The CDC Advisory Panel voted to lift the Johnson & Johnson vaccine pause and recommended its use in those over the age of 18.
After the vote, U.S. health officials lifted the 11-day pause on Johnson & Johnson vaccinations.
The outside panel of experts said the benefits of the single dose vaccine in preventing COVID-19 infections and deaths outweighed the risks. The FDA will include a warning statement with the Emergency Use Authorization detailing the risk of rare blood clots.
Out of the nearly eight million doses given, there have been 15 confirmed cases of the rare blood clots, including three deaths. All of the cases have been in women, but the Centers for Disease Control and Prevention stressed that that doesn’t mean there is no risk for men.
“There could be cases that simply weren’t reported and there could be cases that become apparent later on that just haven’t appeared,” said Dr. Tom Shimabukuro, with the CDC COVID-19 Response team. “As of now we had zero cases in males.”
The symptoms of the rare blood clots developed six to 15 days after receiving the vaccine.
“These initial symptoms are fairly vague and nonspecific, mainly headache, but importantly, the headaches for these started six or more days after vaccination,” Shimabukuro said.
None of the patients had a previous history of blood clotting disorders, seven were obese and two were using oral contraceptives.
The highest risk was in women, ages 30-39. In that age group, the risk was 11.8 per million.
The manufacturer of the Johnson & Johnson vaccine stressed that there are unique benefits to having a single-dose vaccine that can be stored at refrigerator temperatures.
“An absent or a restricted Johnson & Johnson vaccine will not just delay the full vaccination of the U.S. population but potentially leave unvaccinated a portion of the population,” said Dr. Mathai Mammen.