Pfizer and BioNTech have made a formal application to the European Medicines Agency (EMA). If permission is granted, it would enable them to begin distributing the vaccine across Europe within weeks.
Dr Albert Bourla, Pfizer Chairman and CEO, said, “We have known since the beginning of this journey that patients are waiting, and we stand ready to ship Coid-19 vaccine doses as soon as potential authorizations will allow us.”
The companies announced that they had applied on November 30, and that the first doses were expected to arrive by the end of the year.
Data was recently released showing that, in phase-three clinical trials of 44,000 volunteers in multiple countries, Pfizer and BioNTech’s vaccine had an efficacy rate of 95 percent, with no significant safety problems.
The vaccine will now face an assessment by the EMA to ensure it meets its standards for quality, safety, and efficacy. It is currently awaiting emergency authorization from the US Food and Drug Administration, after applying for assessment by that body last week. While Pfizer and BioNTech’s vaccine is not currently authorized for usage anywhere in the world, the companies have initiated rolling submissions in Australia, Canada, and Japan, with plans to apply to drugs-authorization agencies around the globe.
Pfizer and BioNTech’s announcement comes a day after Moderna filed for emergency regulatory approval in the US and Europe, raising the prospect of a vaccine being available before the end of 2020. Moderna believes its vaccine is “very highly efficacious”, having shown 94.1 percent effectiveness and 100 percent efficacy against severe Covid-19 cases in phase-three trials.
Last week, Russian officials reported that the Sputnik V vaccine had shown more than 95 percent efficacy in new preliminary data. Many countries have expressed an interest in using it, and India has ordered the production of 100 million doses.
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