The U.S. Food and Drug Administration (FDA) and Center for Disease Control and Prevention (CDC) announced it will pause administration of the Johnson & Johnson vaccine in the United States, causing N.C. public health, local counties and providers to follow suit on Tuesday.
The pause comes after six 18-to-48-year-old women, within six to 13 days after receiving the J&J vaccine, were diagnosed with a rare blood clot (cerebral venous sinus thrombosis) in combination with low blood platelets (thrombocytopenia). It left one dead and another in serious condition.
Pre-existing conditions were not found in all cases, according to officials, though they haven’t ruled them out entirely for some.
“I want to stress: These events appear to be extremely rare,” Dr. Janet Woodcock, acting FDA commissioner, stated in a press conference earlier.
The one-shot vaccine has been administered 6.8 million times over the last month.
Adverse symptoms from the J&J vaccine have included severe headaches, abdominal and leg pain, and shortness of breath — “different from flu-like symptoms,” according to Dr. Peter Marks, director of FDA Center for Biologics Evaluation and Research. “For people who got the vaccine more than a month ago, risk is very low at this time.”
New Hanover Public Health is urging people who were inoculated with J&J to monitor their health closely and reach out immediately to a primary care physician if any adverse reactions occur.
“These reported adverse reactions are extremely rare, and we want to encourage the public to continue trusting the FDA-approved vaccines because they are effective at preventing serious illness and death from COVID-19,” David Howard, New Hanover’s public health director, said.
Normal, temporary side effects from vaccinations have been reported as sore arm, headache, fever, nausea, feeling sluggish and achy — all signs that the vaccine is building immunity, according to officials.
New Hanover confirmed it is only conducting clinics for Pfizer and Moderna currently. Though, it hosted a J&J walk-up clinic on Monday, Apr. 12.
UNCW has been hosting J&J clinics on campus for students and faculty since last month. It announced today it, too, will stop until further notice, and that the clinic has not received reports or health concerns from recipients of the vaccine.
Marks said a reaction to J&J mirrors a similar pattern that doctors and scientists noticed in Europe’s AstraZeneca, which also led to blood clotting in some patients. “We have to take the time to understand the complication and address it properly,” he said.
Marks recommended healthcare providers who treat patients with adverse reactions should ask about vaccination history, specifically if one was taken within a few weeks of symptoms. More importantly, he said providers should avoid the use of the blood thinner Heparin to treat these specific, rare blood clots and low platelet combination as it could be fatal.
“It’s dangerous and alternative treatments will need to be given,” Marks said.
The FDA and CDC are working to revise the J&J fact sheet that is given to healthcare providers, recipients and caregivers, in order to appropriately note the possibility of adverse reactions. Though the federal organizations are recommending states pause the use of J&J, Marks made it clear it’s not a mandate. They are not stopping providers from administering J&J if they determine with their patients the benefits outweigh the risks.
The N.C. Department of Health and Human Services released a statement that it will follow FDA and CDC guidelines to stop administering J&J for now but urges folks to keep their appointments for the Moderna and Pfizer vaccines.
While Pender County Public Health hasn’t been administering J&J vaccines, Brunswick Public Health has received some shipment but said it will follow federal guidelines until further notice.
“Health Services still has enough local reserves of the Pfizer and Moderna COVID-19 vaccines and does not anticipate needing to reschedule any appointments this week as long as individuals accept one of these versions,” a Brunswick County spokesperson said.
Dr. Phillip Brown, vice president and chief physician of New Hanover Regional Medical Center, said they will be switching out J&J appointments with another vaccine. Today’s vaccine clinic, specifically, will be replaced with Pfizer.
He also said he doesn’t expect it to cause too many scheduling issues, as the hospital hadn’t received a large shipment of the J&J vaccine to begin with. “So we’re able to continue to vaccinate at the same rate that we have had before so far.”
Brown said the pause that federal health officials are taking is part of the process to ensure transparency and safety among the public.
“There is a true abundance of caution being exercised,” he said, “and when you look at those risks of the clotting, it’s actually, the incidence from the Johnson & Johnson vaccine is lower than the incidence in the general population.”
He said he expects, after the FDA and CDC take a closer look at the science and evidence, to see J&J returning to the vaccination fold soon.
Health officials from the FDA and CDC said taking swift action helps disseminate important messaging throughout the health community that can ultimately save lives.
“Steps we are taking today is to make sure the health system is ready to treat, diagnose and record to keep everyone safe,” Dr. Anne Schuchat, principal deputy director of the CDC, said at the Tuesday press conference. How long the pause will last, she added, is unknown currently.
On Wednesday, an independent Advisory Committee on Immunization Practices will review all data of the six cases to determine J&J’s safety moving forward. It will be open to the public.
“It has introduced extra doubt into the process,” Brown admitted. “And, right now, that’s really dangerous because we need to get significantly more people vaccinated to really have the type of herd immunity that we would hope to get.”
According to CDC and FDA, over 180 million Moderna and Pfizer vaccines, out of a total of 190 vaccines, have been administered in the U.S. to date.
Individuals should report any possible adverse effects to the CDC’s Vaccine Adverse Event Reporting System (VAERS).
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