Pfizer-BioNTech seeks full marketing approval from UK for COVID-19 vaccine

  • 1 month ago
Pfizer-BioNTech seeks full marketing approval from UK for COVID-19 vaccine

Pfizer is seeking full marketing authorisation from Britain for its COVID-19 vaccine, an executive said on Wednesday as the U.S. drugmaker gears up to deliver by the weekend the first shots following approval for emergency use in the country.

The application for full approval is “in parallel” with emergency use approval (EUA), said Berkeley Phillips, medical director of Pfizer UK, in a briefing.

He said regulators will review the same data provided for the emergency use by Pfizer and its partner BioNTech for the full approval. He did not say when that decision may come.

Deliveries, which could land in British warehouses as soon as the weekend, could not have started until the regulators had given their go ahead, he said. Regulators will assess each batch of the vaccine for quality.

Other countries are looking at possibly following in Britain’s footsteps and applying for emergency use in an effort to speed up access to the vaccine, said Ralf Rene Reinert, Pfizer Vaccines’ vice president, regional lead medical and scientific affairs. He declined to name countries that are doing this.

There is no cap on volumes delivered under the EUA, said Ben Osborn, manager of Pfizer UK.

 

 

Reporting by Alistair Smout and Kate Kelland in London, John Miller in Zurich and Ludwig Burger in Frankfurt; Writing by Josephine Mason; Editing by Louise Heavens, Kirsten Donovan / REUTERS

Comments