vaccines in the home stretch

Written by Steven mark

Pressure is mounting on laboratories and regulatory agencies as public opinion grows impatient. When will the first doses arrive in France? While clinical trials were completed in record time, there are still uncertainties over the timing and organization of the vaccine campaign.

● When will vaccines be authorized?

On Thursday, the President of the European Commission, Ursula von der Leyen, indicated that the marketing authorization of the two vaccines of Pfizer-BioNtech and Moderna could come “From the second half of December, if the procedures go smoothly”. The examination of the two dossiers by the European Medicines Agency (EMA) has been underway since the beginning of autumn as part of a continuous evaluation procedure: within the EMA, the European Committee for the evaluation of medicinal products for human use (CHMP) examines data as it becomes available, before a full application is submitted. Additional elements will be sent to him “next week”, said BioNTech director Ugur Sahin. “We are working very hard”. “If the CHMP gives a positive opinion, it is then up to the European Commission to grant a marketing authorization”, specifies a spokesperson for Pfizer.

In the United States, Pfizer-BioNTech submitted its emergency clearance request to the Food and Drug Administration (FDA) on Friday. It should take a few more days for Moderna, who is waiting to pass the milestone of 151 sick patients. While Donald Trump’s eagerness might have led to the belief that Americans would get the vaccines sooner, Brussels corrected things on Thursday: EMA is “In daily discussions” with his American counterpart for “Synchronize their vaccine evaluations” against Covid, says Ursula von der Leyen. Meanwhile, preliminary vaccine results from AstraZeneca and Oxford, and Johnson & Johnson are also expected by the end of the year.

● What are the production capacities?

The stake is crucial. Europe has pre-ordered 1.3 billion doses from major laboratories and taken options for an additional 660 million. However, not all can be produced immediately. Pfizer-BioNTech has committed to deliver 50 million doses by December to Europe and the United States, Moderna 20 million. “Subject to regulatory authorizations and the signing of the contract (with the European Commission, Editor’s note), the first doses could be available in Europe as early as December ”, indicated on Friday at Figaro the spokesperson for American biotech.

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 by providing for 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 manufacture the vaccine while Moderna, which has its own site in Massachusetts, has teamed up with Swiss Lonza, the world number one pharmaceutical subcontracting.

● Can the pace be increased?

Moderna and Pfizer-BioNTech are already working on ramping up. “We are considering investing more at the 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 them, the French Delpharm, one of the world champions in the sector, will produce from April “Several tens of millions of doses” in its Normandy factory. “Our client will send us the vaccine, we will be responsible for filling it in sterile vials, explains Stéphane Lepeu, boss of Delpharm. The vaccine will arrive at – 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 as global demand is high. He is busy ordering huge volumes of dry ice and ultra-low temperature freezers to store the vaccines. BioNTech has also enlisted the Swiss subcontractor Siegried and the German Dermapharm.

● What logistical challenges?

Logistics should also play a crucial role in the timing of vaccine distribution. A colossal challenge due to 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, ultra-low temperature, high volume, worldwide supply chain when we don’t yet know exactly where we will ship the vaccine and what will be the storage capacities in these destination points ”, recognizes a spokesperson for Pfizer, which has provided thermal containers to transport and store vaccines. All the major carriers, road and air, are in the starting blocks. Including Air France-KLM which is already working on “Different scenarios”, its fleet of 150 wide-body aircraft and its six cargo planes being equipped to face 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 Friday the Pr Daniel Floret, vice-president of the Technical Committee for Vaccinations of the Haute Autorité de santé, responsible for drawing up the recommendations. “Those who will be vaccinated as a priority will be health and medico-social professionals in direct contact with patients, and people most at risk of severe forms of the disease, elderly people or those with co-morbidities.” That is respectively 3 and 30 million people.

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 (will they prevent infection, limit- they risk severe form? Will they be effective in the elderly?). The general principles outlined in the summer will therefore be “Refined according to work still in progress, in particular a mathematical modeling study” the weight of the various comorbidities in the extreme risk of excess. The HAS will issue a final opinion on the priority audiences at the end of November, then “On the implementation of the vaccination campaign during the month of December”, according to the Pr Élisabeth Bouvet, President of the Technical Committee on Vaccinations.

● Who will be responsible for immunization?

Everyone has in mind the fiasco of 2009 and its “vaccinodromes”, huge barnums set up to vaccinate the French population against the H1N1 flu. “We must analyze what has not worked well, in particular the non-involvement of general practitioners and nurses and the failure to adapt communication to knowledge of the epidemic, which has turned out to be much less serious than expected”, noted the Pr Floret. The idea seems to be, this time around, to rely on city health professionals, subject to any logistical constraints (storage at very low temperature, presentation in multidose vial, etc.).

● Can vaccination be compulsory?

For the time being, “That’s not the point”, said Daniel Floret. The vaccination obligation “Does not seem appropriate to us because we do not know everything about these vaccines, but this could change”. Daniel Floret identified three priorities for obtaining good immunization coverage: on the one hand, “Be transparent about scientific data” still under construction; then, “Health professionals, who carry out vaccination, must be convinced of the validity of the campaign and of the quality of the vaccines they are going to be asked to administer. What makes a person decide whether or not to be vaccinated is first and foremost the opinion of their attending physician “ ; finally, it is necessary “Simplify the journey, so that people can get vaccinated as close as possible to their homes, in the least complicated and most flexible way possible”. Pharmacists, who have recently been able to administer the flu vaccine, could thus be put in the loop.

● How much will it cost?

The price of vaccines will vary widely between manufacturers: AstraZeneca announced a selling price of $ 4 per dose, the figure of $ 20 circulated for Pfizer, Moderna announced a unit cost of $ 25 to $ 37 depending on order volume … These tariffs 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 care, in France the government has planned to provide 1.5 billion euros in the 2021 Social Security budget, for a target of 35 million people vaccinated. We can imagine that, like the flu vaccine, the one against Covid will be covered 100% for people at risk of severe form.

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Steven mark

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