J&J vaccine pause catches White House off guard

It was after 10 p.m. on Monday that officials leading Biden’s ambitious vaccine effort received the news that the US Food and Drug Administration (FDA), with the US Centers for Disease Control and Prevention (CDC), was preparing an announcement for the following morning concerning J&J’s vaccine. Because details were so scant, White House officials didn’t brief the President, according to two people familiar with the situation, write Kevin Liptak, Kaitlan Collins and Kristen Holmes.

Six women in the US have experienced a rare combination of cerebral venous sinus thrombosis — clotting in the sinuses that drain blood from the brain — and low levels of blood platelets following the single-shot J&J vaccine, which has been given to almost 7 million people. One of those cases has been fatal, making the incidence of the blood disorder and fatality rate extremely low. The combination of clots and low blood platelet counts is the same condition reported in dozens of people in Europe who had received the AstraZeneca vaccine.

The early morning alert Tuesday set off a scramble in states that were preparing to administer the J&J shot within a matter of hours, forcing administration health officials to deal with frustrated governors in a midday call. New Hampshire Gov. Chris Sununu, a Republican, asked if there was something driving the decision other than the six cases, complaining it was difficult to explain a pause over something so rare.

“What has to be appreciated is the ability for governors to reinstill confidence after something like this is 100 times harder than the pause in the first place,” he told federal officials on the call.

Meanwhile, J&J has paused its vaccine rollout in Europe, as the European Medicines Agency (EMA) said it was closely monitoring developments around the shot in the US. EMA confirmed a “possible link” between the AstraZeneca Covid-19 vaccine and the same combination of blood clots and low platelet counts last week, but it stopped short of advising countries to limit its use.

YOU ASKED. WE ANSWERED.

Q. I’ve had the J&J vaccine. Should I be worried?

A. It’s important to remember that the combination of blood clotting and low blood platelet counts is extremely rare, less than one in a million at the moment. Dr. Anthony Fauci has explained that the pause is aimed at giving officials time to determine if the problem is more widespread than that, and to inform medical providers not to use a type of blood thinner called Heparin. The drug is usually used to treat blood clots but could be dangerous in people with this rare combination of clots and low platelet counts.

But there are some symptoms that can indicate blood clotting that you should look out for. If you experience a severe headache that doesn’t go away, significant abdominal or leg pain that doesn’t subside, or increasing shortness of breath, health officials say you should call your doctor immediately. All six cases reported were in women between six and 13 days after having the vaccine, but if you’re a man and are experiencing these symptoms, you should still call your doctor. If you received the J&J vaccine more than a month ago, the risk of experiencing a serious blood clot is very low, CDC officials say. Read here for more details.
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TODAY’S PODCAST

“It really allows both the FDA and the CDC to further investigate these cases, to try and understand some of the mechanisms of what it is.” — Dr. Anthony Fauci, chief medical adviser to the President, on the J&J pause

Vaccine passports may help people feel safer when returning to normal life, but given privacy concerns, some experts aren’t in favor. CNN’s Dr. Sanjay Gupta explains the concerns around monitoring people’s vaccination status. Listen now.

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