In a New. York Times op-ed this week, Dr. Ezekiel J. Emanuel and Dr. Paul A. Offit of the University of Pennsylvania worried that potential pressure to produce good news for the Trump administration by October — before the November presidential election — could have negative consequences.
“Giving people a false sense of being protected will most likely lead to serious outbreaks of the disease as people reduce their compliance with physical distancing and other public health measures,” Emanuel and Offit said. “If only 20,000 participants receive the vaccine, serious but rare side effects might be missed. If such harms eventually arise, it could further erode a fragile vaccine confidence and threaten the ability to get enough people vaccinated to establish herd immunity. That would be a disaster.”
FDA approval, even under an emergency use authorization, should still require a review of trial data by an independent data safety and monitoring board in order to reach conclusions about safety and efficacy, the doctors said.
Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, remains cautiously optimistic that there will be a COVID-19 vaccine available by the end of the year. “If we do that, that will overwhelmingly be the fastest we’ve ever gotten a vaccine. That gives me hope,” Fauci recently told Healthline.
A number of vaccine candidates around the world are showing promise and entering the clinical studies phase — a speed of development usually unheard of in the vaccine space. Just today, Johnson & Johnson announced its Janssen Pharmaceutical subsidiary has moved up first-in-human clinical trials of its COVID-19 vaccine candidate to late July, versus the previously planned start in September.
To accelerate the availability of a potential vaccine, the White House has created a private-public partnership called Operation Warp Speed to build manufacturing capacity before clinical trials of vaccine candidates are even completed. The idea is that it’s worth it to risk hundreds of millions of dollars on ramping up manufacturing of a potential vaccine that may not prove effective — the upside being that the vaccine could get to people quickly if it turns out to work.
Filed Under: clinical trials, Drug Discovery, Infectious Disease