Pfizer/BioNTech today submitted data to FDA from the clinical trial of the Covid vaccine for children. This enables the launch of a process that could deliver doses to children aged 5-11 within the next few months.
The number of child cases has risen last week. Children under 18 were almost 27 percent of all newly reported cases. However, they make up only 22 percent of the US population. There is a lot of pressure on the government to quickly move through regulation. Parents who are anxiously waiting for this moment might find that there are more obstacles than they anticipate. It was only part of the challenge to protect children, and it was complex. It will also be difficult to get it distributed and administered.
One, the new shots won't arrive in an already overcrowded system. Because they are dealing with adults, additional doses for immunocompromised patients, and influenza season, the Immunization Action Coalition president and CEO Kelly Moore says that the immunization programs haven’t had time to stop and think about this group. It's coming up quickly and they haven't been capable of catching their breath.
These shots will also be given to children in different places, and likely by different personnel than the adult vaccines last winter. They will be arriving in a more political national landscape than ever before. It is not clear how many Americans are welcoming them. A Gallup poll that was released this morning found that only 45 percent of parents don't plan to immunize their children.
Here's a summary of where we stand on shots and children: First, let us stipulate that these plans only address Pfizer/BioNTech. This is the only manufacturer whose trials are far enough advanced to allow child vaccination. The FDA has approved their vaccine as a new drug in August. However, it is only available for children aged 16 and over. Children 12 and under are still able to get the vaccine.
Since March, Pfizer has been conducting clinical trials to clear the vaccine for children younger than 5 years old. These trials involved approximately 4,500 children. They are divided into three cohorts, 6 to 23 months, 2 to 5 years and 5 to 11. Each group receives a fraction of the adult vaccine, ranging from one-third to one-tenth. The company commented on the pediatric trial results last week. It stated that two doses of the one-third dose achieved the same antibody levels in children aged 5-11 years old as the two doses in full-sized doses in the 16-to-25-year-olds. Today, the FDA received these results along with more data. Data for children under 5 years old is expected to follow.
(The trials of other manufacturers have not been as successful. Modernas vaccine is currently approved for emergency use for 18-year-olds and older. It is currently awaiting approval for adults as well as authorization for younger teenagers. In August, the company started studies on children under 12 years old. J&J is currently behind the other two companies. It still has an emergency authorization that only covers adults.
Pfizer, regulators and business analysts all have been saying since last summer that they expect the first authorization to arrive in October or November. Even though it is optimistic, this estimate remains solid. This is because no one outside of the FDA can predict how quickly the agency will review the likely complex data sets that cover safety, efficacy and side effects. After the meeting, two independent committees must weigh in as advisers to both the FDA and Centers for Disease Control and Prevention. No one can predict how carefully they will review the data. These are the two independent committees that met over the past two weeks in order to discuss and approve booster shots for large swathes of Americans.
