The U.S. Food and Drug Administration along with the U.S. Centers for Disease Control and Prevention have recommended a nationwide pause in the use of Johnson & Johnson’s one shot COVID-19 vaccine due to new evidence of some extremely rare but potentially dangerous side effects in a small number of the millions of U.S. residents who have gotten that particular vaccine.
According to the FDA and CDC, out of the more than 6.8 million U.S. residents who have gotten the Johnson & Johnson vaccine so far, six of them subsequently came down with both an uncommon type of blood clot in the brain and low levels of blood platelets that can cause stroke-like incidents. All six of them are women between the ages of 18 and 48, and their symptoms showed up six to 13 days after getting their shot. One woman has died and another remains hospitalized and in critical condition.
In response, both the Houston Health Department and Harris County Public health have announced they won’t be giving out the Johnson & Johnson vaccine until further notice, and that anyone scheduled to receive a Johnson & Johnson shot will instead be provided with either the Pfizer or Moderna vaccines.
Harris County Public Health will not be dispensing the Johnson & Johnson vaccine at any of its other vaccination sites until further guidance.Our mobile community vaccine sites will operate as scheduled with the Moderna vaccine.— Harris County Public Health #SocialDistance (@hcphtx) April 13, 2021
Will continue to provide updates as we have it.
The Houston Health Department is following the guidance of the CDC and FDA to pause use of Johnson & Johnson’s COVID-19 vaccine out of an abundance of caution as rare adverse reactions are investigated. The department will await guidance on future use of the vaccine. #HouNews pic.twitter.com/UhBycSTAlo— Houston Health Dept (@HoustonHealth) April 13, 2021
Houston Mayor Sylvester Turner said Tuesday that he and city health officials “don’t anticipate having to cancel any scheduled appointments for this week” due to the city’s supply of Moderna and Pfizer vaccines.
The Texas Department of State Health Services has also asked all vaccine providers in Texas to temporarily stop giving out the Johnson & Johnson shot, and recommended that any Texans who received that specific vaccine and experience a severe headache, abdominal pain, leg pain or shortness of breath within three weeks of vaccination “should contact their health care provider.”
DSHS is asking vaccine providers in Texas to pause all administration of the J&J COVID-19 vaccine following today’s recommendation from the @CDCgov and @US_FDA.#TexasDSHSNewsRelease for full information: https://t.co/sgPXlnOXiM #COVID19TX #HealthyTexas pic.twitter.com/wAidQ2eDES— Texas DSHS (@TexasDSHS) April 13, 2021
In a joint press conference, FDA and CDC officials explained Tuesday that the pause they’ve recommended was made “out of an abundance of caution” and is intended to give healthcare providers across the country enough time to learn about the symptoms and treatments for this specific type of blood clot.
“We’re recommending this pause while we work together to fully understand these events,” said Acting FDA Commissioner Dr. Janet Woodcock, “and also so we can get information out to healthcare providers and vaccine recipients.”
Dr. Peter Marks of the FDA’s Center for Biologics Evaluation and Research said that “The issue with these types of blood clots is 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.”
He said that if doctors “see people who have low blood platelets, or if they see people who have blood clots, they need to inquire about a history of recent vaccination and then act accordingly.”
Woodcock said that the FDA and CDC don’t anticipate the pause to last long at this time: “The timeframe will depend obviously on what we learn in the next few days. However, we expect it to be a matter of days for this pause.”
Dr. Anne Schuchat, Principal Deputy Director of the CDC, said that of the three vaccines being used in the United States right now — made by Johnson & Johnson, Pfizer and Moderna — “We are not seeing these clotting events with low platelet counts with the other two vaccines.”
“I know there are people who have gotten the [Johnson & Johnson] vaccine who are probably very concerned,” Schuchat said, “[but] for people who got the vaccine more than a month ago, the risk for them is very low at this time.”
“For people who recently got the vaccine within the last couple of weeks,” she continued, “they should be aware to look for any symptoms. If you’ve received the vaccine and develop severe headaches, abdominal pain, leg pain or shortness of breath, you should contact your health care providers and get medical treatment.”
Dr. David Persse, the city’s Chief Medical Officer, stressed Tuesday that people should be encouraged rather than scared by the FDA and CDC’s announcement.
“I think one thing for people to recognize here is that we are fortunate that there are systems — and there’s not just one — but there are multiple systems in place such than an anomaly that occurs in six out of 6.8 million people gets on the radar,” Persse said, “so I think that speaks pretty well to how strong the filter is trying to catch those things.”
Turner and Persse both said they’d been informed by the state health department that none of the six women who suffered from blood clots and low platelet counts after getting the Johnson & Johnson vaccine were Texans. They also both said that the city had been receiving far fewer doses of Johnson & Johnson vaccine than the Moderna and Pfizer vaccines, so it shouldn’t cause any significant delays in local vaccinations.
However, Turner said the city was expecting to get an influx of Johnson & Johnson shots in the weeks ahead, so “if anything, it will slow up how we ramp up moving forward.”
Turner said he’s definitely concerned that the news around Johnson & Johnson’s vaccine may lead to more residents being hesitant to get any of the available coronavirus vaccines. “That’s why I’m stressing the fact that out of 6.8 million people who have taken the J&J, we’re talking about six cases,” he said.
“I don’t want for people to say ‘OK, we’re not going to take any of these vaccines, we’re just not going to do it.’” Turner said.
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