EU nod wanted for vaccine
Germany’s BioNTech and its US partner Pfizer said yesterday they had applied for EU regulatory approval for their Covid-19 vaccine, raising hopes that the first jabs could be administered this month.
The companies said they had submitted an application to the European Medicines Agency (EMA) on Monday seeking “conditional marketing authorisation” for their vaccine.
Large-scale tests showed their vaccine was 95% effective against Covid-19 and triggered no serious side-effects.
If approved by the Amsterdam-based EMA, the vaccine could potentially be rolled out “in Europe before the end of 2020”, the companies said in a statement.
Pfizer and BioNTech already fi led for emergency use authorisation with the US Food and Drug Administration on 20 November.
If US regulators give the green light, Americans could start getting vaccinated soon.
UK regulators are also screening the BioNTech/Pfizer vaccine.
“We have known since the beginning of this journey that patients are waiting and we stand ready to ship Covid-19 vaccine doses as soon as potential authorisations will allow us,” Pfizer chief executive Albert Bourla said.
A fellow frontrunner in the global vaccine race, US biotech company Moderna, said on Monday it had sought emergency regulatory approval for its Covid-19 shot in the US and Europe.
The Moderna and Pfizer/BioNTech vaccines are both based on a new technology that uses messenger ribonucleic acid to train the immune system to be ready to att ack.