The European Medicine’s Medicines Agency’s human medicines committee (CHMP) has said in a statement on Tuesday, that together with its experts, they 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.
It explained that 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, the CHMP said that an exceptional meeting of the CHMP has now been scheduled for 21st of December to conclude if possible.
The committee added that the meeting planned for 29 December will be maintained if needed.
The CHMP’s statement continued that it 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, it explained that 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 went on to say that, together with its European experts and the European Commission, they 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, the committee said.
The CHMP concluded by saying that the vaccine 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.
Speaking in Parliament this evening, Health Minister Chris Fearne, welcomed the news, saying that if all goes to plan, the country should start to receive the first vaccines later this month.
However, he expressed caution, with an appeal for the public to keep following the measures as issued by the health authorities for a long as they are in effect.
Dr Fearne also explained that arrangements have already been made with Pfizer for transportation of the vaccine to Malta. He went on to reiterate that storage for the vaccine once it is in Malta is also ready.