Date Published: 16/12/2020
ARCHIVED - European Medicines Agency could authorise Pfizer covid vaccine for use in Spain before Christmas
ARCHIVED ARTICLE
Germany has been pressuring for the approval date to be brought forward so the country can begin vaccinating before the end of the year.
The European Medicines Agency (EMA) confirmed on Tuesday that the evaluation meeting for approval of the covid-19 vaccine developed by Pfizer / BioNTech is being brought forward a week to December 21st instead of December 29th.
The December 29th meeting will remain in the schedule in case the vaccine cannot be approved on the 21st.
The committee on human medicines (CHMP), has received the additional data requested from the pharmaceutical companies that have developed the vaccine and said that, provided "the data on quality, safety and efficacy are sufficiently robust and complete", that it will be able to announce its endorsement of the drug on that same day.
Providing the EMA gives the go-ahead, the European Commission (EC) will 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 have been working towards the first marketing authorisation of a COVID-19 vaccine for several weeks, but must ensure that all the safeguards, controls and obligations that a CMA imposes are observed, 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.
The German Government is keen to start vaccinating almost immediately and wants to begin its programme on December 26th, according to German media, as cases are spiralling in the country which today enters a harsh lockdown until 10th January; 926 fatalities were notified by the German Government in the last 24 hours.
The EU would like to see the programme begin simultaneously in all member states.
Several countries have already authorized this same Pfizer vaccine using the"emergency authorization" status which is only temporary and must be reviewed including the United Kingdom, Qatar, the United States and Canada.
On Wednesday morning the latest coronavirus figures marked another record day; 13,998 deaths worldwide and 625,000 cases in the last 24 hours.