Moderna is leading the way in coronavirus vaccine development; however, an investigator commented that he is worried about possible political pressures that can affect its regulatory approval.
Dr. Carlos del Rio, an investigator for the drug company’s clinical trials, said politics have already affected scientific studies. He was referring to previous research regarding the coronavirus pandemic that did not require vaccine compliance.
Del Rio is an infectious disease expert from Atlanta’s Emory University School of Medicine. He mentioned his concern on the timing of the FDA’s granting of emergency approval to use convalescent plasma to fight coronavirus. This novel treatment was used on hospitalized coronavirus patients with the official announcement before the Republican National Convention.
The investigator also referred to the recent report published by Politico that said communications heads in the Department of Health and Human Services were forced to change reports on COVID -19 released by the CDC.
Del Rio further said that there is so much evidence of political pressure in science, and if this is happening until now, there’s no reason why it could not happen again. Meanwhile, Dr. Stephen Hahn, head of the FDA, said that there should be no worries about vaccine trials’ political interference. He also said that he has absolute confidence in scientists and researchers in the FDA and said he is not interested in overruling these FDA experts’ decisions.
Moderna has recently published its Phase III coronavirus vaccine study contract as the company enrolls more participants. More than 10,000 have received the vaccine’s first and second doses. The Cambridge, Massachusetts – headquartered company said that their COVE study is on its third phase, and it is dedicated to publishing the results of its research online.
The document that described Moderna’s study of the SARS-CoV-2 virus vaccine is 135 pages long and breaks down every little detail of how their vaccine development and trials were accomplished. The report also mentioned how the company plans to ensure that the vaccine is safe and will not cause any dangerous side effects.
According to the current development of the vaccine trial and Moderna’s manufacturing capacity, it is unlikely that an approved vaccine could be ready for every resident in the United States in the first quarter of next year. The coronavirus vaccine will likely be widely available during the second half of 2021.
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