United States' top infectious diseases expert, Dr. Anthony Fauci stated in an interview on Tuesday that if clinical trials produce overwhelmingly positive results, the vaccine may be made available for public use earlier than initially expected.
According to Fauci, while clinical trials on two vaccines, with more than 30,000 volunteers, are set to end by the year's end, there is a way to expedite the process. The National Institute of Allergies and Infectious Diseases director stated that if interim results of the trials reap positive results weeks before its conclusion, an independent board can authorize to end it.
Fauci also added that if the Data and Safety Monitoring Board could state that the data is already good enough to prove that the vaccine is safe and effective, researchers would be obligated to cut the trials short. Thus, they would need to give the vaccine to all who were involved in the study, including the placebo group, and expedite the process of making the vaccine available to millions, CNN stated in a report.
The statement from the infectious diseases expert follows the increasing concern that those who are overseeing the vaccine trials and federal regulators are succumbing to the pressure of the Trump administration.
Moreover, the confidence of people in vaccines has also eroded that at least 40% of Americans have stated that they will not get the COVID-19 vaccine even if it would be given for free.
Experts have also expressed worry about Trump possibly rushing the development of a vaccine to increase his ratings before the election in November.
On the other hand, Fauci has expressed confidence that the members of the DSMB, who are not government employees and are experts on the field will scrutinize the data without being swayed by political influence. Independent members of the board are usually vaccine science experts in the academe and are employed in top medical schools.
Duties of the Data and Safety Monitoring Board
On top of this, Fauci explained that the role of the DSMB is to review the data from the clinical trials periodically in order to determine if it is still ethical for the enrolment of volunteers to continue. The volunteers are under a randomized placebo trial which means that the volunteers, not the health workers do not know ho are receiving the test vaccines and the placebo.
According to Daily Mail, at the moment Department of Health and Human Services deputy chief of staff for policy, Paul Mango stated that only the DSMB has access to the data from the vaccine trials. He also noted that they are still unable to give a specific date on when the results of the trials will be available but they are looking into a timeframe between October and December.
Meanwhile, Scripps Research in San Diego's executive vice president for research, Dr. Eric Topol stated that while the stopping rules have been set by the board at the beginning, the decision on ultimately ending the trials lies in the hands of those running the experiment.
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