Washington: The United States regulator on Tuesday suggested to hit a “pause” in the administration of single-dose Johnson & Johnson COVID-19 vaccine amid rising reports of blood clots. A type of brain blood clot called ‘cerebral venous sinus thrombosis’ was diagnosed in combination with low levels of blood platelets in six women between the ages of 18 and 48, the Centers for Disease Control and Prevention and the Food and Drug Administration said in a statement.
As of 12 April, more than 6.8 million doses of the J&J vaccine have been administered in the US alone. “Right now, these adverse events appear to be extremely rare,” the statement added.
Amid rising concerns, US federal distribution channels, including mass vaccination sites, will pause the use of the J&J shot, and states and other providers are expected to follow.
“Centers for Disease Control will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. The Food and Drug Administration will review that analysis as it also investigates these cases,” the statement added.
“Until that process is complete, we are recommending this pause,” it said.
“This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot,” it said.
The move from the US regulators comes less than a week after Europe’s drugs regulator said it was reviewing rare blood clots in four people in the United States who received the J&J shot.
The COVID-19 vaccine developed US healthcare giant, has already been approved in United States, the European Union and other nations including Thailand and South Africa.
Last week, Johnson & Johnson reportedly claimed to be in touch with the central government to start clinical trial of its much awaited single-dose COVID-19 vaccine in India.
“We are in discussions with the (government) with the objective of starting a bridging clinical study of our Janssen COVID-19 vaccine candidate in India, subject to local regulatory approvals,” a local J&J representative was reported saying.
While, the US regulator was earlier quoted saying that the Johnson & Johnson’s one-shot vaccine is ‘safe and effective’ against COVID-19 infection.