What FDA Approval Might Mean for Vaccine Mandates

August 11, 2021 by Alexa Hornbeck
What FDA Approval Might Mean for Vaccine Mandates
(Food and Drug Administration photo)

As the Delta variant continues to spread, COVID cases surge among the unvaccinated, and rates of new vaccinations decline, the U.S. Food and Drug Administration is receiving pressure from President Joe Biden to approve a COVID vaccine. Biden recently said during a town hall event that he expects a fully approved vaccine to be made available by fall. 

“They’re not promising me any specific date, but my expectation, talking to the group of scientists we put together… plus others in the field, is that sometime, maybe in the beginning of the school year, at the end of August, beginning September, October, they’ll get a final approval,” Biden said.

Pfizer-BioNTech, Moderna, and Johnson &Johnson vaccines have been authorized for emergency use in the U.S., and Moderna and Pfizer have filed applications for full licensure at the start of the summer in May-June, but a full FDA approval typically requires six months of efficacy data.

Pfizer issued a statement in July that the FDA granted the vaccine for priority review designation for the Biologics License Application for the mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older, and the goal date for the decision by the FDA is in January 2022. Acting FDA Commissioner Janet Woodcock issued a statement that a decision should come well before that time. 


The conflict posed by having only an emergency use authorization for vaccines is whether or not COVID-19 vaccines can be legally mandated.


That’s why a full approval of a vaccine could mean a wave of new mandates from employers, schools, hospitals, etc.

The University of California system initially announced that they would require students to get vaccinated “with FDA approval” and has since decided to require vaccinations anyway under the emergency use approval. 

Already there have been lawsuits filed over vaccine mandates, such as a situation at Houston Methodist Hospital, in which 200 employees were suspended without pay for failing to get vaccinated, leading to 117 suspended employees filing a lawsuit that the vaccines were experimental and dangerous. 


The courts dismissed the lawsuit, indicating that the requirement does not violate federal or public policy.

Many companies and universities will continue to toe the line on whether a vaccine could be mandated without full FDA approval, and other potential lawsuits could emerge if an individual does not wish to comply with the mandate. 

A+
a-

In The News

Health

Voting

Health

Arizona Clinic Has Workaround for Abortion Pill Ban

PHOENIX (AP) — A Phoenix abortion clinic has come up with a way for patients who can end their pregnancy... Read More

PHOENIX (AP) — A Phoenix abortion clinic has come up with a way for patients who can end their pregnancy using a pill to get the medication quickly without running afoul of a resurrected Arizona law that bans most abortions. Under the arrangement that began Monday,... Read More

Kids With Disabilities Face Off-the-Books School Suspensions

The phone call from her son’s school was alarming. The assistant principal told her to come to the school immediately.... Read More

The phone call from her son’s school was alarming. The assistant principal told her to come to the school immediately. But when Lisa Manwell arrived at Pioneer Middle School in Plymouth, Michigan, her son wasn’t sick or injured. He was sitting calmly in the principal’s office.... Read More

October 3, 2022
by Dan McCue
9/11-Related Illness Deaths for FDNY Will Soon Surpass Deaths on Day of Attack

NEW YORK — Within the next year, the number of members of the New York City Fire Department who will... Read More

NEW YORK — Within the next year, the number of members of the New York City Fire Department who will have died from a 9/11-related illness will surpass the number of fire fighters and emergency medical technicians who died in the terror attack 21 years ago.... Read More

UnitedHealth Closes Roughly $8B Deal for Change Healthcare

MINNETONKA, Minn. (AP) — UnitedHealth Group said Monday that it completed its acquisition of Change Healthcare, closing the roughly $8... Read More

MINNETONKA, Minn. (AP) — UnitedHealth Group said Monday that it completed its acquisition of Change Healthcare, closing the roughly $8 billion deal a couple weeks after a judge rejected a challenge from federal regulators. UnitedHealth is merging the technology company with its Optum segment. The health... Read More

It's Flu Vaccine Time and Seniors Need Revved-Up Shots

Doctors have a message for vaccine-weary Americans: Don’t skip your flu shot this fall — and seniors, ask for a special... Read More

Doctors have a message for vaccine-weary Americans: Don’t skip your flu shot this fall — and seniors, ask for a special extra-strength kind. After flu hit historically low levels during the COVID-19 pandemic, it may be poised for a comeback. The main clue: A nasty flu season just ended in... Read More

September 30, 2022
by Dan McCue
HHS Rolls Out First-Ever Diaper Distribution Program

WASHINGTON — Families in need in six states and one tribal territory will be the beneficiaries of a new diaper... Read More

WASHINGTON — Families in need in six states and one tribal territory will be the beneficiaries of a new diaper distribution program rolled out by the Department of Health and Human Services this week. The pilot program will award $8 million in funding to community service... Read More

News From The Well
scroll top