EMA - Update on assessment of the BioNTech and Pfizer BNT162b2 vaccine marketing authorisation application - Meeting scheduled for 21 December - EU re

[Gert van der Hoek]

Share
News 15/12/2020

EMA’s human medicines committee (CHMP) and its experts have been working intensively over the past weeks to evaluate data submitted by BioNTech and Pfizer in the context of the conditional marketing authorisation (CMA) application for BNT162b2, a COVID‑19 mRNA vaccine.

The rate of progress is reliant on a robust and complete assessment of the quality, safety and efficacy and is determined by availability of additional information from the company to respond to questions raised during the evaluation.

Following receipt yesterday evening of additional data requested by the CHMP from the company and pending the outcome of its evaluation, an exceptional meeting of the CHMP has now been scheduled for 21 December to conclude if possible. The meeting planned for 29 December will be maintained if needed.

The CHMP will conclude its assessment at the earliest possible timepoint and only once the data on the quality, safety and effectiveness of the vaccine are sufficiently robust and complete to determine whether the vaccine’s benefits outweigh its risks.

Once the CHMP recommends a marketing authorisation, the European Commission will then fast track its decision-making process with a view to granting a marketing authorisation valid in all EU and EEA Member States within days.

EMA, its European experts and the European Commission are working towards the first marketing authorisation of a COVID-19 vaccine, with all the safeguards, controls and obligations that a CMA imposes, including:

• full prescribing information and package leaflet with detailed instructions for safe use;
• a robust risk-management and safety monitoring plan;
• manufacturing controls including batch controls for vaccines and conditions for storage;
• an investigation plan for use in children;
• legally binding post-approval obligations (i.e. conditions) and a clear legal framework for evaluation of emerging efficacy and safety data.

A marketing authorisation ensures that COVID-19 vaccines meet the same high EU standards as for all vaccines and medicines. It will be valid in all EU Member States at the same time enabling all Member States to benefit from the joint work done at EU level and allowing them to start rolling out their vaccination campaigns at the same time.


Related content

• Treatments and vaccines for COVID-19
• COVID-19 vaccines: key facts
• COVID-19 vaccines: development, evaluation, approval and monitoring
• COVID-19 vaccines: studies for approval
• Transparency: exceptional measures for COVID-19 medicines

 

[Gert van der Hoek]

Covid-19: EU regulator gives conditional approval to Pfizer/BioNTech vaccine

The European Medicines Agency (EMA) has granted “a conditional marketing authorisation” for the Pfizer/BioNTech vaccine.

An expert committee has recommended conditional approval for the vaccine to be used across the European Union, the agency said.

The move comes weeks after the shot was first granted permission under emergency provisions in Britain and the United States.

The decision comes after a closed-door discussion during which EMA scientists responsible for assessing the vaccine presented their analysis to other experts and scrutinised data from companies.

The approval needs to be rubber-stamped by the European Commission and the pharmaceutical companies will need to submit follow-up data on their vaccine for the next year.

Authorities in Germany and several other European countries have said they hope to begin vaccinating people on December 27.

The EMA said in a statement that the human medicines committee (CHMP) "has completed its rigorous evaluation" of the vaccine, "concluding by consensus that sufficiently robust data on the quality, safety and efficacy of the vaccine are now available to recommend a formal conditional marketing authorisation".

..................................................

Conditional marketing authorisation

The EMA said that conditional marketing authorisation is "a formal authorisation of the vaccine, covering all batches produced for the EU and providing a robust assessment to underpin vaccination campaigns".

It is one of EU’s regulatory mechanisms "for facilitating early access to medicines that fulfil an unmet medical need", such as the Covid-19 pandemic.

A statement revealed that because it has only been granted conditional marketing authorisation, Pfizer/BioNTech "will continue to provide results from the main trial, which is ongoing for two years.

"This trial and additional studies will provide information on how long protection lasts, how well the vaccine prevents severe Covid-19, how well it protects immunocompromised people, children and pregnant women, and whether it prevents asymptomatic cases.