The FDA’s Full Grant of Approval of Pfizer

The FDA’s Full Grant of Approval of Pfizer

Since the FDA first authorized the first COVID-19 vaccine in December 2020, many people have been hesitant to receive it until the FDA has officially approved it. As of August 23, 2021, the Pfizer-BioNTech COVID-19 Vaccine has been approved by the FDA and will now be marketed as Comirnaty to prevent COVID-19 disease in individuals 16 years of age and older. Here are some of the main changes that will come as a result of the FDA approval. 

 

What Happens to the Pfizer Vaccine?

Availability

Although the Pfizer (Comirnaty) vaccine procedures will be undergoing some adjustments, the availability of the vaccine continues to stay the same for the time being. Individuals 16 years of age and older are authorized to receive the vaccine. It continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of the third dose in certain immunocompromised individuals. The vaccine’s physical properties will not undergo any changes, but individuals who receive it after the FDA granted full approval will be receiving it under its new name: Comirnaty. 

 

Booster Shots

Currently, no booster or extra shots of Comirnaty are available. Still, CEO of Pfizer, Albert Bourla, expressed the need for booster shots in the near future in an interview with NBC News’ Lester Holt: “The booster will be needed because of the combination of the delta variant … and the fact that the immunity after six months starts waning. So a booster dose is a must.” Additionally, after September 20th, immunocompromised individuals will have the option to receive a third dose of the vaccine, although the FDA has not yet approved it. 

Safety Monitoring

In the FDA’s official news release on August 23rd, they explained their continuity in testing and carrying out safety protocols: “The FDA is requiring [Pfizer] to conduct post-marketing studies to further assess the risks of myocarditis and pericarditis following vaccination with Comirnaty. These studies will include an evaluation of long-term outcomes among individuals who develop myocarditis following vaccination with Comirnaty. In addition, although not FDA requirements, the company has committed to additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Comirnaty during pregnancy.”

COVID-19 Testing with ClearStar

Employers may decide to require their employees to be vaccinated due to FDA approval. To read more about the legalities surrounding employers requiring vaccines, visit https://www.clearstar.net/oshas-new-covid-standard-for-healthcare-companies/.

 

If an employer wants to test an employee for COVID, ClearStar provides a CRL Rapid Response™ kit — a saliva-based molecular diagnostic test — to determine whether the virus is active or not. The results are available within 24-48 hours, on average. Keep in mind that all COVID-19 screening results must be kept confidential.

 

To place an order for a COVID-19 test, contact the ClearStar Medical Information Services office at 321.821.3383 or [email protected] To ask about background checks and other medical screening services, call +1.888.982.4648 or visit https://www.clearstar.net/contact/.

 

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