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On Tuesday, the U.S. Food and Drug Administration recommended pausing the use of Johnson & Johnson’s COVID-19 vaccine for at least a few days after six women under the age of 50 developed rare blood clots after receiving the jab, proving a new setback to global efforts to confront COVID-19.
Johnson & Johnson stated it would delay the vaccine's rollout to Europe just a week after regulators there said they were reviewing rare blood clots in at least four recipients of the shot in the United States. South Africa also decided to suspend the use of J&J’s vaccine.
Acting U.S. FDA Commissioner Janet Woodcock said the agency expected the pause to last just a few days, and was designed to provide information to healthcare providers on how to detect and treat the clots.
The decision come after European regulators said last week that they had found a possible link between AstraZeneca’s COVID-19 vaccine and a similar blood clotting problem that led to a handful of deaths.
FDA official Peter Marks said it was “plainly obvious” the J&J cases were “very similar” to the AstraZeneca ones while confirming there had been no similar blood clot cases reported among recipients of the Moderna or Pfizer/BioNTech vaccines - both of which use a different technology and account for the vast majority of U.S. vaccinations so far.
Immunology experts agreed with U.S. officials in highlighting that the risk posed by the J&J vaccine appeared quite low.
Dr. Amesh Adalja, an infectious disease expert at the Johns Hopkins Center for Health Security in Baltimore, said that “even if causally linked to the vaccine: 6 cases with about 7 million doses ... is not something to panic about,” noting that the risk appears lower than that of clots from oral contraceptives.
The FDA reported there had been one reported death from the rare blood clotting condition among recipients of the J&J vaccine, while another person was in a critical condition.
The White House said appointments to receive the J&J shot were being rescheduled nationwide to the other two authorized vaccines, and that there were enough Pfizer and Moderna shots to hit President Biden’s goal of administering 200 million shots during his first 100 days in office.
As of April 13, 7.2 million doses of the J&J vaccine had been administered in the United States compared with 185 million of the other two, limited by production issues.
The FDA plans to review the analysi of an advisory committee to the U.S. Centers for Disease Control and Prevention which will meet on Wednesday to review the clotting cases and vote on recommendations for future use of the vaccine.
All six clottingcases involved women between the ages of 18 and 48, with symptoms occurring between six to 13 days after vaccination, consistent with the FDA's warnings that patients watch for symptoms for up to three weeks.
In the six cases, a type of blood clot, or cerebral venous sinus thrombosis (CVST), was seen in combination with low levels of blood platelets, known as thrombocytopenia.
The Chinese and Russian COVID-19 vaccine developers CanSino Biological and Gamaleya Institute rely on a similar biochemical design and approach to that of the J&J and AstraZeneca vaccines, whereas the Pfizer/BioNTech and Moderna vaccines use messenger RNA (mRNA) technology.