On Monday 21 December, the European Union granted a conditional marketing authorisation very soon to the Covid-19 vaccine called Comirnaty and marketed by the Pfizer/BioNTech alliance.
The decision follows a positive opinion issued earlier in the day by the European Medicines Agency (EMA). The President of the European Commission, Ursula von der Leyen, welcomed the fact that all Member States will have access to the doses “at the same time and under the same conditions”. This will make it possible to start the vaccination campaigns at the same time, during the European Vaccination Days on 27, 28 and 29 December. Mrs von der Leyen added that the first doses would come from Pfizer's production site in Belgium.
The EMA assessment
Based on the ongoing evaluation of non-clinical data initiated in October and the results of phase III clinical trials involving 44,000 patients, the EMA considers that Pfizer/BioNTech’s vaccine is effective in preventing Covid-19 in people over 16 years of age.
“The most common side effects with Comirnaty in the trial were usually mild or moderate and got better within a few days after vaccination. These included pain and swelling at the injection site, tiredness, headache, muscle and joint pain, chills and fever. They affected more than 1 in 10 people”, explained Sabine Straus, Chair of the EMA Pharmacovigilance Risk Assessment Committee (PRAC).
Some uncertainty remains about the impact of the vaccine on the spread of the virus from vaccinated individuals or the effects of the vaccine on pregnant and breastfeeding women. The EMA therefore intends to continue its assessments over time. See the EMA recommendation: http://bit.ly/3rjjYYf
Nearly 2 billion pre-reserved vaccines
The European Commission has pre-reserved 200 million doses of the Pfizer/BioNTech candidate vaccine, with an option for an additional 100 million doses (compared to the 400 million doses proposed by the German-American alliance). According to Reuters, it negotiated a price of €15.5 per dose of the vaccine, while the Belgian Secretary of State for the Budget, Eva De Bleeker, had mentioned a price of €12.
In addition to Pfizer/BioNTech, the Commission has concluded advance purchase agreements with AstraZeneca, Johnson & Johnson, CureVac, Moderna and Sanofi-GSK, for a total amount of almost 2 billion doses. A seventh contract is also expected to come into being, following the conclusion of preliminary discussions, with Novavax (see EUROPE 12625/7).
At this stage, the European Medicines Agency has only indicated that it will look at the Moderna vaccine on 6 January (see EUROPE 12613/28).
Learning from the pandemic
The previous week, Member States had adopted, by written procedure, conclusions on lessons learned from Covid-19 in the health field. The document contains actions to improve crisis management at EU level, ensure the supply of medicines, improve access to and sharing of health data and to strengthen the EU’s role in global health.
Key messages include the call for the European Commission to publish a report in the first half of 2021 on the deployment of different mechanisms for emergency assistance and medical countermeasures, including the joint procurement procedure and the Emergency Support Instrument.
There has also been an invitation to the Commission and the Member States to conduct a joint ex-post review, once the Covid-19 pandemic has been overcome, to analyse the action taken and the scope for improvement. This exercise, the document notes, should also include a study on the public health effects of the pandemic and the treatment of patients with communicable and non-communicable diseases, such as cancer and antimicrobial resistance.
On the strategic autonomy of the EU, the conclusions call on the States and the Commission to draw up a list of essential medicines (e.g., antimicrobial active ingredients, active ingredients of intensive care medicines or vaccines).
They also invite the Commission to explore the possibilities of facilitating the maintenance and transfer of manufacturing sites for the active ingredients of essential medicines in the EU and “to use the EU science hub for research needs in case of public health crisis”.
Link: http://bit.ly/34vXKIZ (Original version in French by Sophie Petitjean)