Covid-19 vaccine Pfizer-BioNTech seeks full marketing approval from UK
There are indications from LONDON that (Reuters) – Pfizer is seeking full marketing authorisation from Britain for its COVID-19 vaccine, an executive said on Wednesday as the U.S. drug maker 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.