The U.S. Food and Drug Administration (FDA) expanded the Emergency Use Authorization (EUA) this week for the JYNNEOS Monkeypox shot to include “high-risk” children under 18, even though there have been no clinical trials on that age group, it is a sexually transmitted disease (STD) among homosexual and bisexual men, and there have been no deaths in the United States. However, there are significant adverse effects from the Moneypox shot.
Apparently, under the expanded EUA, health care providers can now administer the Bavarian Nordic’s JYNNEOS “vaccine” through an alternative method of injection. This type of intradermal injection (between layers of the skin rather than below the skin) will increase available doses from 441,000 to more than 2.2 million.
The FDA’s decision to authorize a new route of administration for JYNNEOS comes after the Biden administration declared the Monkeypox virus as a public health emergency on August 4, allowing government health agencies to unlock funding and authorize unapproved medical products or uses of approved medical products for the virus. Prior to issuing the expanded EUA, the FDA confirmed that “numerous” children were granted access to the shot on a “case-by-case basis” through a special permission process, even though it was not approved or authorized for emergency use in that age group.
A recent New England Journal of Medicine study, “Monkeypox Virus Infection in Humans across 16 Countries — April–June 2022,” reports “528 infections diagnosed between April 27 and June 24, 2022, at 43 sites in 16 countries. Overall, 98% of the persons with infection were gay or bisexual men, 75% were White, and 41% had human immunodeficiency virus infection; the median age was 38 years. Transmission was suspected to have occurred through sexual activity in 95% of the persons with infection…Monkeypox virus DNA was detected in 29 of the 32 persons in whom seminal fluid was analyzed. Antiviral treatment was given to 5% of the persons overall, and 70 (13%) were hospitalized; the reasons for hospitalization were pain management, mostly for severe anorectal pain (21 persons); soft-tissue superinfection (18); pharyngitis limiting oral intake (5); eye lesions (2); acute kidney injury (2); myocarditis (2); and infection-control purposes (13). No deaths were reported.”
Dr. Robert Malone, a U.S. virologist and immunologist who has dedicated his professional existence to the development of mRNA vaccines, states this isn’t the first time that there has been an “outbreak” of Monkeypox in the United States. During May and June 2003, the first cluster of human Monkeypox cases in the United Stated was reported.
However, JYNNEOS was licensed by the FDA in 2019 for the prevention of smallpox and Monkeypox in high-risk adults 18 and older only. Yet the Monkeypox virus against which the “vaccine” was tested is not in the context of this current virus. A number of clinical trials were done during the approval process for the JYNNEOS injection, but there has not been a randomized clinical challenge trial, which is the gold standard.
Dr. Malone states there is no data on efficacy or effectiveness for the product as pre- or post-exposure prophylactic for the currently circulating Monkeypox virus. However, the JYNNEOS injection reveals between 1.3 percent and 2.1 percent of recipients had a cardiac event of special interest, compared to 0.2 percent of placebo subjects. According to the FDA review document, which is not mentioned on the label, there were 10 percent and 18 percent of subjects with troponin elevations in two sub-studies. This suggests that somewhere between 1 in 90 and 1 in 6 people will have a troponin elevation or EKG abnormality, indicating some degree of cardiac damage due to the shot.
Also found in the FDA review of the documents and studies that led to JYNNEOS 2019 license, but was not included in the label, eight percent of those subjects who were HIV positive could not get their second JYNNEOS dose due to side effects from the first. In addition, seven percent of the HIV positive subjects had worsening of HIV parameters. Apparently, the JYNNEOS shot causes immune suppression.
In addition, the FDA label for the JYNNEOS product states that “safety and effectiveness of JYNNEOS have not been established in individuals less than 18 years of age.”
Liberty Counsel Founder and Chairman Mat Staver said, “The FDA continues to push shots for children that are neither safe nor effective. Even worse, the Monkeypox shot is not necessary for children or the general population as they are not in the risk category of men who have sex with men. Pharmaceutical companies merely see children as a budget item to increase their bottom line. Our precious children should not be their guinea pigs.”
