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Moji razgovori s Emom, treći dio: Medical products composition

Greetings,

following our prior discussion I would like to ask you some more question.

As the EMA-authorized medical products stated on the official EMA website as ‘COVID-19 vaccines’[1] are subjected to wide public health interventions on the European population, EMA is asked to provide a precise answer on the exact composition of these authorized products’ content, whereby the content is publicly declared by the producers and accepted as such by EMA[2]. Accordingly, answers are specifically required on the following topics:

1)How did EMA assess the exact composition and the eventual presence of non-declared substances or ‘pollutants’, of the subject medical products beyond inspection and/or evaluation of the producers’ declarations and/or accompanying documentation? What experimental procedures were used for this purpose and if used, were the procedures confined only to declared substances? How were eventual non-declared substances or ‘pollutants’ studied? Please provide accompanying experimental protocols substantiating the answer if available.

2)Does EMA has a mechanism on which it acts upon specific requests sent to EMA substantiated by independent laboratories analyses on eventual breakage of the content declaration of medical products? If yes, please provide details on how to proceed with application of such request to the EMA formally.

3)Which EU laboratories (please enlist them by name and contact details) have been assigned for assessment of the exact content and/or monitoring of the quality and exact content of the subject medical products batches content?

4)How does EMA ensures a continuous assessment of the safety of these massively applied experimental medical products to the EU public, especially in the context of declared or eventually undeclared substances that might have diverse medical implications (i.e. allergies)? Does the monitoring of long-term effects for this experimental products fall only into the pharmacovigilance procedures currently in place and which are these measures?

5)Why has EMA authorized the use of the subject medical products under the label ‘vaccines’ and according to which data (including the data from producers and expert panels opinion) and regulations in vigour within the EU was this decision based? Please provide the subject substantiation and accompanying documentation.

6)As EMA means an abstract entity, please provide the exact names and official contacts of experts from EMA in charge for the questions above. Who is responsible in front of EMA for the authorization of the above-mentioned medical products? Please provide the official contact of the person or members of panels and /or teams.

[1] Medical products ‘Comirnaty’, ‘Spikevax‘, ‘Vaxzevria‘, ‘COVID-19 Vaccine Janssen‘, https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/covid-19-vaccines

[2] https://www.ema.europa.eu/en/medicines/human/EPAR/comirnatyhttps://www.ema.europa.eu/en/medicines/human/EPAR/spikevax ; https://www.ema.europa.eu/en/medicines/human/EPAR/vaxzevria-previously-covid-19-vaccine-astrazeneca ; https://www.ema.europa.eu/en/medicines/human/EPAR/covid-19-vaccine-janssen

Thank you.

27 October 2021 14:43

Dear Mr Sincic,

I acknowledge receipt of your email and we will come back to you to further clarify how the quality of COVID-19 vaccines, like any other medicine, is carefully assessed before a (conditional) marketing authorisation is granted, in line with the EU legal and scientific requirements.

I have reached out to our quality experts and hope to come back to you shortly, but please bear with us as the same experts are currently also fully involved in the ongoing assessments of COVID-19 medicines.

Best regards,

Hilde

Thu 10/28/2021 1:26 PM

Dear Mr Sinčić,

Thank you again for contacting the European Medicines Agency.

As a general introductory remark, I would like to highlight that details on how EMA assessed the individual vaccines and the information considered in each assessment can be found in the respective assessment report for each COVID-19 vaccine (listed below) published on EMA’s website:

-Comirnaty: https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty

-COVID-19 vaccine Janssen: https://www.ema.europa.eu/en/medicines/human/EPAR/covid-19-vaccine-janssen

-Spikevax: https://www.ema.europa.eu/en/medicines/human/EPAR/spikevax

-Vaxzevria: https://www.ema.europa.eu/en/medicines/human/EPAR/vaxzevria-previously-covid-19-vaccine-astrazeneca

On behalf of EMA, please find below point-by-point answers to the questions and issues you raised:

1) How did EMA assess the exact composition and the eventual presence of non-declared substances or‘pollutants’ of the subject medical products beyond inspection and/or evaluation of the producers’ declarations and/or accompanying documentation? What experimental procedures were used for this purpose and if used, were the procedures confined only to declared substances? How were eventual non-declared substances or ‘pollutants’ studied? Please provide accompanying experimental protocols substantiating the answer if available.

In line with EU legislation, to obtain a marketing authorisation, medicine developers have to submit specific data on their medicine which are the basis for EMA’s assessment to decide whether or not a medicine is safe, effective and of good quality. In addition to the requirements set-out in EU legislation (eg Annex I to Directive 2001/83) EMA provides companies with guidance on the type of data and information that needs to be included in a marketing authorisation application. This includes data on: 

-the quality of the medicine including its chemical and physical properties, such as its stability, its purity and biological activity;

-compliance with international requirements for laboratory testing, medicine manufacture and conduct of clinical trials (‘good laboratory practice’, ‘good clinical practice’ and ‘good manufacturing practice’);

In addition, during an evaluation EMA’s scientific committees may request inspections of the medicine’s manufacturing sites, of the site where  a non-clinical or clinical study was performed or of the pharmacovigilance (safety monitoring) processes involved in the application and such inspections would then be carried out as part of the assessment.

Based on the outcome of any inspection and the assessment of the extensive information provided by the companies, EMA decides whether or not a medicine is safe, effective and of good quality and is therefore suitable for use in patients.

Once a vaccine has received approval, batches can only be marketed and released following quality control testing if the product is in line with the specifications that were approved as part of the respective Marketing Authorisation. This control is carried out by the manufacturer. EMA does not carry out its own analysis. However, for most centrally authorised vaccines EU legislation requires that a Member State’s Official Medicines Control Laboratory performs an additional independent control for each batch before it is put on the EU market. This independent control is referred to as Official Control Authority Batch Release (OCABR[1]) and includes testing of agreed quality parameters and a compliance check of the manufacturer’s own test results.

2) Does EMA have a mechanism on which it acts upon specific requests sent to EMA substantiated by independent laboratories analyses on eventual breakage of the content declaration of medical products? If yes, please provide details on how to proceed with application of such request to the EMA formally.

Any concerns about a medicine, including concerns about quality and compliance with good manufacturing practice, when reported to EMA are promptly investigated by EMA and the EU/EEA network to decide what, if any, actions are needed to protect public health. EMA has published guidance documents in this area which you may find useful:

-Management and classification of reports of suspected quality defects in medicinal products and risk-based decision-making (Compilation of Union Procedures on Inspections and Exchange of Information – revision 18 (europa.eu))

-Dealing with reports of suspected defective medicinal products (2018 SOP – Dealing with Reports of Suspected Defective Medicinal Products (europa.eu))

For your information, marketing authorisation holders are required to notify any (suspected) quality defect or possible falsification to the regulatory authorities. For further information please refer to the following webpages:  Quality defects and recalls | European Medicines Agency (europa.eu)Falsified medicines: reporting obligations | European Medicines Agency (europa.eu)). In case of reports from third parties EMA has also put in place a policy on handling these: Handling reports of alleged improprieties from external sources | European Medicines Agency (europa.eu). Such reports may include allegations of non-compliance with standards of good practices that could have an impact on the evaluation and supervision of medicines.

If needed, inspections may be carried out in response to an issue reported to EMA or to verify compliance with good practice standards. For any issues EMA always works closely with other regulators including international regulatory authorities.

3) Which EU laboratories (please enlist them by name and contact details) have been assigned for assessment of the exact content and/or monitoring of the quality and exact content of the subject medical products batches content?

As explained in question 1, once a COVID-19 vaccine has received approval, batches can only be marketed and released following quality control testing by the manufacturer as well as following Official Control Authority Batch Release (OCABR) by a Member State official medicines control laboratory. More information about  the OCABR process for the authorised COVID-19 vaccines can be obtained from the EDQM which coordinates this process: https://www.edqm.eu/en/contact-edqm

4) How does EMA ensure a continuous assessment of the safety of these massively applied experimental medical products to the EU public, especially in the context of declared or eventually undeclared substances that might have diverse medical implications (i.e. allergies)? Does the monitoring of long-term effects for this experimental products fall only into the pharmacovigilance procedures currently in place and which are these measures?

Please note that COVID-19 vaccines have a marketing authorisation and therefore cannot be considered as ‘experimental medicinal products’.

As for all medicines, a comprehensive safety monitoring and risk management system (set out in the EU good pharmacovigilance practices (GVP)) is in place for COVID-19 vaccines.

The safety monitoring of COVID-19 vaccines takes place more frequently and includes activities that apply specifically to COVID-19 vaccines. Companies for example provide monthly safety reports in addition to the regular periodic updates required by the legislation. Safety data is collected through spontaneous reporting systems and observational studies. This is detailed in EMA’s Pharmacovigilance plan for COVID-19 vaccines: https://www.ema.europa.eu/en/documents/other/pharmacovigilance-plan-eu-regulatory-network-covid-19-vaccines_en.pdf

5) Why has EMA authorized the use of the subject medical products under the label ‘vaccines’ and according to which data (including the data from producers and expert panels opinion) and regulations in vigour within the EU was this decision based? Please provide the subject substantiation and accompanying documentation.

The mentioned medicinal products have been classified as vaccines based on the European Pharmacopeia, EU legislation and scientific guidelines, listed below:

-European Pharmacopeia, Monograph of Vaccine for human use:   

Vaccines for human use are preparations containing antigens capable of inducing a specific and active immunity in man against an infecting agent or the toxin or antigen elaborated by it. Immune responses include the induction of the innate and the adaptive (cellular, humoral) parts of the immune system. Vaccines for human use shall have been shown to have acceptable immunogenic activity and safety in man with the intended vaccination schedule.  

Vaccines for human use may contain: whole micro-organisms (bacteria, viruses or parasites), inactivated by chemical or physical means that maintain adequate immunogenic properties; whole live micro-organisms that are naturally avirulent or that have been treated to attenuate their virulence whilst retaining adequate immunogenic properties; antigens extracted from the micro-organisms or secreted by the micro-organisms or produced by genetic engineering or chemical synthesis. The antigens may be used in their native state or may be detoxified or otherwise modified by chemical or physical means and may be aggregated, polymerised or conjugated to a carrier to increase their immunogenicity. Vaccines may contain an adjuvant. Where the antigen is adsorbed on a mineral adjuvant, the vaccine is referred to as ‘adsorbed’.  

-Directive 2001/83/EC article 1(4)a:  

Immunological medicinal product:   

Any medicinal product consisting of vaccines, toxins, serums or allergen products:   

(a) vaccines, toxins and serums shall cover in particular: (i) agents used to produce active immunity, such as cholera vaccine, BCG, polio vaccines, smallpox vaccine; (ii) agents used to diagnose the state of immunity, including in particular tuberculin and tuberculin PPD, toxins for the Schick and Dick Tests, brucellin; (iii) agents used to produce passive immunity, such as diphtheria antitoxin, anti-smallpox globulin, antilymphocytic globulin;  

-Scientific guidelines

EMA guideline on clinical evaluation of new vaccines:

https://www.ema.europa.eu/en/clinical-evaluation-new-vaccines

WHO guidelines on clinical evaluation of vaccines:

https://www.who.int/teams/health-product-and-policy-standards/standards-and-specifications/vaccine-standardization/clinical-evaluation-of-vaccines

Specific guidelines have been issued by EMA and other regulatory agencies for COVID-19 vaccines development. The ones issued by EMA can be found here:

https://www.ema.europa.eu/en/ema-considerations-covid-19-vaccine-approval

https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-regulatory-requirements-vaccines-intended-provide-protection-against-variant_en.pdf

All vaccines currently authorised in the EU have been authorised via a Conditional Marketing Authorisation. This type of marketing authorisation is explained in more detail in the link below:

https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/conditional-marketing-authorisation

The authorisation guarantees that the vaccines meet rigorous EU standards for safety, efficacy and quality and that comprehensive data is still generated post-approval. It also offers a robust post-authorisation regulatory framework based on legally binding obligations.

In addition, enhanced and stringent safety monitoring is in place for all COVID-19 vaccines, to ensure that the benefits always outweigh the risks.

COVID-19 vaccines were approved based on studies showing a significant reduction in the number of symptomatic COVID-19 cases in the people who received the vaccine compared with people who received a placebo or a non-COVID vaccine (e.g. meningococcal vaccine in some of the trials used to support the approval of Vaxzevria).

Further details on the individual assessment can be found in the above-mentioned assessment reports of the respective vaccines.

6) As EMA means an abstract entity, please provide the exact names and official contacts of experts from EMA in charge for the questions above. Who is responsible in front of EMA for the authorization of the above-mentioned medical products? Please provide the official contact of the person or members of panels and /or teams.

Assessments of medicines for human use are carried out by the Agency’s Committee for Medicinal Products for Human Use (CHMP). For an application of a new medicine, two Committee members − known as rapporteur and co-rapporteur − from different countries are appointed to lead the assessment. The names of the rapporteur and co-rapporteur are published in the assessment report of the medicine (which can be found through the links provided above).

The rapporteurs for the vaccines are as follows:

Comirnaty: Rapporteur: Filip Josephson Co-Rapporteur: Jean-Michel Race

COVID-19 vaccine Janssen: Rapporteur: Christophe Focke Co-Rapporteur: Sol Ruiz

Spikevax: Rapporteur: Jan Mueller-Berghaus Co-Rapporteur: Andrea Laslop

Vaxzevria: Rapporteur: Sol Ruiz Co-Rapporteur: Johann Lodewijk Hillege

The benefit-risk evaluation and decision for a medicine is taken collectively by the entire CHMP committee after discussion of the rapporteur and co-rapporteur assessment reports.

This is the list of the current CHMP members: https://www.ema.europa.eu/en/committees/chmp/members.

For a general overview of responsibilities for human medicines within the Agency please refer to the following webpage:

https://www.ema.europa.eu/en/about-us/who-we-are/human-medicines#head-of-human-medicines-section


We hope that the above reassures you that the assessment of COVID-19 vaccines is robust and follows stringent scientific requirements for quality, safety and efficacy and that enhanced and stringent safety monitoring is in place as stipulated by EU legislation.

We thank you for your interest in the EMA’s work and we will continue doing all we can within our mandate to ensure that EU citizens will be able to benefit from safe and effective vaccines and therapeutics to help fight the pandemic.

Best regards,

Hilde Boone


Nov 24, 2021, 9:32 AM

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