Macías: We must vaccinate everyone because the covid will not go away 2:43
(CNN) --
The director of the US Centers for Disease Control and Prevention (CDC, for its acronym in English), Dr. Rochelle Walensky, approved the vaccines against covid-19 for young children 5-year-old on Saturday, paving the way for vaccines to be administered soon.
This move comes after CDC vaccine advisers voted unanimously Saturday in favor of recommending the Moderna and Pfizer/BioNTech Covid-19 vaccines for children up to 6 months.
"Together, with science leading the way, we have taken another important step in our nation's fight against COVID-19. We know that millions of parents and caregivers are eager to vaccinate their young children, and with today's decision, they can," Walensky said in a statement.
"I encourage parents and caregivers with questions to talk to their local doctor, nurse or pharmacist to learn more about the benefits of vaccines and the importance of protecting their children by getting them vaccinated."
Vaccinations may not begin until Tuesday in some locations.
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US President Joe Biden praised the CDC's decision to recommend the vaccines on Saturday.
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"Today a monumental step was taken in our nation's fight against the virus, with virtually all Americans now eligible for the protections provided by COVID-19 vaccines," Biden said in a written statement, adding: "To parents across the country, this is a day of relief and celebration.
Walensky approved the administration of two doses of Moderna's vaccine to children 6 months to 5 years old, and three doses of Pfizer's vaccine to children 6 months to 4 years old.
The CDC's Advisory Committee on Immunization Practices (ACIP) noted Saturday that if any Pfizer vaccine is administered, then the vaccination series must contain three doses.
"We will monitor inventory as vaccines are delivered to clinics, pharmacies and other clinical settings beginning Monday to determine when the under-five vaccine search will be available on vaccines.gov," said Dr. Kevin Chatham -Stephens, the Pediatric Vaccine Planning and Implementation Lead with the CDC Vaccine Task Force, at the ACIP meeting.
"Parents and caregivers can contact their child's pediatrician or family doctor or local health department, pharmacy, etc. to ask if they have the vaccine, understanding that not all clinics or pharmacies will receive their vaccine on Monday." .
Moderna and Pfizer/BioNTech Covid-19 vaccines are already licensed for young children
On Friday, the US Food and Drug Administration (FDA) expanded emergency use authorizations for Moderna's vaccine to include children ages 6 months to 17 years and Pfizer/BioNTech for Children from 6 months to 4 years.
CDC vaccine advisors will discuss the use of the Moderna vaccine in children ages 6 to 17 years and older at their June 23 meeting.
About 17 million children under the age of 5 are now eligible for COVID-19 vaccines.
Covid-19 is the leading cause of infectious disease-related death in people ages 19 and younger, but data shows those deaths are preventable through vaccination, Dr. Matthew Daley said at the ACIP meeting on Friday.
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"Covid-19 is the leading cause of death among infectious diseases in people ages 0 to 19. And it's the seventh most common cause of death among people ages 0 to 19," said Daley, principal investigator at the Institute for Health Research of Kaiser Permanente Colorado, to the committee.
"As of March 2022, unvaccinated people aged 5 years and older had a 10-fold increased risk of dying from COVID-19 compared to those vaccinated with at least the primary series," Daley noted, adding that, in other words, The data "provides real-world evidence that most Covid-19 deaths are preventable through vaccination."
At the ACIP meeting on Saturday, Dr. Veronica McNally said she was "shocked" by the impact Covid-19 has had on children.
"I'm amazed at these numbers: 2 million cases, 20,000 hospitalizations and more than 200 deaths. And I'm also concerned that the potential seriousness of a respiratory virus in children this age is really underestimated and that parents sometimes don't understand well the long-term consequences, including MIS-C," McNally said.
"The benefits seem to clearly outweigh the risks"
Under FDA authorization, the Moderna vaccine can be administered as a two-dose primary series, at 25 micrograms each dose, to infants and children 6 months through 5 years of age.
For older children, ages 6 to 11, the doses are 50 micrograms each.
The Pfizer/BioNTech vaccine can now be administered as a three-dose primary series, at 3 micrograms each dose, for use in infants and children 6 months to 4 years of age.
FDA vaccine adviser Dr. Paul Offit said Wednesday that children receiving Pfizer's vaccine will need to complete a three-dose series to get enough protection.
"'The benefits outweigh the risks' is something I can support, but I have some concerns about this vaccine," said Offit, director of the Center for Vaccine Education at Children's Hospital of Pennsylvania.
Dr. Jeannette Lee of the University of Arkansas for Medical Sciences, who is also on the FDA's vaccine advisory committee, agreed.
"Certainly, three doses will benefit. I am very concerned that many of these children are not getting a third dose," he said.
"My concern is that you have to get all three doses to really get what you need."
FDA authorizes Moderna and Pfizer/BioNTech covid-19 vaccines for children 6 months and older
Based on clinical trial data, common side effects of both vaccines include pain at the injection site, headache, fever, chills, and fatigue.
The vaccines appeared to elicit similar immune responses in children as have been seen in adults.
The FDA's Advisory Committee on Vaccines and Related Biological Products determined that the benefits of both vaccines outweigh the risks and noted that the vaccines have been "well tolerated" among children who received them in clinical trials.
"The benefits seem to clearly outweigh the risks, particularly for those with young children who may be in kindergarten or group daycare," he said in a discussion of the Moderna vaccine.
The number of hospitalizations and deaths of children from COVID-19 is concerning and far higher compared to deaths and hospitalizations related to the flu, said Dr. Peter Marks, director of the FDA's Center for Biological Evaluation and Research.
"There was still, during the omicron wave, a relatively high rate of hospitalization during this period," he said.
"That hospitalization rate is actually quite concerning, and when you compare it to what we see in a terrible flu season, it's worse."
Marks said the number of deaths in children under 4 during the first two years of the pandemic "also compares terribly to what we've seen with influenza in the past."
"We're dealing with an issue where I think we have to be careful not to become insensitive to the number of pediatric deaths because of the overwhelming number of deaths of older people here. Every life matters," he said, adding that "Preventable deaths for vaccines are those that we would like to try to do something about.
He added that the Covid-19 vaccines are an intervention similar to the influenza vaccine, which has been widely and routinely used and accepted to prevent deaths at all ages.
CNN's Virginia Langmaid, Brenda Goodman and Sam Fossum contributed to this report.