US recommends 'pause' for J&J vaccine over clot reports
The United States is recommending a “pause” in administration of the single-dose Johnson & Johnson COVID-19 vaccine after one US patient died from blood clotting complications while another is in critical condition.
Overall, six women aged between 18 to 48 developed a rare form of brain blood clotting with low blood platelets between six and 13 days after receiving the shot.
“One case was fatal, and one patient is in critical condition,” Peter Marks, a senior scientist for the Food and Drug Administration, said in a call with reporters.
In a joint statement on Tuesday, the Centers for Disease Control and Prevention and the FDA said they were investigating.
More than 6.8 million doses of the J&J vaccine have been administered in the US, the vast majority with no or mild side effects.
US federal distribution channels, including mass vaccination sites, will pause the use of the J&J shot, and states and other providers are expected to follow.
The other two authorized vaccines, from Moderna and Pfizer, make up the vast share of COVID-19 shots administered in the US and are not affected.
CDC’s Advisory Committee on Immunization Practices will meet on Wednesday to discuss the cases and the FDA has also launched an investigation into the cause of the clots and low platelet counts.
“Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” Dr Anne Schuchat, principal deputy director of the CDC, and Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a joint statement.
They are recommending that people who were given the J&J vaccine who are experiencing severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after receiving the shot contact their health care provider.
Officials say they also want to educate vaccine providers and health professionals about the “unique treatment” required for this type of clot.
Johnson & Johnson said it was aware of the reports of “thromboembolic events,” or blood clots, but that no link to its vaccine had been established.
“We are aware that thromboembolic events, including those with thrombocytopenia, have been reported with COVID-19 vaccines,” said Johnson & Johnson in a statement.
“At present, no clear causal relationship has been established between these rare events and the Janssen COVID-19 vaccine.”
The J&J vaccine received emergency use authorization from the FDA in late February with great fanfare, with hopes that its single-dose and relatively simple storage requirements would speed vaccinations across the country. Yet the shot only makes up a small fraction of the doses administered in the US as J&J has been plagued by production delays and manufacturing errors at the Baltimore plant of a contractor.
Last week the drugmaker took over the facility to scale up production in hopes of meeting its commitment to the US government of providing about 100 million doses by the end of May.
Only about 9 million of the company’s doses have been delivered to states and are awaiting administration, according to CDC data.
AstraZeneca link to blood clot
Australia said on Tuesday a second person had been diagnosed with a blood clot after receiving the AstraZeneca Plc vaccine but there had been no rise in inoculation cancellations as authorities try to steady a bungled immunization campaign.
This week Australia abandoned a goal of vaccinating all of its nearly 26 million population by year-end, after Europe’s drug regulator reported rare cases of blood clots among some adult recipients of AstraZeneca doses, suggesting a link.
This prompted Australian officials to recommend that those younger than 50 receive the Pfizer Inc’s vaccine in preference to AstraZeneca’s shot, throwing the vaccination program into disarray.
“We had anticipated potentially a significant drop (in vaccination numbers, but that is) not what we have seen at this stage,” Health Minister Greg Hunt told reporters in Canberra.