The EMA sees a possible relationship with very rare cases of thrombi, but supports its use

The European Medicines Agency (EMA) has come to the conclusion of the need to add a warning on blood clots low platelet count to product information from the covid-19 vaccine from Janssen / Johnson & Johnson. Of course, its safety committee (PRAC) has established that these events should appear as ‘very rare’ side effects of the vaccine.

“A careful review of the cases and the available evidence has led us to state that these blood clotting disorders are very rare side effects of the Janssen vaccine,” he said Sabine straus, president of the PRAC, during the press conference.

The committee has reviewed the currently available evidence, including eight reports from the United States of severe cases of unusual blood clots associated with low platelet levels, one of which had a fatal outcome. Until April 13, 2021, more than 7 million people had received the Janssen vaccine in the US.

The review of the cases and the available evidence has led us to affirm that these blood clotting disorders are very rare side effects of the Janssen vaccine

Sabine Straus, president of the PRAC

In order to Emer Cooke, Executive Director of the EMA, “the PRAC is issuing a recommendation before the vaccine is distributed in the European Union, which will help member states to make the best decision about its administration according to their national situation.”

So far, all cases occurred in people under the age of 60 in the three weeks after vaccination, and most of them were in women. Based on currently available evidence, specific risk factors have not been confirmed.

Similarly, the PRAC noted that blood clots occurred in rather unusual places, such as in the veins of the brain (cerebral venous sinus thrombosis, CVST) and abdomen (splanchnic vein thrombosis) and in the arteries, along with low levels. platelets and sometimes bleeding. The cases reviewed were very similar to those that occurred with the vaccine developed by AstraZeneca, Vaxzevria.

“AstraZeneca and Janssen are very similar vaccines but with differences, as the first is based on a chimpanzee adenovirus and the second is a human adenovirus. The cases [de trombos y trombocitopenia] they are very similar and the hypotheses that explain them are also very similar, but it is too early to draw conclusions ”, stated Straus.

More studies needed

From the EMA they insist that health professionals and people who are going to receive the vaccine should be aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets in the three weeks following vaccination .

“The reported combination of blood clots and low platelet levels in the blood is very rare, and general benefits of the vaccine against covid-19 by Janssen outweigh the risks of side effects ”, they have reported.

According to Emer Cooke, Executive Director of the EMA, “Our investigations will continue; we will impose studies on Janssen to delve into the data “

Thus, the scientific evaluation of the EMA supports the safe and effective use of the vaccine. Now, the administrations of the different member states must take into account, in addition to this scientific evidence, the situation of the pandemic and the availability of the vaccine in each country to make the most appropriate decision on the use of the vaccine in the campaigns of vaccination.

According to Cooke, “Our investigations will continue. We will impose studies on Janssen to dig into the data. ” Thus, the EMA has also commissioned an investigation into cases of thrombosis in covid-19 through two research consortia.

Immediate medical treatment

For the EMA experts, a plausible explanation for the combination of blood clots and low platelets is a immune response, which would lead to a condition similar to that sometimes seen in heparin-treated patients, called heparin-induced thrombocytopenia or HIT.

By recognizing the signs of blood clots and low platelets and treating them promptly, professionals can help those affected recover and avoid complications.

The PRAC has underlined the importance of a rapid specialized medical treatment. “By recognizing the signs of blood clots and low platelets and treating them in time, professionals can help those affected in their recovery and avoid complications.”

“Healthcare workers should consult the applicable guidelines or consult specialists to diagnose and treat this condition,” they have concluded from the agency, which will continue to monitor the safety and efficacy of this and other vaccines.

Information on other vaccines

The director of the data analysis and methods working group, Peter alett, has specified the number of cases of thrombosis with thrombocytopenia registered with all vaccines in the world. A) Yes, to April 13 of this year, have been reported 8 cases in people vaccinated with Janssen, 287 in vaccinated with Oxford / AstraZeneca, 25 in Pfizer and 5 in Moderna.

As Arlett has indicated, the cases registered in the population vaccinated with Pfizer and Moderna “They are not higher than what is expected in the general population,” while AstraZeneca’s reports are higher. For the cases related to the Janssen option, the EMA understands that it will be necessary to wait for this option to be distributed in the European Union to have more accurate data on these reported side effects.

As of April 13, 2021, 8 cases of this type of thrombosis have been reported in people vaccinated with Janssen, 287 in vaccinated with Oxford / AstraZeneca, 25 in Pfizer and 5 in Moderna.

Asked by journalists about the Sputnik V and if there are reports of these side effects in the population vaccinated with this serum, Emer Cooke has indicated that the EMA data review “is in progress. very early stage and it has not reached the pharmacovigilance data ”, so they cannot confirm that these cases also occur.

However, it has expressed that the PRAC will be “very attentive” to these possible reports given that it uses an adenovirus as a vector, like Oxford / AstraZeneca and Janssen.

Fountain: EMA

Rights: Creative Commons.