Season 1 of the Covid-19 series ended at the end of December 2020 with some optimism, thanks to the arrival of vaccines and the face of Mauricette, and a threat, the arrival of British variant. The pitch of this show which holds France and the whole world in suspense is definitely well put together and will certainly be a hit for its second season.
It begins with the hope carried by the first vaccinations – which is more in the rules of the art, with three to four weeks between the two doses, but also by two major challenges: the hiccups supply vaccine doses and the emergence of variants found around the world and potentially more contagious, more deadly and resistant to existing vaccines.
The scenario becomes more difficult as the French are exhausted both by health measures and by a powerful feeling of uncertainty. “We are at war”, had hammered Emmanuel Macron on March 16, 2020 on the eve of the first confinement. There is something that is proving to be correct today: on the front lines, the nursing staff, the biologists, the researchers but also the teachers and the people who carry out essential missions. In the trenches, those who wait and suffer psychologically and economically from the situation: students, restaurateurs, nightclub, entertainment and culture professionals. And, in the rear, the rest of the French subject to restrictions and curfew. Between the lines, journalists and top reporters.
Today, faced with the threat of variants, but also because we will not be able to vaccinate the entire European population (and not only the French) before summer, we obviously need to change our strategy, strike hard, in order to limit the spread of the virus and its variants as much as possible. It is an effort that seems essential to us and the zero Covid strategy»Imposes itself on us as an essential change of course.
The problem of supply
At the same time, we must vaccinate as many people as possible in a campaign on an absolutely unprecedented scale. The fact remains that we cannot play it “in war as in war” and do anything. The messenger RNA vaccines not only prove to be extremely efficient and reliable, but they are also those which would adapt the most “easily” (this remains of course very technical) and the most quickly to the new variants. Promising, they are, almost beyond expectations.
However, they are subject to patents as well as to strict technical requirements, in particular due to their status as biomedicines, which cannot suffer from generic replication as is the case for the chemical processes surrounding the manufacture of medicinal products. drugs.
But where the problem is with supply – we can only regret the importance given to antivax (fluctuating entity inappropriately mixing conspirators, real anti-vaccines and some hesitant who demand to see the data and have more perspective before deciding) by the government when ordering doses.
According to the site Covidtracker, 2.79% of French people had received at least one dose of vaccine in early February. And, if you believe his Vaccine Planner, a tool for estimating the date on which everyone can be vaccinated against Covid19 depending on their situation and the current vaccination rate, a 40-year-old person without a history or risk factor will have to wait about two years to receive the precious doses …
Is the summer deadline realistic?
It is therefore crucial to significantly increase the rate of vaccination. For some media voices, from Axel Kahn to Jean-Luc Mélenchon, it would be enough to free the vaccines from their patents to speed up the pace.
WE love slogans such as “Vaccines: common good for humanity”. Of course, we would like that in this more than troubled period the pharma companies would take their part in the war effort against this coronavirus. But, does it all come down to a story of patents that would be jealously guarded? In the short and medium term, counterintuitively, giving up your patents would not speed up the current rate of vaccination at all. Clearly, the complexity of vaccine production is poorly understood today. It is an extremely concentrated industry and not all pharmaceutical companies know how to produce vaccines.
This is especially true with messenger RNA vaccines which require advanced technologies. So, even if the patents were free, and Moderna announced that it renounced to his family during the pandemic, he would lack the know-how and the equipment. It would also be necessary to go through all the stages of accreditation which allow the regulatory authorities to grant a marketing authorization. Typically, building a vaccine production line takes almost three years. In the current context where researchers, laboratories and administrators are showing unprecedented mobilization, it would undoubtedly go faster but not enough to vaccinate the entire French population before the summer.
If Pfizer-BioNTech is able to produce the bulk of its Comirnaty, bottling is a bottleneck. In general, in pharmaceutical production, the world demand for sterile products and therefore the world capacities for aseptic filling are quite limited. In a context of a pandemic and therefore of enormous need, capacities are quickly under strain. To put it another way, when Pfizer-BioNTech produces vaccine, it makes a bulk of the active substance that far exceeds its bottling capabilities.
The CureVac vaccine is bottled in a factory of the British pharmaceutical company GlaxoSmithKline (GSK) in Wavre (Belgium) on February 8, 2021. | Kenzo Tribouillard / AFP
So, ugly provided by Sanofi-Pasteur or Novartis to Pfizer-BioNTech to contribute to the bottling of doses is far from negligible. And this even if the concrete results should not occur until the summer. Indeed, when a product is registered, it is registered for a production site: each time this product is manufactured on a new site, the laboratory must demonstrate that the product is equivalent.
A very tight schedule
If on the side of Sanofi-Pasteur and Novartis, information is extremely limited because of confidentiality clauses, we can imagine the agenda. First of all, the laboratories must sign agreements between themselves, which is not without difficulties given the secrets of formulations. They will therefore have to find compromises. Then it is a matter of transferring technology. This is relatively small since Sanofi-Pasteur and Novartis will only intervene for the fill and finish, the final phase of filling in bottles, but that cannot be done in two weeks either. They will also need to equip themselves.
Then they will make test batches and carry out analytical controls of the products, the release of the batches and the verification of bioequivalence: will the batches manufactured by these two providers be equivalent to those manufactured initially? In addition, you should file with the‘European Medicines Agency the registration file, and on the side of Pfizer-BionNTech, declare a new supplier in fill and finish.
Finally, the regulatory authorities will have to give their authorization. Alongside this, Sanofi-Pasteur specifies that its first priority remains the pursuit of development of its two Covid-19 vaccines. At the same time, Sanofi-Pasteur could not set aside the production of their other vaccines because creating a shortage in this area would amount to undressing Pierre to dress Paul.
So it’s going to take some time, and the summer 2021 deadline might look a little optimistic, but not impossible. To date, Sanofi tells us that it has reorganized the activities of its sites to be able to produce more than 125 million doses of the Covid-19 vaccine from Pfizer-BioNTech before the end of 2021, that is to say while waiting to be able to produce its own vaccine.
Of course, at the same time, there are other mRNA vaccines like those developed by CureVac or Moderna on which we hope to be able to count. There are also vaccines using other methods such as the non-replicating viral vector vaccine such as that ofAstra Zeneca, whatever it might be ineffective faced with certain variants – this is a data to be confirmed today and we must be patient.
The effectiveness of the European Medicines Agency
There are many avenues for vaccinating as many people as possible. If public opinion, sometimes relayed by journalists, certain experts or politicians, has been able to demonstrate Western-centricism or even hints of xenophobia vis-à-vis Chinese and Russian vaccines, one of the latter, Sputnik V, seems quite promising. But above all, the desire of the Russians to reach the Western podium led them to submit a registration dossier with the European Medicines Agency, which is very interesting progress in the field. Applying for a marketing authorization in Europe is subject to important non-negotiable transparency conditions. All the data that the experts ask for will have to be sent to them with the registration dossier, and here we are talking about the raw data, not just the analyzes carried out by the Russian manufacturer itself.
In addition, the European Agency can initiate impromptu inspection missions in Russian manufacturing sites, without the Russian authorities or the manufacturer being able to ask to review them. Neither in the schedule of these visits, nor in the composition of the expert inspector missions, nor in the scope of these inspections.
In the event of the slightest unfavorable opinion on the return of these missions, the Agency may temporarily or definitively suspend its marketing authorization. To date, the Chinese have not yet taken the step to seek registration from Western authorities. But getting the Russians to do it is really good news.
Let us add a new note of optimism concerning European construction. We are talking about the European Medicines Agency, which has proven that it was able to grant marketing authorization for vaccines in record time, with a quality of expertise that has not yet been called into question. This MA was issued on the same day, between Christmas and New Year, in the twenty-seven countries of the EU. Suffice to say that we are far from a bureaucratic or dusty administration, but in a public service of the XXIe century of which we can be proud.
Now we are working at full speed to approve it & make it available in the EU.– Ursula von der Leyen (@vonderleyen) January 6, 2021
“Good news for our efforts to provide Europeans with vaccines against Covid! @EMA_News has found the @moderna_tx vaccine to be safe and effective. […]»
What is more, the political level of the EU, through its Commission, has distinguished itself by fair distribution doses between all the countries of the Union, in proportion to the respective sizes of their populations. The Germans who held the BioNTech patent did not assert any privilege. Once again, we saw a Europe that worked well here. Let us hope that it will once again be in unison when it comes to defining a strategy for exiting the crisis in the months to come.
Source: Slate.fr by www.slate.fr.
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