In tight elections, people fear an “October surprise” that can jolt voters one way or another. A possible one to consider: @realdonaldtrump pushes the @US_FDA to approve a coronavirus vaccine before it’s tested & shown to be safe and effective. A thread. nytimes.com/2020/06/08/opi…
Given how this president has behaved toward science agencies like the @US_FDA, this incredibly dangerous scenario is not far-fetched. 2/
First, consider that it will likely take at least another 8-12 mo. to determine whether coronavirus vaccines are effective. NO vaccine since the 1950s has been approved and licensed without completing large, prospective, placebo-controlled studies of safety and effectiveness. 3/
But that’s just the start. You also need effectiveness trials to see if the vaccine really reduces the infection rate, as well as how many people develop uncommon side effects. For the rotavirus vaccines, this took about 4 yrs; for PPV to prevent cervical cancer took 7 years. 4/
Then the @WhiteHouse badgers the @US_FDA to permit use — just like #hydroxychloroquine. More pressure would come from big drug companies who stand to gain. With the fate of Rick Bright in mind, the FDA could issue an “emergency authorization.” 6/
But antibody production does not prove a vaccine is effective in preventing infection. Not only could we miss rare and serious side effects, but it also could give a false sense of security and lead to more serious Covid-19 outbreaks. 7/
The @US_FDA must require more than the production of antibodies to approve a vaccine, even for an emergency authorization, much less licensing. We need independent data and a monitoring board of ind. scientists to review the data before approval. 8/
Over 100K Americans have already died from #COVID19 as Donald Trump perpetually postponed effective public health interventions & made poor therapeutic recs. We must prevent him from corrupting the rigorous assessment of safety & effectiveness of vaccines: nytimes.com/2020/06/08/opi…
