Citing insufficient data, Pfizer today said it will delay applying for Emergency Use Authorization of its COVID vaccine for infants and children 6 months to 4 years old.
Pfizer today said it will 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 efficiency of a third dose.
The U.S. Food and Drug Administration (FDA) in response postponed a meeting that had been scheduled for Feb. 15 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.
The FDA did not say when the Feb. 15 meeting would be rescheduled, and Pfizer did not indicate when it would submit the application.
Keep up the pressure! Tell the FDA ‘Don’t Break Our Hearts’
Despite today’s news that Pfizer is delaying its application, Children’s Health Defense is asking everyone to send a message to the FDA asking the agency to Protect the Kids.
The National Institutes of Health on Feb. 4 urged the public to participate in National Wear Red Day as part of an American Heart Month initiative to spotlight heart disease as the number one killer of Americans.
That same day, the Centers for Disease Control and Prevention’s (CDC) Advisory Committee for Immunization Practices overlooked thousands of reports of myocarditis, heart attacks and other cardiovascular events experienced by people who received COVID vaccines as the panel voted unanimously to recommend Moderna ‘Spikevax’ vaccine for people 18 and older.
These experimental COVID vaccines may pose more risk than benefit to the nearly 20 million American infants and preschool-aged children who will be eligible.
The shots don’t work
Pfizer’s clinical trial data showed that two doses failed to produce a “non-inferiority” immune response in 2- to 4 year-olds. According to partner BioNtech’s press release:
“Compared to the 16- to 25-year-old population in which high efficacy was demonstrated, non-inferiority was met for the 6- to 24-month-old population but not for the 2- to under 5-year-old population in this analysis …The decision to evaluate a third dose of 3 µg for children 6 months to under 5 years of age reflects the companies’ commitment to carefully select the right dose to maximize the risk-benefit profile. If the three-dose study is successful, Pfizer and BioNTech expect to submit data to regulators to support an Emergency Use Authorization (EUA) for children 6 months to under 5 years of age in the first half of 2022.”
In other words, Pfizer and BioNTech are evaluating a third dose because they have not yet found the right dose to maximize the risk-benefit profile for our youngest vaccine recipients.
And they won’t know if three doses will work until after the first two doses are approved. This is concerning. These are our babies.
Pfizer’s December 2021 press release noted the updates to its clinical trial were “informed by the effectiveness data for three doses of the vaccine for people 16 years and older, and the early laboratory data observed with Delta and other variants of concern, including Omicron, which suggest that people vaccinated with three doses of a COVID- 19 vaccine may have a higher degree of protection.”
However, breakthrough infections and hospitalizations have become commonplace among the vaccinated since that time. And we don’t know whether a third dose of this vaccine will increase the likelihood of adverse events.
What we do know is that there is no public health emergency for this age group. Children are at extremely low risk of serious outcomes from COVID.
Multiple studies attribute this to a stronger innate immune response in the upper respiratory tract that prevents viral replication early on. This may explain why children are also far less likely to contribute to disease transmission.
CDC data indicate deaths among children make up a fraction of a percentage of those who have died from COVID.
A study by Johns Hopkins showed a mortality rate of zero among 48,000 children without preexisting conditions and a large COVID study conducted in Germany found the case fatality rate among children is three out of a million, and zero deaths occurred in children under five.
But data about adverse events following Pfizer’s COVID vaccines continues to accumulate.
A Hong Kong study showed 1 out of 2,700 boys got myocarditis after receiving the Comirnaty vaccine. Among male adolescents, the incidence of myocarditis after the second dose was 37.32 per 100,000 people vaccinated.
A study from Kaiser found the same rate of myocarditis in 12- to 17-year-old American boys, 1 out of 2,700. This is alarming.
The Vaccine Adverse Event Reporting System (VAERS) has recorded more than 1,000,000 adverse events following COVID vaccinations: 31,545 of those were in children 17 and under.
Of the more than 23,000 reported deaths, including U.S. and foreign reports, 62 were children under age 17. VAERS also lists 829 cases of myocarditis and pericarditis in children following COVID shots.
With long-term health impacts still unknown and growing evidence of risks of myocarditis, neurological events, thrombosis and other serious side effects, the potential risks to our children likely outweigh any potential benefits.
We must act now!
Pfizer’s pediatric vaccine, if the FDA authorizes it for emergency use, will be available to more than 19 million children under the age of 5, many of whom already have robust natural immunity.
It also will be an important milestone in the pharmaceutical industry’s ultimate goal of getting COVID shots added to the CDC’s recommended childhood vaccine schedule, which means vaccine makers will have permanent immunity from liability for injuries and deaths caused by the vaccines.
If you’re seeing red, you’re not alone.
If the color red and the month of February are about love and heart health, then it’s time we reclaim those values to protect the hearts and health of those we love the most: our children.
What can you do?
Reach out to the regulatory authorities, local health departments, legislative offices and public officials and demand they join the “Don’t Break Our Heart. Protect our Health” campaign to stop the EUA of these experimental pediatric shots.
Here are five ways to remind regulators that red also means STOP:
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! 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 envelope 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 all the decision-makers directly from our Advocacy Portal. Fill out this form to email all the members of the VRBPAC committee and the other public officials listed on this page. Make sure to follow up with phone calls to each person asking if they’ve received your email. Phone numbers can be found at the bottom of this page.
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 likely upcoming meeting. Be sure to use the hashtags #DontBreakOurHearts and #SeeingRed.
4. Organize a Convoy for Kids. 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.
5. Get Social and Share, Share, Share! Over the next few days, you’ll see a series of social media graphics as well as our video from Mary Holland, CHD president and general counsel. Share any content we put out there to combat censorship and help educate others. Be our army of truth and help get this crucial information to the world.
Let’s make Valentine’s Day a “Red Letter Day” for children’s health! You can find a sample letter in CHD’s Protect the Kids Campaign page.