{"id":80293,"date":"2021-08-24T11:19:03","date_gmt":"2021-08-24T15:19:03","guid":{"rendered":"http:\/\/stateofthenation.co\/?p=80293"},"modified":"2021-08-24T11:22:47","modified_gmt":"2021-08-24T15:22:47","slug":"this-proves-the-fda-is-nothing-but-a-marketing-arm-and-muscle-for-big-pharma","status":"publish","type":"post","link":"http:\/\/stateofthenation.co\/?p=80293","title":{"rendered":"This proves the FDA is nothing but a marketing arm and muscle for Big Pharma<\/i>"},"content":{"rendered":"

FDA Grants Full Approval of Pfizer Vaccine, Critics Blast Agency for Lack of Data, Scientific Debate<\/h1>\n

<\/p>\n

Critics said it was concerning that full approval was based on only six months\u2019 worth of data \u2014 despite clinical trials designed for two years \u2014 and that there was no public discussion of the data.<\/em><\/h3>\n

By Megan Redshaw
\nThe Defender<\/p>\n

\"\"<\/p>\n

The U.S. Food and Drug Administration (FDA) today granted full approval<\/a> to the Pfizer\/BioNTech COVID vaccine for people 16 years and older \u2014 without allowing public discussion<\/a> or holding a formal advisory committee meeting to discuss data.<\/p>\n

This is the first COVID vaccine<\/a> approved by the FDA, and is expected to open the door to more vaccine mandates<\/a> by employers and universities.<\/p>\n

\u201cFor businesses and universities that have been thinking about putting vaccine requirements in place in order to create safer spaces for people to work and learn, I think this move from the FDA, when it comes, will actually help them to move forward with those kinds of plans,\u201d U.S. Surgeon General Dr. Vivek Murthy<\/a> on Sunday told CNN\u2019s<\/a> Brianna Keilar.<\/p>\n

\u201cThe FDA\u2019s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,\u201d said Dr. Janet Woodcock, acting FDA commissioner in a press release<\/a> issued Monday.<\/p>\n

\u201cWhile this and other vaccines have met the FDA\u2019s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident this vaccine meets the high standards for safety, effectiveness and manufacturing quality the FDA requires of an approved product.\u201d<\/p>\n

Woodcock said she believes FDA approval will instill additional confidence in people to get vaccinated.<\/p>\n

ORDER TODAY:<\/span> Robert F. Kennedy, Jr.’s New Book \u2014 ‘The Real Anthony Fauci’<\/a><\/span><\/div>\n

According to The Washington Post<\/a>, Pfizer\u2019s vaccine approval was the fastest in the agency\u2019s history, coming less than four months after Pfizer\/BioNTech<\/a> filed for licensing on May 7.<\/p>\n

\u201cIt\u2019s been remarkably fast,\u201d said Holly Fernandez Lynch, a bioethics expert and lawyer at the University of Pennsylvania, who said careful handling of the approval was crucial to potentially persuading the \u201cvaccine hesitant<\/a>\u201d to receive the licensed product.<\/p>\n

The approval of Pfizer\u2019s COVID vaccine was based on its clinical trial of 44,000 people \u2014 half of whom got the shots, the company said. The median six-month follow-up period for safety and efficacy began after participants received their second dose, Pfizer said.<\/p>\n

\u201cBased on the longer-term follow-up data we submitted, today\u2019s approval for those aged 16 and over affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed,\u201d Pfizer CEO Albert Bourla said in a statement<\/a>. \u201cI am hopeful this approval will help increase confidence in our vaccine.\u201d<\/p>\n

The company plans to follow the 44,000 enrollees for a total of 24 months, from the start of the trial. In order to qualify for FDA Emergency Use Authorization<\/a> (EUA) last December, Pfizer followed trial participants for a median of only two months after participants received their second dose.<\/p>\n

Pfizer\u2019s COVID vaccine received EUA<\/a> on Dec. 11, 2020, for use in individuals 16 years and older. On May 10, the authorization was expanded to include 12- through 15-year-olds.<\/p>\n

According to the FDA<\/a>, EUAs can be used by the agency during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing or treating a disease, provided the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose or treat the disease, outweigh the known and potential risks of the product.<\/p>\n

Pfizer\u2019s vaccine will remain under EUA for 12- through 15-year-olds, and for a third dose in certain immunocompromised individuals.<\/p>\n

However, full approval gives doctors flexibility<\/a> in using vaccinations for \u201coff-label use<\/a>,\u201d which is not permitted for EUA products. This would allow doctors to give patients booster shots<\/a> before the FDA clears them.<\/p>\n

Data released Friday by the Centers for Disease Control and Prevention (CDC) showed that between Dec. 14, 2020 and Aug. 13, 2021, a total of 326,535 adverse events<\/a> had been reported to the Vaccine Adverse Events Reporting System<\/a> (VAERS) attributed to Pfizer\u2019s COVID vaccine<\/a>, including 9,027 deaths<\/a> and 56,607 serious injuries<\/a>.<\/p>\n

Critics accuse FDA of \u2018unprecedented, naked power grab\u2019<\/strong><\/p>\n

According to an article<\/a> published Aug. 20 in the BMJ, transparency advocates have criticized the FDA decision not to hold a formal advisory committee meeting to discuss Pfizer\u2019s application for full approval \u2014 an important mechanism used to scrutinize data.<\/p>\n

Last year the FDA said it was \u201ccommitted to use an advisory committee<\/a> composed of independent experts to ensure deliberations about authorisation or licensure are transparent for the public.\u201d<\/p>\n

But in a statement to The BMJ, the FDA said it did not believe a meeting was necessary ahead of the expected full FDA approval.<\/p>\n

An FDA spokesperson said the agency held numerous meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) related to COVID vaccines in 2020, and did not believe a meeting was needed related to this biologics license application for Pfizer.<\/p>\n

According to the BMJ, companies typically apply for full approval after a longer period has elapsed so that more data are available for review.<\/p>\n

Kim Witczak, a drug safety advocate who serves as a consumer representative on the FDA\u2019s Psychopharmacologic Drugs Advisory Committee, said the decision removed an important mechanism for scrutinizing the data.<\/p>\n

\u201cThese public meetings are imperative in building trust and confidence especially when the vaccines came to market at lightning speed <\/a>under emergency use authorization,\u201d said Witczak. Wticzak was one of 27 experts who launched a citizen\u2019s petition<\/a> demanding the FDA \u201cslow down and get the science right\u201d before approving COVID vaccines.<\/p>\n

\u201cThe public deserves a transparent process<\/a>, especially as the call for boosters and mandates are rapidly increasing,\u201d Wticzak said. \u201cThese meetings offer a platform where questions can be raised, problems tackled and data scrutinised in advance of an approval.\u201d<\/p>\n

Witczak said it\u2019s concerning that full approval is based on only six months\u2019 worth of data \u2014 despite clinical trials designed for two years \u2014 and there\u2019s no control group after Pfizer offered the product to placebo participants before the trials were completed.<\/p>\n

\u201cThey know they can\u2019t win this argument on the science and that\u2019s why they had to abolish the public process and independent oversight,\u201d said Children\u2019s Health Defense<\/a> Chairman Robert F. Kennedy Jr. \u201cThey believe themselves so powerful now that they are stripping off all pretenses that this is about public health, and are baldly revealing the corruption.\u201d<\/p>\n

Kennedy told The Defender<\/a>:<\/p>\n

\u201cThis is a sinister scheme for mandating a badly flawed vaccine<\/a>that has already made history with record deaths and injuries<\/a>, that neither prevents disease nor transmission, and does not improve mortality. Pfizer\u2019s most recent six-month data show<\/a>that while the jab prevents some COVID deaths, it causes more heart attacks yielding a net loss of life.\u201d<\/p>\n

Diana Zuckerman, president of the National Center for Health Research<\/a>, told The BMJ<\/a> it\u2019s obvious the FDA has no intention of hearing anyone else\u2019s opinion, and says making decisions behind closed doors can feed vaccine hesitancy.<\/p>\n

\u201cIt\u2019s important to have a public discussion about what kind of data are there, and what the limitations are,\u201d Zuckerman said. \u201cAs we think about risk versus benefit, we need to know.\u201dJoshua Sharfstein<\/a>, vice dean for public health practice and community engagement at the Johns Hopkins Bloomberg School of Public Health and former FDA deputy commissioner during the Obama administration, said advisory committee meetings are more than just a way of receiving scientific input from outside experts.<\/p>\n

\u201cIt\u2019s also an opportunity to educate the public about the important work that the FDA has done reviewing an enormous amount of data about a product,\u201d Sharfstein told The BMJ<\/a>. \u201cIt\u2019s a chance for questions to be asked and answered, building public confidence.\u201d<\/p>\n

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FDA Grants Full Approval of Pfizer Vaccine, Critics Blast Agency for Lack of Data, Scientific Debate<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-80293","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"http:\/\/stateofthenation.co\/index.php?rest_route=\/wp\/v2\/posts\/80293","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/stateofthenation.co\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/stateofthenation.co\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/stateofthenation.co\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/stateofthenation.co\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=80293"}],"version-history":[{"count":0,"href":"http:\/\/stateofthenation.co\/index.php?rest_route=\/wp\/v2\/posts\/80293\/revisions"}],"wp:attachment":[{"href":"http:\/\/stateofthenation.co\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=80293"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/stateofthenation.co\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=80293"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/stateofthenation.co\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=80293"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}