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U.S. recommends 'pause' for J&J vaccine, but expects restart in 'matter of days'

Six women have developed unusual clots that occurred

Six women have developed unusual clots that occurred six to 13 days after receiving the Johnson & Johnson vaccine, resulting in one death. The Centers for Disease Control and Prevention and the Food and Drug Administration said they were investigating. Newsday's Cecilia Dowd reports. Credit: James Carbone, Howard Schnapp, YouTube / The White House, U.S. Food and Drug Administration;

This story was reported by Robert Brodsky, Lisa L. Colangelo, Cecilia Dowd, David Reich-Hale and David Olson. It was written by Olson.

Medical experts are telling people who received the Johnson & Johnson COVID-19 vaccine not to panic, after the federal government recommended a "pause" in using the vaccine following reports of potentially dangerous blood clots.

New York State on Tuesday said it would stop using the single-dose vaccine at state sites while federal agencies investigate the clotting, but that it was not expected to slow the vaccination process.

Nassau County Executive Laura Curran said the 360 people who were slated to get vaccinated on Tuesday with J&J at the Nassau Coliseum would get Moderna shots instead. Suffolk County Executive Steve Bellone said the pause will have no immediate impact on the county’s efforts, but will affect upcoming homebound vaccinations.

"This is an incredibly, incredibly rare event, with an incidence of less than one case per million doses given," said Dr. Sharon Nachman, chief of pediatric infectious diseases at Stony Brook Children’s Hospital and a member of the state's clinical advisory task force.

What to know

  • The blood clots were in six women, aged 18-48. One died.

  • The six cases were out of more than 6.8 million J&J doses given nationally.

  • All occurred six to 13 days after vaccination and were in veins that drain blood from the brain.

  • Key symptoms: Severe headache, abdominal pain, leg pain or shortness of breath within three weeks of receiving the shot.

Even so, Food and Drug Administration Acting Commissioner Janet Woodcock said at a news conference, "COVID-19 vaccine safety is a top priority. We expect it to be a matter of days for this pause."

The FDA and Centers for Disease Control and Prevention said they were investigating six cases of unusual clots that occurred six to 13 days after vaccination in women ages 18 to 48. There was one death. A CDC committee will meet Wednesday to discuss the cases.

The CDC and FDA are recommending that people who were given the vaccine and are experiencing severe headache, abdominal pain, leg pain or shortness of breath within three weeks after receiving the shot contact their health care provider.

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Dr. Leonard Krilov, an infectious disease specialist and chief of pediatrics at NYU Langone Hospital-Long Island in Mineola, said if the clots were a result of the vaccine, they likely were triggered by inflammation caused by the body’s immune system response to the vaccine.

But, he said, that same type of inflammation can occur when someone contracts the coronavirus, and clotting is "relatively common" in people with COVID-19. The risk of the vaccine leading to a blood clot is "dramatically less than the disease" causing a blood clot, he said.

Dr. Bruce Farber, chief of infectious diseases at North Shore University Hospital in Manhasset and Long Island Jewish Medical Center in New Hyde Park, hopes the pause on administering the J&J vaccine is a short one.

"It would be an extraordinary disappointing chain of events with a profound effect on controlling the epidemic if this vaccine is taken off the market," said Farber, also a member of the state task force.

Dr. Howard Zucker, New York's health commissioner, said in a statement that the state will "follow the CDC and FDA recommendation and pause the use of the Johnson & Johnson vaccine statewide immediately while these health and safety agencies evaluate next steps."

Anyone at a state vaccination site scheduled to receive the J&J vaccine Tuesday instead was offered the Pfizer-BioNTech one, he said.

The J&J vaccine was an ideal option for transient populations, including people in homeless shelters, and college students, because of the single dose, Nassau County Health Commissioner Lawrence Eisenstein said. The other authorized vaccines, from Pfizer-BioNTech and Moderna, require two doses spaced out over several weeks. The J&J vaccine also was administered to 135 county jail inmates.

Michael Burns, of Lindenhurst, who received his first dose of the Moderna vaccine on Tuesday at the Nassau Coliseum, said he had doubts about the J&J vaccine before the announcement of the blood clots.

"I’d rather not take J&J. I just don’t trust it," Burns said. "It’s a gut feeling."

Nassau residents who have received the J&J vaccine and have questions can call the county hotline at 516-227-9570.

In Suffolk, Bellone said the county exhausted its supply of J&J on Monday and was not anticipating additional doses for another week or two because of problems at a Baltimore plant that was manufacturing the vaccine. But Bellone concedes the pause likely will impact the county’s effort to vaccinate homebound residents.

"The homebound program relies on that one-shot dose because it’s such a labor-intensive task to go door to door to administer it to these individuals," Bellone said.

Bellone said he will evaluate how long the delay will be with J&J and could switch to Pfizer-BioNTech and Moderna if it extends for a prolonged period.

Nassau's plan to vaccinate homebound residents is on hold because it hinged on using the J&J vaccine, Curran said.

Some Long Island pharmacists also have been using the J&J vaccine. Tom D'Angelo, who runs home infusion pharmacy Americare in Garden City South and Franklin Square Pharmacy, said he's getting phone calls from customers who were administered the J&J shots.

"I'm telling them I'm not too concerned, but to be aware of the possibilities," D'Angelo said.

Mount Sinai South Nassau hospital in Oceanside administered about 1,000 J&J shots through its traveling "Vaxmobile" the past few weeks, mostly to seniors, and it will use the Pfizer-BioNTech vaccine for the next few stops, hospital spokesman Joe Calderone said.

Krilov worried that some who received the J&J vaccine would now incorrectly believe they were deliberately given an inferior vaccine.

"It may pose some concerns about, ‘Oh you’re giving us the dangerous vaccine and keeping the Pfizer and Moderna vaccines for different populations,’ " he said.

Krilov said it is yet to be determined whether the clots were caused by the J&J vaccine. Many people who have never received a vaccine also get blood clots, he said.

But, he said, "It’s an unusual type of clotting," so there’s a strong possibility the vaccine did cause it.

Nachman said the quick action by the CDC and FDA, even though there were only six cases of blood clots, should reassure those concerned about vaccine safety.

"The system worked," she said. "Events were reported. They were looked at, even though it was six cases out of 6.8 million doses."

The clots occurred in veins that drain blood from the brain. The reports appear similar to a rare, unusual type of clotting disorder that European authorities said is possibly linked to another COVID-19 vaccine not yet cleared in the United States, from AstraZeneca.

The Pfizer-BioNTech and Moderna vaccines are different from the J&J vaccine in how they stimulate the body’s immune system, Krilov said. But he worried that people who are already vaccine-hesitant will lump all three together and may be less likely to be inoculated with any vaccine.

"If you already have some doubts, anything that comes out that’s a new wrinkle and raises concerns, it could potentially exacerbate those concerns," Krilov said.

Dr. Adhi Sharma, chief medical officer at Mount Sinai South Nassau, said there’s no reason for anyone who has gotten or will get the Pfizer-BioNTech or Moderna vaccines to be worried.

"They’ve detected this issue within the first six to seven million doses of J&J, and we’ve already given out 180 million doses of the other two," he said. "I would hate to see us lose ground on such progress we’ve made for vaccinations because of any increased hesitancy as a result of this."

Bellone urged residents not to lose sight of the importance of vaccinations.

"Our pathway out of this pandemic is getting the necessary amount of people vaccinated," he said, alluding to the 70% to 90% of vaccinated Americans who experts say are need to reach herd immunity, when the spread of the virus is greatly limited. "This is the way we get back to normal."

With AP

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