- In addition, the EMA investigates the inclusion of facial swelling
- Likewise, it maintains the evaluation of cases of myocarditis
The 5th Pharmacovigilance Report on COVID-19 Vaccines , prepared by the Spanish Agency for the Spanish Medicines and Health Products Agency (AEMPS) and published this Tuesday, includes the new side effects of the Pfizer and AstraZeneca vaccines that the European Medicines Agency ( EMA) has established or has has under evaluation.
The New Side Effects of Pfizer's Vaccine
The EMA Pharmacovigilance Risk Assessment Committee (PRAC) evaluated the following aspects of the safety of the Covid-19 vaccine.
1. Skin rash and itching: the PRAC has recommended that the technical data sheet and package leaflet for this vaccine be modified by adding skin rash and itching (itching of the skin), as uncommon adverse reactions (they occur in less than 1 out of every 100 people). For their part, urticaria (raised, red and itchy skin rash) and angioedema (rapid swelling under the skin) should be updated as adverse reactions that occur rarely (in less than 1 in 1,000 people).
2. Localized inflammation in people who have previously received injections of dermal fillers in the face: the PRAC has also concluded that it is possible that this effect is related to the vaccine, so it will be incorporated as a possible adverse reaction to the technical data sheet and the leaflet.
3. Thrombosis syndrome with thrombocytopenia: the PRAC is closely monitoring whether mRNA-based vaccines (Pfizer and Moderna) could also be related to the rare cases of thrombosis syndrome with thrombocytopenia in unusual sites already identified for AstraZeneca and Janssen. Few cases have been reported so far, which in the context of people exposed to these vaccines, represent a lower frequency than would occur in unvaccinated people. Furthermore, these cases do not appear to present the specific clinical pattern that has been observed in the other two adenovirus-based vaccines.
4. Myocarditis and pericarditis: Some cases of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane surrounding the heart) have been reported following vaccination with the Pfizer vaccine. The analysis of these cases does not indicate at the moment that there is a relationship with these vaccines. However, the PRAC will continue to evaluate this matter in detail.
The AEMPS points out that both thrombosis and inflammation of the heart are also being investigated among those vaccinated with Moderna.
Suspected Side Effects of AstraZeneca
1. Capillary leak syndrome: the PRAC began reviewing a signal related to capillary leak syndrome, a disorder characterized by extravasation of fluids from blood vessels, which causes tissue inflammation and a sudden drop in blood pressure. Between Europe and the United Kingdom, five cases have been reported out of a total 34 million doses of this vaccine administered.
2. Guillain-Barré Syndrome: the PRAC is regularly reviewing the reported cases of Guillain-Barré Syndrome after vaccination with AstraZeneca, as already during the authorization of this vaccine it was identified as a potential adverse effect that required close monitoring. This syndrome consists of an immune disorder that causes inflammation of the peripheral nerves leading to pain, altered sensation, muscle weakness and difficulty walking.
Regarding thrombosis as side effects of AstraZeneca, the AEMPS reports that in Spain until April 25, 11 cases have been reported, three of them ended in death. In addition, they have occurred mainly among the population aged 30 to 39 years.
