A committee of scientists, experts, specialists and researchers put together by the US Food and Drug Administration (FDA) has voted recommending approval of the Pfizer-BioNTech COVI-19 vaccine for emergency use.
The committee was asked whether, “based on the totality of scientific evidence available, do the benefits of the Pfizer- BioNTech COVID-19 vaccine outweigh its risk for use in individuals 16 years of age and older?”
Although the vote by the independent experts, including infectious disease specialists, biostatisticians and other scientists, is not officially binding, the FDA is expected to adopt the recommendation.
Britain, Canada, Bahrain and Saudi Arabia already approved the vaccine, the first in the world to complete the phase 3 clinical trial.
Russian and Chinese vaccines are already being administered on a large scale, without having completed the requisite 3-phase clinical trials.
The full results of the trial, which included nearly 44,000 people, were published in the New England Journal of Medicine, another major milestone.
These confirmed the vaccine was 95 percent effective with no serious safety issues.
Pfizer scientist Kathrin Jansen told the panel this was a result of the innovative messenger RNA technology behind the vaccine, an approach that has never before been approved.
Britain reported two health care workers developed significant allergic reactions to the vaccine as the country rolled out its massive drive.
The FDA pledges to include a warning label on the vaccine if it’s approved.AFP