FDA & CDC: Pause Johnson & Johnson Vaccines During Investigation of Rare Blood Clotting Disorder in Brain in 6 Recipients

The FDA and CDC on Tuesday, April 13, 2021 recommended a pause in use of Johnson & Johnson’s single-dose coronavirus vaccine after six United States recipients of the Johnson & Johnson vaccine developed a rare disorder involving blood clots “thrombocytopenia” within about two weeks of vaccination. In these cases, a type of blood clot in the brain called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). Specifically, symptoms occurred 6 to 13 days after vaccination.

The regulators described the blood clot-related reports as a “safety signal” defined as a cluster of cases requiring further investigation. Initially it is not clear whether the vaccines caused the clots.




All six recipients were women between the ages of 18 and 48. One woman died and a second woman in Nebraska has been hospitalized in critical condition. People who have received the Johnson & Johnson vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should immediately contact their health care provider.

Nearly seven million people in the United States have received Johnson & Johnson vaccines, and roughly nine million more doses have been shipped out to the states, according to data from the Centers for Disease Control and Prevention (CDC).

“We are recommending a pause in the use of this vaccine out of an abundance of caution,” Dr. Peter Marks, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, and Dr. Anne Schuchat, principal deputy director of the CDC, said in a joint statement. “Right now, these adverse events appear to be extremely rare.”




Scientists with the FDA and CDC will jointly examine possible links between the vaccine and the disorder and determine whether the FDA should continue to authorize use of the vaccine for all adults or limit the authorization. An emergency meeting of the CDC’s outside advisory committee (Advisory Committee on Immunization Practices (ACIP) ) has been scheduled for Wednesday, April 14, 2021.

The initial recommendation targeted independent health practitioners and corporations in the United States. Additionally, the federal government is expected to pause administration of the vaccine at all federally run vaccination sites. Federal officials expect that state health officials will also activate a pause in the administration of the Johnson & Johnson vaccine.




Regulators in Europe and elsewhere are concerned about a similar issue with blood clots with the coronavirus vaccine developed by AstraZeneca and Oxford University researchers. The AstraZeneca version has not been authorized for emergency use in the United States. Among 34 million people who received the AstraZeneca vaccine in Britain, the European Union and three other countries, 222 developed blood clots that were linked with a low level of platelets. The majority of these cases occurred within the first 14 days following vaccination, mostly in women under 60 years of age.

Statistics from United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA)

Up to and including 31 March 2021, the MHRA had received 79 UK reports of blood clotting cases alongside low levels of platelets following the use of the COVID-19 Vaccine AstraZeneca:

44 of the 79 cases were of CVST with thrombocytopenia

35 of the 79 cases were of thrombosis in other major veins with thrombocytopenia

79 cases occurred in 51 women and 28 men, aged from 18 to 79 years. It should be noted that more women have been vaccinated with COVID-19 Vaccine AstraZeneca than men.

Sadly, 19 people have died out of the 79 cases – 13 females and 6 males. 11 out of the 19 people who died were under the age of 50, 3 of whom were under 30. 14 of these 19 cases were of CVST with thrombocytopenia and 5 were of thrombosis with thrombocytopenia.

All 79 cases occurred after a first dose of the vaccine.

— MHRA issues new advice, concluding a possible link between COVID-19 Vaccine AstraZeneca and extremely rare, unlikely to occur blood clots (April 7, 2021)

The AstraZeneca vaccine and the Johnson & Johnson vaccine use similar “Adenovirus vector” technology, which is different than the “RNA (modRNA in lipid nanoparticles)” technology used by the Pfizer–BioNTech COVID-19 vaccine and the Moderna COVID-19 vaccine — both available in the United States under Emergency Use Authorization (EUA). The vast majority of the nation’s vaccine supply is available from Pfizer-BioNTech and Moderna. There have been no significant safety concerns about either of those vaccines.

The Johnson & Johnson vaccine requires only a single dose, and is not required to be stored at extremely low temperatures as are the Pfizer and Moderna vaccines.




Federal officials are concerned that physicians may not be trained or prepared to look for the rare disorder if recipients of the Johnson & Johnson vaccine develop symptoms of thrombocytopenia. The federal health agencies announced Tuesday morning, April 13, 2021, that “treatment of this specific type of blood clot is different from the treatment that might typically be administered” for blood clots. Normally, the anticoagulant Heparin is used for blood clots, but may be dangerous when administered for the thrombocytopenia that might be connected to the administration of the Johnson & Johnson vaccine.

“Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given,” the CDC statement said.




In a news release, Johnson & Johnson said: “We are aware that thromboembolic events including those with thrombocytopenia have been reported with Covid-19 vaccines. At present, no clear causal relationship has been established between these rare events and the Janssen Covid-19 vaccine.” Janssen is the name of Johnson & Johnson’s division that developed the vaccine.

In the United States alone, 300,000 to 600,000 people a year develop blood clots, according to CDC data. But the particular blood clotting disorder that the vaccine recipients developed, known as cerebral venous sinus thrombosis, is extremely rare.

Late last month in an incident initially described as a production problem, the company discovered that workers at a Baltimore plant managed by its subcontractor had accidentally contaminated a batch of vaccine, forcing the firm to throw out the equivalent of 13 million to 15 million doses. The Baltimore plant was supposed to take over supply of the vaccine to the United States from Johnson & Johnson’s Dutch plants, which were certified by federal regulators earlier this year.

FDA certification of the Baltimore has been delayed due to the contamination incident while inspectors investigate quality control issues. During the past weekend it was announced that the Johnson & Johnson vaccine would temporarily not be available because of the “production problem.”

SOURCE:

CDC | Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine




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