The Pharmaceutical Services issued a written statement today regarding the process followed for the licensing of vaccines against COVID in the European Union.
Specifically, the European Union has granted Conditional Marketing Authorization to the following vaccines against COVID-19:
- Comirnaty (known as BioNTech-Pfizer)
- Spikevax (formerly Moderna vaccine name)
- Vaxzevria (former AstraZeneca vaccine name)
- Janssen (also known as Johnson & Johnson)
What is the procedure for licensing COVID- 19 vaccines in the European Union:
Any vaccine developer wishing to place a vaccine on the European Union (EU) market must first apply for a marketing authorization for the vaccine. The request is submitted to the European Medicines Agency (EMA), which evaluates the safety, efficacy and quality of the vaccine. If Coreper issues a positive recommendation, the European Commission can proceed with the licensing of the vaccine for marketing on the EU market.
To address public health threats, such as the current pandemic, the EU has a special regulatory tool that allows medicines to be made available in a timely manner for emergencies. The conditional marketing authorization process is specifically designed to allow marketing authorizations to be granted as soon as sufficient evidence is available, precisely in emergencies such as pandemics or to treat other serious illnesses without prior medication. This process provides the EU with an even framework for faster approval and post-approval assurances and security controls. In addition, Coreper examines applications for vaccines against COVID-19 through a “rolling evaluation” process, ie the various documents are submitted and evaluated in real time and as soon as they are submitted, without having to wait for them to be collected before filing. This saves valuable time without adversely affecting the level of evaluation.
During the evaluation, Coreper will conduct an independent, thorough and thorough evaluation of all data submitted by the vaccine developer. The Coreper Committee for Medicinal Products for Human Use (CHMP) issues a positive recommendation only when evidence conclusively demonstrates that the benefits of vaccination outweigh the risks of vaccination.
Marketing authorization from the European Commission
The European Commission is legally responsible for the marketing authorization. Following a positive recommendation from the EMA Committee for Medicinal Products for Human Use (CHMP), the European Commission is verifying all marketing authorization documentation.
The Commission, after consulting the Member States, shall take its decision on the marketing authorization of the vaccine. The vaccine can then be marketed anywhere in the EU.
Conditional marketing authorization does not lag behind in ensuring the safety, quality and effectiveness of medicines from the standard marketing authorization. The conditions contained in the marketing authorization ensure:
- strict monitoring of drug safety throughout the EU, through the EU pharmacovigilance system,
- the post-approval monitoring of security at regular intervals and allows the collection of additional data in a structured manner,
- strict manufacturing conditions, including the release of batches of vaccines and distribution,
- investigating the future use of the drug in children.
These are essential elements in ensuring a high level of protection for citizens during a mass vaccination campaign and are a key component of the EU vaccine strategy. All 27 EU Member States have formally co-authored the EU Vaccine Strategy and agreed to follow the conditional marketing authorization process through the European Medicines Agency for COVID-19 vaccines.
The conditional marketing authorization is valid for a period of one year, is renewable and implies for the holder the same rights and responsibilities as the ordinary marketing authorizations. In addition, the holder of such a license has specific obligations in order to confirm that the benefit / risk balance remains positive.
In the context of the conditional marketing authorization procedure, vaccine producers are primarily responsible for:
- continuous monitoring of vaccine safety,
- the reporting of serious adverse events,
- updating product information,
- conducting safety and efficacy studies,
- examining the performance of their products in larger populations on the market, and
- regular reporting on the safety and benefit-risk balance to the EMA.
Member States are responsible for:
- overseeing the collection of information on suspected adverse reactions during signal evaluation, periodic safety reports, post-approval safety studies and risk management plans.
Coreper is responsible for:
- monitoring of all reported adverse reactions,
- providing additional guidance and requirements to vaccine producers for the development of COVID-19 vaccine risk management plans,
- the monthly summary safety approval reports from the producers (in addition to the semi-annual periodic safety monitoring reports),
- the development and maintenance of EudraVigilance, a system for managing and analyzing information on suspected adverse drug reactions, and
- analyzing information and conducting studies in the general population to monitor both the safety and efficacy of vaccines.
Finally, it should be emphasized that the EU issues COVID-19 vaccine marketing authorizations once all the clinical trials required for the submission of applications (Phase I, II, and III) have been completed and in no case The vaccines in question constitute “experimental preparations”.
More information is available at the link: https://ec.europa.eu/commission/presscorner/detail/en/qanda_20_2390?fbclid=IwAR3t50Jg5l7Z1FpRfyFTvG8t5xCx1jQa_olaKChBrEw5qmlZ.
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