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Parents' long wait for COVID-19 vaccines for young children is almost over. The Moderna and Pfizer/BioNTech COVID-19 vaccines are now authorized for emergency use for children as young as six months, the US Food and Drug Administration announced today.
The Moderna vaccine is authorized for use on those who are six months through 17 years old. Previously it had only been authorized for individuals 18 and older. The Pfizer-BioNTech vaccine, which had only been available to those five and older, is now authorized for use on individuals age six months to 4 years old.
"Many parents, caregivers and clinicians have been waiting for a vaccine for younger children and this action will help protect those down to 6 months of age," FDA Commissioner Robert Califf, MD, said in a statement. "As we have seen with older age groups, we expect that the vaccines for younger children will provide protection from the most severe outcomes of COVID-19, such as hospitalization and death."
In making its announcement today, the FDA said its' evaluation and analysis of the safety, effectiveness and manufacturing data of the vaccines was rigorous and comprehensive.
"The agency determined that the known and potential benefits of the Moderna and Pfizer-BioNTech COVID-19 vaccines outweigh the known and potential risks in the pediatric populations authorized for use for each vaccine," the FDA said in a statement.
Here's what to know about the vaccines, their possible side effects, and when they will be available.
Vaccine Availability Timeline
The White House said it expects vaccinations for younger children to begin next week. Before that can happen however, there's one last hurdle to clear. The Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) must vote on whether to recommend the vaccines. That vote is scheduled to take place tomorrow, after which CDC Director Rochelle Walensky, MD, must also sign off on the recommendation.
Assuming there are no hold-ups, the vaccines could be ready to be given to children as early as this Tuesday, June 21. (Monday, June 20, is a federal holiday, which may pose a small delay in the administration of shots.)
What Are the COVID-19 Vaccine Options for Children Under Age 5?
A decision on vaccines for this age group has been a long time coming. Many parents have been anxiously awaiting the day that a COVID-19 vaccine would be available for young children. To date, there hadn't been any COVID-19 vaccines for these youngest of Americans.
Based on their safety and efficacy in infants and young children however, the FDA's Vaccines and Related Biological Products Advisory Committee voted earlier this week to recommend emergency use of vaccines from both Moderna and Pfizer.
Moderna's COVID-19 vaccine for infants and children six months through five years of age consists of two shots given four weeks apart. Each dose is a quarter of what is given to an adult.
Pfizer's vaccine for infants and children six months through 4 years of age is a three-shot series. Children would get the first two doses three weeks apart. A third dose would be given after two months. Each dose is one-tenth of the adult dose.
How Effective Are the Vaccines?
Evidence from clinical trials of the two vaccines show that the kids' COVID-19 vaccines are effective in priming the body to fight the infection.
"What we saw from both the Pfizer and the Moderna vaccines is that they are able to produce antibody responses that are similar to the antibody responses that we saw in adults," Jennifer Nayak, MD, associate professor of pediatric infectious disease at the University of Rochester Medical Center, told Health.
While children's risk of severe disease from COVID-19 is less than that of adults, they're not immune to the virus. "In the height of the Omicron wave, we still saw a lot of children who were being hospitalized," Dr. Nayak said. "And the vaccines are the best protection that we have against that."
That doesn't mean kids who are vaccinated won't catch COVID at all. Like in adults, the amount of protection these vaccines provide has waned over time as new variants and subvariants of the disease have emerged. "Your child still could get COVID, but they'll be less sick," she said.
"Prevention is really the way to go," Hayley Altman Gans, MD, a professor of pediatrics at Stanford University Medical Center, and a member of the FDA advisory committee. Not only are the options for treating young kids with COVID very limited, the immune response from vaccination versus COVID infection is different. With infection comes viral replication and tissue invasion and damage, said Dr. Gans. "Getting an immune response without that should be an option for individuals so that they don't have to suffer from the actual viral disease."
The Moderna vaccine is authorized for use on those who are six months through 17 years old. Previously it had only been authorized for individuals 18 and older. The Pfizer-BioNTech vaccine, which had only been available to those five and older, is now authorized for use on individuals age six months to 4 years old.
"Many parents, caregivers and clinicians have been waiting for a vaccine for younger children and this action will help protect those down to 6 months of age," FDA Commissioner Robert Califf, MD, said in a statement. "As we have seen with older age groups, we expect that the vaccines for younger children will provide protection from the most severe outcomes of COVID-19, such as hospitalization and death."
In making its announcement today, the FDA said its' evaluation and analysis of the safety, effectiveness and manufacturing data of the vaccines was rigorous and comprehensive.
"The agency determined that the known and potential benefits of the Moderna and Pfizer-BioNTech COVID-19 vaccines outweigh the known and potential risks in the pediatric populations authorized for use for each vaccine," the FDA said in a statement.
Here's what to know about the vaccines, their possible side effects, and when they will be available.
Vaccine Availability Timeline
The White House said it expects vaccinations for younger children to begin next week. Before that can happen however, there's one last hurdle to clear. The Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) must vote on whether to recommend the vaccines. That vote is scheduled to take place tomorrow, after which CDC Director Rochelle Walensky, MD, must also sign off on the recommendation.
Assuming there are no hold-ups, the vaccines could be ready to be given to children as early as this Tuesday, June 21. (Monday, June 20, is a federal holiday, which may pose a small delay in the administration of shots.)
What Are the COVID-19 Vaccine Options for Children Under Age 5?
A decision on vaccines for this age group has been a long time coming. Many parents have been anxiously awaiting the day that a COVID-19 vaccine would be available for young children. To date, there hadn't been any COVID-19 vaccines for these youngest of Americans.
Based on their safety and efficacy in infants and young children however, the FDA's Vaccines and Related Biological Products Advisory Committee voted earlier this week to recommend emergency use of vaccines from both Moderna and Pfizer.
Moderna's COVID-19 vaccine for infants and children six months through five years of age consists of two shots given four weeks apart. Each dose is a quarter of what is given to an adult.
Pfizer's vaccine for infants and children six months through 4 years of age is a three-shot series. Children would get the first two doses three weeks apart. A third dose would be given after two months. Each dose is one-tenth of the adult dose.
How Effective Are the Vaccines?
Evidence from clinical trials of the two vaccines show that the kids' COVID-19 vaccines are effective in priming the body to fight the infection.
"What we saw from both the Pfizer and the Moderna vaccines is that they are able to produce antibody responses that are similar to the antibody responses that we saw in adults," Jennifer Nayak, MD, associate professor of pediatric infectious disease at the University of Rochester Medical Center, told Health.
While children's risk of severe disease from COVID-19 is less than that of adults, they're not immune to the virus. "In the height of the Omicron wave, we still saw a lot of children who were being hospitalized," Dr. Nayak said. "And the vaccines are the best protection that we have against that."
That doesn't mean kids who are vaccinated won't catch COVID at all. Like in adults, the amount of protection these vaccines provide has waned over time as new variants and subvariants of the disease have emerged. "Your child still could get COVID, but they'll be less sick," she said.
"Prevention is really the way to go," Hayley Altman Gans, MD, a professor of pediatrics at Stanford University Medical Center, and a member of the FDA advisory committee. Not only are the options for treating young kids with COVID very limited, the immune response from vaccination versus COVID infection is different. With infection comes viral replication and tissue invasion and damage, said Dr. Gans. "Getting an immune response without that should be an option for individuals so that they don't have to suffer from the actual viral disease."
