high ethical standards, according to a historic pledge signed by nine biopharma CEOs amid vaccine hesitancy and political pressure for a speedy approval.

“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 pledge reads.

The nine companies included in the pledge are Moderna, BioNTech, Pfizer, AstraZeneca, GlaxoSmithKline, Johnson & Johnson, Merck, Novavax and Sanofi.

The pledge came on the same day AstraZeneca halted a Phase 3 study of its COVID-19 vaccine to review safety data after a study participant in the United Kingdom experienced an adverse reaction, according to multiple reports.

The company said it was a routine action and the illness is being investigated. Details about the nature of the reaction weren’t immediately released.

The CEOs who signed the safety pledge have agreed to follow clear guidance from the Food and Drug Administration to ensure a sufficient supply of vaccine and adhere to high scientific and ethical standards in the clinical trial and manufacturing processes.

The pledge also states that the companies will only submit a vaccine for approval after demonstrating safety and efficacy through a Phase 3 clinical study.

Many public health officials and scientists have expressed concerns that the Food and Drug Administration is under pressure from the White House to approve a vaccine before President Trump faces re-election on Nov. 3.

Trump hinted Monday that the U.S. could approve a coronavirus vaccine in October, ahead of the November election.

But, Americans may be unwilling to receive a shot if they believe it was rushed to market based on the campaign timetable.

2020 Democratic presidential candidate Joe Biden said Monday he would heed the advice of scientists about whether to get a coronavirus vaccine if one were to become available before November’s presidential election.

Pascal Soriot, CEO of AstraZeneca said in a statement, “We are putting science and the interest of society at the heart of our work. We are moving quickly but without cutting corners.”

Scientists must also confront potential vaccine hesitancy. An Associated Press poll conducted in May found that 20% of Americans said they would refuse to get a COVID-19 vaccine.

About half of the participants said they would get the vaccine and 31% said they weren’t sure yet if they would get vaccinated.

In Massachusetts, a COVID-19 Command Center spokeswoman said plans are being developed to ensure “equitable and speedy distribution to Massachusetts communities based on guidance provided by the CDC.”

Herald wire services contributed to this report. 

from Boston Herald https://ift.tt/3m2LkPM