Renewal of marketing authorisations and proof of quality of vaccines (France)

Many requests for additional information on vaccines are regularly made. Among them, the question of conditional marketing authorisations is on the agenda, directly linked to the question of documents attesting to the effectiveness of vaccines, normally provided by their respective manufacturers.

Indeed, as we have exceeded the deadlines for submitting an initial renewal application provided for by the marketing authorisations, and as we have no news from the health authorities, we are entitled to ask ourselves the following question: will the wave of third doses, which has already been announced, take place in accordance with the European regulation? Either it has not been respected, or it has been respected but without any transparency on the different steps to be respected, which an authority such as the french National Agency for the Safety of Medicines and Health Products (ANSM) should report publicly in view of the stakes.

Faced with the lack of response from the authorities and the non-availability of this information, three associations (the International Association for Independent and Benevolent Scientific Medicine, the National League for Vaccination Freedom and BonSens) filed a petition with the Council of State in the framework of a summary procedure against the National Agency for the Safety of Medicines and Health Products, the Minister for Solidarity and Health and the High Authority for Health. The purpose of this procedure is to obtain the requested documents concerning the vaccines, through Me Teissedre, the lawyer who represents the associations.

By letter dated 26 August 2021, the counsel for the applicant associations wrote to the Director General of the ANSM to request that she provide the elements needed to ensure that the procedure in question – provided for by two European regulations on conditional marketing authorisations – was properly followed. To date, this letter has remained unanswered and the associations have therefore mandated Mr Teissedre to obtain a ruling.

This is crucial information, as the French government has been engaged in a forced vaccination since President Macron’s announcement of 12 July 2021. This announcement led to mandatory vaccination for healthcare workers and a health pass for the rest of the population.

On paper, a conditional marketing authorisation lasts for one year, but requires vaccine manufacturers to apply for renewal six months before the final deadline. This is because the authorisations are based on a thorough review of the documents provided by the manufacturers, which takes time – the opinion of the European Medicines Agency must be given within 90 days of the application. These deadlines are therefore supposed to be imperative, especially as they now concern the entire population.

Please note:
The BioNTech/Pfizer vaccine was granted a European conditional marketing authorisation on 21 December 2020.
The Moderna vaccine was granted conditional marketing authorisation on 6 January 2021.
AstraZeneca vaccine was granted conditional marketing authorisation on 29 January 2021.
Janssen vaccine was granted conditional marketing authorisation on 11 March 2021.

It is therefore necessary to verify whether the procedure described above was followed for the Pfizer, Moderna and AstraZeneca vaccines.

The lawyer’s brief then elaborates on the incompleteness of the evidence relating to the quality of the vaccines authorised in Europe, on the arguments relating to their efficacy, explaining that they are incapable of blocking the spread of the Delta variant. With a shorter and weaker protection than that announced by the manufacturers and the government, it is necessary to verify that the above-mentioned European regulations have been respected, especially since vaccination is also at the origin of various measures that are increasingly infringing on the fundamental rights and freedoms of the human person.

Me Teissedre therefore asks the Council of State:

1 –  To enjoin, under a fine of €1,000 per day of delay, the National Agency for the Safety of Medicines and Health Products, the Ministry of Solidarity and Health and the High Authority for Health to produce, as soon as possible, which may not exceed 15 days from the date of the order to be made, the information and evidence referred to in the regulation*, as well as the additional information and data referred to in Annexes 2, paragraph E, of each conditional marketing authorisation, for each Covid-19 vaccine authorised in France and in the European Union. This information and data concerns in particular the quality of the active substance used and of the excipients, the manufacturing process, the reproducibility of the batches marketed, once the deadlines stipulated in each of these annexes have been exceeded;
[*(EC) No 507/2006 of 29 March 2006 concerning compliance with the procedure for the annual renewal of conditional marketing authorisations.]

2 –  Failing this, to order the suspension on French territory of the use of the four vaccines to which a conditional marketing authorisation has been granted by the European Medicines Agency and the European Commission;
And to order the Minister of Solidarity and Health, the ANSM and the High Authority for Health to pay the applicants the sum of €4,500 on the basis of the provisions of Article L. 761-1 of the Administrative Justice Code.

Contacted today, Me Teissedre informs us that his brief has been received and registered. It remains to be seen whether this will lead to a hearing.

Originally published in France Soir.

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