Yellow fever card
Photograph ©2016 by Brian Cohen.

First Vaccine Officially Approved For the 2019 Novel Coronavirus by the Food and Drug Administration

Which vaccine earned the honors?

The Food and Drug Administration of the United States officially approved the first vaccine for the prevention of the 2019 Novel Coronavirus earlier today, Monday, August 23, 2021 — and that vaccine is is now being marketed under the name Comirnaty, which has been known as the Pfizer-BioNTech COVID-19 Vaccine.

First Vaccine Officially Approved For the 2019 Novel Coronavirus by the Food and Drug Administration

The vaccine had been available under Emergency Use Authorization by the federal agency since Friday, December 11, 2020 for individuals who were at least 16 years of age; and the authorization was expanded on Monday, May 10, 2021 to include younger individuals between 12 and 15 years of age.

For all vaccines which undergo the standard process for reviewing the quality, safety and effectiveness of medical products in order to meet approval, the Food and Drug Administration evaluates data and information included in the submission of a biologics license application — which is also known as a BLA — by the manufacturer.

“A BLA is a comprehensive document that is submitted to the agency providing very specific requirements”, according to this official press release from the Food and Drug Administration of the United States. “For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made. The agency conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval.”

Comirnaty contains what is known as messenger RNA, which is a kind of genetic material. “The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19”, according to the aforementioned announcement. “The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into — nor does it alter — an individual’s genetic material. Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart.”

As with the other vaccines which are available in the battle against the 2019 Novel Coronavirus, Comirnaty continues to be available under Emergency Use Authorization for individuals who are at least twelve years of age — as well as for the administration of a third dose in certain individuals whose immune systems are compromised. Those other vaccines include those which have been developed by Janssen Biotech, Incorporated, which is also known as the Johnson & Johnson vaccine; and ModernaTX, Incorporated.

The approval is already apparently having an impact, as the Department of Defense of the United States is reportedly requiring members of all branches of the military in the United States to be vaccinated by Wednesday, September 15, 2021. At the time this article was written, that report has yet to be confirmed at any of the official Internet web sites of the federal government of the United States.

“Majorities of Americans support businesses requiring people to show proof of vaccination in order to participate in some public activities, but not others”, according to a poll from a survey conducted by Gallup between Monday, April 19, 2021 and Sunday, April 25, 2021. “Specifically, U.S. adults favor mandated vaccination certification for travel by airplane (57%) and to attend events with large crowds, such as concerts or sporting events (55%). However, there is less public support for proving vaccination to go to one’s workplace (45%), stay in a hotel (44%) or dine indoors at a restaurant (40%), with majorities opposing it in each instance.”

Final Boarding Call

Now that at least one of the vaccines has received official approval from the Food and Drug Administration, will that help change the minds of those individuals who are still not vaccinated against the 2019 Novel Coronavirus or its variants — and what impact will that official approval have on the travel industry?

As with the vaccine for yellow fever, should travelers be required to carry documentation which demonstrates proof of vaccination against the 2019 Novel Coronavirus? Must passengers be fully vaccinated in order to be able to board an airplane? Should the federal government of the United States issue a mandate to require that everyone be required to be fully vaccinated?

Photograph ©2016 by Brian Cohen.


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