EMA puts facial swelling in people with fillers as BioNTech/Pfizer jab side effect

The agency communicates as well its evaluation of safety signals on other vaccines authorised for use in the EU

Photo: EU EMA's headquarters in Amsterdam.

The Pharmacovigilance Risk Assessment Committee (PRAC), EMA’s safety body, concluded review of signal of facial swelling with Covid-19 vaccine of BioNTech/Pfizer, known as Comirnaty, and has recommended a change to product information.

After reviewing all the available evidence, including cases reported to the European database for suspected side effects (eudra vigilance) and data from the scientific literature, PRAC considered that there is at least a reasonable possibility of a causal association between the vaccine and the reported cases of facial swelling in people with a history of injections with dermal fillers, also known as 'wrinkle fillers', which are soft, gel-like substances injected under the skin.

PRAC concluded that facial swelling in people with a history of injections with dermal fillers should be included as a side effect in section 4.8 of the summary of product characteristics and in section 4 of the patient information leaflet for Comirnaty. The benefit-risk balance of the vaccine remains unchanged.

The committee is also assessing reports of myocarditis with Comirnaty and Moderna vaccines. As EMA wrote, it is aware of cases of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane around the heart) mainly reported following vaccination with Comirnaty.

The agency stated that there is no indication at the moment that these cases are due to the vaccine, but PRAC has requested the marketing authorisation holder BioNTech/Pfizer to provide further detailed data, including an analysis of the events according to age and gender, in the context of the next pandemic summary safety report and will consider if any other regulatory action is needed.

Additionally, the PRAC has requested the marketing authorisation holder for Moderna vaccine – also an mRNA  – to monitor similar cases with their vaccine and to also provide a detailed analysis of the events in the context of the next pandemic summary safety report. EMA will communicate further when new information becomes available.

PRAC has concluded its review of unusual blood clots with low blood platelets with Janssen’s Covid-19 vaccine and confirmed, as previously communicated, that the benefits of the vaccine in preventing Covid-19 outweigh the risks of side effects.

In finalising the review, the Committee recommended on 20 April further refinement of the warning about thrombosis (formation of blood clots in the vessels) with thrombocytopenia (low blood platelets) syndrome, which was listed previously in the product information for Janssen vaccine. The product information will now also include advice that patients who are diagnosed with thrombocytopenia within three weeks of vaccination should be actively investigated for signs of thrombosis.

Similarly, patients who present with thromboembolism within three weeks of vaccination should be evaluated for thrombocytopenia. Lastly, thrombosis with thrombocytopenia syndrome will be added as an ‘important identified risk’ in the risk management plan for the vaccine. The marketing authorisation holder will provide a plan to further study the possible underlying mechanisms for these very rare events.

The committee is closely monitoring as well whether mRNA Comirnaty and Moderna vaccines might also be linked to cases of rare, unusual blood clots with low blood platelets, a side effect that has been reported in AstraZeneca’s Vaxzevria and Janssen vaccines.

Following a review of reports of suspected side effects, the PRAC considers at this stage that there is no safety signal for the mRNA vaccines. Only few cases of blood clots with low blood platelets have been reported.

When seen in the context of the exposure of people to the mRNA vaccines, these numbers are extremely low, and their frequency is lower than the one occurring in people who have not been vaccinated. In addition, these cases do not seem to present the specific clinical pattern observed with Vaxzevria and Janssen vaccines. Overall, the current evidence does not suggest a causal relation.

EMA will continue to monitor this issue closely and communicate further if necessary. Enhanced safety monitoring in the form of pandemic summary safety reports is one of the commitments required from the marketing authorisation holders in the context of the conditional marketing authorisation. Marketing authorisation holders are required to submit pandemic summary safety reports to EMA on a monthly basis. These reports are reviewed by the PRAC and any area of concern further investigated, if needed.

As part of the review of the regular pandemic summary safety reports for AstraZeneca’s vaccine, the PRAC is analysing data provided by the marketing authorisation holder on cases of Guillain-Barre syndrome (GBS) reported following vaccination. GBS is an immune system disorder that causes nerve inflammation and can result in pain, numbness, muscle weakness and difficulty walking.

This syndrome was identified during the marketing authorisation process as a possible adverse event requiring specific safety monitoring activities. PRAC has requested the marketing authorisation holder to provide further detailed data, including an analysis of all the reported cases in the context of the next pandemic summary safety report.

The committee continues its review and will communicate further when new information becomes available.

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