EDQM initiatives in the context of COVID-19 vaccines and therapies
The EDQM is committed to supporting competent authorities, manufacturers and developers of medicines, (including vaccines), and health professionals during the COVID-19 pandemic – and to contributing to the wider global effort to combat the virus – by openly sharing knowledge and offering free access to relevant standards and guidance.
Details of EDQM initiatives concerning COVID-19 vaccines and therapies can be found below.
- Antiviral medicines: supportive pharmacopoeial texts available for free
- CEP fast-track procedure
- Paediatric formulations
- Illegal and falsified medical products
- Blood transfusion and organ, tissue and cell transplantation
The EDQM has contributed to efforts to develop vaccines for COVID-19 from the outset, providing support in the form of guidance documents, quality standards and training materials, among others.
EDQM document on recombinant viral vectored vaccines to support COVID-19 vaccine developers
The EDQM published a text on the control of viral vectored vaccines in order to support COVID-19 vaccine developers working on candidate vaccines based on this technology. This work was accomplished in collaboration with the European Pharmacopoeia Group of Experts on vaccines for human use (Group 15).
More information available in the related News item, published on 3 November 2020.
COVID-19 vaccines: release of guidelines critical for co-ordinated independent batch control by EU OMCLs
The EDQM published Official Control Authority Batch Release (OCABR) guidelines first in November 2020, with updates in April and November 2021 and March and May 2022. These include guidelines for four different categories of vaccines (mRNA; non-replicating adenovirus-vectored; recombinant spike protein vaccines and inactivated vaccines). These guidelines outline the tests to be performed by Official Medicines Control Laboratories (OMCLs) in the EU OCABR Network as part of the independent control of pandemic COVID-19 vaccine batches. Full guidelines also contain the model protocols for manufacturers. Since July 2020, a list of OMCLs with capabilities for OCABR of COVID-19 vaccines and recommendations for early transfer of methods for potential OCABR tests are also available to involved manufacturers upon request. The capability list is updated as needed with new information. The latest update was in June 2021.
EDQM releases updated European Pharmacopoeia vaccines package
Following the publication of the text on recombinant viral vectored vaccines (details above), the EDQM published an updated set of guidance and pharmacopoeial quality standards applicable to candidate COVID-19 vaccines. This was to ensure that all the relevant European Pharmacopoeia (Ph. Eur.) documents are freely available to users.
EDQM continues to support COVID-19 vaccine developers by providing selected training materials
Further to the publication of the COVID-19 vaccine developers’ package of pharmacopoeial texts, the EDQM compiled a companion list of training materials on the European Pharmacopoeia and on Ph. Eur. texts related to vaccines to support users in applying those texts.
Additional information available in the related news item published on 11 June 2020.
COVID-19 vaccines and therapies: EMA and Ph. Eur. texts
In developing and marketing COVID-19 vaccines and therapies, it is essential to help developers identify relevant and applicable guidelines and standards rapidly. This is why the European Medicines Agency (EMA) and the European Pharmacopoeia have facilitated access to COVID-19 vaccine and therapy guidelines, resources and pharmacopoeial texts for developers on their websites.
Ph. Eur. and British Pharmacopoeia offer free access to supportive pharmacopoeial texts
The European Pharmacopoeia and the British Pharmacopoeia worked together to make supportive pharmacopoeial texts (monographs, general chapters, appendices and supplementary chapters) relevant for antiviral medicines available for a limited period of time at no cost to users. The texts – available as downloadable PDFs – include monographs, general chapters, appendices and supplementary chapters to support those developing, manufacturing or testing relevant substances and products during the pandemic.
More information available in the related news item published on 20 April 2020.
The EDQM established a fast-track procedure to respond to users’ needs as quickly as possible. This procedure is applied upon request from holders of Certificates of suitability to the Ph. Eur. monographs (CEPs) or authorities and on a case-by-case basis for those substances specifically related to COVID-19. This procedure has made it possible to assess applications and grant CEPs more rapidly.
The Ph. Eur. Commission’s European Paediatric Formulary (PaedF) Working Party continues to compile existing knowledge on paediatric formulations and marketed products that may be useful in the treatment of COVID-19.
Products and extemporaneous preparations of paediatric formulations
In March 2020, stakeholders were asked to support this initiative and to submit information on formulations and products. The tables (currently for dexamethasone and lopinavir/ritonavir) will be continually updated. Updating of tables for chloroquine and hydroxychloroquine has been discontinued.
More information available in the related news item published on 16 October 2020.
The danger to public health inherent in the coronavirus pandemic has been amplified by the sale of unauthorised medicines claiming – without any proof – that they can prevent or treat COVID-19, and of falsified medicines and test kits. Criminals have been quick to take advantage of the increased demand for medical, personal-protection and hygiene products, including by advertising and selling their products online. Valid, up-to-date information on medicines and medical products from reliable sources is an important factor in public health protection under normal circumstances, but has become crucial for all during the pandemic.
Advice to the public on illegal and falsified medical products
European citizens are advised to exercise extreme caution when buying medicines online, as illegal online pharmacies and other vendors may try to benefit from the pandemic situation to sell unauthorised, falsified or low-quality medicines.
The EDQM reminds the public that there are currently only a very limited number of authorised medicines to treat COVID-19 and that they should not buy medicines falsely advertised as such online. Medicines are available to treat symptoms on advice from their doctor or pharmacist.
Regarding vaccines, the EDQM stresses that the EMA and national health authorities have established strict control procedures to ensure that only safe vaccines are authorised, and that they are distributed through a secure supply chain. Most alerts to the public on the risk of fake vaccines published by various law-enforcement authorities relate to the trafficking of vaccines through unofficial and unauthorised channels.
COVID-19 vaccines are distributed directly to government agencies and are not for sale: any vaccine for sale is therefore clearly a falsified or unauthorised product.
Generally speaking, the EDQM strongly recommends that the public obtain medical products, regardless of their nature, exclusively through official, authorised channels.
Impact of COVID-19 on illegal activities – Regular assessments by national authorities in Europe
Exchanges of experience and information related to the COVID-19 pandemic take place regularly at the meetings of the Committee of Experts on Minimising Public Health Risks Posed by Falsification of Medical Products and Similar Crimes (CD-P-PH/CMED) and have focussed on various issues as the situation developed. Although delegates initially reported shortages of medicines and medical devices and attempts to profit illegally from the situation, these shortages have since been brought under control. Very few cases of falsified vaccines have been encountered in Europe, thanks to strict supply chain and distribution controls. Most cases of fraud involve scams with no real products behind them. More recent issues involve borderline products being offered as prevention (unauthorised medicines, miracle products, etc.), with demand being fuelled by vaccine hesitancy and consumers favouring alternative medicines.
The CD-P-PH/CMED has continued to involve other organisations (e.g. WHO and the Heads of Medicines Agencies network) in its work to exchange on common challenges and trends on COVID-related falsifications.
More information on the CD-P-PH/CMED is available here: Background & mission.
At a time of unprecedented challenges to the health sector, the Council of Europe calls on governments to be extremely vigilant against falsified medical products. States can rely on the MEDICRIME Convention to safeguard public health and target criminals trying to take advantage of the current crisis by offering falsified medical products for sale.
Learn more about the Council of Europe MEDICRIME Convention.
The World Health Organization (WHO) provides general advice and information on its COVID-19 pages, and more specifically releases alerts on falsified medical products. Due diligence is required from all stakeholders in the procurement, use and administration of medical products, in particular those affected by the COVID-19 pandemic.
The EMA continues to provide impartial advice to patients and healthcare professionals on the safe use of medicines during the COVID-19 pandemic on its website.
Information on the numerous Europol initiatives undertaken since the beginning of the pandemic are detailed on its site. These include operations revealing global counterfeit medicine trafficking, face mask scams and intellectual property violations, and the publication of reliable information for the general public on safe practices and fake news.
Blood transfusion and organ, tissue and cell transplantation: minimising the impact of the COVID-19 pandemic
In the field of substances of human origin (SoHO), the EDQM, through its European Committee on Blood Transfusion (CD-P-TS), European Committee on Organ Transplantation (CD-P-TO) and subordinate working groups, is facilitating the exchange of information and fostering co-operation between member states and health authorities to minimise the impact of the COVID-19 pandemic.
The EDQM, in collaboration with the European Commission, held a virtual conference in October 2020, entitled “Keeping up with Reality and Quality: A Challenge for European Blood Establishments”, to mark 10 years of successful collaboration in the field of blood. One of the webinar sessions focused on the COVID-19 pandemic and featured key stakeholders from the sector discussing how they have managed the crisis in order to ensure the continuity of blood supply and elaborating on lessons learnt.
Two webinars, entitled “Tissue donation from deceased donors during the COVID-19 pandemic” (April 2020) and “Keep calm and use your QMS to carry on: Tissue banking in the new normality” (July 2020) were also organised. They featured leading experts in the field discussing how the pandemic has affected national programmes for tissue donation from deceased donors and daily practices in tissue establishments, and provided a forum to support forward-looking decisions.
More information on transplantation events training resources