Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 January 2021
First monthly summary safety report for COVID-19 vaccine Comirnaty
Starting this month, EMA’s safety committee (PRAC) will evaluate summary safety reports submitted monthly by marketing authorisations holders of COVID-19 vaccines. The first such report will be for Comirnaty.
The outcome of the PRAC’s assessment will be communicated on EMA’s website shortly after.
During the pandemic, marketing authorisation holders for COVID-19 vaccines are expected to submit monthly summary safety reports, in line with the risk management plan and as described in the safety monitoring plan for COVID-19 vaccines prepared by EMA and the national competent authorities of the EU Member States. The plan outlines how relevant new information emerging after the authorisation and roll-out of COVID-19 vaccines will be collected and promptly reviewed.
The monthly summary safety report will include, among others, information on reported suspected adverse reactions, including adverse events of special interest (AESIs).
The submission of such reports complements the submission of periodic safety update reports (PSURs).
PRAC concludes evaluation of risk of acute adrenal insufficiency in children when switching to Alkindi
The PRAC evaluated a safety signal regarding the risk of acute adrenal insufficiency that may occur in children when switching from conventional oral hydrocortisone formulations to Alkindi granules, due to potential inaccurate dosing with other oral hydrocortisone formulations, crushed or compounded.
Alkindi, available as capsules containing granules, is a medicine for children (from birth to up to 18 years of age) whose adrenal glands cannot make enough of a hormone called cortisol.
This review was triggered by a case report of a baby developing severe adrenal insufficiency after switching from hydrocortisone soluble tablets to Alkindi granules.
Following a careful evaluation of the provided data, the PRAC recommended actions to minimise the risk.
These include a direct healthcare professional communication letter (DHPC), which warns doctors that carers should carefully observe the child for symptoms of adrenal insufficiency such as tiredness, headache, unstable temperature and vomiting during the first week after switching to Alkindi. Doctors should advise carers to increase the doses of Alkindi granules if the child develops symptoms of adrenal insufficiency, as recommended in the product information, and seek immediate medical attention.
As Alkindi is a centrally authorised medicine, the DHPC will now be sent to EMA’s human medicines committee (CHMP) for a final opinion. Following the CHMP decision, the DHPC will be disseminated to healthcare professionals by the marketing authorisation holder, according to an agreed communication plan, and published on EMA’s website and in National registers in EU Member States.
- Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association between a medicine and an adverse event that warrants further investigation. Safety signals are generated from several sources such as spontaneous reports, clinical studies and the scientific literature. More information can be found under Signal management.
- Periodic safety update reports, abbreviated as PSURs, are reports prepared by the marketing authorisation holder to describe the worldwide safety experience with a medicine in a defined period after its authorisation. PSURs for medicinal products that contain the same active substance or the same combination of active substances, but have different marketing authorisations and are authorised in different EU Member States, are jointly assessed in a single assessment procedure. More information can be found under .
- Risk management plans, abbreviated as RMPs, are detailed descriptions of the activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicines. Companies are required to submit an RMP to EMA when applying for a marketing authorisation. RMPs are continually updated throughout the lifetime of the medicine as new information becomes available. More information is available under Risk management plans.
- Post-authorisation safety studies, abbreviated as PASSs, are studies carried out after a medicine has been authorised to obtain further information on its safety, or to measure the effectiveness of risk-management measures. The PRAC assesses the protocols (aspects related to the organisation of a study) and the results of PASSs. More information can be found under Post-authorisation safety studies (PASS).
- Referrals are procedures used to resolve issues such as concerns over the safety or benefit-risk balance of a medicine or a class of medicines. In a referral related to safety of medicines, the PRAC is requested by a Member State or the European Commission to conduct a scientific assessment of a particular medicine or class of medicines on behalf of the EU. More information can be found under Referral procedures.