The Food and Drug Administration (FDA) updated the information sheet for the single-dose Wuhan coronavirus (COVID-19) vaccine from Johnson & Johnson. Its update warned of possible immune thrombocytopenia (ITP), or bleeding due to low blood platelet count.
“Reports of adverse events following the use of the [J&J] COVID-19 vaccine under emergency use authorization suggest an increased risk of ITP during the 42 days following vaccination,” the regulator said in its Jan. 11 update. It also pointed out that there was a “very low” chance of ITP occurring.
The FDA added: “Individuals with a history of ITP should discuss with their healthcare provider the risk of ITP and the potential need for platelet monitoring following vaccination with the [J&J] COVID-19 vaccine.” The vaccine maker meanwhile did not respond to a request for comment sent by the Epoch Times on the matter.
Back in October 2021, the European Medicines Agency (EMA) added information about ITP risk linked to the J&J shot. “Cases of ITP – some with very low platelet levels – have been reported very rarely, usually within the first four weeks after receiving the [J&J] COVID-19 vaccine. [These include] cases with bleeding and cases with a fatal outcome. Some of these occurred in individuals with a history of ITP.”
The European regulator also advised healthcare professionals to monitor platelet counts following injection with the single-dose shot. “If an individual has a history of ITP, the risks of developing low platelet levels should be considered before vaccination, and platelet monitoring is recommended after vaccination.”
Furthermore, the EMA urged individuals to be alert to signs and symptoms of ITP such as spontaneous bleeding, bruising or small spots on the skin. Those found with low blood platelet levels after vaccination with the J&J shot “should be actively investigated for signs of thrombosis” to assess if they suffer from blood clots likewise. (Related: Johnson & Johnson vaccine under investigation over deadly blood clot cases.)
The Belgium-based Janssen, which became a J&J subsidiary in 1961, was responsible for developing the single-dose COVID-19 vaccine. It makes use of a human adenovirus to deliver the SARS-CoV-2 spike protein as compared to the vaccines from Pfizer and Moderna that use mRNA technology.
The FDA approved the Pfizer, Moderna and J&J COVID-19 vaccines for use in the United States. However, only 17.8 million doses of the J&J vaccine have been injected in the country as of Jan. 11. Meanwhile, almost 200 million Moderna doses and more than 300 million Pfizer doses have been administered as of the aforementioned date.
Earlier, the FDA warned of thrombosis with thrombocytopenia syndrome (TTS) – blood clots combined with low blood platelet levels – linked to the single-dose vaccine. Several Americans reported TTS following vaccination with the J&J vaccine, leading health authorities to say that the mRNA vaccines are “preferred” because of fears over the syndrome.
Advisers for the Centers for Disease Control and Prevention (CDC) unanimously voted in December 2021 to recommend the agency reveal this preference to the public. The recommendation by the CDC’s Advisory Committee on Immunization Practices (ACIP) said: “mRNA COVID-19 vaccines are preferred over the [J&J] COVID-19 vaccine for the prevention of COVID-19 for all [Americans] 18 years of age [or younger.]”
The CDC reiterated the ACIP recommendation on its web page about the J&J vaccine. “In most situations, Pfizer or Moderna COVID-19 vaccines are preferred over the J&J COVID-19 vaccine for primary and booster vaccination due to the risk of serious adverse events,” the page said.
The public health agency acknowledged the “plausible casual relationship” between the J&J vaccine and the cases of TTS, adding that “it occurs at a rate of about 3.83 cases per [one] million J&J doses and has resulted in deaths.” It recommended those who developed TTS following their initial J&J dose to get the mRNA vaccines for their booster. (Related: CDC recognizes a handful more blood clot cases linked to Johnson & Johnson coronavirus vaccine.)
Watch the video below featuring a J&J vaccine box containing a blank insert, despite warnings about its risks.
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