So much for following science. Instead the FDA is continuing to follow “The Science’ which is consumed with politics and optics. They will fully approve this drug with no public review of their data after only 6 months of vaccinating the public and are doing it as boosters are now recommended after only 8 months. To make matters worse there is no control group to look at in the original trials because some genius decided to vaccinate those that received the placebo. It seems now the unvaccinated in the country are the real control group.
Kim Witczak, a drug safety advocate who serves as a consumer representative on the FDA’s Psychopharmacologic Drugs Advisory Committee,4 said the decision removed an important mechanism for scrutinising the data.
“These public meetings are imperative in building trust and confidence especially when the vaccines came to market at lightning speed under emergency use authorisation,” she said. “The public deserves a transparent process, especially as the call for boosters and mandates are rapidly increasing. These meetings offer a platform where questions can be raised, problems tackled, and data scrutinised in advance of an approval.”
Witczak is one of the more than 30 signatories of a citizen petition5 calling on the FDA to refrain from fully approving any covid-19 vaccine this year to gather more data. She warned that without a meeting “we have no idea what the data looks like.”
“It is already concerning that full approval is being based on 6 months’ worth of data despite the clinical trials designed for two years,” she said. “There is no control group after Pfizer offered the product to placebo participants before the trials were completed.
“Full approval of covid-19 vaccines must be done in an open public forum for all to see. It could set a precedent of lowered standards for future vaccine approvals.”
Covid-19: FDA set to grant full approval to Pfizer vaccine without public discussion of data | The BMJ