Regulatory Focus™ > News Articles > 2022 > 3 > Euro Roundup: PRAC recommends new safety information for two COVID vax

Posted 17 March 2022 | By Nick Paul Taylor 

Euro Roundup: PRAC recommends new safety information for two COVID vax

2770 The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended updating the safety information on COVID-19 vaccines from Johnson & Johnson and Moderna.
PRAC wants to add small vessel vasculitis with cutaneous manifestations as a side effect of J&J’s vaccine. The side effect describes inflammation of blood vessels in the skin which may result in rash and bruising. Infections, medicines and vaccines can cause small vessel vasculitis, which typically resolve with supportive care.
The recommendation follows the receipt of details of 21 global cases of small vessel vasculitis, including 10 cases consistent with the definition of vasculitis affecting a single organ. Eight of the cases occurred soon after the administration of the vaccine. PRAC is unsure of the frequency of the side effect in recipients of the vaccine, 42.5 million doses of which have been given worldwide.
PRAC also recommended adding a warning about flare-ups of capillary leak syndrome (CLS) to the product information for Moderna’s Spikevax. CLS, a condition defined by the leakage of fluid from small blood vessels, is often related to viral infections, inflammatory diseases and some treatments.
PRAC reviewed Eudravigilance data on cases of CLS reported after the administration of Spikevax and Pfizer/BioNTech’s Comirnaty. No causal association between the vaccines and new cases of CLS was established. However, some cases of flare-ups of CLS pointed towards an association with Spikevax, leading PRAC to propose a warning. PRAC did not find a link to Comirnaty.
The conclusion is based on a review of 11 CLS cases in recipients of Spikevax and 44 cases in recipients of Comirnaty. At the time of the analysis, almost four times as many doses of Comirnaty had been given globally.
EMA Notice
MHRA allies with other UK bodies to improve public involvement in research
The Medicines and Healthcare products Regulatory Agency (MHRA) has teamed up organizations including the Health Research Authority and the National Institute for Health Research to improve public involvement in research and drive up standards in health and social care research in the UK.
MHRA has drafted a statement that commits the many signatories to sharing guidance, policies, systems and incentives while supporting “the research community to carry out excellent public involvement.”
The statement charges the signatories to  listen to and learn from the people and communities they involve and apply and share that learning; build and share the evidence of how to involve the public and the impact this has; support improvements in equality, diversity, and inclusion in public involvement; and promote the UK Standards for Public Involvement.
MHRA’s involvement in the initiative follows criticism of its interactions with patients in an independent, government-commissioned review that is informing the reform agenda at the UK regulatory agency.
MHRA Notice
ICMRA disinvites Russia from international regulatory meetings
Representatives of the Russian Federal Service for Surveillance in Healthcare (Roszdravnadzor) will no longer be invited to upcoming meetings, teleconferences and workstreams of the International Coalition of Medicines Regulatory Authorities (ICMRA).
Emer Cooke, chair of ICMRA and EMA’s executive director, communicated the immediate change in policy toward Roszdravnadzor, which includes cutting it out of information exchanges, in a response to a letter from Grzegorz Cessak, the President of the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
Cessak had called for ICMRA to act in response to the “barbarity” in Ukraine, arguing that the situation justified excluding Roszdravnadzor, an associate member, from all sessions and expelling Russia from the body. ICMRA agreed to exclude Roszdravnadzor but found its terms of reference “do not foresee any mechanism for exclusion of a member or associate member.”
The coalition will consider the need for “appropriate revisions” to the terms of reference.
ICRMA Notice
European Parliament forms special committee on lessons of the pandemic
The European Parliament has created a special committee to consider the European response to the COVID-19 pandemic in the areas of health, democracy and fundamental rights, economy and society.
Once it holds its constitutive meeting, the 38-member committee will have 12 months to compile a set of recommendations on the topic “COVID-19 pandemic: lessons learned and recommendations for the future”. The scope of the committee covers actions within the EU and its global relationships.
Parliament plans to disclose the members of the special committee at a session in Brussels next week. The formation of the committee is part of a broader set of actions intended to act on the lessons of the pandemic that has already seen the EU extend the mandate of EMA. 
Press Release

Other news:
The European Directorate for the Quality of Medicines (EDQM) has called for independent scientists to join its groups of experts and working parties. EDQM Notice


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