02/22/2022 Update: Pfizer announced on Friday, Feb 11 that it has postponed a request to the FDA to expand use of its two-dose Covid-19 vaccine for children as young as 6-months. Pfizer will instead wait for data on a three-dose series of the injection. As a result, the meeting mentioned below has been postponed as well.
According to an NBC report, “Two people familiar with the FDA’s plans said there had already been a lot of pushback on the agency from outside experts who had concerns that Pfizer’s data wasn’t sufficient. The experts felt, one of the people said, that their concerns were “falling on deaf ears” within the agency.”
Last week Pfizer announced that it began the application process for authorization of its experimental Covid-19 vaccine for children ages six months to four years. The U.S. Food and Drug Administration’s (FDA) vaccine advisory panel will meet to discuss the authorization on February 15 and is now requesting public comment.
According to the FDA’s Notice of Meeting, docket number FDA-2022-N-0082 will close on February 14. “Comments received on or before February 10, 2022, will be provided to the committee. Comments received after February 10, 2022, and by February 14, 2022, will be taken into consideration by FDA.”
The World Council for Health (WCH) urges the public to submit comments prior to February 10. Instructions can be found here. International comments are welcome.
As noted in a previous statement from WCH, these experimental injections put children at an increased risk of myocarditis. There remains no Covid-19 emergency for children and nearly all children are not at risk of severe symptoms if they develop Covid-19 after SARS-CoV-2 infection. Additionally, immunity from infection is longer lasting and more robust than immunity from the injections that weren’t created for current or future variants.
- A study published on December 6, 2021 in the American Heart Association’s journal Circulation, investigated 139 children <21 years old that experienced 140 suspected episodes of myocarditis. The study found that suspected myocarditis occurred in 97.8% of the children following an mRNA injection, 94.2% of the suspected episodes followed the Pfizer-BioNTech injection, and 91.4% of the episodes occurred after the second injection.
- A study from the University of Oxford evaluated the association between Covid-19 vaccine and myocarditis in more than 42 million people aged 13 and older. An increased risk of myocarditis was found 1-28 days following the third dose of the Pfizer-BioNTech injection. The increased risk was seen primarily in males younger than 40.
- A study published in Nature Medicine on December 14, 2021 found a greater risk of myocarditis following Moderna’s Covid-19 injection than from catching the virus itself in those under the age of 40.
- A study from Kaiser Permanente Northwest found a ~1/1860 and ~1/2650 risk of myopericarditis in males age 18-24 and 12-17 respectively following their second dose of the Covid-19 mRNA injection.
In October 2021, FDA vaccine advisory panel member Dr. Ofer Levy told CNBC, “As we go into younger and younger age groups, they’re less and less at personal risk of severe Covid, and on the other hand, somewhat more at risk of this inflammatory heart condition with the mRNA vaccine. So it’s a risk benefit analysis, and that’s why you’re seeing that deliberation.”
Based on a plethora of publicly available data, WCH has called for an immediate end to all experimental Covid-19 injections. Please read the Declaration and take action. WCH supports the use of safe, effective, and affordable treatments for Covid-19, as well as safe and effective vaccines, of which the experimental gene-based injections are not.
The world’s children are the future. Their health and wellbeing must be preserved and prioritized.
We are a people-powered platform for world health representing 170+ coalition partners in more than 46 countries.