Published: 2021-04-24 10:05
Last Updated: 2021-05-17 15:44
The US announced the resumption of using the Johnson & Johnson (J&J) coronavirus vaccine, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) said Friday, following an 11-day pause.
“Today, after an extensive review of the available data, the FDA and CDC are lifting the recommended pause on the Johnson and Johnson, or Janssen Covid-19 vaccine. The pause was recommended due to a limited number of adverse events reported after the Janssen Covid-19 vaccine was administered," said the head of Food and Drug Administration (FDA), Janet Woodcock, in a joint statement with the Centers for Disease Control and Prevention (CDC).
“We have concluded that the known and potential benefits of the Janssen Covid-19 vaccine outweigh its known and potential risks in individuals 18 years of age and older," she added.
The head of the CDC Rochelle Walensky said "exceptionally rare events" of clotting were identified, adding that regulators will continue to monitor the rollout of the vaccines.
According to the latest data, of around 3.9 million women who received the J&J shot, 15 developed serious blood clots and three died.
The majority of the confirmed cases, 13 of the 15, was aged under 50 years old. There were no reported cases among men.
Europe's medicines regulator said Tuesday that blood clots should be listed as a "very rare" side effect of J&J’s coronavirus vaccine.
April 13, US regulators recommended halting use of the Johnson & Johnson vaccine due to blood clotting concerns.
“Right now, these adverse events appear to be extremely rare,” the FDA said in a joint statement with the Centers for Disease Control and Prevention (CDC).
“COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously.”