New York: Pfizer Inc. and BioNTech on October 21st announced the results of a Phase 3 randomized, controlled trial to test the efficacy and safety of a 30-µg booster dose of the Pfizer-BioNTech COVID-19 Vaccine. The trial was conducted with over 10,000 individuals aged 16 years and older.
In the trial, it was found that a booster dose given to subjects who were previously administered the two Pfizer-BioNTech primary dose restored vaccine protection against COVID-19 to the levels attained after the second dose, indicating a comparative efficacy of 95.6% when compared to those who were not given a booster.
“These results provide further evidence of the benefits of boosters as we aim to keep people well-protected,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer in a press release by BioNTech . “In addition to our efforts to increase global access and uptake among the unvaccinated, we believe boosters have a critical role to play in addressing the ongoing public health threat. We look forward to sharing the data with health authorities and work to determine how they can be used to support the rollout of booster doses”
Ugur Sahin, MD, CEO and Co-Founder of BioNTech said that based on these findings "We believe that, in addition to broad global access to vaccines for everyone, booster vaccinations could play an important role in sustaining pandemic containment and a return to normalcy.”
All the subjects participating in the trial had previously been administered the primary two-dose series of the Pfizer-BioNTech vaccine. They were then randomized 1:1 to be given either a 30-µg booster dose or placebo.
The median period between second jab and booster dose was approximately 11 months. Occurrence of symptomatic COVID-19 was measured from at least seven days after the booster shot or placebo, with a median follow-up of two and a half months.
The most notable takeaway from the trail was the outcome that during the study period, there were only 5 cases of COVID-19 in the boosted group, while 109 cases were recorded from the non-boosted group. The observed comparative vaccine efficiency of 95.6% (95% CI: 89.3, 98.6) indicates the reduction in the COVID-19 occurrence in the boosted group against the non-boosted group in those without prior evidence of SARS-CoV-2 infection.
Median age of participants in the study was 53 years, with 55.5% of participants aging between 16 and 55 years, and 23.3% of participants aging 65 years and older. Multiple subgroup analyses showed vaccine efficacy remained 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. According to the press release both the companies, Pfizer and BioNTech plan to submit detailed results from the study for peer-reviewed publication. The two also plan to share these data with the U.S. Food and Drug Administration, European Medicines Agency, and other regulatory agencies around the world as soon as possible.
