Pfizer is taking time till late November to seek FDA authorization of its COVID-19 vaccine until it meets the rigorous safety standard. Their trial will be yielding consecutive results in October. So the company will be ahead of other companies like Moderna Inc. and AstraZeneca PLC and other promising vaccine candidates. The researchers said Pfizer’s clinical trial needs to monitor participants for at least two months after they received the second dose.
“To be successful, the public needs to have the utmost trust in the vaccine and the science behind it,” the letter said. “Submission of an application for a EUA before this standard is met would severely erode public trust and set back efforts to achieve widespread vaccination. “The scientists added that “a premature application would prolong the pandemic, with disastrous consequences.”
The Pfizer spokesperson has confirmed that the company has received the letter and is working on a response. The letter has asked to focus on safety and rigor. The company has signed the pledge earlier this month not to cut the corner with the vaccine.
The signatories of the letter include scientists from a variety of public health backgrounds, including Joshua M. Sharfstein, Vice Dean for public health practice and community Engagement at Johns Hopkins University and a former Second-in-Command at the FDA; Esther K. Choo, an emergency medicine Physician, and Professor at Oregon Health & Science University; and Jeffrey R. Botkin, a University of Utah professor, of pediatrics and medical ethics.
