The FDA recommended temporarily suspending vaccination with the Johnson & Johnson formula against coronavirus after six thrombosis cases in the US.
The Food and Drug Administration and the Centers for Disease Control and Prevention of the North American country asked to investigate the incidents registered among the almost seven million doses applied.
The United States will pause vaccination with the Johnson & Johnson formula against COVID-19 on the FDA's recommendation after six cases of thrombosis are registered among the 6.8 million doses applied in the country.
Health regulators will have a meeting this Wednesday to analyze the data. "Until that process is complete, we recommend this hiatus. This is important to ensure that the healthcare provider community is aware of the potential for these adverse events and can plan for the one-time treatment required with these types of blood clots, "the FDA said in a statement.
The agency detailed that the six cases detected are of "a rare and serious type of blood clot in people after receiving the vaccine," which so far are "extremely rare."
Federal distribution channels, including mass vaccination centers, will temporarily stop using the drug, and states and other providers are expected to do the same. This is a precautionary measure to confirm whether or not there is a link between the formula and the cases of thrombosis.
In combination with a low platelet level, all detected cases are from female patients between 18 and 48 years old, and the symptoms were recorded between six and 13 days after vaccination. One of the patients died in Nebraska, and another is hospitalized in critical condition.
The authorities also warned that the treatment is different from that usually applied for clotting: heparin can be dangerous in these cases. Clotting is not among the vaccine's adverse effects, which do list possible headaches, abdominal pain, leg pain, or shortness of breath within three weeks after inoculation. Anyone with any of these pictures should contact their doctor.
Europe has seen similar thrombotic events with the Oxford / AstraZeneca vaccine. So far, the researchers have not ruled out a link with the vaccine, possibly an immune system reaction, but noted that the benefits of the doses continue to outweigh the risks, especially in the older adult population. Days ago, the European Medicines Agency (EMA) said that it was already investigating whether there was a relationship between the Johnson & Johnson vaccine with clot formation, days before it began to be applied in the Old Continent.
The pharmaceutical company Janssen, part of the Johnson & Johnson conglomerate, began on Monday deliveries to all European Union countries of its vaccine. Fifty-five million doses are expected to be distributed to the 27 members of the bloc between April and June, the European Commission confirmed. In the case of Spain, the first 300,000 vaccines will be applied in the age group between 70 and 79 years of age. This is because the country is currently using the Pfizer formula in those over 80 and AstraZeneca's only in those under 65.
J & J's vaccine, like AstraZeneca's, works on viral vector technology. This is how the CDC explains it: "They contain a modified version of another virus (the vector) to give important instructions to our cells."
In the United States, one of the countries with the highest levels of vaccination against covid-19 in the world, in addition to the J&J vaccine, sera created by Pfizer and Moderna are administered, which use mRNA technology. However, the J&J formula has the benefit of only requiring one dose.