Pfizer applies to EMA for Covid-19 vaccine approval
Pfizer and BioNTech have filed for approval of their coronavirus vaccine in Europe.
The pharmaceutical companies have already applied for authorisation in the US, and to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
On Tuesday the European Medicines Agency (EMA) confirmed it has received an application from the firms for conditional marketing authorisation of the vaccine known as BNT162b2.
The Covid-19 vaccine from Pfizer/BioNTech, which is due to arrive in the UK before the end of the year, is 95% effective and has passed its safety checks, according to data from the firm.
The UK has secured orders for 40 million doses of the jab from Pfizer/BioNTech.
Dr Albert Bourla, Pfizer chairman and chief executive officer, said: “Today’s announcement marks another key milestone in our efforts to fulfil our promise to do everything we can to address this dire crisis given the critical public health need.
“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.”
In a statement the EMA said: “EMA has received an application for conditional marketing authorisation (CMA) for BNT162b2, a Covid‑19 mRNA vaccine developed by BioNTech and Pfizer.
“The assessment of BNT162b2 will proceed under an accelerated timeline.
“An opinion on the marketing authorisation could be issued within weeks, depending on whether the data submitted are sufficiently robust and complete to show the quality, safety and effectiveness of the vaccine.
“Such a short timeframe is only possible because EMA has already reviewed some data on the vaccine during a rolling review.
“During this phase, EMA assessed data on the vaccine’s quality (such as information about its ingredients and the way it is produced) as well as results from laboratory studies.
“EMA also looked at results on the vaccine’s effectiveness and initial safety data emerging from a large-scale clinical trial as they became available.”
The agency will now assess the data submitted as part of the formal application for conditional marketing authorisation.
The European Medicines Agency said it would convene a meeting on December 29 to decide if there is enough data about the safety and efficacy of the Pfizer/BioNTech for it to be approved.
The agency also said Tuesday it could decide as early as January 12 whether to approve an experimental Covid-19 vaccine developed by Moderna.