Source : 'The Pink Sheet'
EU regulators have finalized additional safety reporting requirements for companies developing COVID-19 vaccines to support their ongoing monitoring in the post-authorization phase.
The new requirements include submission of monthly summary safety reports by marketing authorization holders in addition to regular updates specified in the EU pharmacovigilance legislation.
The safety reporting requirements, agreed by the European Medicines Agency and competent authorities in EU member states, are specified in a plan that explains how new information that emerges following the approval and uptake of COVID-19 vaccines in the pandemic situation will be collected, reviewed and made public.
In addition, the EMA has issued a complementary guideline on risk management plans (RMPs) for COVID-19 vaccines. Many elements listed in the safety monitoring plan are explained in the RMP guideline in greater detail.
The plan explains what additional post-market safety reporting requirements COVID-19 vaccine manufacturers will have to comply with in addition to the standard pharmacovigilance requirements that are applicable to all medicines and vaccines.
For example, there are new requirements in relation to submitting periodic safety update reports (PSURs) for evaluation by the EMA. Companies usually submit PSURs at six-month intervals in the first few years of authorization of any medicinal product and with a decreasing frequency thereafter.
For COVID-19 vaccines, companies will be expected to submit monthly summary safety reports, in addition to regular PSURs. The “minimum elements” that these monthly reports should contain are specified in the RMP guideline.
They must contain, for example, information on reported suspected adverse reactions, including adverse events of special interest (AESIs), and sales data. “The need and periodicity of continuing the submission of such reports will be re-evaluated by EMA based on the available evidence from post-marketing for each vaccine,” the RMP guideline states.
For COVID-19 vaccines, real-world monitoring following authorization will be of key importance to track potential safety concerns. For standard drugs and vaccines, this is done via post-authorization safety studies (PASS), which can be initiated by companies voluntarily or upon request from regulatory authorities.
In case of COVID-19 vaccines, the EMA said, the need for observational PASS studies will be carefully considered. In situations where an observational PASS is considered necessary, the EMA has outlined certain factors that companies must consider, such as ensuring that the PASS includes an EU cohort. In addition, it recommends that protocols for PASS studies should follow EU guidance on this topic. ()
The EMA also has contracts in place with academic and private partners to support the readiness of research networks to perform observational studies on COVID-19 treatments and vaccines. ()
The importance of effective observational research for COVID-19 vaccines was recently highlighted in a recent paper in the BMJ’s Evidence Based Medicine journal. The paper stated that it was important for researchers to “select the most appropriate options” for studying the safety and effectiveness of COVID-19 vaccines from the different methodologies available.
Rather than solely relying on “passive” approaches in which patients or healthcare professionals report suspected adverse events and concerns related to effectiveness, “it will be important to conduct ‘active’ surveillance studies” for COVID-19 vaccines, said Saad Shakir of the UK-based Drug Safety Research Unit, who co-authored the BMJ paper.
This kind of active surveillance was also used to monitor the safety of the vaccine developed in response to the 2009-2010 global H1N1 influenza A (swine flu) pandemic, Shakir explained.
An RMP is needed for any medicine or vaccine for which approval is being sought in the EU. The EMA’s new guidance on RMPs for COVID-19 vaccines complements its existing guidance on RMP format and on good pharmacovigilance practices that apply to all medicines.
The new guideline outlines certain additional considerations in relation to COVID-19 vaccines, such as:
Collecting further information on vaccine safety that might be generated after the marketing authorization in special populations, such as the elderly, children, or patients with co-morbidities.
Core requirements for lists of adverse events of special interest, methods for signal detection and follow-up of any safety signals identified in clinical trials.
Traceability tools (eg, stickers with brand name and batch numbers) that can help record who has received which vaccine and from which batch.
On making safety information on COVID-19 vaccines public, the plan follows the EMA’s “exceptional” approach to transparency. In comparison to its usual practice of publishing only the summary of the RMP for standard medicines/vaccines, the agency will publish the “full body of the RMP” for medicines for treatment and prevention of COVID-19.
In addition, the EMA has expanded the scope of the “highlights” that it publishes following the meetings of its pharmacovigilance committee, the PRAC. The PRAC meeting highlights, published monthly, will include information on safety procedures involving COVID-19 treatments and vaccines, including safety signals, PSURs, RMPs and PASS.
The EMA also intends to publish regular pharmacovigilance updates on the approved COVID-19 vaccines, with the latest information. The format and contents of these updates will be developed in collaboration with national competent authorities (through PRAC), and feedback from patients, consumers and health care professionals will be considered during the preparation of some of these communication materials.
By Vibha Sharma