A vaccine for this fall, and if it was (really) possible?

• As the disease continues to spread globally, several vaccine projects have entered the final testing phase.
• In particular that of the English of Astrazeneca, for which a possible distribution was mentioned in the fall.
• How can such a miracle be achieved when conventional procedures generally take years?

"The project announced today is to put Sanofi and France in the excellence of the fight against the virus and to find a vaccine . " Emmanuel Macron who makes buddy-buddy with Sanofi leaders before the guided tour of the Marcy-l'Etoile site (Rhône-Alpes), one of the largest vaccine production plants in Europe. A patchwork on which we would not have bet a kopeck a month ago, when the leaders of the pharmaceutical laboratory were drawn ears for having proposed the remedy against Covid-19 in the United States in priority.

Except that the disease continues to progress on a planetary scale, that Beijing is partially reconfigured, and that the hypothesis of a second wave is already a reality in Iran.

The President of the Republic @EmmanuelMacron is visiting the @SanofiFR site in order to support research and production of vaccines in the fight against the pandemic risk. pic.twitter.com/ay8kEhCsOA

Five projects already entered in the last test phase

Under these conditions, all hope is good to take. There is one of the two vaccine candidates on which Sanofi is working, who took advantage of the president's visit to announce 500 million investment in a new factory capable of producing four vaccines at a time in Neuville-Sur-Saône, not far from the mother house. Or that of the English of Astrazeneca, who has been running wind in the back since his communication with great fanfare last Saturday, after the conclusion of an agreement with "the inclusive alliance for a vaccine", made up of the European avant-garde (France, Germany, Italy, and the Netherlands).

"An agreement that guarantees that hundreds of millions of Europeans will have access to the University of Oxford vaccine after it has been approved." We hope to make the vaccine widely and quickly available, "according to its CEO Pascal Soriot, who even advanced on BFMTV:" We will know in September if the vaccine works, and we will be able to distribute it on a large scale from the month of October »Or less than nine months to find, manufacture, and distribute a vaccine to 400 million people, when the record set so far peaks at five years for a vaccine against Ebola, a disease rubbed against by the best scientists in the world since 1976. A promise that leaves you speechless to say the least. How can such a miracle be achieved, if at all possible? 20 minutes examines the issue with the help of Daniel Floret, president of the Technical Committee on Vaccinations, attached to the High Council of Public Health.

Emmanuel Macron: "200 million euros will be released to finance production, research and development infrastructures" pic.twitter.com/mBjUcjDt9L

Oxford is working on a vaccine derived from the chimpanzee adenovirus

So let's start with the famous research from the University of Oxford. The AZD1222 vaccine developed by the team led by Professor Sarah Gilbert is based on a modified adenovirus affecting chimpanzees. It allows on paper to "generate a strong immune response with a single dose", so that it "cannot cause continuous infection in the vaccinated individual". So much for the initial idea. Daniel Floret explains the instructions to us to verify it while respecting the protocols a little better than the Raoultiens disciples.

“A vaccine trial has four stages. First, a preclinical phase takes place in animals, in order to select the antigens capable of causing a reaction by the immune system. Then clinical development in three phases in humans. A few healthy volunteers are tested to confirm the effect of the antigen and establish a dosage. Then we enter phase two on a larger sample, to assess possible side effects. Then finally phase 3 with a very large-scale test, with, as for the first two phases, a placebo group in control ”.

Note here that phase 3 already represents a certain budget, in the half-million dollars on a conventional procedure, conducted for several years, as recently explained Frédéric Tangy, researcher at the CNRS assigned to the vaccine innovation laboratory of the Pastor Institute. Well, imagine that the Oxford team has already started phase 3, almost at the same time as two Chinese competitors and the Americans of Moderna, to talk about the four or five most advanced projects in terms of scientific research.

Concretely, the British University announced a first differentiated test (vaccine candidate and placebo, in this case a meningitis vaccine regularly given to adolescents) on two volunteers on April 22. The two volunteers became 1.102, all between 18 and 55, recruited exclusively in England. And finally 10,260 since the beginning of June, paid up to 600 euros per head, with the inclusion in the trial of patients over 56 years old and children from 5 to 12 years old “to see if there is a variation on how the immune system responds depending on whether you are an adult or a child, ”explains Andrew Pollard, head of the vaccination laboratory at the British University.

"Phase 3 must be essential and can last several months"

A feat that leaves Daniel Floret pensive: “Phase 3 must be essential. Thousands of subjects are needed for several months. This logic of numbers depends in part on the importance of the circulation of the disease. Because to test the effectiveness of the vaccine, a significant part of the volunteers must catch the Covid-19 in a relatively short time. In France, for example, I'm not sure we can conduct such a study today because the disease has receded, it would take too long, probably six months. If it is a country where the virus is still perennial, the test can be carried out in shorter times ”.

In partnership with @AstraZeneca we've taken the next steps in our commitment to broad and equitable global access to our # COVID19 vaccine. https://t.co/9Srs4ONrsr

Aware that the incidence rate of Covid-19 in Great Britain also shows a clear decline in recent weeks, the University of Oxford has entered into a partnership with the Brazilian health authorities to include in extremis 2,000 patients from the region of Sao Paulo in the test, in addition to British workers on the front line. "The most important thing is to carry out this stage of the study in a country where the epidemiological curve is still going up to give more interesting results", confirms Lily Yin Weck, coordinator of the center of immunology from the University of Sao Paulo.

The Americans have aimed even wider (30,000 volunteers), with the same objective: to present a final result in September. “A highly ambitious calendar” assumed by Andrew Pollard, who undoubtedly serves as a working basis for the CEO of Astrazeneca in his last statements. Except that if the vaccine has really demonstrated its effectiveness by then - which remains to be proven, since both the Oxford team and Astrazeneca recognize, in the small paragraphs at the bottom of press releases, "that the the vaccine may not work ”- there will still be a step to authorize the marketing of the long-awaited product.

The decisive step in marketing authorization

If Daniel Floret can easily imagine the mountain of pressure that the various institutions that will guarantee the transparency of the validation process, particularly the European Medicines Agency, will have to bear in order to reduce authorization times which take several months on average with back-and-forth returns between the laboratory and the agency's experts, the president of the technical committee on vaccinations is worried about the possible side effects of the vaccine which will be presented as the savior at the start of the school year.

“It seems difficult to me to embark on large-scale trials until we know more about it. There have already been attempts to vaccinate against SARS and against MERS, two other coronaviruses, which in the development stages have shown serious pulmonary lesions ”. No floor figure carved in stone, but a well-established jurisprudence in the middle. Gullain-Barré syndromes identified for a swine flu vaccine developed in the United States. In the order of one in 100,000.

"We actually are starting the manufacturing right now .. we're not going to wait until we get the clinical results" @AstraZeneca boss Pascal Soriot tells @bbcdavideades how his firm hopes to quickly supply its potential #coronavirus #vaccine worldwidehttps: // t.co/tuSBH6POxG pic.twitter.com/xyUigtk4Ti

“At this level of recurrence, we wonder. This is the famous benefit / risk balance. If you have a fatal disease for 70% of patients, we will more easily accept side effects that can lead to death. But in the case of the Covid-19, with a very low mortality, we will be much more demanding. I am quite convinced that when it is necessary to give development authorizations, the structures concerned will take a lot of precautions ”. Precautions all the more understandable since the vaccine should certainly be inoculated in hundreds of millions of people, a proportion never seen in the history of medicine. However, for the moment, Sarah Gilbert's team has let nothing filter on the possible harmfulness of her vaccine, only indicating that the research "is progressing well". A certain vagueness which worries the researchers, amazed by the race with the shallot which engaged in the labs to find the Holy Grail.

"There is no point in going too fast"

"There is no point in going too fast: to pass tests on animals to humans so quickly? Let's stay serious. When I see the control barriers that jump right to left, that raises some ethical questions which we will have to come back to later ”, was surprised recently in 20 Minutes Morgane Bomsel, specialist in immunology at the Cochin Institute. This last administrative step of placing on the market alone makes the probability of an effective vaccine AND authorized before the end of 2020 “very difficult”, risks Daniel Floret, who is not a specialist in the procedures that should follow if the vaccine of Oxford passed in fine the cut of the various controls.

AstraZeneca COVID-19 vaccine likely to protect for a year - CEO https://t.co/DvwMub7lfW pic.twitter.com/mDxeLYzI60

If scientific research has progressed at the speed of light on the Covid-19 due to an unprecedented planetary mobilization of the various institutes, it is indeed the liquidity valve wide open by governments and labs that may allow to "jump" the counters established by Ebola. It is the one who will take out the biggest bundle of tickets. Released by the United States in the spring, the EU intends to catch up with a fundraiser which brings the public share of aid to the vaccine to 4.4 billion euros. A generous nest egg that aims to share the risks with the labs, forced to start producing in profusion without even having the certainty that their candidate vaccine will have their bac. So here is a summary of the great upheaval induced by the search for a vaccine against Covid-19: inventing a product with efficacy not yet demonstrated in order to be able to deliver to all continents at the speed of a Rafale.

Public finance more incentive than ever

Astrazeneca has just announced a salvo of agreements with producers located around the world to establish its production chain. Emergent Biosolutions in the United States, the Serum Institute of India where you guess, Catelant in Italy, and Novasep in Belgium. If this last ally of circumstance, whose head office is located very close to that of Sanofi, indicated that it would not be able to condition the AZD1222 vaccine before "current 2021", Catelant specified for its part that it was in the starting blocks to fill his tubes "from August 2020 until March 2022", making (a little) more plausible the hope of a remedy in the fall. It costs nothing to believe it.

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• Emmanuel Macron
• Sanofi
• Vaccine
• Health
• Covid 19