FDA er ríkisstofnun sem starfar undir heilbrigðis- og mannréttindadeild Sameinuðu þjóðanna (HHS). FDA er fyrst og fremst ábyrgur fyrir stjórnun lyfja og tóbaks, matvæla og dýralyfja og alþjóðlegrar regluvirkni og stefnu.
Þann 17. september sl. ræddu nokkrir eftirlitsaðilar stofnunarinnar um ýmis öryggisatriði sem virðist vanta sem snertir Covid-19 bóluefnin á ZOOM fundi sem var birtur á YouTube rás stofnunarinnar.
Þar er m.a nefnt að aukaverkanir tilraunalyfjanna séu mjög varhugaverðar og í miklu hærra hlutfalli heldur en hafi verið reiknað með.
Sjá myndband hér
Samkvæmt fréttamiðlinum NBC-NEWS þá hafnar ráðgjafahópur FDA flestum Covid “bóluefna örvunuarskömmtum” sbr. “Boost”.
Íslensk yfirvöld, Landlæknir, Lyfjastofnun, RÚV og íslenskir meginstraums fjölmiðlar hafa ekkert fjallað um málið.
Atkvæðagreiðslan um kom til í kjölfar þess að nefndin hafnaði sl. föstudag með yfirgnæfandi hætti að mæla með hinum svo kölluðu örvunarskömmtum eða Boost fyrir almenning, var samkomulagið því gert við málsmetandi aðila frá Pfizer-BioNTech og samþykkti nefndin því aðeins að dreifa skömmtunum til fólks á aldrinum 65 ára eða eldri, auk þeirra einstaklinga sem eru í afgerandi áhættuhópi.
FDA on YouTube: U.S. Food and Drug Administration
Vaccines and Related Biological Products Advisory Committee – 9/17/2021
Join us for a Vaccines and Related Biological Products Advisory Committee meeting to discuss Pfizer-BioNTech’s supplemental Biologics License Application for administration of a third dose, or “booster” dose, of the COVID-19 vaccine, Comirnaty, in individuals 16 years of age and older.
Sjá einnig frétt á NBC-NEWS
A Food and Drug Administration advisory panel overwhelmingly voted Friday against giving Pfizer-BioNTech’s Covid-19 booster shots to most people on Friday, agreeing only to distribute them to people ages 65 and up as well as those at high risk of severe illness.
The unanimous recommendation of boosters for a limited group of Americans was the second vote called by the Vaccine and Related Biological Products Advisory Committee, or VRBPAC, during its meeting Friday.
The committee of outside experts was first asked whether a third shot of Pfizer’s vaccine would be safe and effective for everyone ages 16 and older. Members overwhelmingly voted against that recommendation, citing concerns about the level of evidence showing the boosters are safe for younger people.
“We’re being asked to approve this as a three-dose vaccine for people 16 years of age and older, without any clear evidence if the third dose for a younger person when compared to an elderly person is of value,” said committee member Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.
Such feedback led to further debate among the committee members about specific age groups or populations that may be most appropriate for a third dose of vaccine. The panel subsequently narrowed the recommendation to those over age 65 and anyone at higher risk for severe illness.
People at high-risk of exposure at work, such as health care workers and teachers, will likely also be eligible for a booster dose.
The panel’s recommendation will now go to the FDA, which is not required to follow VRBPAC’s vote, but usually does. The FDA will decide whether to issue an emergency use authorization for the booster doses.
Though three Covid vaccines are in use, Friday’s vote focused on the Pfizer vaccine only, and would only apply to those who originally received the Pfizer shots. It does not apply to people who have received the Moderna or Johnson & Johnson vaccines.
The panel’s ultimate recommendation was a measured response and “appropriate based on the data that was provided,” said Dr. Richard Besser, president of the Robert Wood Johnson Foundation and former acting Centers for Disease Control and Prevention director.
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