The United States can immediately resume use of Johnson & Johnson's COVID-19 vaccine, top health regulators said on Friday.
The announcement marks the end of a 10-day pause to investigate the vaccine's link to extremely rare but potentially fatal blood clots.
Janet Woodcock is the acting FDA Commissioner:
"After a thorough review of all available data, the FDA and CDC have concluded that the possibility of this so-called thrombosis thrombocytopenia syndrome occurring is very low. But the investigation into the level of potential vaccination-related risk will continue to be ongoing.Together both agencies have full confidence that this vaccine is known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older."
Out of 8 million shots administered in the U.S., experts found 15 cases of blood clots.
Women aged between 30 and 39 were found to be at the highest risk.
The FDA said it would provide an updated fact sheet for vaccine recipients and providers.
The U.S. decision to resume use of the vaccine follows a similar one made by the European Medicines Agency, which on Tuesday said that the benefits of the J&J shot outweighed its risks.
Unlike Pfizer and Moderna's vaccines, J&J's one is given in a single dose and can stored at regular fridge temperatures.
These features make it a better option for use in hard-to-reach areas.
Johnson & Johnson has faced several other setbacks since its vaccine gained U.S. emergency authorization in February, including drawing scrutiny over production shortfalls.