TRIBUNE – On the validity of marketing authorizations for vaccines (against Covid-19): the ANSM’s response sent to a lawyer is not the one addressed to a doctor.
Text originally published on blog of Dr Amine Umlil.
In our article on August 17, 2021, the validity of the MA (marketing authorization) “Conditional” vaccines against Covid-19 has been questioned.
The questions raised were relayed to Madam ” Executive Director “ of the National Medicines Safety Agency (ANSM), in particular by a lawyer who represents associations of health professionals and citizens. The ANSM has just replied to this lawyer.
Recall of facts
These vaccines, which are medicinal products, only benefit from a temporary MA, the validity period of which does not exceed one year. However, manufacturing laboratories must imperatively submit a renewal request. “Six months before expiration” of this conditional marketing authorization.
In the absence of this renewal request, this Marketing Authorization is no longer valid. And the sale of these products must stop immediately.
The four vaccines concerned are those of the pharmaceutical laboratories BioNTech / Pfizer; Moderna; Astra Zeneca; Janssen. They obtained this conditional centralized European Marketing Authorization on December 21, 2020; January 6, 2021; January 29, 2021; March 11, 2021.
In application of European Commission Regulation n ° 507/2006, the request for renewal of these MAs should have been submitted before June 21, 2021 (for the BioNTech / Pfizer vaccine); before July 6, 2021 (for Moderna); before July 29, 2021 (for Astra Zeneca); before September 11, 2021 (for Janssen).
Moreover, in our article, as of April 2, 2021, for each of these four vaccines, and according to paragraph “E. Specific obligation relating to post-authorization measures concerning the conditional marketing authorization” of Annex II of the conditional Marketing Authorization, published by the European Medicines Agency (EMA), it specifies that “in accordance with Article 14-bis of Regulation (EC) n ° 726/2004, the MA holder must complete, according to indicated schedule, the following measures: (…) ”. From Additional evidence was therefore also expected on the dates set indicated in the tables available on pages “18-19” (for the BioNTech / Pfizer vaccine); page “15” (for Moderna); pages “14-15” (for Astra Zeneca); page “18” (for Janssen).
Or, several of these dates have also passed : January 2021, March 31, 2021, April 2021, July 2021 (for the BioNTech / Pfizer vaccine); January 2021, April 2021, June 2021 (for Moderna); March 5, 2021, April 30, 2021 (for Astra Zeneca); March 31, 2021, August 15, 2021 (for Janssen).
For each of these dates, proof was expected. This evidence concerns in particular the “Quality” from « substance active » and « excipients », of ” manufacturing process “, from “Batch reproducibility” marketed ; that is to say the intrinsic quality, the composition, the very heart, of these vaccines against Covid-19. What is unpublished.
Asked about these points, the ” executive management “ ANSM has just answered the lawyer.
On the validity of conditional marketing authorizations for Covid-19 vaccines: the ANSM’s response sent to a lawyer
This lawyer had questioned the ” Executive Director “ of the ANSM by sending a letter, dated August 26, 2021, in which he informs the ANSM that “these deadlines are imperative because they concern the various anti-covid-19 vaccines currently inoculated to the population (…) administered to human beings in several countries of the world ”. He added: “My clients are obviously inclined to think that the AEM and the ANSM are in possession of this essential information and that the aforementioned procedure has indeed been respected with regard to the issues, but they nevertheless wish to ensure that these are respected. obligations since the non-renewal of authorizations would automatically void conditional marketing authorizations “. And then, this lawyer notes:
“I draw your attention as necessary to the existence of Article 20.4 of Regulation (EC) No 726/2004 which provides that when emergency action is essential to protect human health or environment, a Member State may, on its own initiative or at the request of the committee, suspend the use in its territory of an authorized medicinal product for human use in accordance with these regulations. “
However, by a letter, dated September 7, 2021, the ” Executive Director “ of the ANSM answers this lawyer in particular this:
You sent me, in your capacity as lawyer of (…), a letter dated August 26, 2021, in which you inform me of your concern about several legal matters concerning the respect of imperative deadlines from European regulations, from Annex II of each conditional marketing authorization (MA) included in the European public assessment report (EPAR) of the various anti-covid-19 vaccines.
In this regard, I am in a position to clarify the following elements to you.
In the present case, in the case of pharmaceutical specialties benefiting from centralized MAs granted by the European Commission, MA applications, requests for modifications as well as requests for their renewal are submitted by the manufacturers to the European Medicines Agency (EMA) for evaluation of these elements.
Accordingly, I inform you that I have forwarded your request to the Executive Director of the EMA so that she can provide you with the desired answers.
This answer is surprising.
Does this mean that the ANSM One sait pas whether the conditional MAs for these vaccines are still valid? That the ANSM was not worried about the respect of these imperative deadlines which nevertheless condition the validity of these temporary MAs?
How, in this case, and when a “Emergency action is essential to protect human health” citizens, could France “On his own initiative (…) suspend use on its territory of a medicinal product for authorized human use ”if the ANSM, which is the policeman of the medicinal product, does not follow up the said mandatory deadlines, compliance with which conditions the validity of the said marketing authorizations?
But, another information calls out. To the questions of a doctor, this time, the ANSM provides another answer, of a different nature!
On the validity of conditional marketing authorizations for vaccines against Covid-19: the other response from the ANSM, this time sent to a doctor
On September 7, 2021, a doctor questions the ANSM as follows:
ʺThe conditional marketing authorization brings together all control locks a standard marketing authorization to ensure a high level of patient safety.
Can you tell me what these control locks are?
The next day, September 8, 2021, the “User reception unit” of the ANSM answers this doctor, in an impersonal way, in particular this:
We have received your request dated 07/09/2021 concerning the conditional MA for covid-19 vaccines.
To accelerate the availability of vaccines against Covid-19 in the context of a pandemic, the European Medicines Agency (EMA) has set up a continuous review of marketing authorization applications (AMM), otherwise called ʺrolling reviewʺ (link on the ANSM site: (…). The data, transmitted by the manufacturers, are thus analyzed in real time by agencies competent national within the EMA, dont l’ANSM.
Once a conditional MA has been granted, the laboratories must provide the Additional data from new or ongoing studies in deadlines set by the EMA.
Conditional Marketing Authorizations are valid for 1 year and the request for renewal of the Marketing Authorization must be submitted 6 months before the end of the conditional Marketing Authorization. Requests for renewal of conditional marketing authorizations for anti-Covid vaccines have been submitted by the laboratories concerned within the regulatory deadlines, i.e. 6 months before the end of the conditional MA. These renewals are currently being assessed by the EMA.
What to say ?
The ANSM therefore provides two different answers according to the qualification of the author of the questions on the one hand; and according to the qualification of the author of the response within the ANSM on the other hand.
At thelawyer, specialist in law, the ” Executive Director “ of the ANSM is content to relay the questions put to the executive director of the EMA.
At doctor, which prescribes these vaccines against Covid-19, “User reception unit” of the ANSM replies that “all is well”: the conditional marketing authorizations for these vaccines against Covid-19 are still valid.
It should be recalled that in a report, published in 2017 by the European Medicines Agency (EMA) which reviewed the first ten years of its practice of conditional MAs from 2006 to 2016, often, this expected evidence is not provided by pharmaceutical companies. The journal Prescrire notes: “Questions that remain unanswered if the EMA is not more demanding, with the risk of leaving patients exposed to drugs for a long time with an unfavorable benefit-risk balance”.
And it is health professionals, and professionals from other professions, who are, since Wednesday September 15, 2021, automatically hanging of their functions, immediately deprived of their remuneration, prohibited from exercising any other remunerated activity; for refusing to inject these products, the very validity of which of the MA would, more than ever, be doubtful.
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