Pfizer’s CEO set a schedule for when Americans can expect the earliest news of shots for young children.
The vaccination schedule for young children looks a little more solid. This morning, Pfizer submitted data to the FDA This shows that the COVID-19 vaccine is effective and safe for children ages 5-11 ‘time. “Before the end of the year,” he confirmed in an interview with Craig Melvin, who today News anchor and MSNBC anchor at The Atlantic Festival. Filing with the FDA will follow soon thereafter, Bourla said.
Waiting for COVID-19 vaccines is done while an ongoing Increase in cases in children. Vaccines take so long to reach children because the studies follow the classic strategy of age de-escalation. Manufacturers tested their shots first on adults, then on teenagers and lastly on children aged 2 years. Pfizer is also conducting a pediatric study for the youngest children, ages six months to 2 years. Bourla did not provide a schedule for this cohort, but expects results sometime after those of the 2-4 year old group.
Once the results have been collected for each age cohort, Pfizer will submit them to the FDA for review for safety and effectiveness. The agency doesn’t operate on a set schedule, but in context, the emergency application of the Pfizer vaccine from filing to approval took 21 days for adults and 31 days for teens 12-15 years old, likely to be able to get shots all about Halloween and the 2 through 4 will be eligible early next year. (Don’t be surprised if the Timelines stretch, However.)
All eyes are on Pfizer’s vaccine as pediatric studies are the most advanced. Moderna and Johnson & Johnson, the other two companies whose COVID-19 vaccines were approved in the US, have not yet released data from their studies of children under 12 at the age of six months.) The first shot that children used Available will almost certainly come from Pfizer.
The studies of COVID-19 vaccines in adults and children differ in a few key ways. First, Pfizer is testing a smaller dose in children. For adults and adolescents, each shot of Pfizer’s two-dose regimen contained a 30 microgram dose. For children under 11 years of age the dose has been reduced to only 10 micrograms per shot, and then further reduced to 3 micrograms for children from 6 months to 2 years. Based on Pfizer’s announcements, the data the company has collected to date suggests that the smaller dose is indeed safe and elicits a strong immune response from the 5-11 year old cohort; their antibody responses are similar to those of adults who received the higher dose.
Speaking of the immune response, scientists rate the vaccine’s effectiveness in children somewhat indirectly – this is another difference between these adult and pediatric studies. The COVID-19 vaccine is already known to be effective in adults, so the researchers are studying antibody responses rather than counting the number of people who received COVID-19 versus the unvaccinated who received COVID-19, as in the original study with Adults was the case. To test the effectiveness of waiting for enough children in a study to catch COVID-19, it would take a much larger study – and a lot more time to complete. These studies, which focus on the antibody response, are called “Immunbridging” studies and are standard in the study of vaccines.
Even if young children can be vaccinated – and surveys currently suggest that many parents are still reluctant – the coronavirus is unlikely to go away. That’s why pharmaceutical companies like Merck, Roche, and Pfizer are also making efforts to develop antiviral drugs to treat patients with COVID-19. In this week, Pfizer announced that it is studying an oral pill that could block the replication of the coronavirus. Attempts to see if the pill can mitigate or prevent COVID-19 “are currently underway,” Bourla told Melvin, and the first results are expected before the end of the year. The world is entering a third year with the coronavirus, but this time with a lot more pharmaceutical defenses in the arsenal.
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