FDA Meeting September 17th to Decide on FDA approval for Pfizer Booster Shot - Live link provided | |
Daniel Higdon
(OP) User ID: 69657566 United States 09/17/2021 04:11 AM Report Abusive Post Report Copyright Violation | Re: FDA Meeting September 17th to Decide on FDA approval for Pfizer Booster Shot - Live link provided Link to read public comments (Submission period for comments ended on September 16th) [link to www.regulations.gov (secure)] |
Daniel Higdon
(OP) User ID: 69657566 United States 09/17/2021 04:16 AM Report Abusive Post Report Copyright Violation | Re: FDA Meeting September 17th to Decide on FDA approval for Pfizer Booster Shot - Live link provided FDA shows skepticism on COVID booster shots ahead of key Friday meeting The Food and Drug Administration refused to take a definitive stance on the need for a booster shot of Pfizer’s COVID-19 vaccine ahead of a key meeting Friday — despite the Biden administration publicly backing a third dose. A 23-page FDA briefing document released Wednesday details the evidence its advisory panel will consider Friday to determine whether a booster dose is necessary and when Americans need to get them. [link to nypost.com (secure)] Direct link to the FDA briefing document: [link to www.fda.gov (secure)] |
Jake Warlock User ID: 80848634 United States 09/17/2021 04:16 AM Report Abusive Post Report Copyright Violation | Re: FDA Meeting September 17th to Decide on FDA approval for Pfizer Booster Shot - Live link provided Link to read public comments (Submission period for comments ended on September 16th) Quoting: Daniel Higdon [link to www.regulations.gov (secure)] Comment from Kristen Michener Posted by the Food and Drug Administration on Sep 15, 2021 As a mother of a toddler who is still ineligible to be vaccinated against COVID-19, I urge the FDA reviewers to expedite more access of the COVID-19 vaccine to younger children as soon as possible/safe. Children are now greater targets for the delta virus due to their unvaccinated status. And families, children, parents and extended families, are all sacrificing mental health to keep our children safe. Personally, it has taken an enormous mental health toll on our family to keep my child quarantined away from any unvaccinated individuals and prevented us from doing so many 'normal' things with my child who was born shortly after the pandemic started. I long for the day when I can get my child vaccinated and start to live a normal life without constant fear of him becoming a statistic of one of the children who end up in the hospital/ or with long term side effects from this emerging and unpredictable virus. ----------- WOW... |
Anonymous Coward User ID: 80873108 United States 09/17/2021 04:16 AM Report Abusive Post Report Copyright Violation | |
Anonymous Coward User ID: 79964821 United States 09/17/2021 04:21 AM Report Abusive Post Report Copyright Violation | Re: FDA Meeting September 17th to Decide on FDA approval for Pfizer Booster Shot - Live link provided Vaccines and Related Biological Products Advisory Committee September 17, 2021 Quoting: Daniel Higdon The committee will meet in open session to discuss the Pfizer-BioNTech supplemental Biologics License Application for COMIRNATY for administration of a third dose, or “booster” dose, of the COVID-19 vaccine, in individuals 16 years of age and older. [link to www.fda.gov (secure)] [link to youtu.be (secure)] Of COURSE, they're gonna say we need a booster, too much money in it. It's not about if we need it or not... |
CK Dexter Haven
User ID: 78826108 South Africa 09/17/2021 04:26 AM Report Abusive Post Report Copyright Violation | Re: FDA Meeting September 17th to Decide on FDA approval for Pfizer Booster Shot - Live link provided Tonight the Circle is Meeting Again [link to youtu.be (secure)] Last Edited by CK Dexter Haven on 09/17/2021 04:28 AM |
Daniel Higdon
(OP) User ID: 69657566 United States 09/17/2021 04:40 AM Report Abusive Post Report Copyright Violation | Re: FDA Meeting September 17th to Decide on FDA approval for Pfizer Booster Shot - Live link provided Link to read public comments (Submission period for comments ended on September 16th) Quoting: Daniel Higdon [link to www.regulations.gov (secure)] Comment from Kristen Michener Posted by the Food and Drug Administration on Sep 15, 2021 As a mother of a toddler who is still ineligible to be vaccinated against COVID-19, I urge the FDA reviewers to expedite more access of the COVID-19 vaccine to younger children as soon as possible/safe. Children are now greater targets for the delta virus due to their unvaccinated status. And families, children, parents and extended families, are all sacrificing mental health to keep our children safe. Personally, it has taken an enormous mental health toll on our family to keep my child quarantined away from any unvaccinated individuals and prevented us from doing so many 'normal' things with my child who was born shortly after the pandemic started. I long for the day when I can get my child vaccinated and start to live a normal life without constant fear of him becoming a statistic of one of the children who end up in the hospital/ or with long term side effects from this emerging and unpredictable virus. ----------- WOW... Multiple comments from mothers begging for their young children to get the clot shot. These people have been completely brainwashed. |
Anonymous Coward User ID: 80883082 United States 09/17/2021 04:53 AM Report Abusive Post Report Copyright Violation | Re: FDA Meeting September 17th to Decide on FDA approval for Pfizer Booster Shot - Live link provided Link to read public comments (Submission period for comments ended on September 16th) Quoting: Daniel Higdon [link to www.regulations.gov (secure)] Comment from Kristen Michener Posted by the Food and Drug Administration on Sep 15, 2021 As a mother of a toddler who is still ineligible to be vaccinated against COVID-19, I urge the FDA reviewers to expedite more access of the COVID-19 vaccine to younger children as soon as possible/safe. Children are now greater targets for the delta virus due to their unvaccinated status. And families, children, parents and extended families, are all sacrificing mental health to keep our children safe. Personally, it has taken an enormous mental health toll on our family to keep my child quarantined away from any unvaccinated individuals and prevented us from doing so many 'normal' things with my child who was born shortly after the pandemic started. I long for the day when I can get my child vaccinated and start to live a normal life without constant fear of him becoming a statistic of one of the children who end up in the hospital/ or with long term side effects from this emerging and unpredictable virus. ----------- WOW... Multiple comments from mothers begging for their young children to get the clot shot. These people have been completely brainwashed. Parents have offered their children up for ritual sacrifice and murder for thousands of years. Nothing has changed. |
Daniel Higdon
(OP) User ID: 69657566 United States 09/17/2021 04:55 AM Report Abusive Post Report Copyright Violation | Re: FDA Meeting September 17th to Decide on FDA approval for Pfizer Booster Shot - Live link provided Two leading vaccine regulators who had previously announced their resignations from the Food and Drug Administration have now come out against the Biden administration's plan to offer COVID-19 booster shots. In a viewpoint article published in The Lancet on Monday, Marion Gruber, the outgoing director of the FDA's Office of Vaccines Research and Review (OVRR), and Phil Krause, the outgoing deputy director of the OVRR, argue against the current booster plans. "Currently available evidence does not show the need for widespread use of booster vaccination," the pair, along with colleagues, conclude in the article. Even if there are benefits from boosters, the shots still carry risks, and any benefits "will not outweigh the benefits of providing initial protection to the unvaccinated," they write. Gruber and Krause penned the Lancet article with 16 international colleagues, including several high-ranking experts at the World Health Organization. Krause is listed as the first author of the article and a corresponding author. [link to arstechnica.com (secure)] Direct link to the article published in the Lancet: Considerations in boosting COVID-19 vaccine immune responses [link to www.thelancet.com (secure)] |
Daniel Higdon
(OP) User ID: 73901730 United States 09/17/2021 08:35 AM Report Abusive Post Report Copyright Violation | Re: FDA Meeting September 17th to Decide on FDA approval for Pfizer Booster Shot - Live link provided Vaccines and Related Biological Products Advisory Committee September 17, 2021 Quoting: Daniel Higdon The committee will meet in open session to discuss the Pfizer-BioNTech supplemental Biologics License Application for COMIRNATY for administration of a third dose, or “booster” dose, of the COVID-19 vaccine, in individuals 16 years of age and older. [link to www.fda.gov (secure)] [link to youtu.be (secure)] Meeting has started. |