{"id":171716,"date":"2020-11-02T12:00:48","date_gmt":"2020-11-02T12:00:48","guid":{"rendered":"https:\/\/www.transcend.org\/tms\/?p=171716"},"modified":"2021-02-19T09:20:40","modified_gmt":"2021-02-19T09:20:40","slug":"liability-free-covid-vaccine-makers-seek-additional-free-pass-from-fda","status":"publish","type":"post","link":"https:\/\/www.transcend.org\/tms\/2020\/11\/liability-free-covid-vaccine-makers-seek-additional-free-pass-from-fda\/","title":{"rendered":"Liability-Free COVID Vaccine Makers Seek Additional \u2018Free Pass\u2019 from FDA"},"content":{"rendered":"
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The FDA\u2019s \u201cEmergency Use Authorization\u201d allows drugmakers to skip inspections designed to ensure the safety of their manufacturing plants and operations.<\/em><\/p>\n<\/blockquote>\n

\"\"<\/a><\/p>\n

29 Oct 2020 – <\/em>The winner of the race for approval of the first COVID-19<\/a> vaccine will get a bonus prize \u2014 the ability to pull the switch on vaccine production without having to undergo the standard mandatory safety and compliance inspection of its manufacturing facilities.<\/p>\n

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Current regulations require that before pharmaceutical companies<\/a> can take their products to market, their manufacturing plants must pass a compliance inspection by the U.S. Food and Drug Administration (FDA).<\/p>\n

The only way a company can bypass the inspection is if the FDA approves the company\u2019s drug for \u201cemergency\u201d use. The FDA\u2019s Emergency Use Authorization<\/a> is limited to situations \u201cwhen there are no adequate, approved and available alternatives.\u201d<\/p>\n

That\u2019s why drugmakers in the running to produce a COVID-19 vaccine or therapeutic are also racing to be the first to get FDA Emergency Use Authorization<\/a> \u2014 not just because it would allow them to skip the mandatory plant inspections, but also because once the FDA grants the authorization for one vaccine or one therapeutic, no other company can get it.<\/p>\n

On Tuesday, Associated Press reported <\/a>that Pfizer plans to seek emergency use authorization in November, Albert Bourla reportedly told investors he doesn\u2019t know whether Pfizer will be the first company to get that authorization.<\/p>\n

Once a drugmaker gets emergency use authorization for a drug or vaccine, the FDA waives the mandatory manufacturing plant inspection, leaving the drugmaker solely responsible for certifying the safety of the manufacturing process.<\/p>\n

Eli Lilly<\/a>, which has been working on a COVID therapeutic drug, recently had a run-in with the FDA over problems with one of its manufacturing plants. Reuters reported<\/a> earlier this month that the FDA had cited \u201cserious quality control problems\u201d at an Eli Lilly plant working on an antibody therapy.<\/p>\n

A former associate counsel at the FDA told Reuters the violations were \u201cserious enough and have a significant enough impact on the public health that something needs to be fixed.\u201d If Eli Lilly wins approval of its COVID antibody drug, the company plans to partner with the Gates Foundation<\/a> to send the drugs to low-and middle-income countries.<\/p>\n

So far, no vaccine maker is yet ready to start production of a COVID vaccine, and several that are working on developing vaccines have encountered problems with their clinical trials.<\/p>\n

For example, AstraZeneca\u2019s<\/a> trials were halted after a trial participant developed a neurological disorder consistent with that of transverse myelitis. Transverse myelitis often results in weakness of the limbs, problems emptying the bladder and paralysis. Patients can become severely disabled and there is currently no effective cure<\/a>.<\/p>\n

And in May, as Children\u2019s Health Defense reported<\/a>, Moderna experienced a 20% \u201cserious\u201d injury rate in one of its COVID vaccine trials:<\/p>\n

\u201cThe vaccine, developed and championed by Anthony Fauci<\/a> and financed by Bill Gates<\/a>, used an experimental mRNA technology<\/a> that the two men hoped would allow rapid deployment to meet President Trump\u2019s ambitious \u201cwarp speed\u201d timeline. Dr. Fauci was so confident of his shot\u2019s safety that he waived ferret and primate studies<\/a> (Moderna suspiciously reported no specific health data from its mouse studies). That appears to have been a mistake.\u201d<\/p>\n

Moderna\u2019s COVID vaccine technology has never been approved for use on humans \u2014 and the drugmaker\u2019s manufacturing plant has never been<\/a> inspected by government regulators \u2014 but the company is also in the running for FDA\u2019s emergency approval, according to<\/a> the Associated Press.<\/p>\n

Pharmaceutical companies working on COVID-19 vaccines and therapeutics are protected from liability<\/a> for vaccine injuries under the Public Readiness and Emergency Preparedness Act (PREP Act).<\/p>\n

__________________________________________<\/p>\n

\"\"<\/a><\/em><\/p>\n

 <\/p>\n

Jeremy Loffredo is a reporter for<\/em> The Defender.<\/p>\n

 <\/p>\n

Go to Original – childrenshealthdefense.org<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

29 Oct 2020 – The winner of the race for approval of the first COVID-19 vaccine will get a bonus prize \u2014 the ability to pull the switch on vaccine production without having to undergo the standard mandatory safety and compliance inspection of its manufacturing facilities.<\/p>\n","protected":false},"author":4,"featured_media":171720,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2236],"tags":[887,1829,550,1868,888],"class_list":["post-171716","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-covid19-coronavirus","tag-big-pharma","tag-coronavirus","tag-corruption","tag-covid-19","tag-vaccines"],"_links":{"self":[{"href":"https:\/\/www.transcend.org\/tms\/wp-json\/wp\/v2\/posts\/171716","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.transcend.org\/tms\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.transcend.org\/tms\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.transcend.org\/tms\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.transcend.org\/tms\/wp-json\/wp\/v2\/comments?post=171716"}],"version-history":[{"count":0,"href":"https:\/\/www.transcend.org\/tms\/wp-json\/wp\/v2\/posts\/171716\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.transcend.org\/tms\/wp-json\/wp\/v2\/media\/171720"}],"wp:attachment":[{"href":"https:\/\/www.transcend.org\/tms\/wp-json\/wp\/v2\/media?parent=171716"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.transcend.org\/tms\/wp-json\/wp\/v2\/categories?post=171716"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.transcend.org\/tms\/wp-json\/wp\/v2\/tags?post=171716"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}