The contract was signed in early October related to doses of Remdesivir, even though the WHO had not issued its conclusions concerning it. Once again, is this the sign of an unpreparedness or Big Pharma lobbies operating within Europe?
According to information from our French colleagues at le Canard Enchaîné, the European Commission signed a huge contract concerning the drug from the American company Gilead, known as Remdesivir.
The agreement was inked on October 7, supposedly to fight against Covid-19. However, on the one hand, no study had been done on the effectiveness of this drug, but above all, a body of the WHO (World Health Organization) had not yet delivered its conclusions. Worse still, the amount paid by Europe is astronomical according to the French newspaper, since each dose was purchased at the price of… 1 970 euros!
And because calamities always happen in a series, barely a week after signing the contract, the body responsible for monitoring the effectiveness of the drug delivered its verdict: “Remdesivir seems to have little or no effects on hospitalized patients.” An EC source later said he was not aware of the existence of the study.
This ignorance is peculiar, according to the Canard, because European representatives meet WHO emissaries in Brussels every week. In addition, despite numerous meetings, the ongoing study of Gilead’s drug was never mentioned. Also, in August, the European Health Security Committee had mentioned the use of Remdesivir, reaffirmed it in September, twice, then in October too before the signing of the contract without informing the WHO representative.
However, according to our colleagues, the WHO had already known about the unsatisfactory results since September 23, results that the organization transmitted to the laboratory but not to Europe. As an excuse, the WHO claimed that it acted only “as an observer”.
The contract did not bear “any mention of an obligation to purchase” but many countries still paid for the doses, except France which had already judged it to be ineffective earlier.
According to two German media outlets, France has also delayed the purchase of vaccinations to favor Sanofi in the European Union even though the French company’s vaccine will not be ready before the end of 2021.
This information must taken with a grain of salt, but according to the “serious” mainstream German newspapers Der Spiegel and Die Zeit, the European Union has been offered 500 million (as well as an additional 100 million) doses of the vaccine from the company BioNTech, the German partner of the American firm Pfizer. But the offer was rejected, allegedly to help Sanofi.
According to the Brussel Times, the French government opposed this new offer because the contract had changed to more than 800 million doses. Interestingly, the vaccine from Pfizer/BioNTech has been valued at around twelve euros, against only €7,50 for that of Sanofi. The costs had been confidential until a Belgian official tweeted — and then deleted — the price list.
The European Union declined to respond to the revelations by Der Spiegel.
In France, the first vaccinations against Covid-19 are due to start in January. And big reinforcements will be deployed to monitor potential side effects related to vaccines, FranceInfo reported. The whole population will be targeted and surveyed.
Thus mass surveillance, cloaked as “pharmacovigilance” will have to meet several challenges in 2021: specifying the efficacy and risks of vaccines and responding to the fears of the French, who are very suspicious of vaccination. The first vaccines that will be available in January in France were developed in record time, and are therefore subject to doubts in terms of safety and efficacy.
To overcome them, vaccine surveillance systems will be strengthened, said the National Agency for the Safety of Medicines and Health Products (ANSM). It will be necessary “to identify the possible undesirable effects which would not have been observed during the clinical trials”.
But the equation is complex: Six vaccine candidates have been pre-ordered for the European Union, with four different technologies used and a vaccination schedule which still has to be defined.
Candidates for Covid-19 vaccines will go through the sieve of the Committee for Medicinal Products for Human Use (CHMP), just like their predecessors, assured the European Medicines Agency (EMA), in charge of the attribution of marketing.
Once the valuable marketing authorizations (AMM) have been issued, a new phase of evaluation of these vaccines will begin. On the one hand through the pursuit of longer-term industrial and academic studies (phase 4) of people who have been involved in phase 3 clinical trials. But above all, “in real life”. The vaccines will be injected into several hundred thousand people, which will make it possible to trace any adverse effects not observed during the previous stages, they maintain.
“The clinical trials are adapted to the evaluation of the benefit but remain insufficient for the study of the drug risk since they include too few patients, are too short or too often exclude the subjects at risk,” explained the Regional Center of Pharmacovigilance from Toulouse.
“Only post-marketing follow-up makes it possible to clearly specify the undesirable effects and therefore the benefit/risk ratio of the drug.” Clearly, citizens are being used as the proverbial guinea pigs.
The United Kingdom began its vaccination campaign on December 7. “When we begin to vaccinate in France, the English will already have vaccinated over a million people, said Bégaud Bernard, professor of pharmacology at ANSM. “That will be very valuable, because we will thus have a hindsight of at least a month on a mass vaccination.”
A large platform, called SI-Vaccination, will monitor the massive roll-out. It was designed to help general practitioners, who asked for the installation of a tool allowing them to forward a maximum of information on the vaccination, while organizing the follow-up of the patients concerned.
Additional technical and human resources should make it possible to cope with this unprecedented vaccination campaign, announced the ANSM. An artificial intelligence module will in particular be made available to the centers to facilitate the classification of declarations.
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