Breaking: [US] FDA Postpones Meeting on COVID Shots for Kids Under 5 After Pfizer Says Not Enough Data. But Don’t Let Up!

CHD-FDA-postponement
 
 

Dear Friend,

The FDA won’t be meeting tomorrow, but that doesn’t mean we stop the pressure. We need to be stronger than ever! 

If you haven’t yet, please take a few minutes now to take part in our campaign “Protect the Children: Don’t Break our Hearts”.

As of today, thousands of you completed our online action alert, sending almost 400,000 emails and letters to top public health officials and the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) urging them to reject Pfizer’s application for Emergency Use Authorization (EUA) of its COVID vaccine for children 6 months up to children 5 years of age.

We also saw hundreds of your letters in red envelopes as many of you shared them with us and posted with #DontBreakOurHearts and #SeeingRed to social media. Thank you for your passionate pleas to the FDA demanding they vote no! 

On Friday, Pfizer withdrew their application and the meeting was postponed by the FDA. This delay is a gift to the medical freedom movement. If you participated in the campaign last week: please do it again! If you didn’t, there is still time! Let’s show the FDA that we will never stop  advocating on behalf of children!

While this is a temporary win for us, as we gain more time to mount opposition, this isn’t going away. Let’s focus on keeping the pressure on!

 
 

Here’s What Happened

On Friday, Pfizer announced that the drug giant would delay applying for Emergency Use Authorization (EUA) of its COVID vaccine for infants and children 6 months to 4 years old stating there’s not enough data on the efficacy of a third dose.

The FDA then postponed the February 15 meeting that had been scheduled to review Pfizer’s application for the pediatric vaccine. 

Two separate clinical trials of Pfizer-BioNTech’s COVID vaccine for the younger age group are in progress: one involving children between the ages of 6 months to 2 years old, the other involving children between ages 2 and 4. CNBC last month reported two shots did not induce an adequate immune response in children 2 to 4 years old in Pfizer’s clinical trials, leading Dr. Anthony Fauci to predict children in that age group would need a three-dose regimen of the vaccine.

In what the New York Times described as a “highly unusual move,” the FDA urged Pfizer to apply for EUA of the vaccine, even though two doses failed to produce the hoped-for immune response among children 2 to 4 years old and the vaccine maker did not yet have data on the efficacy of a third shot. Pfizer had planned to submit its application to the FDA next week, then provide additional data in the coming weeks on a third dose, NBC reported.

Moving forward with an application without any studies showing safety or efficacy is unprecedented. That’s when CHD launched the campaign “Protect the Children: Don’t Break our Hearts” to stop this approval from happening. In just a few days, we received a huge response from all around the country.

On Thursday of last week, a letter from Children’s Health Defense (CHD), along with Chairman and Chief Legal Counsel Robert F. Kennedy, Jr., was delivered to top public health officials and the FDA VRBPAC members urging them to reject Pfizer’s application for EUA of its COVID vaccine for children 6 months up to 5 years of age. Learn more about this letter from this article in The Defender.

The letter read, in part:

“We are writing to put you on notice that should you recommend this pediatric EUA vaccine to children under five years old, CHD is poised to take legal action against you. 

“CHD will seek to hold you accountable for recklessly endangering this population with a product that has little, no, or even negative net efficacy but which may put them, without warning, at risk of many adverse health consequences, including heart damage, stroke and other thrombotic events and reproductive harms.”

As news of the meeting delay broke midday on Friday, CHD discussed the situation live on Friday’s Q&A Show on CHD.TV and also as covered in an article in The Defender.

Watch episode 18 of our Q&A show to learn more about this breaking news and hear from Dr. Liz Mumper and Dr. Brian Hooker on COVID vaccine risks and what we’re seeing in the medical literature. Mary Holland broke things down from a legal perspective, while Aimee Villella McBride walked viewers through the current campaign “Protect the Children: Don’t Break our Hearts” and how people can participate.

This delay gives everyone time to participate in this campaign. Let’s keep the momentum going!

 

Here are Five Ways to Get Involved

1. Send a letter of opposition, mailed in red envelopes, to the public health officials and VRBPAC members involved in this decision-making process. Cover their desks in a sea of red envelopes over the next few weeks! Use this letter CHD sent to the members of the VRBPAC committee from our advocacy portal or write your own. To encourage people to join in, post a picture of your red envelopes to social media before you mail them with #DontBreakOurHearts and #SeeingRed and let’s get these hashtags trending! Red envelopes are available at many retailers including Staples, Office Depot, Walmart and Amazon. Phone calls and emails also are important.

2. Email your federal legislators directly from our Advocacy Portal. Fill out this form to email your congressional representatives to let them know your concerns about this upcoming FDA meeting. Make sure to follow up with phone calls to each person asking if they’ve received your email. 

3. Get Ready, Get Set … TWEET! Take part in our Twitter storm. Follow the CHD Twitter account and re-tweet our tweets targeting the FDA, public health officials and VRBPAC members to convince them to vote no at the upcoming meeting. Bringing public exposure to this issue is critical and people pay attention to what trends on Twitter. Be sure to use the hashtags #DontBreakOurHearts and #SeeingRed when you retweet. Let’s let these committee members know the world is watching. 

4. Organize a Convoy for Kids and Educate from the Heart. Keep on Truckin’ in your own neighborhood by organizing your own convoy. Decorate your cars with red signs and messages, including the hashtags #DontBreakOurHearts #SeeingRed. Drive to the FDA, Pfizer Headquarters, Washington, DC, your state capital, legislative offices or your Board of Health meetings. Wear red and wave red signs. Deliver handmade “Don’t Break Our Hearts, Protect Our Health” Valentine messages and hand out CHD’s Second Opinion Fact Sheets. Utilize the information in this flyer to educate on the known harms and risks of this vaccine. This handout is carefully cited and referenced so share with confidence knowing the science is on our side.

5. Get Social and Share, Share, Share! Share our video from Mary Holland, CHD president and general counsel, explaining the importance of stopping the EUA for this age group. You’ll also see a series of infographics that explains these same risks posted to our social media accounts over the next few weeks. Share CHD’s content to combat censorship and help educate others. Be our army of truth and help get this crucial information to the world!

Help us continue to sound the alarm. The science is clear. We know if the FDA grants this EUA for the younger age group, it will be putting our very youngest children and babies at risk. The meeting is not canceled, it’s only postponed. Let’s do everything we can to stop this approval from happening. 

Be a defender of truth, freedom and health!

Thank you,

The Children’s Health Defense Team

 

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Our mission is to end the childhood health epidemics by working aggressively to eliminate harmful exposures, hold those responsible accountable, and establish safeguards so this never happens again.
 

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