- The US will resume using Johnson & Johnson’s coronavirus vaccine.
- The decision came after a CDC committee voted to recommend using the shots.
- The US paused its rollout on April 13, citing concerns over rare blood clots.
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The US will resume using Johnson & Johnson’s COVID-19 vaccine, more than a week after regulators paused the rollout to investigate reports of rare but serious side effects.
The Food and Drug Administration is adding a warning to the vaccine about the risk of unusual blood clots in women under 50. Still, the shots remain a valuable tool to stop the pandemic, and US health authorities said the benefits of the vaccines in preventing COVID-19 outweigh the risks.
Janet Woodcock, acting administrator of the Food and Drug Administration, told reporters on Friday that regulators had “full confidence that this vaccine’s known and potential benefits outweigh its known and potential risks.”
Rochelle Walensky, director of the US Centers for Disease Control and Prevention, said health care providers could resume use of the vaccine immediately.
“This vaccine was shown to be safe and effective for the vast majority of people,” she said.
An independent group of experts that advises the US Centers for Disease Control and Prevention recommended on Friday that use of the shot resume.
Now included in the materials the FDA provides for those getting J&J’s shot is a warning that most of the cases of blood clots have happened in women ages 18-49. “Some have been fatal,” it says. The warning also notes that a causal link between the blood clots and the vaccine is “plausible.”
Prior to the pause, the US had administered about 8 million J&J vaccine doses. Regulators in Europe said on April 20 that use of the shot should resume, and that recipients should be warned about the risk of clots.
J&J now faces a daunting task in carving out a meaningful role for its vaccine in the US immunization campaign, the resumption coming at a time when the supply of COVID-19 vaccine doses is expected to soon outstrip demand.
More than 220 million coronavirus vaccine doses have been given in the US, mainly shots from Pfizer-BioNTech and Moderna. Those vaccines use a different technology than J&J’s shot, and US regulators haven’t identified any safety concerns with those immunizations.
J&J’s vaccine is more accessible than other coronavirus vaccines, because it’s given as a single shot. Vaccines from Moderna and Pfizer-BioNTech require two doses given several weeks apart.
In a statement, Paul Stoffels, chief scientific officer at J&J, said the company was confident its vaccine would be of use, despite the setback. “We will collaborate with health authorities around the world to educate health care professionals and the public to ensure this very rare event can be identified early and treated effectively,” he said.
Getting to a better understanding of a rare but serious blood clot issue
The CDC and FDA recommended the pause for J&J’s shot after unusual blood clots appeared in six people of the 6.8 million who had received J&J’s vaccine at that time.
All six had experienced a rare type of blood clot in the brain called a central venous sinus thrombosis that can lead to headaches or a stroke. The rare blood clot occurs in a given year in five of every one million people.
By pausing, regulators hoped to get a better understanding of how to communicate the risks of the rare adverse event to those receiving the vaccine.
Data shared Friday at the meeting of CDC advisors found that 15 people had developed the rare clots after receiving J&J’s shot. All were women, and three of the 15 cases were fatal.
According to data presented to the CDC panel, women under 50 had a higher risk of developing a blood clot compared to those over 50 and men.
Manufacturing issues and blood-clot links have shaken public confidence
Public-health experts have shared fears that pausing the rollout of J&J’s shot could delay the push to end the pandemic.
Public confidence in the vaccine has dropped significantly in the week and a half since this pause began. Just 19% of Americans would now be willing to get the shot, according to data presented to the advisory group Friday.
Manufacturing challenges surrounding the vaccine have also brought scrutiny to J&J’s shots. Emergent Biosolutions, a Baltimore-based contractor used by J&J, has run afoul of US regulators, with a recent FDA report describing the plant in poor condition, including peeling paint and workers doing jobs they are not trained to do.
The Emergent plant has not produced any doses of J&J’s vaccine that have been administered. Regulators have held up any shipments from the plant until it can address the agency’s concerns. All the J&J supply used in the US so far has come from other factories in Europe.
J&J’s shot isn’t alone in running into issues with rare blood clots. Earlier this month, European regulators said that blood clots are a side effect of AstraZeneca’s coronavirus vaccine. Some countries have put the use of AstraZeneca’s shot on hold, though the European Medicines Agency has said the benefits of the vaccine outweigh the risks.
The two shots use similar technology, leading experts to consider that the clotting issues may be related.