A new side effect of the Johnson & Johnson vaccine has been identified by the European Medicines Agency as small vascular dermatitis.
The European Medicines Agency has discovered a new vaccine side effect that the Pharmacovigilance Risk Assessment Committee (PRAC) has suggested adding to the potential side effects of Janssen, Reuters reported. No new side effects were observed for all other vaccines.
In particular, the PRAC recommended cutaneous vasculitis of the small vessels (inflammation of the blood vessels in the skin that can lead to a rash,
sharp or flat red spots under the skin’s surface, or bruising) has been added to the product information as a possible side effect of Janssen Vaccine.
Small vessel vasculitis of the skin can also be caused by infections, medications, and vaccines. In most cases, symptoms resolve with proper supportive care.
This finding was based on 37 cases reported worldwide at the end of October 2021. A total of 8 cases assessed by PRAC as likely vaccine-related, including 6 cases confirmed by biopsy. Another 10 cases were thought to be vaccine-related. An estimated 36 million doses of the vaccine had been administered to citizens worldwide by the end of October 2021.
Experts confirm that the benefits of the Janssen COVID-19 vaccine continue to outweigh the risks of COVID-19 and related complications, including hospitalization and death.
At the same time, the European Union’s Medicines Regulatory Administration announced that available data support the safety and efficacy of administering a third booster dose of Covid-19 vaccine three months after the second dose.
“While it is currently recommended to administer booster doses after six months, the data available today support the safety and efficacy of increasing the third booster dose of Covid-19 three months after the second dose,” said Marco Cavaleri, head of vaccination strategy at the European Medicines Agency ( EMA) during a press conference.
Referring to the vaccination campaign for children aged 5 to 11, he said no problems had been reported so far.