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.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
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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