Live Updates: U.S. recommends
Apr 13, 2021 6 mins, 39 secs

The White House said Tuesday that the pause "will not have a significant impact" on the nationwide vaccine plan.

The agencies said the "adverse events" seem to be extremely rare, but that the pause is important so that health care providers can be made aware of the reactions and properly recognize and manage the cases, given the unique treatment required.

"We have made the decision to proactively delay the rollout of our vaccine in Europe and pause vaccinations in all Janssen COVID-19 vaccine clinical trials while we update guidance for investigators and participants," the company said an updated statement on Tuesday. ?

A top official with the FDA said Tuesday that there was "no clear association" between reports of rare blood clots following the Johnson & Johnson COVID-19 vaccine and oral contraceptives.

Blood clots are a known, rare potential risk posed by the drug.

However, in Europe, an investigation of similar side effects from AstraZeneca's COVID-19 vaccine — which is based on a similar technology to Johnson & Johnson's — had also uncovered several men who also had suffered the rare events after those doses as well. .

pause on Johnson & Johnson's COVID-19 vaccine, and is monitoring reports of rare blood clots combined with low blood platelet counts.

The WHO cleared Johnson & Johnson's COVID-19 vaccine for an emergency use listing in March, following sign-off from regulators in the U.S.

It is also a prerequisite for use of the shots in the international COVAX vaccination effort backed by Gavi, the Vaccine Alliance, which struck a deal in December for up to 500 million doses of Johnson & Johnson's vaccine.

The pause on Johnson & Johnson vaccines could be over as soon as Wednesday, according to a health alert issued to medical providers by the CDC on Tuesday, which only urges clinicians to pause using the doses until an advisory committee convenes to deliberate on changes to use of the doses. .

Virginia state health authorities say they are still gathering details surrounding a potential death matching the worrying combination of rare blood clots and low blood platelets following the Johnson & Johnson vaccine in the state. .

Danny Avula, Virginia's COVID-19 vaccine coordinator, told reporters at a press briefing on Tuesday.

A Food and Drug Administration official said Tuesday that the regulators were examining six total cases of the rare blood clotting events after receiving the Johnson & Johnson vaccine, including one death and one that remained in "critical" condition.

Last week, officials in Nebraska had confirmed a resident in their late 40s had been treated for this kind of rare blood clotting event, after receiving the Johnson & Johnson vaccine.

Briefly addressing concerns over vaccine supply given the Johnson & Johnson pause, President Biden said he's made sure the U.S.

"I made sure we had 600 million doses – not of either Johnson & Johnson and/or AstraZeneca," the president said, insisting there'll be enough vaccine that is "basically 100% unquestionable" for "every single solitary American.".

The nation's capital city joined several states in suspending the Johnson & Johnson COVID-19 vaccine that's become the focus of a federal examination of rare blood clots.

LaQuandra Nesbitt says she's not aware of any cases of dangerous blood clots among the 16,000 Washingtonians who had received the J&J one-dose vaccine before the temporary halt recommended by federal health authorities.

J&J said in a statement Tuesday it was aware of the reports of blood clots, but that no link to its vaccine had been established.

South Africa has suspended giving the Johnson & Johnson vaccine as a "precautionary measure" following the FDA decision in the United States to pause using it while very rare blood clot cases are examined.

South Africa has given more than 289,000 jabs of the J&J vaccine to the country's health workers without any reports of blood clots, Health Minister Dr.

He said South Africa is halting the use of the J&J doses "out of an abundance of caution" and he expects that the questions over the J&J vaccine should "be cleared within a matter of days.".

Johnson & Johnson's vaccine makes up less than 5% of the more than 190 million shots administered to date, and the federal government has secured enough doses from Pfizer and Moderna to remain on the current pace of 3 million shots in arms per day, he said.

Fauci said there have been "no negative red-flag signals" with regard to Pfizer and Moderna's vaccines, which indicates "you're dealing with a really safe vaccine.".

Anthony Fauci, chief medical adviser to President Biden, said the suggested pause on administering Johnson & Johnson's coronavirus vaccine allows federal health agencies to examine the reported blood clot cases and raise awareness among physicians who may be treating patients with this specific type of blood clot.

Johnson & Johnson said it will "proactively delay" the rollout of their vaccine doses in Europe, following the recommended pause for the shots by federal health officials in the U.S. 

The Department of Defense is "immediately" pausing use of the Johnson & Johnson vaccine, Pentagon press secretary John Kirby said Tuesday in a statement. 

Federal health officials said Tuesday there were no similar reports of rare blood clotting issues from the Moderna and Pfizer COVID-19 vaccines that have been administered in the United States. 

In a statement, Moderna also said a review of "available safety data" for the doses of their vaccine administered around the world "does not suggest an association" with the concerning blood clots and low blood platelet counts. 

"It is plainly obvious to us already that what we're seeing with the [Johnson & Johnson] vaccines looks very similar to what was being seen with the AstraZeneca vaccine," said Dr

Of the six cases where federal regulators say they are examining the rare overlap of blood clots and low blood platelets, officials confirmed Tuesday that one had passed away and another was in critical condition. 

Acting FDA Commissioner Janet Woodcock told reporters on Tuesday that she expects the recommended pause to last "a matter of days," while federal health officials review the data and mull updated guidelines for use of Johnson & Johnson's vaccine

Officials said the pause is intended to provide doctors the opportunity to learn more about how to treat the rare combination of symptoms, which can sometimes be worsened by heparin, a standard treatment given to address blood clots

Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a briefing Tuesday that the issue with the kind of blood clots being investigated is with treatment — "that if one administers the standard treatments that we as doctors have learned to give for blood clots, one can actually cause tremendous harm, or the outcome can be fatal."

The White House says the recommended pause will not significantly impact its COVID-19 vaccine plan given that the Johnson & Johnson vaccine accounts for less than 5% of the total number of shots administered in the U.S

"Over the last few weeks, we have made available more than 25 million doses of Pfizer and Moderna each week, and in fact this week we will make available 28 million doses of these vaccines," he said

Howard Zucker said the state will follow the recommendation and pause the use of the Johnson & Johnson vaccine at state-run sites

People with Tuesday appointments for Johnson & Johnson vaccines at state-run mass vaccination sites will instead get the Pfizer vaccine, he said

"We will follow the FDA's guidance to temporarily pause the Johnson & Johnson vaccine out of an abundance of caution, and adapt our vaccine strategy going forward until a further review of the data can be conducted," Bobby Leddy, press secretary for Whitmer, said in a statement.  "With this latest development, it's more important than ever for the federal government to implement a targeted strategy that allocates additional Pfizer and Moderna vaccines to hotspots like Michigan to slow the spread of COVID-19 and save lives."


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