On Wednesday, the FDA (Food and Drug Administration) approved the Pfizer-BioNTech Covid-19 vaccine boosters for people aged 65 and above and those whose jobs put them at a higher risk of contracting Covid.
The FDA approved Pfizer boosters for individuals aged 18 and older who are at potential risk of contracting Covid. However, they must wait at least 6 months after their second dose of the Covid vaccine to receive the booster.
Dr. Janet Woodcock, the FDA commissioner in a recent statement, listed the qualifying jobs that put employees at severe risk of catching the virus. It included, “health care workers, teachers and daycare staff, grocery workers and those in homeless shelters or prisons, among others.”
The decision for Pfizer boosters was taken 6 weeks later when the FDA approved extra vaccine doses of Moderna and Pfizer for those who are gravely immune-compromised.
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Albert Bourla, chairman and CEO of Pfizer, stated, “We believe Pfizer boosters have an important role to play in addressing the continued threat of this disease, alongside efforts to increase global access and uptake among the unvaccinated”
The Pfizer boosters will not be brought to the vaccination centers unless Disease Control and Prevention organize a committee to decide who should be getting the Pfizer boosters.
Pfizer and Moderna had not initially asked for FDA’s approval for Pfizer boosters. A month before the decision came, they applied to get authorization to introduce Pfizer boosters for people aged 16 and those who have waited 6 months since their 2nd dose of the vaccine.
After analyzing the application and data that Pfizer and Moderna submitted, the FDA concluded and announced the authorization on Wednesday, Sept 22.
On Friday, the FDA’s advisory committee noticed that the available data is not sufficient to mandate the Pfizer boosters for people aged 65 and above.
Phyllis Arthur, VP of infectious diseases and diagnostics policy, said “that was relatively unusual” on the information presented. “A lot of their conversation was around whether there was enough ability to parse the data out by population… to ensure the data was clear for multiple populations,” – she stated.
Medical researchers from Israel suggested that the Covid-19 vaccine’s impact will wane after 6 months with mild infection causing to vaccinated people and leading to severe disease.
The FDA committee is waiting for more data to gather to make the final decision to approve Pfizer booster for people aged 16 and above.
However, the Vaccines and Related Biological Products Advisory Committee cast their votes to introduce the 3rd dose of vaccine that will be given after 6 months of the 2nd dose and to those at high risk of contracting Covid.
The Pfizer boosters require CDC committee approval to make it publicly available. The CDC is expected to make a final decision on Wednesday afternoon. Then, the final verdict will be signed by Dr. Rochelle Walensky for authorization.
Once the CDC approves, Pfizer boosters will be made publicly available for health care workers.