Package insert for the Jynneos monkeypox vaccine says heart problems of “special interest” occur in 1 in 75 vaccine recipients who have not already been vaccinated against smallpox and in 1 in 48 vaccine recipients who have already been vaccinated against smallpox.
QUICK FACTS:
- The U.S. Food and Drug Administration (FDA) announced Wednesday that nearly 800,000 doses of Danish biotech company Bavarian Nordic’s Jynneos vaccine, which is meant to prevent smallpox and monkeypox.
- “Aggressively responding to the monkeypox outbreak is a critical priority for HHS,” said U.S. Department of Health and Human Services Secretary Xavier Becerra. “The expedited inspection and approval by FDA of Bavarian Nordic’s fill-and-finish capabilities means that an additional 786,000 doses of vaccine are now available for use in the U.S.”
- The Jynneos vaccine package insert states that heart problems of “special interest” occur in 1 out of 75 vaccine recipients who have not already been vaccinated against smallpox. Heart disease also occurs in 1 out of 48 vaccine recipients who have already been vaccinated against smallpox.
- “Cardiac AESIs were reported to occur in 1.3% (95/7,093) of JYNNEOS recipients” who were “smallpox vaccine-naïve” (had not received a smallpox vaccine in the past), according to page six of the insert published on the FDA’s website.
- But the risk of heart disease after vaccination nearly doubles for individuals who have received a smallpox vaccine. “Cardiac AESIs were reported to occur in 2.1% (16/766) of JYNNEOS recipients who were smallpox vaccine-experienced,” the vaccine package insert says.
- Bavarian Nordic added “tromethamine,” a drug given to treat heart attacks, to the Jynneos vaccine, according to the insert.
OTHER PROBLEMS ASSOCIATED WITH THE JYNNEOS MONKEYPOX VACCINE:
- The U.S. Centers for Disease Control and Prevention reported how one in four (25%) women who became pregnant after being injected with the Jynneos monkeypox vaccine suffered a “spontaneous abortion.”
- The Jynneos insert also says the vaccine “has not been evaluated” for “impairment of male fertility.”
- The insert also warns the Jynneos vaccine “has not been evaluated for carcinogenic or mutagenic potential,” meaning it is unknown whether the vaccine causes cancer or genetic mutations in humans.
READ THE JYNNEOS PACKAGE INSERT:
BACKGROUND:
- The Jynneos vaccine has never been widely used in response to an outbreak like this, The Associated Press notes.
- There have only so far been 3,591 cases of monkeypox among the United States’ 329 million population.
- More than 99% of monkeypox patients identify as “gay” or similar, according to the U.K. Health Security Agency (UKHSA), meaning the disease disproportionately affects only the gay community.
- Bavarian Nordic, which manufactures the Jynneos monkeypox vaccine, is owned by World Economic Forum-Linked money managers.
