Full FDA Approval For Pfizer Vaccine : What Does It Mean?

Full FDA Approval For Pfizer Vaccine : What Does It Mean?

Pfizer Comirnaty is the first COVID-19 vaccine to receive full FDA approval!

Find out what this means, and how it differs from the earlier EUA!

 

Pfizer Comirnaty Vaccine Receives Full FDA Approval!

On 23 August 2021, the US FDA announced that they approved the first COVID-19 vaccine – the Pfizer-BioNTech COVID-19 Vaccine.

It is now allowed to be marketed as the Pfizer Comirnaty (koe-mir’-na-tee) vaccine for the prevention of COVID-19 disease in individuals 16 years of age and older.

The Comirnaty vaccine continues to be available under the EUA (Emergency Use Authorisation) for individuals 12 to 15 years of age, and for the administration of a third dose in certain immunocompromised individuals.

The full FDA approval was based on updated data from the original clinical trial, with a longer follow-up period. Here are the new findings :

  • the vaccine was 91% effective in preventing COVID-19
  • most common side effects : pain, redness and swelling at injection site; fatigue, headache, muscle or joint pain, chills, and fever.
  • myocarditis / pericarditis risk : highest in males 12-17 years of age

Read more : Why COVID-19 Vaccine Efficacy Does Not Matter!

 

Pfizer Comirnaty Vaccine : Full FDA Approval vs. EUA

The Pfizer Comirnaty vaccine had been available for use under the EUA (Emergency Use Authorisation) since 11 December 2020.

While antivaxxers claim that this is proof that it is still experimental, that is categorically FALSE.

Vaccines approved under EUA have to undergo the same rigorous FDA approval process. They are just issued earlier, after passing critical safety and efficacy trials, to address an emergency.

The full FDA approval is then given after trial participants are followed up for at least 6 months, and the FDA has more time to increase oversight and inspection of manufacturing facilities.

Read more : Full FDA Approval vs EUA for Vaccines : What’s Different?

 

Full FDA Approval For Pfizer Vaccine : What Does It Mean?

Some of the press mistakenly claimed that Cominarty is the “new name” for the vaccine. That’s not true – the name was announced many months ago.

It was just not allowed to be officially marketed to the public as Comirnaty until it received the full FDA approval.

The full FDA approval will allow governments and private businesses to enact vaccination mandates as they see fit.

  • the military can mandate vaccinations using the Pfizer Comirnaty for their troops,
  • corporations may require vaccinations for their employees to return to the workplace,
  • businesses may limit shopping or dining privileges to only fully-vaccinated people

Despite receiving full FDA approval, Pfizer is required to conduct postmarking studies to further assess the risks of myocarditis and pericarditis in people who received their vaccine.

Pfizer has also committed to additional studies, including a pregnancy registry study to evaluate pregnancy and infant outcomes of mothers who received their vaccine during pregnancy.

 

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Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.

He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.

 

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