According to an April 22 statement by the Oregon Health Authority (OHA), it received word of the adverse reaction on April 20. Two days earlier, on April 18, the CDC was notified of the incident. The statement noted that the woman received the one-dose vaccine before authorities recommended halting its use temporarily.
The OHA statement elaborated that the 50-year-old woman "developed a rare but serious blood clot … in combination with very low platelets." Both symptoms reportedly occurred "within two weeks following vaccination" with the single-dose adenovirus vector shot. The Beaver State's health department said six others in the U.S. inoculated with the J&J vaccine reported similar blood clots.
Furthermore, the statement said that information about the vaccine-related fatality had been forwarded to the CDC's Vaccine Adverse Event Reporting System. "The case … will add to the evidence of potential risk associated with [the J&J] vaccine," it continued. However, OHA noted that it cannot be concluded "whether [the woman's] death is related to the vaccine" until a probe on the matter is complete. CDC and OHA officials are investigating the death as of writing.
Blood clots in tandem with low platelet counts were reported in 10 individuals who got the J&J vaccine against the Wuhan coronavirus, including the Oregon woman. Five of them developed cerebral venous sinus thrombosis – clots that affect the vessels draining blood from the brain. Meanwhile, one person developed deep vein thrombosis – a blood clot that affects distant vessels such as the ones located in the legs.
The report of the 50-year-old Oregonian's death came a day before the CDC's Advisory Committee on Immunization Practices (ACIP) April 23 meeting. The committee would talk about the J&J vaccine and subsequently issue their recommendations with regard to it. Some ACIP members have said it should come with a warning about younger women possibly developing blood clots. (Related: Johnson & Johnson vaccine under investigation over deadly blood clot cases.)
True enough, the committee members voted to lift the suspension on the J&J vaccine during the six-hour meeting. A report by FOX 5 said that CDC advisers voted 10-4 to resume the use of the vaccine, which the Food and Drug Administration (FDA) authorized for emergency use in late February 2021. The ACIP members argued that "the vaccine's benefits outweigh [the] serious but small risk" of blood clots.
CDC Director Dr. Rochelle Walensky noted that the blood clots caused by the J&J vaccine coming to light meant that vaccine safety systems were functioning properly. She said in a statement: "Above all else, health and safety are at the forefront of our decisions. Our vaccine safety systems are working." Walensky added that the public health agency "identified exceptionally rare events – out of the millions of [J&J vaccine] doses" and will continue to monitor any adverse events.
U.S. Surgeon General Dr. Vivek Murthy also lauded the vaccine safety mechanisms, adding that the suspension of the J&J vaccine reflects how seriously officials are considering the matter. "This is your safety system working for you, what you are seeing right now. A signal came up, the FDA and CDC jumped on it and decided to investigate thoroughly and that's what's happening. That … should increase people's confidence that [authorities] are being told what's going on and that any signals are being investigated," he said.
J&J Chief Scientific Officer Dr. Paul Stoffels said his firm was "grateful to the [ACIP] and its medical experts for the rigorous evaluation" of the single-dose COVID-19 vaccine. "The Committee's recommendation is an essential step toward continuing urgently needed vaccinations … for millions of people in the U.S.," he added.
The J&J executive remarked: "As the global pandemic continues to devastate communities around the world, we believe a single-shot, easily transportable COVID-19 vaccine with demonstrated protection against multiple variants can help protect the health and safety of people everywhere." He also reiterated the pharmaceutical company's willingness to collaborate with health authorities worldwide "to ensure this very rare event can be identified early and treated effectively." (Related: Mass vaccination site in Colorado shut down after people experience adverse reactions from Johnson & Johnson vaccine.)
Visit VaccineDeaths.com to read more reports about adverse reactions linked to the J&J single-dose COVID-19 vaccine.
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