Coronavirus (COVID-19) Update: FDA Authorises Moderna and Pfizer-BioNTech COVID-19 Vaccines For 6-Month-old Babies

Written by on December 20, 2022

Today, the U.S. Food and Drug Administration authorized emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include use in children down to 6 months of age.

  • For the Moderna COVID-19 Vaccine, the FDA amended the emergency use authorization (EUA) to include use of the vaccine in individuals 6 months through 17 years of age. The vaccine had been authorized for use in adults 18 years of age and older.
  • For the Pfizer-BioNTech COVID-19 Vaccine, the FDA amended the EUA to include use of the vaccine in individuals 6 months through 4 years of age. The vaccine had been authorized for use in individuals 5 years of age and older.

Key points:

  • The FDA’s evaluation and analysis of the safety, effectiveness and manufacturing data of these vaccines was rigorous and comprehensive, supporting the EUAs.
  • The agency determined that the known and potential benefits of the Moderna and Pfizer-BioNTech COVID-19 vaccines outweigh the known and potential risks in the pediatric populations authorized for use for each vaccine.
  • Prior to making the decision to authorize these vaccines for the respective pediatric populations, the FDA’s independent Vaccines and Related Biological Products Advisory Committee was consulted and voted in support of the authorizations.

The approval comes dispite data proving vaccinated children are 30,200%/ 303x more likely to die than unvaccinated children.

 

The U.S. Food & Drug Administration (FDA) has questionably authorised emergency use of both the Pfizer and Moderna mRNA Covid-19 injections for use among children aged 6 months and above despite data from the UK’s Office for National Statistics revealing that children are 82 to 303x more likely to die following Covid-19 vaccination than children who have not had the Covid-19 vaccine.

 

On June 17th 2022, the U.S. Food and Drug Administration (FDA) criminally extended the emergency use authorisation of the mRNA Covid-19 injections for use in children as young as 6 months.
There has never been an emergency in regard to Covid-19 infection among children. Two years of evidence show the alleged disease has only adversely affected the elderly and vulnerable. Children have been unlucky to suffer symptoms more severe than those associated with the common cold.
But despite this fact, the FDA has decided it is perfectly safe to administer an experimental injection to babies and toddlers, with FDA Commissioner Robert Califf saying –
“Many parents, caregivers and clinicians have been waiting for a vaccine for younger children and this action will help protect those down to 6 months of age.  As we have seen with older age groups, we expect that the vaccines for younger children will provide protection from the most severe outcomes of COVID-19, such as hospitalization and death,” said FDA Commissioner Robert M. Califf, M.D. “Those trusted with the care of children can have confidence in the safety and effectiveness of these COVID-19 vaccines and can be assured that the agency was thorough in its evaluation of the data.” 
On 16th May 2022, the Office for National Statistics (ONS) published a dataset containing details on ‘deaths by vaccination status in England’ between 1st Jan 2021 and 31st March 2022.
The dataset contains various tables showing details such as, ‘Monthly age-standardised mortality rates by vaccination status for deaths involving COVID-19’, and ‘Monthly age-standardised mortality rates by vaccination status for non-COVID-19 deaths’.

FDA Safety Data

Risks of Myocarditis and Pericarditis

The FDA and CDC safety surveillance systems have previously identified increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of tissue surrounding the heart) following vaccination with the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine, particularly following the second dose. The observed risk is highest in males 18 through 24 years of age for the Moderna COVID-19 Vaccine and in males 12 through 17 years of age for the Pfizer-BioNTech COVID-19 Vaccine.

The FDA and the CDC analyses of available safety surveillance data from the U.S. and other countries on myocarditis outcomes continue to strengthen the evidence that most cases of myocarditis associated with the Moderna and Pfizer-BioNTech COVID-19 vaccines are characterized by rapid resolution of symptoms following conservative management, with no impact on quality of life reported by most patients who were contacted for follow-up at 90 days or more after reporting myocarditis. The risks of myocarditis and pericarditis are described in the fact sheets for each of these vaccines.

Ongoing Safety Monitoring

As part of their original EUA requests, both ModernaTX Inc. and Pfizer Inc. submitted plans to continue to monitor the safety of the vaccines as they are used under EUA. These plans for monitoring the overall safety of the vaccines and ensuring that any safety concerns are identified and evaluated in a timely manner, and which include monitoring for myocarditis and pericarditis, have been updated to include the newly authorized populations. In addition, longer-term safety follow-up is ongoing for participants enrolled in the clinical trials for both vaccines. Furthermore, the FDA and the CDC have several systems in place to continually monitor COVID-19 vaccine safety and allow for the timely detection and investigation of potential safety concerns.

It is mandatory for both ModernaTX Inc. and Pfizer Inc., as well as vaccination providers, to report the following to the Vaccine Adverse Event Reporting System (VAERS) for these two COVID-19 vaccines: serious adverse events, cases of Multisystem Inflammatory Syndrome and cases of COVID-19 that result in hospitalization or death. It is also mandatory for vaccination providers to report all vaccine administration errors to VAERS for which they become aware and for vaccine manufacturers to include a summary and analysis of all identified vaccine administration errors in monthly safety reports submitted to the FDA.

The EUA amendment for the Moderna COVID-19 Vaccine was issued to ModernaTX Inc. and the EUA amendment for the Pfizer-BioNTech COVID-19 Vaccine was issued to Pfizer Inc.

LINK TO FDA : https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-and-pfizer-biontech-covid-19-vaccines-children

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