(Trends Wide) — Millions of childhood doses of Pfizer’s covid-19 vaccine are being shipped from the company’s facilities to distribution centers across the country, ready to go to pharmacies and pediatrician’s offices, said Monday. Joe Biden’s government. They are just waiting for the go-ahead from the US Centers for Disease Control and Prevention (CDC), whose independent advisers will vote on Tuesday whether to recommend a Covid-19 vaccine for children ages 5 to 11.
The Advisory Committee on Immunization Practices (ACIP), the independent group of experts that advises the CDC, meets to take this penultimate regulatory step before the final decision passes to Dr. Rochelle. Walensky, director of the CDC. If the group recommends the vaccine for children ages 5 to 11, and Walensky approves of the recommendation, children in this age group can start getting vaccinated.
About 28 million children would be eligible for the first time, and for some parents and pediatricians, the decision may not come soon enough. According to a report released Monday by the American Academy of Pediatrics, children now make up a disproportionate number of new COVID-19 cases, accounting for a quarter of all new cases last week.
The U.S. Food and Drug Administration (FDA) authorized Pfizer’s vaccine for this younger age group on Friday, giving the company the distinction of having the first use authorization. Emergency for a Covid-19 Vaccine for Young Children in the United States. The FDA said the benefits of the vaccine outweigh the risk for children.
Pfizer exposes to advisers
At the CDC meeting, which takes place from 11 a.m. to 5 p.m. ET, Pfizer will present its data to advisers in the morning.
In the informational documents it submitted to the FDA, Pfizer says its clinical trial showed that the vaccine provides 90.7% protection against symptomatic disease among this age group, with one-third of the dose that 12 people receive. years or more. The company hopes the smaller dose will reduce potential side effects.
In the afternoon, CDC scientists will present information on potential side effects, and will also discuss the general need for a Covid-19 vaccine in children. According to the American Academy of Pediatrics report, just last week nearly 101,000 more children tested positive for COVID-19.
Although COVID-19 cases have been declining, even among children, the number of children with COVID-19 is still considered “extremely high,” according to the AAP. On Friday, immediately after the FDA cleared the vaccine, FDA Acting Commissioner Dr. Janet Woodcock urged parents to vaccinate their children as soon as possible.
Cases grow among children
“Tragically, Covid-19 is among the top 10 causes of death for children ages 5 to 11 in the United States,” Woodcock said.
According to the CDC, 172 children between the ages of 5 and 11 have died from covid-19 as of this Monday. In this age group there have been more than 8,300 hospitalizations related to covid-19 until September of this year, and about 1.9 million cases.
The CDC will also explain the vaccine’s safety data, including the low risk of myocarditis, an inflammatory heart disease, to the committee. It is a condition that has been seen in some adolescents and adults who received the Pfizer / BioNTech and Moderna vaccines.
Committee chair Dr. Grace Lee told Trends Wide that although data is limited, existing surveillance systems are doing a good job of detecting vaccine safety signals. He said the CDC is also conducting a long-term study of people who develop myocarditis after vaccination.
Dr. William Schaffner, chair of the department of preventive medicine at Vanderbilt University School of Medicine and liaison for the non-voting committee, said he believes a pair of voting members could express concern about myocarditis But he believes the committee will vote overwhelmingly in favor of the vaccine.
Noting that myocarditis generally occurs less frequently in this younger population, Schaffner said he believes the theoretical risk of myocarditis is outweighed by the benefits of the vaccine.
“It makes up for it enormously,” Schaffner told Trends Wide. “I think there is no question.”
A difficult decision
Lee said that committee members will have to make a decision about the vaccine for children even if they do not have all the data on the impact of COVID-19 on children. For example, it is not clear what is the impact of long-lasting COVID-19 on children or the full impact of missing school when children are sick with COVID-19.
“I think making decisions under uncertainty creates a lot of challenges,” Lee, a professor of pediatric infectious diseases at Stanford University, told Trends Wide. “During much of the pandemic, what we have seen the ACIP do is struggle with the data that exists and what we would like to have.”
But he believes that ultimately a decision has to be made.
“Not making a decision is itself a decision,” Lee said.
CDC advisers will also discuss possible ways to implement the pediatric vaccine program, as well as which children specifically should receive the vaccine.
Schaffner said the possibility of targeting the vaccine on children with underlying health problems could also be debated, but he doesn’t think that idea will go very far, as many of the children who have been hospitalized or have long-lived covid-19. , or a serious illness related to covid-19 called multisystemic inflammatory syndrome (MIS-C), had no underlying disease.
“Ultimately, we will get to approve this vaccine and recommend its use in children ages 5 to 11, but I think there will be a bit of this discussion on the sidelines,” Schaffner said. “I think the vote will be overwhelmingly in favor. I cannot predict that it will be unanimous.”
Government plans for pediatric vaccination
The Biden administration has been making plans to vaccinate as many children as possible as soon as the vaccine is authorized. The administration said it has contracted with Pfizer to get enough supply to vaccinate all children in this age group. The administration has also helped more than 25,000 doctors’ offices, pharmacies, community health centers and rural health clinics administer vaccines.
The question remains of how many parents will vaccinate their children. Pfizer’s vaccine is already licensed for children ages 12 to 15, and approved for those over 16, but preteens and teens are the least vaccinated age group.
As for children ages 5 to 11, a Kaiser Family Foundation survey released last Thursday revealed that most parents said they would not immediately vaccinate their children. About a third of parents with children in this age range would wait to see how other children fared with the vaccine before inoculating their own children, but experts say parents shouldn’t wait.
“As a parent, if I had young children in this age group, I would vaccinate them now,” the FDA’s Woodcock said Friday. “I wouldn’t want to risk them being one of those developing long-term covid-19, developing multisystem inflammatory syndrome, or having to be hospitalized for the virus.”
According to Woodcock, vaccines are not limited to protecting the individual. Vaccines can help protect the community.
“One of the ways we can do this is by decreasing transmission in all age groups,” Woodcock said. “So I think the recommendation would be that we continue to vaccinate children.”
With information from Elizabeth Cohen.
