A report released yesterday by the US Government Accountability Office (GAO) says supply chain issues could interfere with a smooth rollout of a COVID-19 vaccine and that the Food and Drug Administration (FDA) should disclose scientific review of vaccine and drug efficacy and safety data when issuing emergency use authorizations (EUAs). The report states that Operation Warp Speed, an effort of the Department of Health and Human Services, the Department of Defense, and private industry to dramatically accelerate development of COVID-19 vaccines and therapeutics, has condensed the timeline by directing more than $10 billion to vaccine manufacturers. But, it adds, the FDA needs to address public concerns that the process has been rushed, casting doubt on vaccine and drug effectiveness and safety. Four COVID-19 vaccine candidates are undergoing phase 3 trials in the United States: mRNA vaccines by Moderna and Pfizer/BioNTech and replication-defective live-vector vaccines by Janssen and AstraZeneca. All four vaccines allow cells to generate the spike protein of SARS-CoV-2, the virus that causes COVID-19, so the body can produce antibodies against it.

 

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