EMA warns of new side effects from AstraZeneca and Johnson & Johnson

About new side effects of vaccines AstraZeneca and Johnson & Johnson, which are based on vector technology, the European Medicines Agency warned on Friday.

In the case of Johnson & Johnson’s vaccine, manufactured by its Swiss subsidiary Janssen, Coreper recommends not using it in people with capillary leak syndrome. This is a rare condition that causes swelling and a drop in blood pressure.

For the AstraZeneca vaccine, the EMA proposes that the rare Guillain-Barré neurological syndrome be included in the list of possible side effects. In both cases, the instructions booklet should be updated.

What is Guillain-Barré Syndrome?

Guillain-Barré neurological syndrome is a condition that occurs when the immune system attacks the peripheral nervous system. According to a study published in 2011 in the Neuroepidemiology Review, autoimmune syndrome is extremely rare as it affects one to two people in 100,000 people.

The disease occurs suddenly and causes pain, muscle weakness, or paralysis that begins in the limbs and can spread to the trunk over a period of days or hours. Only 7.5% of patients lose their lives, although recovery can take months or years. In a third of cases, weakness is permanent.

What is capillary leak syndrome?

Capillary leak syndrome is a condition in which blood leaks from the capillaries into muscles and body cavities, characterized by swelling and a decrease in blood pressure. The EMA began reviewing these cases in April, and today’s recommendation is added to other potential problems with the AstraZeneca vaccine.

Last month, the EMA recommended against a second dose of vaccine AstraZeneca people with thrombosis… The European regulator is also expanding its investigation into myocarditis and pericarditis following vaccinations with AstraZeneca and other vaccines from Pfizer, Moderna and J&J.

How to treat the third dose

The EMA also stressed that the available evidence suggests that existing vaccines are effective against the coronavirus strains circulating in Europe. For this reason, it is considered premature to recommend re-vaccination after primary vaccination.

On Thursday, Pfizer announced plans to obtain approval to sell a booster dose of its Covid-19 vaccine in the EU and the US, citing signs of declining efficacy six months after the initial vaccination, as well as the rapid spread of the Delta strain.

However, the US authorities agree with Coreper that there is no reason to provide assistance yet.

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