Food & Drug Administration paused Johnson & Johnson vaccine in the US

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US Centers for Disease Control has confirmed that more than 7 million doses of the Johnson & Johnson COVID-19 vaccine have been administered in the United States, as of April 12. The CDC reviewed data and said there have been 6 reported cases that have caused a rare and critical type of blood clot. So, the US FDA has recommended immediately halting the use of single-dose of Johnson & Johnson vaccine. The Director of FDA Center for Biologics Evaluation and Research, Dr. Peter Marks issued a statement that they are reviewing data. He said, “Involving 6 reports of a rare type of blood clot of the clots seen in the United States, one case was fatal and one patient is in critical condition”. The CDC ACIP (Advisory Committee on Immunization Practices) will meet on Wednesday, April 13, to review the situation.

The Arkansas Secretary of Health, Dr. José Romero chairs the ACIP. Romero acknowledged a positive of the situation and that is the country’s VAERS (Vaccine Adverse Event Reporting System). Romero said, “For the system to find these very rare events to be detected, the system has been in place for decades. This is a success story referring to the VAERS system”. The six cases involved women between the ages of 18 and 48. Symptoms happened 6 to 13 days after getting vaccinated. CDC said that treatment for CVST is different than other types of blood clots. Usually, an anticoagulant drug, heparin, is used, but in this setting that may be dangerous, and another treatment drug needs to be given. People who have received the J&J vaccine who develop a severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider.

It is noteworthy that health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System. CDC said, “Right now, these adverse events appear to be extremely rare. COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following the COVID-19 vaccination very seriously”. The US Food and Drug Administration is also doing its own investigation of the Johnson & Johnson vaccine. The vaccine received emergency use authorization from the FDA in late February. The ACIP met from February 28 to March 1, 2021, about COVID-19 vaccines. The committee and other doctors reviewed Janssen’s single-dose vaccine in 5 different reports.