CDC, FDA provide guidance for administering COVID-19 Vaccine, as Texas leads the nation in doses administered

The Centers for Disease Control has published several fact sheets and information online to inform health care administrators about the COVID-19 vaccine, including a list of people who should not take it.

On Thursday, the CDC reported that Texas has administered more doses than any other state so far.

On the CDC website, fact sheets for health care providers administering the vaccine and for recipients and caregivers are provided, along with full prescribing information, instructions about vaccine storage, and adverse event reporting.

Both the CDC and Pfizer-BioNTech, which produced and distributed the first approved COVID-19 vaccine in the U.S., state multiple times that the vaccine “has not been approved or licensed by the FDA.” It has been authorized for emergency use by FDA under an Emergency Use Authorization for individuals 16 years of age and older.

A six-page fact sheet for health care providers states that the vaccine is not approved by the FDA, is an experimental vaccine, has not undergone the same type of rigorous testing as other FDA-approved drugs, some who participated in clinical trials were given less doses than those who are receiving the doses today, the long-term side effects are unknown, and receiving the vaccine is completely voluntary.

The website warns professions not to administer the Pfizer-BioNTech COVID-19 vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis).

It also states, “Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine.”

The immunocompromised, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the vaccine, the fact sheet states.

Because there is no available data on the effects of the vaccine administered to pregnant women, the CDC states “there is insufficient evidence to inform vaccine-associated risks to those who are pregnant” or want to become pregnant.

Data is also not available to assess the effects of the vaccine on breastfed infants or on milk production/excretion.

Health care providers are told that they “must communicate to the recipient or their caregiver, information consistent with the “Fact Sheet for Recipients and Caregivers” (and provide a copy or direct the individual to to obtain the Fact Sheet) prior to the individual receiving Pfizer-BioNTech COVID-19 Vaccine.

Nationally, the total number of people initiating vaccination (first dose received) is 11.1 million people, the CDC reports. Among them, 1.2 million live in long-term care facilities.

As of Thursday, California has distributed the most vaccines of any other state, 3.5 million, compared to Texas’ 2.1 million. But Texas has administered the most doses of any state, more than 1 million, roughly 25,000 more than California.

More than 1 million Texans have received at least the first of two doses of the vaccine, the CDC reports.

Texas Gov. Greg Abbott said Texas leads the nation, one month to the day the first doses arrived at vaccine providers in the state on Dec. 14.

“Texas is leading the way for our nation once again,” Abbott said in a statement. “This is the biggest vaccination effort we have ever undertaken, and it would not be possible without the dedication and tireless efforts of our healthcare workers. We still have a long road ahead of us, but Texans continue to prove that we are up to this challenge.”



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