New and expanded EUA protects maker of monkeypox vaccine, permits use in high-risk children
The mainstream media has reported about the dwindling supply of Bavarian Nordic's Jynneos
, the vaccine used against monkeypox, as cases continue to mount across the globe.
Because of the supposed shortage, the federal government has decided to give recipients just a 20 percent of the normal dose administered intradermally instead of subcutaneously. Patients may respond to a lower dose of a vaccine given intradermally than when the same vaccine is given at a higher dose subcutaneously.
Meryl Nass, a physician and researcher, pointed out that Jynneos would be susceptible to vaccine injury lawsuits under ordinary circumstances. However, the Food and Drug Administration
(FDA) pulled a fast one yet again that effectively shielded Bavarian Nordic
and the government from liability. The agency did it by issuing a new emergency use authorization (EUA) for "fractional doses" of the vaccine.
"We all know what that means. You can't sue anybody even if the vaccine kills you," she said.
The new EUA also permits Jynneos inoculation to children under 18 years of age if they are deemed high risk
. (Related: UK authorities now trying to target CHILDREN with monkeypox vaccines, even though monkeypox is primarily spread through gay sexual behavior
Prior to issuing the expanded EUA, the FDA confirmed that "numerous" children were granted access to the vaccine on a "case-by-case basis" through a special permit process, despite the vaccine not being authorized for emergency use in that age group.
reported the move to allow monkeypox vaccination in adolescents is based on findings from the vaccine's use in adults and on data on pediatric smallpox vaccination. As per the Centers for Disease Control and Prevention
(CDC), the monkeypox vaccine is approved to be administered subcutaneously into the fatty tissue over the triceps area in the upper arm.
Although the National Institute of Allergy and Infectious Diseases is conducting a dose-sparing study of the Jynneos vaccine using intradermal injection, it could take months to complete, a Politico article
The CDC describes monkeypox as "generally a mild disease," involving little more than rashes, fevers and chills that typically require "no specific treatment."
"Monkeypox is not likely to kill anybody in the United States, with short-lived pain being about the worst that it might do," a public health expert at Johns Hopkins Bloomberg School of Public Health
Jynneos monkeypox vaccine did not go through clinical trials for children
The vaccine manufactured by Bavarian Nordic
and administered in a two-dose regimen has not been tested through clinical trials
According to the CDC, similar vaccines have been tested in children without serious safety concerns.
"Jynneos contains a non-replicating vaccinia virus. While it has not been studied specifically for children or adolescents, the same non-replicating vaccinia virus has been used in studies as part of vaccines against other diseases, including tuberculosis, measles, and Ebola," CDC said in a statement. "These studies included children as young as five months old, and no serious safety concerns were reported."
The CDC is firm in saying that monkeypox is spread primarily through direct, skin-to-skin contact between someone who has the virus and someone who does not, despite most recent studies concluding that the virus is not spreading through simple skin contact but is rather a product of homosexual activity
for the latest monkeypox-related news.
Watch the below video as Dr. Peter McCullough explains the serious issues associated with the Jynneos vaccine
This video is from the The HighWire with Del Bigtree channel on Brighteon.com
More related stories:
SCHLONG COVID: Global study finds that almost every case of monkeypox occurs among a homosexual or bisexual male
Monkeypox is a gay disease spread by seminal fluid, not merely skin contact, study finds
FDA expands monkeypox vaccine eligibility to include "high-risk" children… HUH?
States, counties and big cities declare monkeypox a public health emergency, even though primary spreaders are homosexual males