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U.S. Calls for Pause on Johnson & Johnson Vaccine After Clotting Cases

It is unclear to what extent the use of the Johnson & Johnson vaccine can be prevented, which will return the Biden administration’s plan to deliver enough vaccines to be able to vaccinate all adults in the United States by the end of May.

According to CDC data, in the United States alone, 300,000 to 600,000 people develop blood clots per year. But particularly blood clotting disorders that the recipient of the vaccine developed, known as cerebral venous thrombosis, is extremely rare. All women developed the condition between six and 16 days after vaccination, and government experts believe there was an immune system response triggered by the vaccine.

The decision is a fresh setback for Johnson & Johnson and the administration’s plans. At the end of last month, the company found that workers at the Baltimore plant run by its subcontinent mistakenly contaminated a batch of vaccines, forcing the firm to throw away the equivalent of 13 million to 15 million doses. . That plant was to take vaccine supplies from the Dutch plants of Johnson & Johnson to the United States, certified earlier this year by federal regulators.

Authentication of the Baltimore plant by the FDA has now been delayed, while inspectors investigated quality control issues, sharply reducing the supply of the Johnson & Johnson vaccine. The sudden drop in available doses led to widespread complaints from governors and state health officials, who were expecting a much larger shipment of Johnson & Johnson vaccines this week than they received.

States have made extensive use of the vaccine at mass vaccination sites and campuses. Authorities have also directed it to transient, rural and isolated communities, where it is more complex to follow up with a second dose.

It is common for regulators to check for so-called “safety signals” in new vaccines and other medical products. Very often, signs do not prove to be a concern. But Johnson & Johnson’s concern about AstraZeneca about the vaccine mirror, which European regulators began investigating last month, when some recipients developed blood clots.

Of the 34 million people who received the vaccine in the UK, European Union and three other countries, 222 experienced blood clots that were associated with low platelet levels. Most of these cases occurred within the first 14 days after vaccination, mostly in women under 60 years of age.