Moderna vaccine enters Phase 3 | Daily News


Moderna vaccine enters Phase 3

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, on Tuesday told the editor of the Journal of the American Medical Association (JAMA) that an experimental coronavirus vaccine being developed by the biotech company Moderna will enter the last stage before potential governmental approval in July.

“We are preparing the sites for the phase 3 study,” Fauci told JAMA editor Dr. Howard Bauchner in the interview. “The real business end of this all is the phase three trial that starts in the first week in July.” Phase 3 trials are the final stage in a drug’s development before the U.S. Food and Drug Administration (FDA) considers approving it for mass production to the general public. Fauci projected that the study of 30,000 patients will include individuals as young as 18 and some who are elderly.

The public health official noted that the decision to begin working on the vaccine is a bold, and potentially dangerous, one.

“We and the companies and the federal government are doing this at risk,” Fauci told Bauchner regarding the government’s decision to start manufacturing dosages of the drug, even though there is a possibility that they may not work.

“We are going to start manufacturing doses way before we know whether the vaccine works — that’s going to be done as we are testing the vaccine,” Fauci explained. “We may know whether it’s efficacious by November or December. By that time, we would have 100 million (doses).” He added that by early 2021, the goal would be to have a “couple hundred million” more of those dosages available to the public

Last month Moderna’s stock price surged in value after it announced promising preliminary test results from its coronavirus vaccine trial. The company managed to suddenly reach a $29 billion market value as a result of its announcement, prompting former Securities and Exchange Commission chairman Harvey Pitt to say in an interview that “the confluence creates an appearance, which may be inaccurate, that people were in a rush to take advantage of an early positive trial in what is often a long and tortured development of a new drug.”

One possible challenge to the effectiveness of any vaccine is that many Americans may choose not to take it. A survey released by the Associated Press-NORC Center for Public Affairs Research released last week found that if a vaccine became available 49 percent of respondents would get vaccinated, 31 percent are not sure and 20 percent absolutely would not.

Dr. Russell Medford, Chairman of the Center for Global Health Innovation and Global Health Crisis Coordination Center, told Salon at the time that this would be a serious problem.

“By most estimates, at least 70% or more Americans need to be vaccinated against SARS-CoV-2 to develop effective herd immunity and to eliminate the virus in the US population,” Medford told Salon. “A vaccination rate of 50% will not achieve this.”


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