The European Medicines Agency will issue information on Janssen’s vaccine next week | Sociedad

The European regulator has “accelerated” its evaluation of its six cases of rare thromboembolism registered in the United States, an investigation that the EMA Security Committee (PRAC) initiated last week, as well as recommending temporary sanitary authorities of this vacancy. The EMA, which will decide next week “if a regulatory action is needed” in relation to the use of this vaccine in the European Union, notes that the United States has administered more than 6.8 million doses of Janssen.

The cases under investigation by the PRAC, the committee responsible for evaluating the safety issues of human medicine, affecting six people who received Janssen’s vaccine and unrolled between six and 13 days of venous cerebral thrombosis (CVST) by its English seals), in combination with low levels of blood platelets (thrombocytopenia).

The Centers for the Control and Prevention of United States (CDC) and the Administration of Drugs and Food (FDA) recommend this March that the suspension of Janssen’s has been investigated in six cases of a type of blood clot ” raro y grave ”, with the objective of determining whether there is a causal relationship with the preparation against covid-19 developed by the subsidiary of the pharmaceutical pharmacy Johnson & Johnson.

The EMA has added that Janssen has announced that the proactive withdrawal of the dose from the UE will continue the PRAC investigations, which “are underway in collaboration with the FDA of the United States and other international regulators”. the “necessary recommendations to minimize the risks and protect the health of the people”.

“The vacancy was authorized in the EU on March 11, 2021, but has not yet begun its generalization within the EU. The company is in contact with the national authorities, recommending that the dose and receipts be maintained that the PRAC issue an accelerated recommendation, ”the agency said.

The European regulator has recorded that its opinion polls “proportionate to the EU Member States the information needed to take decisions on vacancies in its national evacuation campaigns” and has reported that the most common secondary effects Jans be “live the moderates, and bestow one or two days after” the injection.

This investigation is produced in the context of what is known as a “safety signal”, information about a new ad event or documented prevention, which may be caused by a drug, but this signal “does not necessarily mean that a drug caused the adversity event ”and the search should be established if there is a causal relationship.

New recommendations about AstraZeneca

On the other hand, the EMA has informed that it is evaluating and is updating the recommendations for the second dose of the AstraZeneca vaccine in those individuals who have received the first dose. The agency said that “vigilando sig” the very rare blood clots with many levels of plaques that he produced during the evacuation with the dose of AstraZeneca, with the goal of proportioning “more context” of this risk.

In agreement with a petition from the Commissioner of Health and Food Security of the EU, Stella Kyriakides, during the week-long meeting with the Ministries of Health of the EU, the EMA detailed that “there is a review of the evacuation dates and dates on the epidemiology of illness, including infection rates, hospitalizations, mortality and mortality ”.

As a result, the European regulatory body has detailed the revision of the EMA’s Committee on Medicinal Products (CHMP, by its seal in English) “will allow the authorities to locate the risks of the AstraZeneca vaccine in the context of the benefits of the current vacancy campaigns ”.