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Phase III trial of Comirnaty shows efficacy as booster for COVID-19.

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Last updated:22nd Oct 2021
Published:22nd Oct 2021
Pfizer and BioNTech announced topline results from a Phase III randomized, controlled trial evaluating the efficacy and safety of a 30-µg booster dose of the Pfizer-BioNTech COVID-19 Vaccine Comirnaty in more than 10,000 individuals 16 years of age and older.

In the trial, a booster dose administered to individuals who previously received the Pfizer-BioNTech primary two-dose series restored vaccine protection against COVID-19 to the high levels achieved after the second dose, showing a relative vaccine efficacy of 95.6% when compared to those who did not receive a booster. These are the first efficacy results from any randomized, controlled COVID-19 vaccine booster trial.

Symptomatic COVID-19 occurrence was measured from at least 7 days after booster or placebo, with a median 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-boosted group. The observed relative vaccine efficacy of 95.6% (95% CI: 89.3, 98.6) reflects the reduction in disease occurrence in the boosted group versus the non-boosted group in those without evidence of prior SARS-CoV-2 infection. Median age of participants was 53 years, with 55.5% of participants between 16 and 55 years, and 23.3% of participants 65 years and older. Multiple subgroup analyses showed efficacy was consistent irrespective of age, sex, race, ethnicity, or comorbid conditions. The adverse event profile was generally consistent with other clinical safety data for the vaccine, with no safety concerns identified.

Condition: Coronavirus/COVID-19 Infection
Type: drug

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