FDA Postpones Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age
Note: Children's Health Defense has a primer on the FDA advisory committee meeting, which was supposed to take place yesterday. Protect the Kids: Demand the FDA Vote No on EUA for 6 month olds up to 5 years!
Also yesterday, CDC published Effectiveness of Maternal Vaccination with mRNA COVID-19 Vaccine During Pregnancy Against COVID-19–Associated Hospitalization in Infants Aged <6 Months — 17 States, July 2021–January 2022.
CDC said the following: Completion of a 2-dose mRNA COVID-19 vaccination series during pregnancy might help prevent COVID-19 hospitalization among infants aged <6 months.
The Reuters headline? COVID vaccination during pregnancy helps protect babies after birth -U.S. study
The push to vaccinate while pregnant is well underway. Mom receives the full adult dose while pregnant. The dose for children 12 - 17 is lower than the adult dose, and the pediatric dose is said to be lower still. So how do we possibly know that the fetus can safely participate in Mom's vaccination?
February 15, 2022
Source: US FDA Press Release
Coronavirus (COVID-19) Update: FDA Postpones Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age
The following is attributed to Acting FDA Commissioner Janet Woodcock, M.D., and Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research
The U.S. Food and Drug Administration has been notified by Pfizer that new data have recently emerged regarding its emergency use authorization request for the use of the Pfizer-BioNTech COVID-19 Vaccine in children 6 months through 4 years of age. As part of its rolling submission, the company recently notified the agency of additional findings from its ongoing clinical trial. Based on the agency’s preliminary assessment, and to allow more time to evaluate additional data, we believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization.
Therefore, the FDA is postponing the Vaccines and Related Biological Products Advisory Committee meeting originally scheduled for Feb. 15. This will give the agency time to consider the additional data, allowing for a transparent public discussion as part of our usual scientific and regulatory processes for COVID-19 vaccines. We will provide an update on timing for the advisory committee meeting once we receive additional data on a third dose in this age group from the company’s ongoing clinical trial and have an opportunity to complete an updated evaluation.
Since the early days of the pandemic, we have always followed the science in this ever-changing situation. Given the recent omicron surge and the notable increase in hospitalizations in the youngest children to their highest levels during the pandemic so far, we felt it was our responsibility as a public health agency to act with urgency and consider all available options, including requesting that the company provide us with initial data on two doses from its ongoing study. The goal was to understand if two doses would provide sufficient protection to move forward with authorizing the use of the vaccine in this age group. Our approach has always been to conduct a regulatory review that’s responsive to the urgent public health needs created by the pandemic, while adhering to our rigorous standards for safety and effectiveness. Being able to begin evaluating initial data has been useful in our review of these vaccines, but at this time, we believe additional information regarding the ongoing evaluation of a third dose should be considered.
The agency will ensure the data support effectiveness and safety before authorizing a COVID-19 vaccine for use in our youngest children. In the meantime, the best way to protect children, including when they are at school or daycare, is to practice social distancing and masking in accordance with public health recommendations, and for their family members and caregivers to get vaccinated or receive a booster dose when eligible.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Very interesting statistics.....
https://sonsoflibertymedia.com/more-government-documents-prove-covid-shots-are-causing-aids/
Posted by: Emmaphiladelphia | February 20, 2022 at 01:54 PM
They are coming for the adults too....
"Hidden camera: FDA exec says Biden will impose annual COVID shots on Americans
Not formally announced because 'they don't want to rile everybody up'"
https://www.wnd.com/2022/02/hidden-camera-fda-executive-discloses-biden-will-require-annual-covid-shots/
Posted by: Emmaphiladelphia | February 18, 2022 at 09:01 PM
CDC is currently changing milestones for children. That’s part of delay in approval, surely!!!
Posted by: Patrick | February 18, 2022 at 12:20 PM
How are they able to place Paul Offit back on this committee??? Unbelievable!!
Posted by: Patrick | February 18, 2022 at 10:25 AM
Today Mercola has a video that is in German.
You can get it to translate into English if you fiddle with the settings. I did, but sometimes the written word is just so much better.
So here is his article in a glance:
* The German Club of Clear Words takes a deep dive into the network of individuals and organizations responsible for the COVID scam
* Whether blatantly visible or not, you can identify just about any network by connecting dots between individuals and organizations. Who’s working with whom, where, and why? Who’s paying whom? And once you’ve done that, you can more clearly identify the motivations behind various decisions
*The Bill & Melinda Gates Foundation appears to be near the top, or the center, of this COVID plandemic network. Gates is also a major funder of mainstream media, and his network extends into global food and climate change policy
*The Gates Foundation, through its funding of the WEF, also plays an important role in The Great Reset, which was officially unveiled during a WEF summit in May 2020
*Every conceivable aspect of life and society is scheduled to be “reset” according to their plan. Ultimately, that’s where this criminal COVID enterprise is trying to take us
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According to the anonymous IT specialist who created the document, the core of this “COVID criminal network,” around whom most everything revolves, is no larger than 20 or 30 people. Several of them appear on page 36.
Hermann Gröhe, Christian Democration Union (CDU) member and former Minister of Health
Ralph Brinkhaus, Parliamentary leader of the CDU
Dr. Angela Merkel, former Chancellor of Germany and a CDU member
Ilona Kickbush, Ph.D., Graduate Institute of International and Development Studies, Geneva
Tedros Adhanom Ghebreyesus, Director-General of the WHO
Dr. Christian Drosten, a German virologist who in early 2020 created the COVID PCR test
Dr. Clarissa Prazeres da Costa, microbiologist and infectious disease specialist
Joe Cerrell, managing director for Europe, the Middle East and East Asia for The Gates Foundation
Professor Jeremy Farrar, director of the Wellcome Trust
Dr. Georg Kippels, CDU member
Jens Spahn, CDU member and a former Minister of Health
_____________________________________________
money flows in through, such as grants, donations and other payments. As one example, as shown on page 3 of the document, at least 21 U.S. universities are financed by and through just three key organizations:
The Bill & Melinda Gates Foundation
The Open Philanthropy project, a research and grantmaking foundation, which is linked to the WEF
The Wellcome Trust, the world’s second-largest health foundation, located in the UK
_____________________________________________
My take on it is that once upon a time Bill Gates was in big trouble and in front of Congress and got all confused about the definition for the word: Concerned.
Congress - the law - the courts; pushed him out of Apple, or was it Microsoft , and let him keep his money and continue to thrive, feed on other things. The lesson will be going forward for human society that: IF WE ESCAPE THIS; that people like Gates that displays to us they have the mentality of a high rolling criminal; then society had better never let them thrive again.
Posted by: Benedetta | February 17, 2022 at 01:41 PM
"It highlighted that MMR and HPV vaccine uptake has plummeted during the pandemic, believed to be due to the emphasis placed on the Covid jab rollout."
This is a natural experiment. What is the autism/SIDS/ rate for 2020 born children as compared to children born prior?
Was there a huge outbreak of measles and mumps and rubella in this age group?
Naming names......
"The second invoice dated July 6, 2021 was for 14 male beagle puppies. Their names are/were Bon Jovi, Ozzy, Lynyrd, Garth, George, Vince, Travis, Bach, Beethoven, Mozart, Eminem, Jay-Z, Ice Cube, and Snoop Dogg. "
https://www.breitbart.com/entertainment/2022/02/16/report-beagles-killed-in-nih-funded-experiment-named-after-celebrities-tv-characters/
Posted by: Emmaphiladelphia | February 16, 2022 at 10:05 PM
Its a slam dunk! win in the UK win win win for pharma profits and a loose loose loose for the innocents health.
England will start offering Covid jabs to ALL over-5s: Vaccines will be rolled out on a 'non-urgent' basis because their Covid risk is so low and should not be prioritised over MMR or HPV shots
Advisers say jabs will protect 'very small number of children from serious illness'
They stressed that jabs are not urgent for age group and should not be priority
Move comes after Scotland and Wales both announced expansion of rollouts
Healthy children aged five to 11 in England will be offered two Covid jabs on a 'non-urgent' basis, it was announced today.
No10's vaccine advisers have said that the jabs will protect a 'very small number of children from serious illness and hospitalisation'.
Officials stressed that the offer is not urgent because Covid poses such a tiny risk to children. Experts estimate as few as 0.001 per cent of youngsters who get infected will die, with the risk even lower for the healthy.
The Joint Committee on Vaccination and Immunisation (JCVI) has warned the jabs — which will safeguard youngsters against future waves — shouldn't be prioritised over other childhood vaccinations in this age group.
It highlighted that MMR and HPV vaccine uptake has plummeted during the pandemic, believed to be due to the emphasis placed on the Covid jab rollout.
https://www.dailymail.co.uk/news/article-10519777/England-offer-Covid-jabs-5s-Vaccines-rolled-non-urgent-basis.html
Pharma For Prison
MMR RIP
Posted by: Angus Files | February 16, 2022 at 02:14 PM
Elaine Dow -- at lass I think it is getting in that third dose and making more money.
These guys got drunk on the money for every shot that these vaccines bring in.
Posted by: Benedetta | February 16, 2022 at 01:03 PM
My Spidey Senses are making me wonder if waiting for Pharma friendly Robert Calliff to get appointed played a roll. I’m guessing Pfizer will now sail through the approval process.
https://www.statnews.com/2022/02/15/senate-narrowly-confirms-robert-califf-to-lead-the-fda/
Posted by: annie | February 16, 2022 at 11:28 AM
I cannot believe that they postponed their application for the vaccine for young children, without a good reason. We never know who they tested them out on and what happened, did the children have an increase in serious adverse effects? This just smells bad to me. They are not interested in public health, they are interested in promoting vaccines. With the reports of miscarriage to Vaers , I cannot believe they are pushing them for pregnant women.
Posted by: elaine dow | February 16, 2022 at 09:40 AM