November 29, 2021

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FDA expands EUA for Pfizer/BioNTech COVID-19 vaccine Comirnaty

FDA expands EUA for Pfizer/BioNTech COVID-19 vaccine Comirnaty.



 

FDA expands EUA for Pfizer/BioNTech COVID-19 vaccine Comirnaty.  FDA expands Pfizer/BioNTech vaccine Comirnaty emergency use authorization (EUA): boost shot for people ≥18 years of age!

This expansion of EUA will allow a wider range of people to be vaccinated with booster shots to provide a high level of protection against COVID-19.

 

Recently, Pfizer (Pfizer) and BioNTech announced that the US Food and Drug Administration ( the FDA ) has expanded COVID-19 mRNA vaccine Comirnaty (BNT162b2) booster shot (booster dose) of the Emergency Use Authorization (EUA): for 18 years and over The crowd .

The booster injection should be given at least 6 months after completion of Comirnaty vaccination (2-shot vaccination program), and the dose intensity is the same as that in the 2-shot vaccination program.

This expansion of EUA will allow a wider range of people to be vaccinated with booster shots to provide a high level of protection against COVID-19.

 

Albert Bourla, Chairman and CEO of Pfizer, said: “As we have been fighting against COVID-19 for nearly two years, the expansion of the Coirnaty booster to people 18 years and older is a key milestone.

Now, the booster vaccination will help more people. Many adults have the opportunity to maintain a high level of protection against COVID-19.

We thank the FDA for its rigorous review, and we hope that today’s actions will help us speed up our escape from this epidemic.”

 

Ugur Sahin, CEO and co-founder of BioNTech, said: “The FDA ‘s decision today is supported by clinical data. These data show that the immune response after the Comirnaty booster injection is strong, even surpassing the high-efficiency 2-dose primary immunization program. Immune response.

These data indicate that the Comirnaty booster has the potential to maintain a high level of protection against multiple variants including Delta.”

 

In October this year, Pfizer and BioNTech announced the positive results of the Phase 3 randomized controlled trial of Comirnaty booster needles.

The trial evaluated the effectiveness and safety of 30μg booster Comirnaty in more than 10,000 subjects 16 years and older. In this trial, subjects who had previously received a 2-shot Comirnaty immunization program were vaccinated with a booster dose of Comirnaty.

 

It is worth mentioning that this is the first batch of efficacy results of any randomized, controlled COVID-19 vaccine booster dose trial.

Data shows that when the Delta variant is prevalent, compared with subjects who did not receive a booster dose, the protective effect of subjects vaccinated with a booster dose against COVID-19 returned to the highest level after the second injection. Level, showing a relative vaccine efficacy of 95.6%.

 

In this trial, all subjects had previously completed the Comirnaty 2-injection immunization program, and then randomly received a 30μg booster dose (the same dose intensity as the 2-injection series) or a placebo at a 1:1 ratio. The median time between the second dose and the booster or placebo dose is about 11 months. The incidence of symptomatic COVID-19 is measured at least 7 days after the booster shot or placebo, and the average follow-up time is 2.5 months.

During the study period, there were 5 cases of COVID-19 in the enhanced group and 109 cases in the non-enhanced group.

The observed relative vaccine efficacy of 95.6% (95% CI: 89.3, 98.6) reflects the lower incidence of disease in the boosted group compared with the non-boosted group in people without evidence of SARS-CoV-2 infection.

 

The median age of the study subjects was 53 years old, 55.5% of the subjects were between 16-55 years old, and 23.3% of the subjects were 65 years and older. Multiple subgroup analyses show that the effectiveness is consistent regardless of age, gender, race, race, or comorbidity. The profile of adverse events was basically consistent with other clinical safety data of the vaccine, and no safety issues were found.

 

FDA expands EUA for Pfizer/BioNTech COVID-19 vaccine Comirnaty.

Comirnaty vaccine (photo source: haber7.net)

 

 

Pfizer/BioNTech’s COVID-19 vaccine is based on BioNTech’s proprietary mRNA technology and is jointly developed by BioNTech and Pfizer.

BioNTech is the holder of marketing authorizations in the United States, the European Union and the United Kingdom, as well as the holder of emergency use authorization (EUA) or equivalent authorizations in the United States (together with Pfizer), Canada, and other countries. The parties plan to submit an application to seek regulatory approval in the country that initially granted the EUA or equivalent authorization.

 

Comirnaty is a COVID-19 vaccine approved by the U.S. FDA as a 2-shot immunization program for immunization of people aged 16 and over to prevent COVID-19.

 

The vaccine has also been granted an emergency use authorization (EUA): (1) a 2-shot immunization program for immunization of adolescents aged 12-15 to prevent COVID-19; (2) for those who are 12 years of age and older with weakened immune function For the population, the third dose of immunization is provided.

 

At the same time, the vaccine has also been granted EUA as a single-dose booster: (1) For people 18 years and older who have completed the 2-dose immunization program; (2) For use in another different COVID-19 vaccine immunization program People aged 18 and over. 

 

 

 

 

 

Reference:

Pfizer and BioNTech Receive Expanded US FDA Emergency Use Authorization of COVID-19 Vaccine Booster to Include Individuals 18 and Older

FDA expands EUA for Pfizer/BioNTech COVID-19 vaccine Comirnaty

(source:internet, reference only)


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