The White House has announced its plans to prepare for the vaccination of 28 million children. The plan is to go into effect as soon as the FDA and CDC give their approvals and recommendations.
Just two weeks ago, Pfizer submitted data and requested EUA approval for its COVID-19 vaccine for children ages 5-11. The vaccine is one-third as potent as the adult version for ages 12 and over and follows the same 2-dose regimen three weeks apart. This formula was created for the initial variant of the SARS-CoV-2 virus.
Amidst the confusing endorsement of boosters before approvals and recommendations were granted, the White House indicated this was just preparation. Their goal is to have the vaccines in over 25,000 pediatrician’s offices and other public clinics within a week of approval. FEMA will assist in instituting school and community-based clinics that will be funded and supported.1
Near the end of July, the FDA called for both Pfizer and Moderna to expand their studies to include 3,000 children each. The data that is reported on reflects 2,268 participants. At the time of publishing, the results of the remaining 732 children have not been found. If the study did immediately enroll more children at that time, those children wouldn’t have been considered fully vaccinated until just two to three weeks before data was submitted for review.
The study for efficacy did not reflect actual cases of COVID that was reduced by vaccination as there weren’t enough cases in either the control or test group to consider. Instead, a “bridging” study was done. The researchers relied on blood serum tests to indicate the antibody levels found in older cohorts and determined that since they were similar, the shot had been effective. Some question the difference between a child’s immune system and an adult’s; children are not mini-adults. Can these tests be sufficient in determining safety and efficacy?
Next Steps to Consider Before White House Plan
The FDA’s VRBAC committee is scheduled to meet October 26 to discuss its approval. The website is open to submit a public comment for the committee’s consideration. Once the FDA gives its stamp of approval, the CDC’s ACIP committee will determine its recommendations as to how and when the vaccines are used. The CDC is scheduled to meet November 2-3.
The Biden administration is wasting no time and, it appears, anticipating EUA approval and CDC recommendations:
Within hours of formal approval, which is expected after the Food and Drug Administration signs off and a Centers for Disease Control and Prevention advisory panel meets on Nov. 2-3, millions of doses will begin going out to providers across the country, along with the smaller needles needed for injecting young children.
Within days of that, the vaccine will be ready to go into arms on a wide scale.1
The White House indicated 15 million doses would be prepared and ready to ship the first week.
Around the World
Vaccinating young kids has not been done on a large scale around the world. Israel is also awaiting FDA approval for this new age group.
Cuba will begin vaccinating children as young as 2 against the coronavirus this week, making it the only country so far to immunize children that young.
Chile has begun vaccinating children 6 and older. China and the United Arab Emirates are now vaccinating children as young as 3.2
With the concerns of Nordic countries with Moderna’s mRA vaccines, we will see how they move forward with vaccinating children. Singapore3, Malaysia4, and Denmark5 have decided it is time to abandon the need for strict COVID protocols and learn how to live with COVID in the endemic phase.