Coronavirus US: CDC recommends ending the J&J vaccine pause
The Johnson & Johnson shot was paused last week after reports of rare blood clots in some recipients. The FDA is now expected to reverse the vaccine's suspension.
On Friday an advisory panel for the Centers for Disease Control and Prevention (CDC) voted in favour of lifting the pause on the Johnson & Johnson vaccination that has been in place for the last 11 days. The shot has been linked to extremely rare instances of blood clots in female recipients and advisors have recommended adding a label about the potential risk.
Around eight million doses of the J&J vaccine have been administered so far and the CDC have so far found 15 cases of the rare blood clotting disorder, known as cerebral venous sinus thrombosis.
In light of the CDC’s recommendation, federal health officials are expected to leap into action and advise states lift the pause on distribution as soon as possible.
Why was there a pause on the J&J vaccine?
In the course of the meeting on Friday the CDC confirmed that an additional nine cases had been found in their investigation, bringing the total to 15, all of which were women.
The majority of those found were among women aged 18 to 49, who have reported seven instances of thrombosis per million shots administered. Three of those who have been confirmed to have suffered the blood clots have died, while a further seven remain hospitalised.
The CDC has learned of 15 cases of the rare blood clot condition linked with Johnson & Johnson’s coronavirus vaccine, per CDC’s Dr. Tom Shimabukuro.— Kaitlan Collins (@kaitlancollins) April 23, 2021
— All have been women
— 13 were women under the age of 50
— 3 died and 7 are hospitalized
When the pause was first announced Dr Anthony Fauci, the White House’s senior medical advisor, made clear that the purpose of the suspension was two-fold. He told reporters that the pause was designed to give time for experts to gather further information and to warn physicians across the country of the associated risks.
Johnson & Johnson vaccine benefits “outweigh the risks”
The CDC’s recommendation is not binding and will need to be discussed by the FDA but other regulatory bodies have reached a similar decision. Earlier this week the European Union drug authority released its own verdict on the J&J shot, finding that the benefits "in preventing covid-19 outweigh the risks of side effects."
Dr. Ashish Jha, dean of Brown University's School of Public Health, has argued that the complete pause on distribution was unnecessary given that only women appear to be affected by the extremely rare side effect. Jha tweeted: "Keeping vaccine paused for everyone makes little sense," adding that the decision to do so had been “WAY off.”
Given that most cases of vaccine-related CVST appears in women— Ashish K. Jha, MD, MPH (@ashishkjha) April 15, 2021
ACIP should have recommended continuing pause for women 18-49 but resuming for everyone else
Keeping vaccine paused for everyone makes little sense
Risk-benefit keeping vaccine paused for everyone WAY off
Now that the advisory group has reversed their recommendation to pause it seems likely that the FDA will look to restart the administration of the J&J vaccine at speed. Dr. Peter Marks, the FDA’s top vaccine regulator, said on Thursday that “it’s not a good thing to leave the pause going for any longer than it absolutely has to go for.”
He added: “Once, essentially, the adequate discussion has occurred, we’re prepared to move as quickly as we possibly can.”
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