US to pause Johnson & Johnson vaccine distribution amid clotting concerns

FDA and CDC to investigate safety concerns about the vaccine

The US Food and Drug Administration and the Centres for Disease Control and Prevention called for a pause in the use of Johnson & Johnson’s single-dose Covid-19 vaccine.

Six women in the US between the ages of 18 and 48 developed a disorder involving blood clots about two weeks after they were immunised.

One of the women died and a second woman was admitted to hospital.

“Out of an abundance of caution, we’re recommending a pause in the use of the Johnson & Johnson Covid-19 vaccine due to reports of six cases of a rare and severe type of blood clot following vaccine administration,” acting FDA commissioner Janet Woodcock said.

“We’re recommending this pause while we work together to fully understand these events and also so we can get information out to healthcare providers and vaccine recipients.

“Right now, I’d like to stress these events appear to be extremely rare. However, Covid vaccine safety is a top priority for the federal government and we take all reports of adverse events following vaccination very seriously.”

Dr Woodcock said the FDA expected the Johnson & Johnson vaccine pause to last “for a matter of days”.

Anne Schuchat, the CDC’s principal deputy director, said the pause was intended to better equip US healthcare providers to diagnose and treat severe blood clots, which are different from the standard flulike symptoms that some people experience after receiving their Covid vaccine.

Dr Schuchat said people who received the Johnson & Johnson vaccine more than a month ago were at “very low” risk of developing blood clots.

But patients who had the shot within the past two weeks should contact their healthcare providers if they develop symptoms that include severe headaches, abdominal pain, leg pain or shortness of breath.

“While these events are very rare, we’re recommending a pause in the use of the [Johnson & Johnson] Covid-19 vaccine in order to prepare the healthcare system to recognise and treat patients appropriately and to report severe events they may be seeing in people who’ve received the [Johnson & Johnson] vaccine,” Dr Schuchat said.

“The pause will also allow the CDC’s expert committee to review the situation.”

The CDC’s advisory committee on immunisation practices will convene to review the initial data on the blood clots.

“This will allow careful deliberation about what we know so far about these events and consider next steps given the current context of the Covid-19 pandemic in the United States and our broader immunisation efforts,” Dr Schuchat said.

Seven million people in the US have received the Johnson & Johnson vaccine. About nine million more doses have been shipped across the country.

Although the new guidelines will be enforced at all federal vaccination sites, the FDA and CDC expect state officials to enact the rules as well.

The CDC said most US vaccinations involved the two-dose Pfizer-BioNTech or Moderna shots, which account for a combined 23 million doses.

The extent to which the pause will affect vaccine administration is unknown.

“It’s too early for us to know the impact on the supply longer term,” Dr Schuchat said.

But Jeff Zients, the White House response co-ordinator for the Johnson & Johnson vaccine, said the pause would not have any major effect on distribution.

“This announcement will not have a significant impact on our vaccination programme,” he said.

“The [Johnson & Johnson] vaccine makes up less than five per cent of the more than 190 million recorded shots in arms in the United States to date.”

Updated: April 13, 2021 10:03 PM

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