The chief executive officers of nine leading drug companies working on making a vaccine for COVID-19 signed a pledge to develop their vaccines by observing the highest ethical standards and making the safety and well-being of the vaccinated individuals their top-most priority.
The nine companies are AstraZeneca AZN, Pfizer PFE and its German partner BioNTech BNTX, Glaxo GSK, J&J JNJ, Merck MRK, Moderna MRNA, Novavax (NVA, and Sanofi. Of these, COVID-19 vaccine candidates of AstraZeneca (AZN)/Oxford University, Moderna, and Pfizer/BioNTech are already in large late-stage clinical studies. J&J is expected to initiate a pivotal phase III study this month.
The companies vowed not look out for approval or emergency use authorization (EUA) for their vaccine candidates from the FDA and other regulatory agencies until their respective vaccines are proven to be safe and effective through large phase III studies, which meet the requirements of the FDA. The companies pledged to observe high ethical standards in conducting clinical studies and manufacturing the vaccines. The companies also ensured an adequate supply of a range of vaccine options for global use.
The FDA, in June, had issued guidance documents, specifying the data that the companies need to submit in order to get approval for their COVID-19 vaccines. Though the FDA is looking to expedite the development of a vaccine, it made it clear that it “will not cut corners” and sacrifice its standards for quality, safety, and efficacy while giving its decision for approval. The FDA encouraged that the clinical studies should be large and of high quality and should include diverse patient populations including children and elderly. The guidance mentioned that the primary efficacy endpoint point of a placebo-controlled efficacy trial should be at least 50%, which means the vaccine should be able to lower the risk of the disease caused by the SARS-CoV-2 virus in at least 50% of the people who are vaccinated.
The news of the joint safety pledge comes amid rising pressure by the Trump administration to get a vaccine approved before the re-election in November. The U.S Centers for Disease Control and Prevention (CDC) also recently asked states to be ready to distribute a potential COVID-19 vaccine by Nov 1. Last month, Trump had publicly expressed frustration at the slow pace of approval for coronavirus treatments/vaccines by the FDA for political reasons.
However, on Thursday, the White House Press Secretary Kayleigh McEnany said that there is no political pressure on U.S. regulatory agencies to quickly approve a vaccine. Meanwhile, FDA’s head Stephen Hahn, last month, said that the regulatory agency may consider granting EUA to a COVID-19 vaccine as long as its benefits outweigh the risks, which is the regulatory agency’s criteria for EUA bbefore advanced phase III studies are completed. However, he clarified that it will not do so to please President Trump.
The joint safety pledge should come as a bit of a relief over rising public concerns about political noise influencing the FDA’s decision and resultant pre-mature approval of a COVID-19 vaccine.
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