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 company is expected to submit their monthly summary safety report in mid-January. The PRAC will evaluate and discuss it during its PRAC plenary virtual meeting at the end of January.

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.

Posted on the EMA website on 15 January 2021