After six cases of cerebral vein thrombosis, American authorities suspended vaccinations with the active ingredient from Johnson & Johnson. Unrestricted use is now allowed again.
Dhe corona vaccine from the American manufacturer Johnson & Johnson can be used again without restriction in the United States. The temporary suspension that was decided about ten days ago will be lifted with immediate effect, the CDC health authority and the FDA announced on Friday evening.
An advisory body to the American health authority CDC had previously spoken out in favor of resuming corona vaccinations with the active ingredient from Johnson & Johnson (JJ) in the United States without restriction. The members of the “Advisory Committee on Immunization Practices” (ACIP) voted for this on Friday after several hours of deliberations.
Ten members voted in favor, four against, one abstained. The recommendation is not binding, but is expected to be followed by the CDC and the FDA. The vaccine should therefore be given a label stating that the vaccine can cause an extremely rare but potentially dangerous blood clotting disorder.
About two weeks ago, the two authorities had decided to temporarily suspend the corona vaccinations with the JJ active ingredient after six cases of cerebral vein thrombosis had been recorded in America in this context. The exposure was recommended out of “excessive caution,” it said. At a first emergency meeting of the advisory committee shortly afterwards, the members had spoken out in favor of collecting more information before making a recommendation on how to proceed.
Shortly before the advisory panel was announced, a CDC scientist told the CDC that nine more cases had occurred, bringing the total to 15. All cases occurred in women, 13 of them in women between 18 and 49 years of age. You would have the greatest risk with 11.8 cases per million doses given. Three women have died from the rare clots and seven are still in the hospital, four of them in intensive care, a CDC scientist said at the meeting on Friday.
“This break was important to educate the public,” said Dr. José R. Romero, chairman of the advisory board, at the meeting, according to the New York Times. The overall risk of developing the coagulation disorder is extremely low. “These cases are not just numbers for each of us. We take them very seriously, ”said Joanne Waldstreicher, Johnson & Johnson’s Chief Medical Officer responsible for medical issues, at the meeting. The company supports the fact that a warning label is stuck on the vaccination vials. The wording was agreed with the American FDA.
To date, more than 7.2 million doses of the vaccine, which was approved in the United States in late February and only takes one dose, have been injected in America. The vast majority of the vaccinations were carried out with the mRNA-based active ingredients from the American companies Moderna and Pfizer with its German partner Biontech.
After the temporary suspension by the CDC and FDA in the United States, Johnson & Johnson initially delayed the launch of its vaccine in Europe, but continued it after the EU Medicines Agency (EMA) gave the go-ahead after a re-examination on Tuesday.
About ten million doses or more of the JJ vaccine, which was made in one of the company’s factories in the Netherlands, are on shelves in the United States and could be used immediately. The vaccine is considered very practical to use. It is easy to store and only one syringe is needed for immunization. This makes it easier to use with hard-to-reach populations, including people who are home-bound, homeless, or incarcerated.
Other possible cases of the coagulation disorder, including some in men, are currently being investigated. A CDC scientist mentioned a case that developed in a 25-year-old man who was taking part in a clinical trial of the vaccine.
The coagulation disorder is “rare but clinically serious,” said Tom Shimabukuro, deputy director of the CDC’s Vaccine Safety Office, at the meeting. Twelve of the 15 women in the confirmed cases developed blood clots in the brain. Many also had clots in other places. The first symptoms, which include a headache, typically appear six or more days after vaccination, Shimabukuro said.
As the disease progresses, headaches, nausea and vomiting, abdominal pain, one-sided weakness, speech disorders, loss of consciousness and seizures may become more severe. Shimabukuro noted that seven of the women were obese, two had hypothyroidism, two had high blood pressure, and two were taking oral contraceptives. It is not yet clear whether any of these factors could increase your risk of developing the coagulation disorder after vaccination.