The United States can resume use of Johnson & Johnson's COVID-19 vaccine immediately, health regulators say, ending a 10-day pause to investigate the vaccine's link to extremely rare but potentially deadly blood clots.
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The US Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA) said in a joint statement on Friday 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 by 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 use of the vaccine could begin again immediately.
Earlier on Friday, the CDC panel voted 10-4 that the J&J COVID-19 vaccine be recommended for use in people 18 years of age and older, the parameters of its current FDA authorisation.
"The benefits do clearly outweigh the risk from a population and individual perspective," Doctor Beth Bell, a member of the advisory panel and a clinical professor at the University of Washington in Seattle, said.
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, J&J executives told the panel.
"It is an extraordinarily rare risk. A number of vaccines have an extraordinarily rare risk," Dr Paul Offit of the University of Pennsylvania, a member of the FDA's vaccine advisory panel, said.
Dr William Moss, executive director of the International Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health, said the vaccine should be used with warnings of the risk as it will help advance the vaccination effort.
"Giving people the choice to receive a single-dose vaccine will help get more people vaccinated faster and will better protect some populations, such as those who are homeless or incarcerated," Dr Moss said.
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. J&J resumed its rollout there.
The regulator said the blood clots in patients who received the J&J vaccine bear close resemblance to 169 cases in Europe reported with the AstraZeneca vaccine.
Australian Associated Press
