The European Medicines Agency must authorize the marketing of the Pfizer / BioNTech vaccine on Monday.
Never have the actions of the European Medicines Agency (EMA) been scrutinized with such attention. This Monday, the health authority based in Amsterdam will carry out the final review of Pfizer / BioNTech’s vaccine file against Covid, giving the impetus to the continent’s first vaccination campaigns, three weeks after the United Kingdom and two after the United States.
The scientists who will meet this December 21 will give their opinion the same day, and there is little doubt at this stage that they will agree to grant it the Grail: their green light for the issuance of an authorization marketing authorization (AMM) allowing its use throughout the European Union.
Once the EMA’s approval has been given, the European Commission will be responsible for ratifying the MA, which it has promised to do within two days. A formality at the end of which the national authorities will have free rein to launch their respective vaccination campaigns. The President of the European Commission, Ursula Van der Leyen, announced in a tweet Thursday the first injections for December 27, 28 and 29.
“France will put itself in a position to be able to start vaccination within the same schedule”, Periphered the Director General of Health, Jérôme Salomon, Thursday, during a press conference. But the date of the 27 will probably be that of a primarily symbolic launch. “Within a targeted number of establishments”, before a rise in load, according to his administration.
On the procedural side, once the European MA has been issued, the vaccine dossier will have to be examined in France by the Technical Committee on Vaccinations (CTV) of the High Authority for Health. Made up of experts, it formulates vaccine strategy recommendations, for example by defining target populations, vaccination conditions (in town or in hospitals, for example) and possibly reserves for certain patient profiles.
Given the urgency of the case, CTV experts are already working on elements that were sent to it early, at the request of the government, by the pharmaceutical company. This should allow him to decide, once the last documents have been obtained, “as quickly as possible”, likely in a day or two. As of mid-December, establishments welcoming priority elderly people received instructions to anticipate the organization of the campaign, “So as to vaccinate patients as quickly as possible upon receipt of the doses”, according to the Ministry of Health. This involves in particular planning pre-vaccination consultations for their residents and staff. The interview aims to verify that patients have no contraindication, to inform them about the vaccine and to obtain their consent since immunization against Covid will not be mandatory.
In accordance with the government’s wish to place local caregivers “At the heart of the system”, the consultation will be conducted by the attending physician of the residents, by teleconsultation if necessary, or by the department physician for people in long-term hospitalization. The vaccination itself can be done by nurses. Several information documents for caregivers are being developed, and Pfizer will also provide an online tutorial on handling its vaccine at -80 ° C, said the DGS.
“France will be ready”
These interviews will also make it possible to assess the quantity of necessary doses that will be delivered to nursing homes and hospitals within a period of at least fifteen days after the opinion of the HAS, according to a letter sent by the Ministry of Health to the directors of these establishments. On this basis, “The vaccination campaign against Covid-19 will gradually gain momentum from January 4, 2021”, indicates the Ministry of Autonomy. “The campaign will roll out on a larger scale from mid-January.”
Logistically, the government has assured this on several occasions, “France will be ready”. “The preparation has been in place for several weeks, Jerome Salomon assured Thursday. The logistics of the cold chain are complex but we have a good handle on it. ” The Pfizer / BioNTech batches that will be used in France will come from the Belgian plant in Puurs. Because they must be stored at around – 70 ° C, an unusual constraint requiring specialized storage equipment, two distribution circuits have been designed: one passing through eleven private platforms which will then deliver to city pharmacies or nursing homes. , the other passing through a hundred hospitals on which depend structures welcoming the elderly. At the beginning of the month, Olivier Véran announced that this organization would be “Blank tested” before the start of the campaign.
Alongside France, several large European countries have announced their desire to start vaccination on December 27, in accordance with the EU’s wish that they coordinate. Thus in Spain, Italy and Germany, where voices have deplored in recent days that the population did not have earlier a vaccine designed on its territory (BioNTech is based in Mainz).