Illustration of a vaccine against Covid-19.
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SOPA Images / SIPA
As for all vaccines and medicines, the authorization to market vaccines against Covid-19 depends on the European Medicines Agency, and will be done at the same time for all the countries of the Union.
Except for Great Britain, already a little apart, which gave the green light on its side last week.
How does this health authority work?
Are some processes different this time?
Britain started vaccinating its population on Tuesday.
France, it remains suspended to the European decision.
In fact, as with any authorization to market a new drug or a new vaccine, it is the European Medicines Agency (EMA for European Medicines Agency) which studies the file and issues a scientific opinion.
What changes this time for the Covid-19 vaccines?
Are experts skipping steps, at the risk of reduced vaccine safety?
20 Minutes
answers the five questions that arise, while the French government is considering the first injections in January 2021.
Who will issue (or not) the green light for vaccines against Covid-19?
For vaccines against Covid-19, as for all other vaccines, the authorization is studied at the European level.
It is therefore not our National Agency for the Safety of Medicines (ANSM), but the European Medicines Agency (EMA) which is responsible.
And more precisely the Committee for Medicinal Products for Human Use (CHMP), which depends on the EMA.
Who sits on this committee?
One expert and one alternate per Member State, as well as experts from Iceland and Norway, who have not entered the EU but maintain close relations.
For France, they are two members of our national agency, the ANSM.
But there are also up to five co-opted members, chosen from experts by Member States or by the EMA, and recruited to provide additional expertise.
A rapporteur and a co-rapporteur are appointed for each marketing request.
In addition to studying laboratory records in depth, these experts can "raise objections or raise concerns about any aspect of the drug."
If they are not refuted, the major objections prevent any marketing authorization ”, specifies the EMA.
The final recommendation is put to a vote.
In 90% of cases, the CHMP reaches a consensus.
Otherwise, the committee's final recommendation will reflect the majority opinion.
After this scientific recommendation from the EMA, it is the European Commission which gives its approval.
Are the validation criteria the same as for another vaccine?
Yes.
COVID-19 vaccines are developed under the same legal requirements for pharmaceutical quality, safety and efficacy as other drugs and vaccines.
Remember that during phase 1, 2 and 3 clinical trials, the vaccines were tested first in the laboratory, then in animals, and finally on a certain number of human volunteers.
And that in the event of an adverse reaction, the clinical trial should be suspended.
This has also been the case for two candidate vaccines, one developed by the Astrazeneca laboratory, the other by the Johnson & Johnson laboratory.
These trials have since restarted, the health authorities having confirmed the absence of risk for the participants.
Why is it going so fast?
According to EU pharmaceutical legislation, "the standard timeframe for the evaluation of a drug [after marketing authorization application, MA] is a maximum of 210 active days," explains the EMA.
Who is committed to giving a response for the Pfizer vaccine by December 29, and by January 12 for that of Moderna, between a month and a month and a half after the MA request.
How could the experts shorten this time?
Three reasons can explain it.
First of all, due to the health emergency, the European Commission has set up a “task force” dedicated to Covid-19.
These experts come to the support of the members of the CHMP to analyze the quantity of data provided by the producers of the vaccines.
Another explanation: for these vaccines against Covid-19, the EMA applies an accelerated procedure, called a rolling review.
What does it change ?
As soon as a vaccine sponsor has data available, they drop it off to the agency, which can therefore study clinical trial results over time, and not all at once.
Thus, European experts began to look at the documents from AstraZeneca from October 1, from Pfizer and BioNTech on October 6, those from Moderna on November 16 and those from Janssen on December 1.
Finally, a third process changed the situation, this time on the delivery side of the vaccines.
In view of the stakes, the laboratories took the risk of producing these vaccines in large quantities in factories even before obtaining the green light from the health authorities.
This is why less than a week elapsed between the authorization of the sale of Pfizer's vaccine by the British government on Wednesday 2 December and the first injections on Tuesday 8 December.
What about transparency?
Once the decision to market has been made, the evaluation report on Covid-19 vaccines will be accessible to everyone, as for all drugs and vaccines authorized by the EMA.
With, this time again, a small specificity on the timing side: if normally, the general public can find it online after two weeks, this time it should be available for consultation after two or three days.
In addition, all clinical data will also be published in open source, probably a little later, the time to anonymize all the results.
An approach that the EMA adopted as early as 2016, then which was suspended during the move from London to Amsterdam in 2019 (following the Brexit vote), before being reactivated for anti-Covid vaccines.
Thousands of pages that the general public will be able to dissect, since they will be translated into all the languages used in the European Union.
This will leave all latitude to researchers to conduct new studies.
What will be the follow-up?
If the green light from the European Union is obtained for one or more vaccines, then a whole pharmacovigilance process will begin.
Indeed, the EMA, but also the ANSM, are responsible for monitoring vaccinated patients in the medium and long term.
A step that is all the more fundamental in this scenario as the clinical trials lasted only a short time, around two months for Moderna's vaccine candidate, for example.
In the event of side effects or health problems, citizens can send their information to these institutions on the ANSM reporting portal.
In addition, the new director of the EMA, Emer Cooke, arrived on November 16, specifies in
Le Figaro
, that “the laboratories will have the obligation to report unforeseen side effects after the injection.
This process will involve our pharmacovigilance system within the EU with stricter rules than usual, with the obligation for companies to report on a monthly basis.
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A cyber attack on the Pfizer-BioNTech vaccine
The EMA announced on Wednesday afternoon that it had been the subject of a cyberattack.
"The agency quickly opened a full investigation, in close cooperation with the police," said the European agency, without specifying when the attack had taken place, or by whom it had been carried out.
The Pfizer group announced in the wake that documents related to the authorization request for its vaccine had been hacked during this cyberattack, but that "neither the BioNTech system nor that of Pfizer (had) been violated in connection with this incident ".
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