Pfizer and BioNTech Receive Expanded U.S. FDA Emergency Use Authorization for Comirnaty Booster in Individuals Aged 18 and Older Amid Global COVID-19 Cases Surpassing 257 Million

November 20, 2021 /BioValleyBIOON/ -- According to Baidu's "Real-time Updates on the COVID-19 Pandemic"Big DataReport》，as of 20:00 on November 20, 2021, globallyCumulative confirmed cases exceed 250 million (257.09 million), with more than 5.15 million deaths (5.1585 million).

Recently,Pfizer(Pfizer) and BioNTech announced that the U.S. Food and Drug Administration (FDA) has expanded the COVID-19 mRNA vaccine Comirnaty (BNT162b2)Booster Shot(booster dose) Emergency Use Authorization (EUA):For individuals aged 18 years and aboveThe booster shot should be administered at least 6 months after completing the Comirnaty vaccination (a 2-dose regimen), with the same dosage strength as in the 2-dose regimen. This expanded EUA will allow a broader population to receive the booster shot to provide a high level of protection against COVID-19.

Pfizer Chairman and CEO Albert Bourla stated: "As we approach nearly two years of fighting COVID-19, the expansion of Comirnaty booster shots to individuals aged 18 and above represents a critical milestone. Now, by receiving the booster, more adults will have the opportunity to maintain a high level of protection against COVID-19. We are grateful...FDA"After strict review, we hope that today's actions will help accelerate our efforts to end this pandemic."

BioNTech Chief Executive Officer and Co-founder Ugur Sahin stated: "FDAToday's decision is supported by clinical data, which show that after receiving the Comirnaty booster shot, there was a strong immune response, even surpassing the immune response after the highly effective two-dose primary vaccination series. These data suggest that the Comirnaty booster has the potential to maintain a high level of protection against various variants, including Delta.

In October this year, Pfizer and BioNTech announced positive results from the Phase 3 randomized controlled trial of the Comirnaty booster. The trial evaluated the efficacy and safety of a 30μg booster dose of Comirnaty in more than 10,000 participants aged 16 and above. In the trial, participants who had previously received a two-dose immunization regimen of Comirnaty were administered the booster dose of Comirnaty.

Notably, these are the first efficacy results from any randomized, controlled trial of a COVID-19 vaccine booster dose. The data shows,During the prevalence of the Delta variant, compared to subjects who did not receive a booster dose, those who received a booster dose regained a high level of protection against COVID-19 similar to that observed after the second dose, demonstrating a relative vaccine efficacy of 95.6%.

In the trial, all participants had previously completed the two-dose Comirnaty immunization regimen and were then randomized 1:1 to receive either a 30μg booster dose (the same dosage strength as the two-dose series) or a placebo. The median time between the second dose and administration of the booster or placebo was approximately 11 months. The incidence of symptomatic COVID-19 was measured starting at least 7 days after receiving the booster or placebo, with an average follow-up period of 2.5 months. During the study period, there were 5 cases of COVID-19 in the booster group and 109 cases in the non-booster group. The observed relative vaccine efficacy of 95.6% (95% CI: 89.3, 98.6) reflects the reduction in disease incidence in the booster group compared to the non-booster group among individuals without evidence of prior SARS-CoV-2 infection.

The median age of the study participants was 53 years, with 55.5% of participants aged between 16-55 years and 23.3% aged 65 years or older. Multiple subgroup analyses showed consistent efficacy across all groups regardless of age, gender, race, ethnicity, or comorbid conditions. The adverse event profile was generally consistent with other clinical safety data of the vaccine, and no safety concerns were identified.

Comirnaty Vaccine (Source: haber7.net)

The COVID-19 vaccine developed by Pfizer/BioNTech is based on BioNTech's proprietary mRNA technology and was co-developed by BioNTech and Pfizer. BioNTech is the marketing authorization holder in the United States, the European Union, and the United Kingdom, as well as the holder of Emergency Use Authorization (EUA) or equivalent authorization in the United States (together with Pfizer), Canada, and other countries. The parties plan to submit applications in countries where EUA or equivalent authorization was initially granted to seek regulatory approval.

The vaccine has also been granted Emergency Use Authorization (EUA): (1) a two-dose immunization schedule for the vaccination of adolescents aged 12-15 to prevent COVID-19; (2) a third dose for individuals aged 12 and above with weakened immune systems.

At the same time, the vaccine has also been granted an EUA as a single-dose booster for: (1) individuals aged 18 and above who have completed a two-dose vaccination regimen; (2) individuals aged 18 and above who have completed a vaccination regimen with a different COVID-19 vaccine. (Bioon.com)

Source of Original Text:Pfizer and BioNTech Receive Expanded U.S. FDA Emergency Use Authorization of COVID-19 Vaccine Booster to Include Individuals 18 and Older