FDA patvirtino ACAM2000 vakciną nuo Mpox, kilus susirūpinimui dėl saugumo

Nepriklausomos užsienio naujienos... FDA patvirtino ACAM2000 vakciną nuo Mpox, kilus susirūpinimui dėl saugumo

In a controversial move, the FDA recently approved ACAM2000, a vaccine initially designed for smallpox, for use against mpox in individuals deemed at high risk. However, this decision has raised alarm among experts and the public alike, as the vaccine comes with a host of serious potential complications outlined in its medication guide. These complications range from myocarditis and fetal death to the unsettling possibility of vaccine recipients transmitting adverse effects to unvaccinated individuals. As discussions about the vaccine's safety intensify, public health officials are left grappling with the implications of this approval.

Last month the FDA approved ACAM2000, a vaccine for mpox that comes with a list of “serious complications,” including myocarditis, death and fetal death.

There is a warning in the FDA’s medication guide which says people who receive the vaccine may spread it to unvaccinated people, who also risk developing vaccine side effects, including death.

The Defender reports: A vaccine approved in August by the U.S. Food and Drug Administration (FDA) for people deemed to be at “high risk” for mpox infection may cause more harm than good, according to the FDA’s own medication guide for the product.

ACAM2000 — made by Emergent BioSolutions, a company specializing in vaccines for biochemical warfare threats such as anthrax and smallpox — was approved for smallpox in 2007.

However, on Aug. 29, the FDA issued an expanded supplement approval for ACAM2000’s use against mpox.

Since then, social media users have been posting clips of the FDA’s ACAM2000 medication guide, which warns the vaccine may cause “serious complications” in both the vaccinated person and those with whom they come into close contact up to 6 weeks after getting the shot.

ACAM2000 is a vaccine used to prevent smallpox and mpox disease.

Read from the FDA site:https://t.co/ZVxvBqVyXq

This is disaster waiting to happen! pic.twitter.com/0RlFN2pttZ

— Toast on the Side (@toastontheside) September 17, 2024

Karl Jablonowski, Ph.D. — senior research scientist at Children’s Health Defense — told The Defender that the FDA’s approval of the shot is a “public hazard, not the practice of public health.”

“You can call ACAM2000 a ‘vaccine,’ but its impact on the United States will be as a ‘disease,’” Jablonowski said.

He added:

“For instance, the drug’s package insert reveals (see Table 3) that the U.S. Department of Health and Human Services (HHS) found roughly 520 per million ACAM2000 recipients contracted myocarditis or pericarditis.

“That is about 1 in 2,000. If the 262 million adults in the U.S. received this vaccine, an estimated 136,000 would contract the serious adverse reaction of myopericarditis.”

Myopericarditis is an umbrella term for myocarditis, inflammation of the heart, and pericarditis, inflammation of the tissue surrounding the heart.

ACAM2000 can also cause fetal death when taken during pregnancy, the package insert states.

Last month, the FDA's approval of ACAM2000 for mpox has sparked significant debate, particularly given its associated risks, including myocarditis and potential fatalities. Notably, the medication guide highlights that vaccinated individuals may inadvertently spread the vaccine's side effects to unvaccinated people. Experts, such as Dr. Karl Jablonowski, have voiced strong concerns, labeling the vaccine a "public hazard" rather than a protective measure, warning that widespread administration could lead to significant health risks. This has led to a surge of social media discussions, as many share the FDA's warnings and express their apprehensions about the vaccine's safety.