Pfizer and BioNTech Announce Phase 3 Trial Data Showing High Efficacy of a Booster Dose of Their COVID-19 Vaccine Comirnaty Amid Global Surge to Over 242 Million Cases

October 21, 2021 /BioonBIOON/ -- According to Baidu's 《Real-Time Novel Coronavirus Pneumonia EpidemicBig DataReport》, as of 22:00 on October 21, 2021, the global cumulativeOver 242 million confirmed cases (242.95 million), over 4.94 million deaths.

Recently,Pfizer(Pfizer) and BioNTech jointly announced the results of a Phase 3 randomized controlled trial of the COVID-19 mRNA vaccine Comirnaty (BNT162b2), which evaluated the efficacy and safety of a 30-μg booster dose of Comirnaty in over 10,000 participants aged 16 years and older. In this trial, participants who had previously completed the 2-dose primary immunization series of Comirnaty received a booster dose of Comirnaty.

Notably, these are the first efficacy results from any randomized, controlled trial of a COVID-19 vaccine booster dose. Data show that,During the predominance of the Delta variant, compared with subjects who did not receive a booster dose, protection against COVID-19 in subjects who received a booster dose was restored to the high level observed after the second dose, demonstrating a relative vaccine efficacy of 95.6%.

In this trial, all participants had previously completed the 2-dose primary series of Comirnaty and were then randomized in a 1:1 ratio to receive a 30 μg booster dose (the same dose strength as the 2-dose series) or placebo. The median interval between the second dose and administration of the booster or placebo was approximately 11 months. The incidence of symptomatic COVID-19 was assessed starting at least 7 days after receipt of the booster or placebo, with a mean follow-up 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 a 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 subjects was 53 years, with 55.5% of subjects aged between 16 and 55 years and 23.3% aged 65 years or older.Multiple subgroup analyses demonstrated that efficacy was consistent regardless of age, sex, race, or comorbidities.The adverse event profile is generally consistent with other clinical safety data for the vaccine, with no safety concerns identified.

Pfizer and BioNTech plan to submit the detailed results of the trial for publication in a peer-reviewed journal. Both companies also plan to, as soon as possible, with the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regulatory agencies worldwide share this data.

Albert Bourla, Chairman and Chief Executive Officer of Pfizer, said: “These results further demonstrate the benefits of booster doses, as our goal is to better protect people against this disease. In addition to our efforts to increase vaccination among the unvaccinated, we believe that boosters play a critical role in addressing the ongoing public health threat of this pandemic. We look forward to sharing these data with regulatory authorities and working together to determine how they can support the availability of Comirnaty booster doses worldwide.”

Comirnaty vaccine (Image source: haber7.net)

The Pfizer/BioNTech COVID-19 vaccine 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, European Union, and United Kingdom, and also holds the Emergency Use Authorization (EUA) or equivalent authorizations in the United States (together with Pfizer), Canada, and other countries. The two companies plan to submit applications for regulatory approval in countries where EUAs or equivalent authorizations were initially granted.

The vaccine has also been granted an Emergency Use Authorization (EUA): (1) a 2-dose immunization regimen for vaccination of adolescents aged 12 to 15 years for the prevention of COVID-19; (2) a third dose for individuals aged 12 years and older who are immunocompromised.

Additionally, the vaccine has also been granted EUA for use as a single-dose booster: (1) for individuals aged 65 years and older; (2) for individuals aged 18-64 years at high risk for severe COVID-19; (3) for individuals aged 18-64 years with frequent institutional or occupational exposure to SARS-CoV-2; (4) for individuals who have completed primary vaccination with a different COVID-19 vaccine. (Bioon.com)

Original Source:Pfizer and BioNTech Announce Phase 3 Trial Data Showing High Efficacy of a Booster Dose of Their COVID-19 Vaccine