- The Washington Times - Tuesday, April 13, 2021

Vaccinators scrambled to reschedule COVID-19 appointments Tuesday after President Biden’s team stopped using the Johnson & Johnson vaccine at federal sites and advised states to do the same because six recipients out of nearly 7 million experienced serious blood clots.

The sudden halt, which should last at least a few days, is an unexpected blow to the U.S. rollout amid fears about viral variants and has sparked debate about whether the clots were common enough to merit any pause in the fight against a pandemic that has killed more than 560,000 Americans.

J&J’s one-shot vaccine is highly efficient and was enthusing governors as it entered the mix of U.S. options after production stumbles. But federal health officials said they needed to investigate the clotting so they could make recommendations to people seeking the vaccine. The clotting, which is difficult to treat, has resulted in one death.

“Right now, I’d like to stress these events appear to be extremely rare,” said acting Food and Drug Administration Commissioner Janet Woodcock. “However, COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of adverse events following vaccination very seriously.”



Mr. Biden insisted Americans will have effective options, no matter what happens with the J&J vaccine.

“There is enough vaccine that is basically 100% unquestionable for every single solitary American,” he said.

All six clotting cases occurred in women ages 18 to 48. One died, and another was reported in serious condition. Officials said the clotting follows a pattern tied to the AstraZeneca vaccine in Europe, which is similar to but not identical to J&J’s version.

A leading theory is that the two vaccines trigger an immune response involving blood platelets and coagulation systems in some people, leading to cerebral venous sinus thrombosis, officials said.

Dr. Woodcock said the length of the pause in distributing the J&J vaccine will depend on “what we learn in the next few days.”

Experts are convening Wednesday to advise the Centers for Disease Control and Prevention.

“We want to make sure that we make some recommendations quickly,” said Anne Schuchat, a principal deputy CDC director.

The news sparked fears that vaccine hesitancy would get worse, and former President Donald Trump warned of permanent damage to the vaccine’s reputation. Others said the move should instill confidence in federal processes.

White House officials said millions of Americans have been vaccinated safely and the pause is “clear evidence” that the FDA will take steps to ensure safety if problems arise.

“I don’t think it was pulling the trigger too quickly,” said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

The pause in using the J&J vaccine is a recommendation and not a mandate to states. But it had an immediate impact in states and localities using the J&J version alongside vaccines from Pfizer-BioNTech and Moderna, which require two doses and remain the dominant options.

Officials in the District of Columbia, Maryland and Virginia said they were immediately halting J&J vaccinations.

Arlington County, Virginia, said people slated to receive the J&J shot at a community center Tuesday would be offered an initial dose of the Moderna vaccine. New York Gov. Andrew Cuomo said people with Tuesday slots would be offered the Pfizer version.

“That’s happening in many places across the country,” White House COVID-19 coordinator Jeff Zients said.

Gov. Chris Sununu said he is seeking alternative supplies and the development “will not slow down New Hampshire” as it manages an impressive rollout.

CVS, Walgreens and other members of the COVID-19 retail pharmacy program halted use of the J&J vaccine, and South Africa suspended its rollout after the U.S. decision.

Experts said the pause could have bigger ramifications outside of the U.S. because many countries rely on deliveries of the J&J and AstraZeneca adenovirus vaccines. Wealthier countries deploy the mRNA vaccines from Pfizer and Moderna that haven’t produced red flags.

“For the U.S., this is a reasonable move to ensure that we have deeper data and analysis to more fully understand the situation. It is highly likely that the administration will restart in a few days with minor disruptions. It will also help raise awareness among vaccine recipients about symptoms of concern and help providers make sure that they know what to watch for,” said Krishna Udayakumar, founding director of the Duke Global Health Innovation Center.

“The longer-term impact on demand and hesitancy, in the U.S. and globally, may be much larger,” he said. “Having the U.S. pause use of the J&J vaccine could well reduce confidence in the vaccine in other parts of the world, which are much more reliant than the U.S. on this vaccine. Coupled to the rare adverse events seen with the [AstraZeneca] vaccine, we may end up with greater vaccine hesitance globally to the two vaccines the world is most dependent on for global access.”

Symptoms in the affected women showed up six to 13 days after vaccination. The J&J version has been given to 6.8 million people in the U.S., the FDA and CDC said in a joint statement.

European regulators have declared that the benefits of the AstraZeneca vaccine outweigh the risks but people should be aware of the possible link to clots. Tuesday’s report is the first known instance of possible adverse reactions to the J&J version.

J&J said it is working with U.S. regulators and will delay its rollout in Europe. It said safety is its top priority and the U.S. pause came from an “abundance of caution.”

“We have been working closely with medical experts and health authorities, and we strongly support the open communication of this information to health care professionals and the public,” the company said.

Federal officials said a common drug for clots, heparin, cannot be used as a treatment in this situation so alternatives will be used.

People who received the J&J shot more than a month ago shouldn’t worry, officials said. Those who received it in recent days or weeks should monitor themselves for severe headaches, abdominal pain or shortness of breath and contact their doctors if needed.

The J&J vaccine, authorized in February for emergency use, was supposed to dramatically accelerate the U.S. vaccination campaign as a “one and done” vaccine. Yet the company fell short of expected deliveries and is recovering from a mix-up at a Baltimore plant that spoiled up to 15 million doses, delaying FDA approval of the facility and holding back expected supply.

The disruption is a key test for Mr. Biden, who has overseen a relatively steady rollout after he took over the campaign started by Mr. Trump.

Governors were hoping to use the J&J shots to immunize younger people who are newly eligible for the COVID-19 vaccine. Michigan Gov. Gretchen Whitmer specifically requested extra J&J shots as she contended with a major surge in COVID-19 cases, though she was rebuffed by the White House.

Mr. Zients on Tuesday downplayed J&J’s role in meeting Mr. Biden’s goal of having enough doses for every U.S. adult by the end of May.

The U.S. is administering an average of 3 million shots per day, and the vaccines from Pfizer and Moderna account for more than 95% of the 190 million shots administered to Americans so far. Those vaccines require two doses taken three to four weeks apart, however, so it takes longer to label someone “fully vaccinated” with those versions.

“This announcement will not have a significant impact on our vaccination plan: Johnson & Johnson vaccine makes up less than 5% of the recorded shots in arms in the United States to date,” Mr. Zients said.

He said the administration secured enough Pfizer and Moderna doses for 300 million Americans and just ramped up its allocation of the mRNA vaccines from 25 million per week to 28 million this week.

“This is more than enough supply to continue the current pace of vaccination,” he said.

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