The US Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration announced 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 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 that the vaccine could be used starting immediately.
Earlier on Friday, the CDC panel voted 10-4 that the J&J COVID-19 vaccine is recommended for use in people 18 years of age and older, the parameters of its current FDA authorization.
“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.
“The Committee’s recommendation is an essential step toward continuing urgently needed vaccinations in a safe way for millions of people in the US,” J&J’s Chief Scientific Officer Paul Stoffels said in a statement.
The FDA will update the emergency use authorization for the vaccine to include information about the risk and how to recognize and treat the condition, J&J executives told the panel.
‘EXTRAORDINARILY RARE RISK’
“It is an extraordinarily rare risk. A number of vaccines have an extraordinarily rare risk,” said Dr. Paul Offit of the University of Pennsylvania, a member of the FDA’s vaccine advisory panel.
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,” Moss said by email.
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. J&J resumed its rollout there.
According to the regulator, the blood clots in patients that got the J&J vaccine was similar to 169 cases registered in Europe with the AstraZeneca Plc vaccine.
J&J has suffered a number of setbacks since receiving US emergency authorisation in February, including scrutiny over supply shortfalls. This week, FDA inspectors cited a lengthy list of significant cleanliness and safety violations at an Emergent BioSolutions plant that manufactures the J&J vaccine.
Johnson & Johnson’s stock finished 0.2 percent higher at $165.52.