In order to meet rigorous and scientific safety standards, Pfizer should wait at least till late November before seeking FDA authorisation of its COVID-19 vaccine, more than 60 leading researchers and bioethicists has said.
A letter which was obtained by Bloomberg Law and verified by six signatories, was sent on September 25 following the reports that Pfizer’s COVID-19 vaccine clinical trial will yield conclusive results in October which puts the company ahead of Moderna and AstraZeneca in the race of the vaccine.
A spokeswoman from Pfizer confirmed the news that the company received the letter and is also working on a response.
As reported by Bloomberg, Pfizer had signed a pledge earlier this month to not to cut corners on a vaccine.
The researchers in the letter said, "Under this standard, trial participants should be monitored for a minimum of two months following administration of the second dose. Given that many trial participants have not yet received their second dose, monitoring should occur through at least late November before an application for an Emergency Use Authorization should be considered by the FDA."
"If your vaccine is 75 percent effective, an estimated two thirds of the population would need to be vaccinated to achieve herd immunity. This vaccination rate would far exceed that of the annual influenza vaccine. To be successful, the public needs to have the utmost trust in the vaccine and the science behind it."
The scientists also added that “a premature application would prolong the pandemic, with disastrous consequences. The reputation of Pfizer and the pharmaceutical industry would be severely damaged."
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