BioNTech/Pfizer file for EU approval of COVID-19 vaccine

BioNTech/Pfizer file for EU approval of COVID-19 vaccine

Tuesday, December 01, 2020

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FRANKFURT AM MAIN,Germany(AFP) — Germany's BioNTech and its US partner Pfizer said on Tuesday they had applied for EU regulatory approval for their COVID-19 vaccine, raising hopes that the first jabs could be administered in December.

The two companies said they had submitted an application to the European Medicines Agency (EMA) on Monday seeking "Conditional Marketing Authorisation (CMA)" for their vaccine.

The move comes after large-scale tests showed their vaccine was 95 per cent 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 filed for emergency use authorisation with the US Food and Drug Administration on November 20.

If US regulators give the green light, Americans could start getting vaccinated around mid-December.

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 CEO Albert Bourla said.

A fellow frontrunner in the global vaccine race, US biotech company Moderna, said on Monday that it had sought emergency regulatory approval for its COVID-19 shot in both the United States and Europe.

The Moderna and Pfizer/BioNTech vaccines are both based on a new technologythat uses mRNA (messenger ribonucleic acid) to deliver genetic material to the body that makes human cells create a protein from the virus.

This trains the immune system to be ready to attack if it encounters the novel coronavirus.

But Moderna's vaccine can be kept in long term storage at minus 20 degrees Celsius (minus four degrees Fahrenheit) while Pfizer's requires minus 70 degrees Celsius (minus 94 degrees Fahrenheit).

The two vaccines have been developed at breathtaking speed as part of an unprecedented effort to end a pandemic that has infected more than 62 million people worldwide and killed more than 1.4 million.

Pfizer and BioNTech have previously said they expect to manufacture up to 50 million doses of their vaccine globally this year, and up to 1.3 billion doses by the end of 2021.


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