The United States can resume use of Johnson & Johnson’s COVID-19 vaccine immediately, top health regulators said on Friday, ending a 10-day pause to investigate the vaccine’s link to extremely rare but potentially deadly blood clots.
Key points:
- The CDC panel voted 10-4 that the Johnson & Johnson COVID-19 vaccine be recommended for use in people 18 years of age and older
- Johnson & Johnson’s chief scientific officer Paul Stoffels said the committee’s recommendation was “an essential step toward continuing urgently needed vaccinations”
- The FDA will update the emergency use authorisation for the vaccine to include information about the risk and how to recognise and treat the condition
The US Centres for Disease Control and Prevention (CDC) and the US Food and Drug Administration said in a joint statement that health systems and vaccine recipients would be warned of the risk of a potentially fatal syndrome involving severe blood clots and low platelets.
The agencies made the decision following a meeting of outside advisers to the CDC that recommended the vaccine pause be ended.
The decision followed investigations by the agencies into the risks of the vaccine.
“We are no longer recommending a pause in the use of this vaccine,” CDC Director Rochelle Walensky told a news briefing, adding that the vaccine could be used, starting immediately.
Earlier on Friday, the CDC panel voted 10-4 that the Johnson & Johnson COVID-19 vaccine is recommended for use in people 18 years of age and older, the parameters of its current FDA authorisation.
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“The benefits do clearly outweigh the risk from a population and individual perspective,” said Dr Beth Bell, a member of the advisory panel and a clinical professor at the University of Washington in Seattle.
In a statement, Johnson & Johnson’s chief scientific officer Paul Stoffels said the committee’s recommendation was “an essential step toward continuing urgently needed vaccinations in a safe way for millions of people in the US”.
The FDA will update the emergency use authorisation for the vaccine to include information about the risk and how to recognise and treat the condition, Johnson & Johnson executives told the panel.
The American Medical Association applauded the decision, saying the data presented at the meeting “clearly demonstrates that the benefits of this approach outweigh the risks, which include becoming infected with COVID-19 and the potential for severe illness or death”.
The European Medicines Agency on Tuesday said the benefits of the shot outweighed its risks and recommended adding a warning about unusual blood clots with low blood platelet counts to the vaccine’s product label. Johnson & Johnson resumed its rollout there.
The regulator said the blood clots in patients who received the Johnson & Johnson vaccine bear close resemblance to 169 cases in Europe reported with the AstraZeneca vaccine.
Reuters/ABC
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