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The pressure on laboratories and regulatory agencies increases with the impatience of public opinion. When will the first doses arrive in France? If the clinical trials have been completed in record time, there are still uncertainties about the timing and organization of the vaccination campaign.
● When will the vaccines be authorized?
On Thursday, the President of the European Commission, Ursula von der Leyen, indicated that the marketing authorization of the two vaccines Pfizer-BioNtech and Moderna could intervene “From the second half of December, if the procedures go smoothly”. The two dossiers have been examined by the European Medicines Agency (EMA) as part of a continuous evaluation procedure since the beginning of autumn: within EMA, the European Evaluation Committee of medicinal products for human use (CHMP) reviews the data as they become available, before a complete application is submitted. Additional items will be sent to him “next week”, said BioNTech director Ugur Sahin. “We are working hard”. “If the CHMP gives a positive opinion, it is up to the European Commission to grant a marketing authorization”, specifies a Pfizer spokesperson.
In the United States, Pfizer-BioNTech filed its emergency clearance application with the Food and Drug Administration (FDA) on Friday. It should take a few more days for Moderna, who is waiting to have passed the goal of 151 patients. If Donald Trump’s enthusiasm could have led to believe that Americans would have received vaccines sooner, Brussels corrected the situation Thursday: EMA is “In daily discussions” with its American counterpart for “Synchronize their vaccine ratings” against Covid, says Ursula von der Leyen. In addition, preliminary vaccine results from AstraZeneca and Oxford and Johnson & Johnson are also expected by the end of the year.
● What are the production capabilities?
The stakes are crucial. Europe pre-ordered 1.3 billion doses from major laboratories and chose options for an additional 660 million. However, not everything can be produced immediately. Pfizer-BioNTech has pledged to supply 50 million doses by December in Europe and the United States, Modern 20 million. “Subject to regulatory authorizations and the signature of the contract (with the European Commission, ed), the first doses could be available in Europe from December “, indicated Friday at Figaro the spokesperson for American biotechnology.
In 2021, Moderna promised to produce 500 million to one billion doses, Pfizer-BioNTech 1.3 billion doses. A colossal industrial challenge that these two laboratories anticipated in the spring by adapting their production capacities and planning separate supply chains for Europe and the United States. Pfizer and BioNTech have dedicated five of their factories (three in the United States, two in Europe) to produce the vaccine while Moderna, which has its own site in Massachusetts, partnered with Swiss Lonza, the world’s number one pharmaceutical subcontractor.
● Is it possible to increase the pace?
Moderna and Pfizer-BioNTech are already working on growth. “We are considering investing more on an industrial level, confided last Monday to Figaro Stéphane Bancel, CEO of Moderna. We could free up space in our factory by outsourcing less critical aspects of production. “ In Europe, several subcontractors have been called in by BioNTech to help. Among these, the French Delpharm, one of the world champions in the sector, will produce from April “Several tens of millions of doses” in his factory in Normandy. “Our client will send us the vaccine, we will be responsible for filling in sterile vials, explains Stéphane Lepeu, head of Delpharm. The vaccine will reach – 70 ° C and we will have to send it back to this temperature, this will be the main constraint. “ Delpharm has purchased millions of sterile vials and caps, products that are already in danger of running out due to high global demand. He’s busy ordering huge volumes of dry ice and ultra-low temperature freezers to store vaccines. BioNTech also recruited Swiss subcontractor Siegried and German Dermapharm.
● What logistical challenges?
Logistics should also play a crucial role in the timing of vaccine distribution. A colossal challenge for the volume of doses to be transported in a short time and their storage temperature. “Our biggest challenge has been to develop a new end-to-end global supply chain, at extremely low temperatures, at high volume, when we don’t yet know exactly where we will ship the vaccine and what the storage capacities will be in these. destination points “, acknowledges a spokesperson for Pfizer, which has provided thermal containers to transport and store vaccines. All major carriers, road and air, are at the starting blocks. Including Air France-KLM which it is already working on “Different scenarios”, its fleet of 150 wide-body aircraft and its six cargo planes are equipped to meet this unprecedented challenge.
● Who will be vaccinated first?
“Almost all developed countries, the World Health Organization, the European Center for Disease Prevention and Control reason with relative consensus on vaccine priorities”, explained Fr.r Daniel Floret, vice-president of the Technical Commission for Vaccinations of the High Authority for Health, responsible for developing the recommendations. “Those who will be vaccinated as a priority will be health and socio-medical professionals in direct contact with patients, and those most at risk of severe forms of the disease, the elderly or those with comorbidities”. That is 3 and 30 million people respectively.
SEE ALSO – Vaccinations before Christmas? “Today, hospitals are not involved in the vaccine distribution strategy,” replies Frédéric Valletoux
But if the HAS issued a first opinion at the end of July, there are still too many unknowns to draw up firm recommendations: this will depend on the number of doses available and the performance of each of the vaccines marketed (they prevent infections, limit – risk serious Will they be effective in the elderly?). The general principles outlined in the summer will therefore be “Refined based on the work still in progress, in particular a mathematical modeling study” the weight of the various comorbidities in the extreme risk of excess. At the end of November, HAS will issue a final opinion on priority audiences, then “On the implementation of the vaccination campaign during the month of December”, according to Fr.r Élisabeth Bouvet, President of the Technical Committee on Vaccinations.
● Who will be responsible for immunization?
Everyone has in mind the 2009 fiasco and its “vaccinodromes”, huge barns set up to vaccinate the French population against the H1N1 flu. “We need to analyze what went wrong, in particular the lack of involvement of general practitioners and nurses and the non-adaptation of communication to the knowledge of the epidemic which turned out to be much less serious than expected”, noted Pr Floret. The idea this time seems to be to rely on citizen health professionals, subject to any logistical constraints (storage at very low temperatures, presentation in multidose vials, etc.).
● Can vaccination be compulsory?
At the moment, “That’s not the topic”, Daniel Floret said. The obligation of vaccination “It doesn’t seem appropriate to us because we don’t know everything about these vaccines, but that could change.”. Daniel Floret has identified three priorities for obtaining good vaccination coverage: on the one hand, “Be transparent about scientific data” still under construction; then, “Healthcare professionals who carry out vaccination must be convinced of the validity of the campaign and the quality of the vaccines they will be called upon to administer. What makes a person decide whether to get vaccinated or not is first and foremost the opinion of their doctor “ ; finally, it is necessary “It simplifies travel, so that people can get vaccinated as close to their homes as possible, in the least complicated and most flexible way possible”. Pharmacists, who have recently been able to administer the flu vaccine, could thus be put on the circuit.
● How much will it cost?
The price of vaccines will vary widely between manufacturers: AstraZeneca announced a retail price of $ 4 per dose, the figure of $ 20 circulated for Pfizer, Moderna announced a unit cost of $ 25 to $ 37 depending on the volume of the vaccine. order. … These rates are then secretly negotiated with each state and international agreements provide for lower selling prices or technology transfers to poor countries. But the overall cost of vaccination will also depend on any additional logistical costs and the number of doses required. As for support, in France the government has planned to allocate 1.5 billion euros in the Social Security 2021 budget, for a target of 35 million vaccinated people. We can imagine that, like the flu vaccine, the Covid vaccine will be 100% covered for people at risk of severe disease.
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