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|FDA, CDC Lift Pause On J&J Vaccine by Valentina1987: 9:03am On Apr 30, 2021|
The CDC and FDA announced Friday evening that Johnson & Johnson’s Jassen COVID-19 (J&J) vaccine could be administered again, following a thorough safety review.
The departments recommended a pause on the vaccine’s use on April 13 after six cases of “rare and severe” blood clots were reported in individuals after receiving the J&J vaccine.
According to the CDC, teams at the FDA and CDC examined data to assess the risk of “thrombosis involving the cerebral venous sinuses,” which are large blood vessels in the brain, as well as other sites in the body such as the abdomen and legs. They also looked at thrombocytopenia, or low blood platelet counts.
Since April 13, nine more cases of the adverse event have been reported. All reported cases have occurred in women between the ages of 18 to 59, with symptom onset between 6 and 15 days after vaccination.
The teams reached out to providers and clinicians to make sure of the potential for adverse events and how to manage them with the unique treatments required for blood clots and low platelets, known as thrombosis-thrombocytopenia syndrome (TTS).
The agencies determined that the J&J vaccine should be resumed for administration in the United States, stating their confidence in its safety and efficacy.
“The FDA has determined that the available data show that the vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older,” the CDC said in a press release.
Current data suggest that the chance of TTS occurring is very low, but the CDC and FDA will continue to investigate the risk.
The Virginia Department of Health will follow the CDC’s guidance and instruct providers state-wide that they can resume administering the J&J vaccine. However, they encourage individuals to educate themselves on potential side effects and “to weigh that against the possibility of hospitalization or death from COVID-19.”
Pittsylvania Danville Health District Director Dr. Scott Spillmann said the release of the J&J to be used again could help the area’s vaccine efforts, now that local organizers are spreading their efforts to different points of distribution.
“We will be talking about how and when to use the J&J vaccine soon,” Spillmann said.
He cautions individuals about the potential for the blood clots and urges them to check with their primary care physician if they have concerns about getting the vaccine.
However, he maintains that the risk for adverse reactions is very low, with individuals having a greater chance of winning the lottery.
“[We] have every reason to recommend the vaccine,” Spillmann said. “Any vaccine has conditions that may cause reactions. If a person has a high likelihood of allergy problems or is sensitive to injections, talk with your provider before getting a vaccine.”
Spillmann maintains, like the CDC and the FDA, that the benefits of getting the vaccine outweighs the risk.
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