FDA Approves Pfizer-BioNTech Vaccine
On August 23, 2021, the U.S. Food and Drug Administration (FDA) fully approved the Pfizer-BioNTech coronavirus vaccine. This licensing could help increase inoculation rates and is likely to encourage the already growing wave of vaccine mandates by employers and universities.
The Pfizer-BioNTech vaccine is the first licensed vaccine for coronavirus. This means that the vaccine has been approved for use outside of emergency use authorization. Rebranded Comirnaty, the Pfizer-BioNTech vaccine has been approved for two doses, three weeks apart, for individuals 16 and older. The vaccine is also available to adolescents ages 12 to 15 and certain immunocompromised indivuals are now eligible for a third dose under emergency authorization. The vaccine is composed of messenger RNA (mRNA), a kind of genetic material that is used by the body to mimic one of the proteins in the virus that causes COVID-19. The vaccine causes the individual’s immune system to react defensively to the virus that causes COVID-19. According to the FDA, the mRNA in the vaccine is only present in the body for a short period of time and does not alter or impact an individual’s genetic material. Over 200 million Americans have already received the vaccine.
A Speedy Process
Some critics of the agency have been pushing the FDA to move faster with the approval process, claiming that the emergency authorization of the vaccine demonstrated the safety and effectiveness of the shot. Despite the criticism, the approval process for the Pfizer-BioNTech vaccine was the fastest in FDA history. The vaccine was approved less than four months after Pfizer filed for licensing in May of this year. Unless a previously unobserved side effect develops, the FDA approval of the vaccine will last indefinitely.
Moving Forward with the Pfizer Vaccine
The Center for Disease Control’s vaccine advisory committee is expected to meet soon to decide on recommending the approved vaccine. The advisory committee has already recommended the Pfizer-BioNTech vaccine for use in an emergency capacity, so it is almost certain that they will recommend the licensed product. Pfizer-BioNTech has also submitted early-stage data to the FDA for its booster licensing application.
Vaccine Mandates by Employers
There may be an increase in vaccination rates with the federal approval of the vaccinations. However, this could also be attributed to the spike in cases of the Delta Variant. There are predictions that the licensing of the Pfizer-BioNTech will lead to increased vaccine requirements by colleges, workplaces, and concert or film venues. This summer, many companies such as Google and United Airlines began to mandate vaccinations for their employees. Experts believe that federal approval will encourage other companies to follow suit. These vaccine requirements are designed to protect workers against the highly contagious virus.
Seek Legal Assistance Today
If you have any questions about vaccines in the workplace, seek legal assistance from the Law Office of Christopher Q. Davis, located in New York City and Livingston, NJ. Contact us today at (646) 430-7930 to schedule a free case evaluation and receive experienced legal counsel.