Washington [US], October 21 (ANI): Pfizer and BioNTech said on Thursday that a booster shot of their COVID-19 vaccine has shown 95.6 per cent efficacy when compared to those who did not receive the booster dose.
They said that the first results from any randomized, controlled COVID-19 vaccine booster trial demonstrate a relative high vaccine efficacy against disease during a period when Delta was the prevalent strain
"Pfizer-BioNTech announced the results from a Phase 3 trial evaluating the efficacy and safety of a 30-ug booster dose of the Pfizer-BioNTech COVID-19 Vaccine in more than 10,000 individuals 16 years of age and older," Pfizer and BioNTech said in a statement.
"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 per cent 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," the statement added.
Albert Bourla, Chairman and Chief Executive Officer, Pfizer, said these results provide further evidence of the benefits of boosters "as we aim to keep people well-protected against this disease".
"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 of this pandemic. We look forward to sharing these data with health authorities and working together to determine how they can be used to support the rollout of booster doses around the world," Bourla added.
Ugur Sahin, CEO and Co-Founder of BioNTech, said these important data add to the body of evidence suggesting that "a booster dose of our vaccine can help protect a broad population of people from this virus and its variants".
"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," Sahin said.
The adverse event profile was generally consistent with other clinical safety data for the vaccine, with no safety concerns identified, the statement said.
It said Pfizer and BioNTech plan to submit detailed results from the trial for peer-reviewed publication. The companies also plan to share these data with the US Food and Drug Administration, European Medicines Agency, and other regulatory agencies around the world as soon as possible.
On September 22, 2021, a booster dose of the Pfizer-BioNTech COVID-19 Vaccine was authorized for emergency use by the US FDA for individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe COVID-19, and individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2.
On October 20, 2021, a booster dose of the vaccine also was authorized for emergency use by the US FDA in eligible individuals who have completed a primary vaccination with a different authorized COVID-19 vaccine.
In addition, a booster dose of the vaccine is authorized in the European Union and other countries, with recommendations for populations varying based on local health authority guidance, the release said. (ANI)