DALLAS - The Texas Department of State Health Services is asking all vaccine providers in the state to stop the use of the Johnson & Johnson vaccine based on new guidance from the federal government.
Both the Food and Drug Administration and the Centers for Disease Control have recommended a pause on the use of the vaccine to investigate reports of a rare type of blood clotting following vaccinations in the United States.
Of the nearly 7 million doses given out, the blood clots were reported in six cases. The people who had them developed symptoms between six and 13 days after getting the one-dose shot. One person died, officials confirmed.
With more than 31,000 Johnson & Johnson vaccine doses left to give out, Dallas County’s Fair Park site had to halt operations administering the one-shot vaccine.
"It was definitely a surprise, but we’ve come to expect surprises. Every day, there’s something new," said Dallas County Health Director Dr. Philip Huang. "Today was sort of a Johnson & Johnson day, so we delayed opening until 9 a.m. and instead are administering Moderna and Pfizer today."
Meanwhile, Tarrant County Public Health spent Tuesday morning canceling and rescheduling appointments originally slated at AT&T Stadium.
"Johnson & Johnson just is off the table," said Tarrant County Judge Glen Whitley.
The site was supposed to administer about 42,000 Johnson & Johnson doses over the next two weeks. For now, it will focus on second doses of the Pfizer vaccine.
An illustration picture shows vials with Covid-19 Vaccine stickers attached and syringes with the logo of US pharmaceutical company Johnson & Johnson. (Photo by JUSTIN TALLIS/AFP via Getty Images)
"We'll wait for the FDA to decide what is the path forward," said Tarrant County Public Health Director Vinny Taneja. "But I'm keeping my fingers cross that this is not that big of an issue and let's just keep on moving forward."
Taneja anticipates, as seen in other countries, the FDA will ultimately move forward with Johnson & Johnson.
"If it doesn't get resolved in favor of using J&J, currently the plan is to not resume that large mass clinic operation. We'll absorb those clients back into our operation," he said.
The new developments are also halting homebound vaccination programs, like the ones in Dallas and Arlington, which planned to mainly use the one-shot vaccine for its efficiency.
"The reality is we’re still moving in the right direction. The Tarrant County vaccine waiting list has been exhausted at this point, so there’s still vaccine available," said Lt. Richard Fegan with the Arlington Fire Department. "There's still vaccine available. Maybe not Johnson & Johnson at this point, but we are reaching a point where those who want it can get it and they can get it quickly."
Fegan said people who were scheduled to receive the Johnson & Johnson shot in Arlington are being rescheduled to receive the Moderna or Pfizer vaccine.
Dallas county set aside 1,500 doses for the city of Dallas and the visiting nurses association to start vaccinating the homebound Tuesday, but that plan is on hold for now.
"We’re definitely going to have to see what the guidance is and what other availability of vaccine we have," Dr. Huang said.
The city of Garland was forced to cancel its mass vaccination event at Johnson Stadium Tuesday because of the announcement.
Both The Dallas and Tarrant County sites will store the vaccine in the meantime. Health officials say they’re not under a serious time constraint as the vaccine can be stored up to three months and doesn’t require an ultra-cold freezer.
Pat Fuller of Fort Worth documented her decision to get the single-dose shot Easter weekend.
"My friend was having it and said they have extra," Fuller said. "And I was like, well this is going to mess up my Easter. And it did. I was very sick."
Fuller’s common side effects wore off pretty fast. Now a week later, she says she’s feeling a little uneasy again.
"I said, well dang!" she said. "I have gone and done this!"
Dr. Susan Bailey is a physician in Fort Worth and president of the American Medical Association. She agrees with the halt.
"I don’t think this should cause fear," she said. "If anything, it should reassure that the system is working."
The halt will allow health officials to confirm whether the blood clotting is directly caused by the vaccine and take next steps.
It’s likely blood clots will be disclosed as a rare side effect moving forward, like many medicines that have lists of common and rare side effects. But it will likely still be deemed safe and effective.
"If this is associated with the vaccine, and we aren’t sure yet, it’s literally one in a million," Dr. Bailey said. "But if you get COVID and have to go to the hospital, your chance of having a clotting even is one in five."
Most people who get a vaccine should expect minor symptoms, like a sore arm, headache or fatigue.
"If you just have the achy kind of headaches after the vaccine, that is normal," Dr. Bailey said.
Fuller says she staying cautious but not regretting the protection she now has.
"We have to do something. that’s just plain and simple," she said.
Federal health officials don’t expect this pause will last long, possibly just a few days. The CDC will meet Wednesday to review the cases.
Meanwhile, Governor Greg Abbott announced that none of the rare cases have been reported in Texas.
"The safety concerns we are seeing are essentially the same ones that had temporarily paused the AstraZeneca vaccine over in Europe. And these are the same safety concerns that I would have in general for the other types of vaccines that are like this," said Dr. Benjamin Neuman, the chief virologist at Texas A&M’s Global Health Research Center.
Dr. Neuman explained there are vaccines being developed in Russia and China that work the same way as the Johnson & Johnson vaccine. He’s not so much concerned about them causing blood clots but that it’s a very rare type of blood clot that can’t be treated like a typical blood clot.
"The problem right now is that this just such a small and relatively rare case that there isn’t a lot of data to go on. And so I think the most likely thing is they will pause this, study it for a few days and I don’t think that they will have enough information to conclude that this is unsafe. And it will probably end up going back in just with a little warning," Dr. Neuman said.
Ultimately Dr. Nueman expects researchers to figure out exactly what it is that makes some people react differently. Then sometimes there are vitamins or steps people can take to reduce the side effects.
"We just have to figure out what it is. That’s where we are right now," he said.
FDA Acting Commissioner Janet Woodcock said he thinks the pause will only last a few days while the investigation wraps up.
"I’d like to stress these events appear to be extremely rare. However, COVID-19 vaccine safety is a top priority," he said at a news conference.
Health experts urge anyone who develops a severe headache, abdominal pain, leg pain or shortness of breath within three weeks of getting the Johnson & Johnson vaccine to contact their doctor immediately.
The CDC thinks the risk for any type of clotting is very low for anyone who received the shot more than a month ago.