translated from Spanish: U.S. authorizes “immediate” resuming vaccination with Johnson & Johnson

The United States on Friday authorized the resumption “immediately” of the use of the vaccine in Janssen, a Belgian subsidiary of Johnson&Johnson (J&J), after its administration was virtually suspended ten days ago for several cases of thrombosis in women. The decision was made by the U.S. Food and Drug Administration (FDA), the regulatory body, shortly after an advisory committee from the Centers for Disease Prevention and Control (CDC) advised it earlier Friday.” We have concluded that the known and potential benefits of the covid-19 (Johnson&Johnson) vaccine outweigh its known and potential risks in people 18 years of age or older,” FDA Acting Director Janet Woodcock said at a press conference.” We are confident, he added, that this vaccine continues to meet our standards of safety, efficacy and quality.” At that same press conference, Dr. Peter Marks, a senior FDA official, explained that resumption takes effect “immediately,” although it will be effective this Saturday morning. He also explained that people who opt for the J&J vaccine will be provided with a paper warning about their potential risks. WARNING FOR WOMEN UNDER 50 YEARSThe scientists of the CDC Advisory Committee on Immunization Practices (ACIP) suggested that this notice say that women under the age of 50 should be aware of possible rabies from the vaccine.U. recommended on April 13 to discontinue administration of J&J serum , after six cases of cerebral thrombosis were detected in women under the age of 48, of whom one died. As of this Friday, the CDC had documented fifteen confirmed cases in J&J vaccines at a wider range of ages and with a total of three dead. During the six-hour ACIP session, scientists shuffled four options when updating the recommendation. The alternatives ranged from completely discouraging its use to recommending it for all ages and sexes, to warning women under 50 of possible risks of cerebral thrombosis or suggesting its administration only to adults over that age. Most patients who had thrombus after being immunized are in their thirties, although there have been cases in women between the age of 18 and 59. All but two of those affected were under the age of 50. FIFTEEN CASES OF THROMBUS AND THREE DEAD IN THE US. But it’s not the first time During the ACIP session, physician Tom Shimabukuro, head of vaccine safety at the CDC, explained that among those fifteen patients still seven are hospitalized, four of them in Intensive Care Units.He stated that thirteen were between the ages of 18 and 49, and twelve of them developed cerebral thrombosis, although many had clots in other parts of the body. The initial symptom was a headache, which usually began six days after being vaccinated, although, as time went on, patients had nausea, vomiting, abdominal pain, weakness on one side of the body, difficulty speaking, loss of consciousness and spasms, the doctor detailed. Shimabukuro emphasized that seven of the women were obese, two had hypothyroidism, two had high blood pressure and two others were taking contraceptives. It is not clear at the moment whether any of these factors could contribute to increasing the risk of developing thrombus. For now, 8 million doses of J&J have been injected into the U.S., whose administration has virtually been paused in the country following last day’s recommendation 13.Shimabukuro said there could be potential cases in men, which 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. J&J representatives also participated in the meeting, which ensured that these cases are being taken “very seriously”. They also revealed before the ACIP vote that they had agreed with the FDA to add to the label a notice that the risk of blood clots may be at risk. THE RISKS OF J&J and ASTRAZENECAIn the virtual meeting, physician Michael Streiff, a thrombus expert at Johns Hopkins University School of Medicine, noted that, according to the data he handles, J&J and AstraZeneca serums cause clots in some people.” So far there seems to be a thrombus response when receiving an adenoviral vector vaccine against SARS-Cov-2,” streiff said, stressing that the reason for this reaction is not clear at the moment. TaI take the J&J vaccine like that of AstraZeneca, which has apparently also caused cases of thrombus in Europe, have been developed through the modification of an adenovirus, unlike others such as Those of Pfizer and Moderna, which have employed a technology based on messenger RNA.USA has granted authorization for emergency use to Pfizer serums , Moderna and J&J, while AstraZeneca has not yet requested that permission. Three days ago, the European Medicines Agency (EMA) found a “possible link” between the development of very rare blood clots and the J&J vaccine, but confirmed that the balance between benefit and risk of this preparation remains “positive”. After two weeks of research on cases detected in the US, the EMA decided to add to the vaccine leaflet a warning of the potential, very small risk of developing blood clotting, but continues to recommend its use in the European Union (EU).



Original source in Spanish

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