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Pfizer-BioNTech booster dose shows high efficacy in phase 3 trial

… roll-out plan moves on despite WHO’s warning

Pfizer-BioNTech has detected high efficacy levels in its anticipated booster dose version of COVID-19 vaccine following a phase three clinical trial.

The biopharmaceutical companies announced on Thursday that a controlled trial evaluating the efficacy and safety of booster dose in more than 10,000 individuals, from 16 years of age and older demonstrated a relative efficacy of 95.6 percent against the disease during a period when Delta was the prevalent strain.

In the trial, a booster dose administered to individuals who previously received the Pfizer-BioNTech primary two-dose series restored vaccine protection to the high levels achieved after the second dose when compared to those who did not receive a booster.

“These results provide further evidence of the benefits of boosters as we aim to keep people well-protected against this disease,” Albert Bourla, chairman/CEO, Pfizer said in an official statement released on Thursday.

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“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.”

Despite the World Health Organisation (WHO) insistence that evidence on the need for a widespread administration booster doses remains inconclusive, Ugur Sahin, chief executive and co-founder, BioNTech said these critical data add to the body of evidence suggesting that a booster dose can help protect a broad population of people from COVID-19 and its variants.

He noted 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.

Pfizer and BioNTech plan to submit detailed results from the trial for peer-reviewed publication and also share data with the U.S. Food and Drug Administration, European Medicines Agency, and other regulatory agencies around the world as soon as possible.

Last September, a booster dose of the Pfizer-BioNTech COVID-19 Vaccine was authorized for emergency use by the U.S. 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 Wednesday, a booster dose of the vaccine also was authorized for emergency use by the U.S. 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 Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer.

BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.

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