FDA Approves Pfizer Vaccine, Mandates Expected

Today, The U.S. Food and Drug Administration approved the Pfizer-BioNTech COVID-19 Vaccine, which will now be Comirnaty according to a statement released earlier. The vaccine is available for people who are at least 16 years of age as well as for children between the ages of 12 and 15 in accordance with emergency use authorization. In addition, a third dose of the vaccine is available for people with an impaired immune system. Kansas City will start to administer third doses today at the Kansas City Health Department Clinic (2400 Troost).

While all other vaccines administered in the United States have been authorized for emergency use, Comirnaty is the first to be approved by the FDA.

“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated," said Acting FDA Commissioner Janet Woodcock, M.D. "Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

How the Vaccine Works

Though FDA approval is likely to put the minds of many to ease, many people are still concerned about how the vaccine works.

Comirnarty contains the genetic material of sorts known as messenger RNA (mRNA) which the body uses to imitate a protein that results in COVID-19. To be clear, COVID-19 is not injected into the body; mRNA only acts like the protein that causes the virus. As a result, the immune system responds in self-defense and builds up strength against COVID-19 before the mRNA is broken down and leaves the body. The mRNA does not enter the nucleus of the cells (where our DNA is stored) and, therefore, cannot alter human DNA.

Different Name, Same Formula

The name may have changed, but the formula has remained the same. Anyone who has received the Pfizer vaccine has received the FDA-approved version.

“We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines," said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. "The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S."

Vaccination Mandates Expected

Along with FDA approval came the announcement of vaccination mandates for government entities, Pentagon staff, and New York City school teachers and staff, The Hill reported.

“For businesses and universities that have been thinking about putting vaccine requirements in place in order to create safer spaces for people to work and learn, I think that this move from the FDA, when it comes, will actually help them to move forward with those kinds of plans,” said Surgeon General Vivek Murthy to CNN yesterday.

Those who wish to be absolved of vaccination mandates may do so per religious and medical exempts, though they will likely have to agree to regular COVID-19 testing–as is the case for Jackson County employees here in Kansas City.