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Coronavirus vaccine manufacturers pledge safety and high standards

 


The chief executive officers of nine leading pharmaceutical companies to produce vaccines against coronavirus are: Joint pledge Tuesday is an endeavor to build public confidence in a vaccine ultimately approved by the US Food and Drug Administration or similar agencies around the world.

The two companies said they would follow “high ethical standards and sound scientific principles” when performing time-sensitive work on global pandemics.

“We believe this commitment will help ensure public confidence in the rigorous scientific and regulatory processes by which the COVID-19 vaccine may be evaluated and ultimately approved,” he said. The two companies said.

U.S. public health officials worry that many Americans will not trust the vaccine to become available and that if it refuses to get the vaccine, it will be difficult to reduce the spread of COVID-19.

Specifically, nine companies promised the following:

• Make the safety of those who receive the coronavirus vaccine “a top priority”.

• Conduct clinical trials of vaccines according to “high scientific and ethical standards”.

• Request regulatory approval of candidate vaccines only after safety and efficacy have been established in Phase 3 clinical trials.

• Produce different vaccines to meet the needs of different people around the world.

This pledge was signed by the CEOs of the American pharmaceutical companies Johnson & Johnson, Merck, Moderna, Nova Vax, Pfizer, and the European companies AstraZeneca, Bio-N-Tech, GlaxoSmithKline, Sanofi.

They collectively noted that their company developed more than 70 vaccines against “some of the most complex and deadly public health threats in the world”.

The statement states that the FDA has received political pressure from President Trump Emergency use permit Before the tests necessary to prove that it is safe and effective are completed, the vaccine

These concerns were renewed last week after it was revealed that the Centers for Disease Control and Prevention called on public health departments across the country to prepare. Distribute coronavirus vaccine In just a few weeks. According to the plan, by October 1st, it should be drafted on a date consistent with “the earliest possible release of the COVID-19 vaccine”. 4-page note From Dr. Nancy Messonier, Director of the National Center for Vaccinations and Respiratory Diseases for CDC.

in addition, Dr. Robert RedfieldThe Director of the Centers for Disease Control and Prevention requested the governor to prepare to distribute the coronavirus vaccine by November 1st. First reported by McClatchy..

The presidential election is November 3rd.

Published last week by an industry association representing the pharmaceutical industry Open letter Demand an “objective evaluation of new data” on vaccines and treatments being developed to counter COVID-19. The letter states that public trust in new products depends on transparency and integrity in the evaluation process.

“The FDA needs to maintain its historical independence as an international regulator of the Gold Standard without being affected by the outside world,” writes the current and former leaders of the Biotechnology Innovation Organization. “Political considerations should be put aside by Republicans and Democrats alike. Leaders of our country should reassure the public that politics do not affect the development and approval of new drugs. “

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