The United States has detected at least 15 confirmed cases of clots, including brain thrombosis, in women who have received the COVID-19 vaccine from Janssen, the Belgian affiliate of Johnson & Johnson (J&J).
This was announced at a meeting of the Advisory Committee on Immunization Practices (ACIP), a body made up of 15 independent scientists that evaluated the data on this serum before issuing a recommendation that will serve as a guide for US authorities on what to do with that vaccine from now on.
Despite these detected cases, the management of the Centers for Disease Prevention and Control (CDC) determined that the J&J vaccine can be re-administered in the United States without restrictions because the benefits far outweigh the risks.
The decision of the group of experts was adopted with 10 votes in favor, 4 against and one abstention. The ACIP recommendation is that the risk of thrombi should be added to the vaccine contraindications, as the EMA also requested in Europe. Now we are waiting for the FDA to approve that recommendation from the CDC.
The United States advised on April 13 to suspend the administration of the J&J vaccine after six cases of cerebral thrombosis were initially detected in women under 48 years of age, of which one died.
During the ACIP session, Dr. Tom Shimabukuro, head of vaccine safety at the Centers for Disease Prevention and Control (CDC), updated that data, noting that there are three deaths so far, and that seven are still hospitalized, of which four are in intensive care units.
Of the 15 patients, 13 are between 18 and 49 years old, and 12 of them developed cerebral thrombosis, although many had clots in other parts of the body.
The initial symptom was headache, which usually began six days after being vaccinated, although, as time passed, the patients developed nausea, vomiting, abdominal pain, weakness on one side of the body, difficulties speaking, loss of consciousness and spasms, detailed the doctor.
Shimabukuro noted that seven of the women were obese, two had hypothyroidism, two had high blood pressure, and another two were taking contraceptives. However, it is not clear at this time if any of these factors could contribute to increasing the risk of developing thrombi.
For now, eight million doses of J&J have been injected in the United States, whose administration has practically been paused in the country after the recommendation of last day 13.
Shimabukuro said there could be potential cases in men and they are currently being studied. Specifically, the scientist mentioned a 25-year-old patient who developed a clot when he participated in clinical trials of the vaccine.