Macías: We must vaccinate everyone because the covid will not go away 2:43
(CNN) —
Vaccine advisers to the US Food and Drug Administration (FDA) voted unanimously Wednesday in favor of expanding the emergency use authorization of the COVID-19 vaccine from Modern to include younger children.
The 21-member Vaccine and Related Biological Products Advisory Committee (VRBPAC) voted "yes" in response to the question: Based on the totality of available scientific evidence, what are the benefits of the vaccine? Modern COVID-19 when administered as a 2-dose series?
(25 micrograms each dose) exceeds its risks for use in infants and children 6 months to 5 years of age?
FDA advisers vote to authorize Moderna vaccine against covid-19 for ages 6 to 17
The committee is expected to vote later Wednesday on whether to support authorization of Pfizer's Covid-19 vaccine for children under 5.
Children under the age of 5 are the only age group currently not eligible to be vaccinated against COVID-19.
About 17 million children under the age of 5 will be eligible for COVID-19 vaccines once they are licensed for this age group.
The FDA, which generally follows the committee's decisions, will now decide whether to authorize the vaccine for emergency use in this young age group.
advertising
However, the vaccines cannot be given until the US Centers for Disease Control and Prevention (CDC)'s own vaccine advisers have voted on whether to recommend them and the director of the CDC, Dr. Rochelle Walensky, has approved the recommendation.
CDC vaccine advisers are expected to vote on Saturday.
The White House has said the shooting could begin as early as next week.
"The benefits seem to clearly outweigh the risks"
"The benefits seem to clearly outweigh the risks, particularly for those with young children who may be in kindergarten or group child care," Oveta Fuller, a committee member and associate professor of microbiology and medicine, said of Moderna's vaccine. immunology at the University of Michigan Medical School.
Dr. Art Reingold, a member of the VRBPAC, added that although the risk of hospitalization and death from covid-19 is lower for young children than for adults, children tend to receive vaccinations to protect them against diseases for which their risk It is low.
"If we have a vaccine with benefits that outweigh the risks, making it available to people is a reasonable option," said Reingold, of the University of California, Berkeley.
"I would point out that we as a country continue to give a large number of vaccines to children where the risk of the child dying or being hospitalized from those diseases is close to zero," Reingold said, referring to diseases such as polio and measles.
Researchers try to unravel mysterious cases of hepatitis in children as cases rise around the world
The number of hospitalizations and deaths of children from Covid-19 is concerning and far higher compared to flu-related deaths and hospitalizations, FDA official Dr. Peter Marks said at Wednesday's meeting, before the committee will vote.
"During the omicron wave there was still a relatively high rate of hospitalization during this period," said Marks, director of the FDA's Center for Biological Evaluation and Research.
"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 need to be careful that we don't become insensitive to the number of pediatric deaths because of the overwhelming number of senior deaths here. Every life matters," he said, adding that "Deaths vaccine-preventable are the ones we'd like to try to do something about.
Marks said the Covid-19 vaccines are a similar intervention to the flu shot, which has been widely and routinely used and accepted to prevent deaths.
The Moderna vaccine is already licensed for adults.
At an earlier meeting Tuesday, VRBPAC members voted unanimously in favor of expanding Moderna's vaccine's emergency use authorization to include older children and adolescents, ages 6 to 17, saying it would offer more benefits than risks.
The covid-19 vaccine is "well tolerated" by younger children
What does the US now require from travelers in order to enter?
2:07
Moderna's Covid-19 vaccine, when given in a 25 microgram dose, is "well tolerated" in children 6 months to 5 years old, Dr. Rituparna Das, vice president of vaccine clinical development, said Wednesday. Moderna's covid-19, to members of VRBPAC, while describing the safety profile of the vaccine among this age group and adverse reactions.
"Pain was the most common event," Das said.
"Events for young children included fever, headache, fatigue, myalgia, arthralgia, nausea, vomiting, and chills. For infants and toddlers, events included fever, irritability, crying, drowsiness, and loss of appetite."
Among those who received the vaccine, these reactions were more common after the second dose of the vaccine and resolved within two to three days, Das said, adding that fever was an important assessment of vaccine safety for this group. old.
Fever after any dose of the vaccine occurred in about a quarter of the children, but fevers occurred more frequently after the second dose, and one incident of febrile seizure was considered to be related to vaccination, Das told the members of the VRBPAC.
The child who experienced the febrile seizure remained in the vaccine study and completed a second dose of the vaccine without serious events.
No deaths, myocarditis or pericarditis were reported among vaccine recipients, Das said.
"In summary, mRNA-1273 was well tolerated," he said, referring to Moderna's vaccine.
Local and systemic reactions were seen less frequently in these younger groups."
CNN's Carma Hassan contributed to this report.
covid-19vaccine against covid-19