Johnson & Johnson's COVID-19 Vaccine Under Scrutiny After 4 'Serious Cases' of Blood Clots - COVID-19 Clinical Trial
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Johnson & Johnson’s COVID-19 Vaccine Under Scrutiny After 4 ‘Serious Cases’ of Blood Clots

AstraZeneca’s COVID-19 vaccine has dominated headlines as reports of rare blood clots mounted, but now European drug safety regulators are investigating potential clotting risks from Johnson & Johnson’s vaccine. So far in the J&J vaccine’s U.S. rollout, EU officials have tracked three cases of unusual blood clots with low blood platelets following vaccination, the European Medicines Agency’s (EMA’s) Pharmacovigilance Risk Assessment Committee said Friday. Another case came in a clinical trial. One of the cases was fatal.

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. The group will decide whether any regulatory steps, such as a warning about side effects, are appropriate. A J&J spokeswoman said the company is working with regulators as more data come in and supports the “open communication” of any new findings with healthcare providers so they can monitor for risks. “We are aware that thromboembolic events including those with thrombocytopenia have been reported with all COVID-19 vaccines,” J&J’s spokeswoman said. “Our close tracking of side effects has revealed a small number of very rare events following vaccination. At present, no clear causal relationship has been established between these rare events and the Janssen COVID-19 vaccine.”

NY Lifts Mandatory Quarantine for International Travel

Less than 10 days after Gov. Andrew Cuomo lifted New York’s longstanding coronavirus quarantine requirement for domestic travelers, the state has announced international travelers who are asymptomatic need no longer self-isolate either. In health department guidance updated Saturday, the state says it has adopted a new policy to correspond to current CDC guidelines. That policy requires proof of a negative test or recent COVID recovery in order to board planes headed to the U.S., but it doesn’t require isolation or testing for international travelers who lack symptoms upon arrival.

Though the quarantine and testing mandates have ended, state health officials still recommend those who are not fully vaccinated delay international travel. They recommend testing for fully vaccinated travelers anyway and say unvaccinated travelers should also get tested three to five days of arrival, too. The latter group should consider self-quarantine, but neither the isolation nor the testing is mandatory.

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