Euro Roundup: EC asks EMA to accelerate approval of vaccine facilities

RoundupsRoundups | 21 January 2021 |  By 

The European Commission has called on the European Medicines Agency (EMA) to “speed up the approval process for new production facilities” to increase access to COVID-19 vaccines as part of its has set out its strategy for beating COVID-19.
Manufacturers are scaling up their operations to meet high demand for COVID-19 vaccines but will need regulatory approval to bring capacity online. The EC wants to ensure that happens as quickly as possible, leading it to outline plans to work with EMA to cut approval times.
The plan is one of several initiatives related to EMA detailed in the strategy document. The Commission also discussed plans for EMA and the European Centre for Disease Prevention and Control to conduct and coordinate EU-wide studies COVID-19 vaccine safety and efficacy.  
Finally, the Commission discussed the role of EMA in the response to variants linked to rising cases of COVID-19 in some countries. The Commission said “there is presently no evidence that the variants decrease the protection offered by any of the vaccines” on the market or in Phase 3 development, but it wants to be prepared in the event that changes.
The EC noted it is important to monitor the situation and “to take steps now to reduce the development time that would be needed if vaccines needed to be modified.” The Commission wants vaccine manufacturers to be ready to provide “EMA with relevant data to accelerate the process if needed.”
Commission Communication
EU, UK resume sharing information on human blood and plasma batch release
Batch release authorities in the EU and UK have formed a memorandum of understanding that clears the authorities to resume sharing information related to human vaccines and medicinal products derived from human blood and plasma. The MOU came into force on 21 January,
The end of the Brexit transition meant that the Official Control Authority Batch Release (OCABR) Network and UK National Institute of Biological Standards and Control (NIBSC) could no longer share  information. The new agreement goes a small way to reversing the changes caused to batch release by Brexit.
Under the agreement, NIBSC, part of the Medicines and Healthcare products Regulatory Agency (MHRA), is an observer to the OCABR Network for human biologicals. The agreement “reinstates the sharing of information related to batch release activity in this field.”
However, as the European Directorate for the Quality of Medicines (EDQM) stated in its notice about the agreement, mutual recognition of batch certificates is outside of the scope of the arrangement between NIBSC and the OCABR Network. A formal agreement between the EU and UK would be needed to reinstate the mutual recognition of batch release certificates.
EDQM Notice
UK faces call to put legal controls on international sharing of data on human drugs
Members of the House of Lords have voted to place restrictions on the ability of UK authorities to share information on human medicines with international partners. The government is likely to resist attempts to include the restrictions in the final version of the Medicines and Medical Devices Bill.
The version of the bill sent to the Lords for debate stated UK authorities may share information with a person based overseas “where required for the purpose of giving effect to an international agreement or arrangement concerning the regulation of human medicines.” The Lords voted to add an amending statement intended to place limitations on when the UK can share information.
Under the revised draft bill, UK authorities will only be able to share information when “it is required as part of international cooperation for pharmacovigilance” or “is in the public interest.” Lord Lansley, a member of the ruling Conservative Party, questioned the choice to single out pharmacovigilance.
“If one were to legislate in this form, it would be inevitable that the reference to pharmacovigilance would be regarded as having additional weight, and the absence of reference to other purposes for which information would be shared would be regarded as less important. I am not sure that that would be at all helpful to have in statute,” Lansley said.
Lansley voted against the amendment, joining with 218 other Conservatives to oppose the proposal. Yet, the amendment passed 312-249. The amendment passed after people including Baroness Thornton, a member of the opposition Labour Party, made the case for restricting the ability of the UK to share data. 
“[The amendment] would allow the Secretary of State to disclose NHS data only under the terms of an international agreement or trade deal for pharmacovigilance, or if it is otherwise in the public interest,” Thornton said. “We believe ‘the public interest’ is a legitimate test that would offer reassurance that substantive and ethical issues relating to the sharing of data would at least be considered.”
Concerns in some quarters about the sharing of health data through trade deals intensified in 2019 when leaked documents showed the US wanted any trade deal with the UK to enable the free flow of information. However, the Conservatives have a large majority in the elected House of Commons, positioning Prime Minister Boris Johnson to resist efforts to restrict what he can agree in trade deals. 
Amendment Summary, Revised Bill, Debate Transcript
Ireland, Finland publish COVID vaccine adverse event monitoring efforts
Adverse events related to COVID-19 vaccinations in Ireland and Finland so far are in line with those seen in clinical trials, according to details released by regulatory authorities in those countries.
Ireland’s Health Products Regulatory Agency (HPRA) received 81 reports of suspected adverse events linked to Comirnaty (Pfizer/BioNTech) up to 11 January. All the reports were consistent with the safety profile seen during clinical development. HPRA was yet to see a case of anaphylaxis or Bell's palsy as of the data cutoff.
The Finnish Medicines Agency (Fimea) shared a similar update. Fimea had received 32 reports linked to Comirnaty as of 15 January. The reports included one anaphylactic reaction and other cases of the sort of injection site reactions and muscle pain seen in clinical trials of the vaccine.
HPRA Statement, Fimea Notice
MHRA posts guidance on revised approval process for medical device clinical trials
MHRA has updated its guidance on notifying authorities of planned medical device clinical trials. The revised guidance features new information on the role of the Health Research Authority (HRA) and Health and Care Research Wales (HCRW).
As MHRA explains in the guidance, “HRA and HCRW approval applies to all project-based research taking place in the NHS in England and Wales.” HRA and HCRW staff assess governance and legal compliance. The independent Research Ethics Committee provides an opinion through the UK Research Ethics Service. 
The process replaced the old system of local checks of legal compliance by each participating organization in England and Wales.
MHRA Guidance


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