US Immediately Resumes J&J COVID-19 Vaccine Shots

By Staff, Agencies

The United State’ top Health regulators declared on Friday the immediate resume of Johnson & Johnson's COVID-19 vaccine,  ending a 10-day pause to investigate the vaccine's link to extremely rare but potentially deadly blood clots.

The Centers for Disease Control and Prevention [CDC] and Food and Drug Administration said in a joint statement that they would warn of the risk of a potentially fatal syndrome involving severe blood clots and low platelets in a fact sheet given to recipients.

Top US FDA officials said the decision was effective immediately, clearing the way for shots in arms as early as Saturday.

"We are no longer recommending a pause in the use of this vaccine," CDC Director Rochelle Walensky told a news briefing. "Based on the in-depth analysis, there is likely an association but the risk is very low."

The agencies made the decision following a meeting by outside advisers to the CDC who recommended that the vaccine pause be ended. The agencies had been investigating the risks of the vaccine.

Earlier on Friday, the CDC panel voted 10-4 that the J&J vaccine be used as recommended in people 18 years of age and older, the parameters of its current FDA authorization.

The CDC said that there had been 15 total cases of the syndrome, including the six original confirmed cases that all occurred in women. There were three deaths.

While the efficacy of the J&J vaccine in clinical testing lagged that demonstrated by the other two approved for use in the United States, it has the advantage over the ones produced by Pfizer Inc and Moderna Inc in that it is given with a single dose rather than two.

It also is stored in a refrigerator and does not need to be frozen during transport, which makes it better for hard-to-reach areas.

The US decision follows a similar one by the European Medicines Agency, which on Tuesday said the benefits of the J&J shot outweighed its risks and recommended adding a warning about unusual blood clots with low blood platelet counts to the vaccine's product label. J&J resumed its rollout there.