The German pharmaceutical company BioNTech and its US partner Pfizer say they have submitted an application for conditional approval of their Corona-virus vaccine with the European Medicines Agency.
The purpose of the marketing authorization application with EMA is to get the agency’s approval to market a medicine within the European Union.
The American and German companies have submitted the application for conditional approval of their vaccine, which is said to be 95% effective against Corona-virus, with the European Medicines Agency (EMA) on Monday.
BioNTech said if the vaccine, currently named BNT162b2, is approved, its use in Europe could begin before the end of 2020.
Pfizer’s move comes at the time when it’s also seeking the emergency use approval from the US Food and Drug Administration (FDA).
The move comes a day after rival Moderna said it was asking US and European regulators to allow emergency use of its COVID-19 vaccine.
BioNTech and Pfizer have already submitted a request for emergency approval with the US Food and Drug Administration and the UK regulator MHRA, as well as rolling submissions in other countries including in Australia, Canada and Japan.
Germany’s science minister Anja Karliczek told reporters in Berlin that the EMA will be holding a public hearing on December 11 on the approval request by BioNTech and Pfizer.
She added that the vaccine will be voluntary and that authorities will work hard to inform the public about possible side effects that might be expected after immunization, such as headaches, localized pain and fever.
Marylyn Addo, a doctor at Hamburg’s UKE hospital who is involved in the trials for a rival vaccine, said the rapid development of a vaccine was the result of enormous efforts by scientists, early funding and experience from previous vaccines.
Pfizer expects to have 50 million doses globally in December. Half of them — or enough for 12.5 million people — are earmarked for the USA.
ABC Flash Point News Pharma 2020.