Filenews 27 July 2021
Useful information on crown vaccines, to which the EU has granted a conditional marketing authorisation, is published by the Ministry of Health.
The European Union has granted conditional Marketing Authorisation to the following COVID-19 vaccines:
- Comirnaty (known as BioNTech-Pfizer)
- Spikevax (formerly called Moderna vaccine)
- Vaxzevria (formerly name of AstraZeneca vaccine)
- Janssen (also known as Johnson & Johnson)
- What is the authorisation procedure for COVID -19 vaccines in the European Union:
Any vaccine developer wishing to place a vaccine on the European Union (EU) market should first apply for marketing authorisation for the vaccine. The request shall be submitted to the European Medicines Agency (EMA), which shall assess the safety, efficacy and quality of the vaccine. If the EMA adopts a positive recommendation, the European Commission can proceed with the authorisation of the vaccine for marketing on the EU market.
To address threats to public health, such as this pandemic, the EU has a special regulatory tool, allowing the timely availability of medicines for use in emergencies. The conditional marketing authorisation procedure is specifically designed to allow marketing authorisations to be granted as soon as possible, as soon as sufficient data are gathered, precisely in emergencies such as the pandemic or to treat other serious diseases without prior medication. This process provides the EU with a sound framework for faster approval and post-authorisation security safeguards and controls. In addition, applications for vaccines against COVID-19 are examined through a "rolling evaluation" procedure, i.e. the various documents are filed and evaluated in real time and as soon as they are submitted, without expecting their collection before filing. This saves valuable time without adversely affecting the level of evaluation.
During the evaluation, the EMA will carry out an independent, thorough and in-depth evaluation of all data submitted by the vaccine development body. The EMA Committee for Medicinal Products for Human Use (CHMP) issues a positive recommendation only when the evidence convincingly demonstrates that the benefits of vaccination are greater than any risks from the vaccine.
- Marketing authorisation from the European Commission
The European Commission is legally responsible for the marketing authorisation. Following a positive recommendation from the EMA Committee for Medicinal Products for Human Use (CHMP), the European Commission shall verify the correctness of all marketing authorisation documentation.
The Commission shall, after consulting the Member States, adopt its decision authorising the marketing of the vaccine. As a result, the vaccine can be marketed anywhere in the EU.
Conditional marketing authorisation is not less than ensuring the safety, quality and efficacy of medicinal products from the normal marketing authorisation.
- The conditions contained in the marketing authorisation shall ensure that:
- strict monitoring of the safety of the medicinal product across the EU through the EU pharmacovigilance system;
- post-authorisation monitoring of security at regular intervals and allows additional data to be collected in a structured manner;
- strict manufacturing conditions, including the release of batches of vaccines and distribution,
- Whereas the conditions of use of the medicinal product are first offered in all EU languages in electronic form, and
- investigation of 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 officially co-signed the EU Vaccines Strategy and have agreed to follow the conditional marketing authorisation process through the European Medicines Agency for COVID-19 vaccines.
The conditional marketing authorisation shall be valid for a period of one year, shall be renewable and shall give the holder the same rights and responsibilities as normal marketing authorisations.
In addition, the holder of such authorisation has specific obligations to confirm that the benefit/risk balance remains positive.
- Under the conditional marketing authorisation procedure, vaccine producers are primarily responsible for:
- continuous monitoring of vaccine safety;
- reporting serious adverse events;
- updating product information;
- carrying out safety and efficacy studies;
- examining the performance of their products in the largest populations on the market, and
- the submission of regular safety reports and the benefit-risk relationship to the EMA.
Member States shall be responsible for:
- supervising the collection of information on suspected adverse reactions, signal assessment, periodic safety reports, post-authorisation safety studies and risk management plans.
The EMA shall be responsible for:
- monitoring all reported suspected adverse reactions;
- providing additional guidance and imposing requirements on vaccine producers to draw up risk management plans for COVID-19 vaccines;
- the monthly summary post-authorisation safety reports from producers (in addition to the six-monthly periodic safety monitoring reports),
- the development and maintenance of Eudra Vigilance, a system for the management and analysis of information on suspected adverse drug reactions, and
- the analysis of information and studies in the general population to monitor both the safety and efficacy of vaccines.
Finally, it should be stressed in particular that the EU issues marketing authorisations for vaccines against COVID-19, once all the planned clinical trials relating to the filing of applications have been completed (Phase I, II, and III) and in no case are the vaccines mentioned to constitute 'experimental preparations'.
More information is available at: https://ec.europa.eu/commission/presscorner/detail/el/qanda_20_2390?fbclid=IwAR3t50Jg5l7Z1FpRfyFTvG8t5xCx1jQa_olaKChBrEw5qm1ZeqoPnlrJra8.
