2023年6月9日金曜日

J&J 米FDAがワクチンの認可取り消し 新型コロナワクチン開発から撤退 Yoshikiなみだ目

J&J's COVID vaccine taken by 19 million Americans is PULLED by FDA after it was paused 'out of an abundance of caution' over rare blood clot concerns - which led to a plummet in demandIt was mired in controversy early on over health and contamination concerns
A brief pause in 2021 after severe blood clots were reported eroded public trust

READ MORE: Over $2Bn taxpayer dollars have been wasted on unused vaccines

By CASSIDY MORRISON SENIOR HEALTH REPORTER FOR DAILYMAIL.COM

UPDATED: 19:13 BST, 8 June 2023

The Food and Drug Administration (FDA) has revoked authorization of Johnson & Johnson’s Covid vaccine after it was paused over rare blood clot concerns, which sent demand plummeting. 

The move was not unexpected because J&J’s parent company Jannsen had requested that federal regulators at the FDA withdraw authorization for its vaccine after it was revealed that the last tranche of doses – about 12.5 million – had expired.

As of year three of the Covid pandemic, nearly 231 million Americans have received either one J&J shot or two doses of an mRNA vaccine from Pfizer or Moderna.

Vaccination fatigue has swept the US, with millions of Americans frustrated by the fact that a shot does not guarantee immunity from the virus but rather protects against severe illness, and all those who had planned on getting fully vaccinated are believed to have done so by now.

With a renewed wave of demand for J&J’s single-dose vaccine highly unlikely, coupled with a beleaguered history of production hiccups and health concerns that severely eroded public trust, the pharmaceutical company has opted to step away from the Covid vaccine field.

Citing ever-shrinking demand, J&J told the FDA it would not update formulations of its shot to confront emerging strains better, a step that Moderna and Pfizer took last year to address the devastating omicron variant.

Dr Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research said: ‘Because FDA understands that… Janssen Biotech, Inc. has requested that FDA withdraw the EUA for the Janssen COVID-19 Vaccine, FDA has determined that it is appropriate to protect the public health or safety to revoke this authorization.’

A fraction of Americans have received J&J’s vaccine compared to the other vaccines approved for use in the US. 

Nearly 367 million Americans have received a Pfizer shot while over 232 million have received a dose of Moderna’s vaccine. A paucity of the total shots administered in the US since early 2021 – just over 19 million – were made by J&J.

Johnson & Johnson’s vaccine was plagued by controversy since it entered the market in February 2021. By that time, more than 2.1 million mRNA shots had already been administered and those from Pfizer and Moderna became the gold standard.

https://www.dailymail.co.uk/health/article-12174791/J-Js-COVID-vaccine-taken-19-MILLION-Americans-pulled-FDA-plummeting-demand.html




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