THE US has moved to officially restart the Johnson & Johnson Covid-19 vaccine for adults after a Centers for Disease Control and Prevention panel of experts voted to lift the pause and add a label about the rare possibility of blood clots.
The country’s decision to greenlight J&J as a third vaccine option came after the panel voted in favor of lifting the ban, despite a CDC scientist showed nine new confirmed cases of the rare blood clotting disorder, bringing the total number of cases in the whole nation to 15.
For 11 days the Food and Drug Administration had held to officially shelving the Johnson & Johnson Covid-19 vaccine.
That changed on Friday when the FDA lifted the restrictions following the CDC advisory panel’s vote to end the pause — the results were 10 to 4 in favor with one abstention, according to The New York Times.
Moving forward, a warning will accompany the J&J label to express the chance of rare blood clots.
Johnson & Johnson injections ground to a halt last week in the United States and Europe after reports emerged of a rare blood clotting disorder in six women who had received the vaccine. Nine additional cases have been confirmed since then, all in women. Three women have died from the rare clots and seven remain hospitalized, four of whom are in the intensive care unit
The vote comes after a second US woman died due to a blood clot two weeks after she was vaccinated.
“This pause was essential to our ability to inform the public,” said Dr. José R. Romero, the chair of the advisory panel, during the vote.
Federal health officials are likely to quickly lift the pause and recommend states follow suit – along with a warning about the blood clotting disorder, which has been only found in women, with 13 of the 15 cases being women between the ages of 18 and 49.
“These cases are not just numbers to any of us, and we take them very seriously,” said Dr. Joanne Waldstreicher, the chief medical officer of Johnson & Johnson, at the vote. “These are people.”
Waldstreicher said the company and CDC have agreed on what language to put on the label and will say that most cases of the extremely rare disorder occurred in women.
The vaccine has been paused since April 13 after reports surfaced of the rare blood clotting disorder called venous sinus thrombosis (CVST) in six women after receiving the vaccine.
CVST could cause deadly brain hemorrhages in otherwise healthy patients, which was reason for the CDC to pause the vaccine after the first woman passed from one.
Although there is insufficient evidence to link CVST to the jab, medical experts are currently investigating how the six women – all aged between 18 and 48 – developed the condition within one to three weeks after receiving the poke.
Health professionals and medical experts warned that the risk of developing a blood clot due to the Johnson & Johnson vaccine is very low.
“It’s an extraordinarily rare event,” said the nation’s leading infectious disease expert Dr. Anthony Fauci.
“My estimate is that we will continue to use it in some form. I doubt very seriously if they just cancel it,” he said when the vaccine went on pause.
The nation has put the vaccine on pause as experts further investigate how it interacts with the body and its clotting mechanisms.
Over 130 million Americans have received at least one dose of the Covid-19 vaccine, with over 7.8 million receiving the Johnson & Johnson jab.
The European Medicines Agency said this is a rare side effect and as such, side effects are expected with all medications and vaccines, including those for the coronavirus.
Fauci echoed the EMA’s results while appearing on NBC’s Meet the Press last weekend.
“I do think that there will likely be some sort of warning or restriction or risk assessment. I don’t think it’s just going to go back and say, ‘Okay, everything’s fine. Go right back.’
“I think it’ll likely say, ‘Okay, we’re going to use it, but be careful under these certain circumstances.’
