En español | If you're one of the 7 million Americans who received the Johnson & Johnson (J&J) COVID-19 vaccine, you may be wondering how the government's new recommendation to pause its use impacts you. Here are five things you should know.
1. The cases under review are ‘really rare'
The recommendation to pause the use of J&J's single-dose vaccine comes out of “an abundance of caution,” officials from the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) said on Tuesday. So far, six cases of a serious type of blood clot, called cerebral venous sinus thrombosis, which prevents blood from draining out of the brain, have been reported in individuals who had received the shot. These six people — all women between the ages of 18 and 48 — also had low levels of blood platelets (thrombocytopenia).
"This is a really rare event,” Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said in a White House press briefing on the topic. Comparing the number of reported cases with the number of shots administered, it's “less than one in a million,” Fauci added.
It's also important to keep in mind that health experts haven't established a definite link between the vaccine and the blood clots, said William Moss, executive director of the International Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health. “That's obviously what's being investigated,” he added, noting that if a causal relationship is identified, health officials may make adjustments to the vaccine's authorization, perhaps restricting its use for certain populations.
When to See Your Doctor
Seek medical attention if within three weeks of receiving the J&J vaccine you experience:
- Severe headache
- Abdominal pain
- Leg pain
- Shortness of breath
The following symptoms are also of concern:
- New neurologic symptoms
- Tiny red spots on the skin
- New or easy bruising
2. The blood clot's symptoms are different from routine side effects
It's not uncommon to experience mild flu-like symptoms — fever, fatigue, muscle aches and headaches — shortly after receiving any vaccine, including a vaccine for COVID-19. But these symptoms typically fade within 48 hours of receiving the shot. When it comes to the blood clots under review, the symptoms were more severe in nature and popped up six to 13 days after vaccination.
If your J&J shot was more than a month ago, you most likely have nothing to worry about, Fauci said on Tuesday. If it was more recent, pay attention to new or worsening symptoms in the days and weeks that follow your vaccine, but “don't get an anxiety reaction because, remember, it's less than one in a million,” Fauci said.
A severe headache — “probably worse than someone has ever experienced” — is one warning sign for this type of adverse event, Moss said. So is abdominal pain and shortness of breath — these symptoms warrant medical attention. In expanded clinic guidance, the CDC also says health care providers should be on the lookout for leg swelling, backaches, new neurologic symptoms, tiny red spots on the skin, and new or easy bruising.
3. Treatment for this blood clot is different from others
An anticoagulant drug, or blood thinner, called heparin is commonly used to treat blood clots. But when it comes to the clots that are under review, heparin may cause more harm than good. Administering it “would be a mistake in this situation because it could be dangerous and make the situation much worse,” Fauci noted.
Instead, a CDC health alert says non-heparin anticoagulants and high-dose intravenous immune globulin (a solution made from blood plasma that contains antibodies) should be considered in treatment of patients who develop this rare blood clot after having received the J&J vaccine, although treatment should be individualized, the CDC's Principal Deputy Director Anne Schuchat said. Consulting with hematology specialists is also recommended.
"So the pause not only allows us to take a look at the cases and learn more, but it is also a signal out there to help the physicians,” Fauci said.
4. It's unclear if certain people are more at risk
Health experts don't yet know if there are certain risk factors or characteristics that may put vaccinated individuals at greater risk for this severe blood clot, but Fauci said that's something that will be studied.
"If they find some common denominators among the women who were involved that might be synergizing and, essentially, enabling this type of an adverse event, they may know that for those who don't have that, [the vaccine] may be much safer,” he explained. “There may be clues when you go down and really get granular about every single case."
Investigators will also want to study any mechanisms, or processes, at play. One theory: J&J's viral vector vaccine, which is different from Pfizer-BioNTech and Moderna's messenger RNA (mRNA) vaccines, may trigger an immune response in which antibodies affect the blood platelets, Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in an April 13 briefing. To date, there are no reports of blood clots that have been linked to the authorized mRNA vaccines.
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5. Pause indicates the ‘system is working'
While some people may find the pause concerning, Moss said it's an indication “the vaccine safety surveillance system is working."
The CDC encourages all vaccinated individuals to report any side effects through its V-safe app and any adverse reactions to the Vaccine Adverse Event Reporting System (VAERS). Health care providers should also report adverse events.
"Our FDA is internationally known for their capability of making sure that we have the safest products out there,” Fauci said. “You want to make sure that safety is the important issue here.”
Rachel Nania joined AARP as a health and medicine writer in 2019 after spending several years as a radio reporter and editor in Washington, D.C. She is the recipient of a 2018 Gracie Award and a 2019 regional Edward R. Murrow Award, and participated in a 2019 dementia fellowship with the National Press Foundation.