Dr. Peter Doshi is a Professor at the University of Maryland and a Senior Editor of the British Medical Journal (BMJ). He recently appeared alongside several other doctors and medical researchers in a panel discussion put on U.S. Sen. Ron Johnson (R-Wis.)
The FDA should demand adequate, controlled studies with long term follow up, and make data publicly available, before granting full approval to covid-19 vaccines, says Peter Doshi
After rollout under emergency authorisation, manufacturers of covid-19 vaccines now have their sights on regulatory approval. But what’s the rush, asks Peter Doshi, and is just six months of data from now unblinded trials acceptable?
With a “vaccine” based on untested technology, and safety trials still ongoing, is it safe to take the shot? And does it even work? And does a disease with an IFR of 0.2% even justify that risk?
This petition for a stay of action is submitted by the undersigned (“Petitioner” or “Lead Petitioner”) to request the EMA a) stay the Phase III clinical trial(s) of BNT162b (EudraCT Number 2020-002641-42) in the EU (current protocol country: Germany)
The ongoing phase III trials for covid-19 vaccines are some of the most consequential randomised trials ever done. In September, following months of campaigning for greater openness, four manufacturers made their full study protocols publicly available. The publications create a rare opportunity for “real time transparency” in which the conduct of clinical trials is opened to public scrutiny while the studies are still under way.
The world has bet the farm on vaccines as the solution to the pandemic, but the trials are not focused on answering the questions many might assume they are. Peter Doshi reports