White House expecting ‘short-term’ impact after pausing J&J vaccines

CDC director: Keep your Pfizer and Moderna appointments

CDC and FDA Recommend Pause of Johnson & Johnson Vaccine, Due to Rare Cases of Blood Clots.Six cases of "rare and severe" blood clots have been reported by people who have received the Johnson & Johnson COVID vaccine.Roughly 6.8 million people have received that version of the vaccine in the U.S.A joint statement was released by both the Centers for Disease Control (CDC) and the Food and Drug Administration (FDA).It revealed that all the reported cases of blood clots occurred in women between the ages of 18 and 48.and that the instances of clotting emerged between six and 13 days after they received the vaccine.CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance, Joint Statement of CDC and FDA, via CNN.FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution, Joint Statement of CDC and FDA, via CNN.The statement reiterated that the cases are "extremely rare", as rare as one case per million doses administered.However, it states that anyone experiencing leg pain, severe headache, shortness of breath or abdominal pain within three weeks of receiving the vaccine should contact their doctor immediately

The White House said Wednesday it is expecting some “short-term” impact on the daily delivery of COVID vaccines throughout the U.S., as federal health agencies continue pausing the use of Johnson & Johnson’s coronavirus vaccine.

Johnson & Johnson’s vaccine will remain in limbo a while longer after U.S. health advisers told the government Wednesday that they need more evidence to decide if a handful of unusual blood clots were linked to the shot — and if so, how big the potential risk really is.

Also Wednesday, Dr. Rochelle Walensky, director of the Atlanta-based Centers for Disease Control and Prevention, urged people to keep their appointments for the Pfizer and Moderna COVID vaccines.

Wednesday’s developments come one day after the CDC and U.S. Food and Drug Administration said they are recommending a pause in using the Johnson & Johnson COVID vaccine after six people suffered “rare” and “severe” blood clots after receiving the vaccine.

On Tuesday night, Johnson & Johnson said it was pausing its vaccine clinical trials after blood clotting issues “while we update guidance for investigators and participants.”

During a Tuesday media briefing, Dr. Peter Marks, director of the FDA center for biologics evaluation and research, said one of those who suffered such a reaction has died, while another is in critical condition. Almost 7 million people have been given the J&J vaccine.

All six cases occurred among women between the ages of 18 and 48, and symptoms occurred six to 13 days after vaccination, according to Marks.

On Tuesday, President Joe Biden said even with a temporary loss of J&J ‘s one-shot vaccine, there is a huge supply of Pfizer and Moderna vaccines, enough that “is basically 100% unquestionable, for every single, solitary American.”

In the opening months of his presidency, Biden has put top priority on a response to the virus that has killed 559,000 Americans, with a vaccine campaign in which nearly 50% of adults have received at least one shot.

His actions have received generally strong reviews, and hesitancy toward taking the vaccine has gradually declined as inoculations have increased. With plenty of supply in the pipeline, Biden has received some criticism for not sharing more vaccines with other nations. The president said Tuesday’s action proved the wisdom of his approach.

“My message to the American people on the vaccine is, I told you all,” Biden told reporters after the announcement, adding that he “made sure we have 600 million doses” just from Pfizer and Moderna in the pipeline.

The Johnson & Johnson pause, which regulators say they hope to resolve within days, comes on the heels of production issues at the Baltimore plant that produces the J&J vaccine.

The White House, which got only about 12 hours’ notice that some sort of announcement was coming and did not have any advance warning about the substance of the FDA and CDC’s action, moved swiftly to minimize concerns about its impact. Aides recognized that they had to portray the decision as ensuring the “gold standard” of safety, to avoid feeding into vaccine hesitancy.

“I think it’s a very strong argument for safety actually,” Dr. Anthony Fauci said.

White House coronavirus coordinator Jeff Zients added that the pause by the agencies “should reassure the American public that they will be very diligent and conservative about how they approach the vaccines.”

They argued the pause proved the prudence of Biden’s cautious approach to promises around vaccine supply and delivery, as well as his administration’s reluctance to make commitments to share excess vaccine with the world because of concerns about potential setbacks such as this.

“They’re clearly trying to reassure people there will be supply, and it will be safe,” said former White House communications director Jennifer Palmieri. “You don’t want this to have happened, but in terms of what are your tools when it does, they used their best ones — the president, the most senior person who has credibility and the top experts — to do it.”

Due to supply issues, the J&J shot reflects just a small share of doses being administered, though it had been one of the most promising vaccines given its ease of administration and distribution. Zients said the U.S. still expects to take delivery of enough doses of the other two emergency-use-approved vaccines for every adult American to get their shots by the end of May. Moderna and Pfizer this week are delivering 28 million doses to the federal government — enough to exceed even the current 3 million shot-per-day pace.

Zients acknowledged that some states may have been caught off guard by Tuesday’s announcement but said that reflected the speed with which officials moved to address the safety concerns. He added it was proof of Biden’s commitment to “follow the science” in responding to the pandemic.

“We want the science agencies to lead with science,” Zients said, saying no one at the White House was involved in the decision to call for the pause. “There’s no reason for us to be involved in any of the scientific decisions; we bring nothing to the table.”

The Associated Press contributed to this report.