The Food and Drug Administration and the Centers for Disease Control and Prevention lifted the ten-day pause on Johnson & Johnson’s coronavirus vaccine late Friday over concerns of a potential link to rare blood clots.
Along with ending the pause, the federal administration has edited the emergency use authorization for the vaccine to include a warning about the potential clotting issue and added a warning about the risk of rare blood clots in people with low platelet counts to fact sheets, Politico reported.
“The FDA and CDC have confidence that this vaccine is safe and effective in preventing COVID-19,” the agencies said in a news release.
“At this time, the available data suggest that the chance of TTS occurring is very low, but the FDA and CDC will remain vigilant in continuing to investigate this risk.”
The CDC is expected to release an analysis of the issue next week in its Morbidity and Mortality Weekly Report, according to Politico.
“The science supports this news,” CDC Director Rochelle Walensky said during a news briefing Friday evening, according to Politico, adding that the agencies did not take the decision lightly.
The CDC and FDA recommended temporarily pausing the distribution of Johnson & Johnson’s vaccine on April 13 after the rare blood clot — known as thrombosis with thrombocytopenia — was found in six women, ABC News reported.
Before the pause was lifted, a CDC advisory panel voted 10-4 to resume the vaccine for adults 18 and over, Politico reported.
Walensky added that even though the pause has been lifted, health care providers should explain the potential risks of the vaccine before it is given, especially to younger women.
“This risk trade-off is one that people have to individually measure for themselves,” Walensky said, according to Politico.
“We invite people to talk to their physicians.”
The FDA’s top vaccine regulator, Peter Marks, said the administration is recommending blood thinners for patients who develop severe blood clots after they are vaccinated.
The risk-benefit analysis found that out of a projected 9.8 million doses of the vaccine administered over the next six months, only 26 cases of clotting could occur.
The CDC also found that all willing adults could be vaccinated 14 days sooner if the jab was given out at the same rate as it did before the pause.
“We are grateful to the Advisory Committee and its medical experts for the rigorous evaluation of our COVID-19 vaccine,” Johnson & Johson’s chief scientific officer, Paul Stoffels, said in a statement Friday.
“We will continue to collaborate with the CDC, FDA and health authorities around the world, including the European Medicines Agency and the World Health Organization, to ensure this very rare event can be identified early and treated effectively.”
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