Johnson & Johnson's COVID-19 Vaccine Under Review At EMA For Blood Clots, AstraZeneca Probe Expanded

AstraZeneca Plc’s AZN COVID-19 vaccine has recently dominated headlines after cases of rare blood clots were reported in European countries. Now, European Medical Agency (EMA) is investigating potential clotting risks from Johnson & Johnson’s JNJ one-shot COVID-19 vaccine.

What Happened: While AstraZeneca has been caught in a frenzy over possible links to rare blood clots and subsequent restriction on the usage of its vaccine, this is a formal disclosure of the J&J probe.

So far, four severe cases of rare blood clots with low platelets have been reported after inoculation with J&J’s vaccine.

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) said three cases of unusual blood clots with low blood platelets followed the vaccination. Another issue came in a clinical trial.

Why It Matters: All four were “serious cases,” the committee says. The reports “point to a ‘safety signal,’ but it is currently not clear whether there is a causal association,” PRAC says.

So far, the JNJ vaccine is only available in the U.S., but European officials recently authorized the jab, and the rollout is expected to start soon.

Meanwhile, the U.S. rollout of the JNJ vaccine has run into some problems. Just 785,000 doses are set to ship out to states next week, down from 4.9 million this week.

In Colorado and North Carolina, two vaccination sites temporarily closed this week after adverse reactions in a limited number of recipients, CBS News reports.

J&J’s vaccine has also been in the news lately due to manufacturing missteps at its partner Emergent BioSolutions when workers at an Emergent plant in Baltimore ruined 15 million doses of vaccines. In response, the Biden administration put J&J in charge at the plant.

That forced AstraZeneca, which had also partnered with Emergent, to look for a new manufacturing partner.

The European agency also said five cases of capillary leak syndrome linked to AstraZeneca’s vaccine were reported. The condition in which blood leaks from the smallest of vessels into muscles and body cavities is characterized by swelling and a drop in blood pressure.

However, the EMA has said that “at this stage, it is not yet clear whether there is a causal association” between the vaccines and the reported conditions, Reuters reported.

Additionally, an Indian government panel of experts is investigating for any domestic cases of blood clotting, even mild ones, as a side effect of the two COVID-19 vaccines being administered in India, financial daily Mint reported.

India is currently administering AstraZeneca’s COVID-19 vaccine and a shot developed by Bharat Biotech called Covaxin.

Price Action: JNJ shares are down 1.46% at $160.6, while AZN shares are up 0.67% at $49.83 during market trading hours on the last check Friday.

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Posted In: BiotechGovernmentNewsHealth CareContractsFDAGeneralCOVID-19 VaccineReuters
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