The first COVID-19 vaccinations for infants, toddlers, and preschoolers in the United States got closer Wednesday.
The Food and Drug Administration's vaccine advisors approved Moderna and Pfizer's vaccinations for infants and toddlers.
Outside experts decided unanimously that the advantages of the vaccinations outweigh the risks for children under five or approximately 18 million children. They are the last age group in the United States without access to the COVID-19 vaccination, and many parents have been eager to protect their infants.
If all regulatory requirements are met, vaccinations should be ready the following week.
One panelist, Dr. Jay Portnoy of Children's Hospital in Kansas City, Missouri, stated, "This is a vaccine that has been a long time in the making." "There are so many parents who are desperate for this vaccine, and I believe we owe it to them to give them the option to receive it if they so choose."
Dr. Peter Marks, the head of the FDA's vaccine division, opened the meeting by presenting data indicating a "very concerning increase" in hospitalizations of young children during the omicron wave and noting that 442 children under the age of four have died throughout the pandemic. He added that this is a much smaller number than adult deaths, but it should not be disregarded when contemplating the necessity to vaccinate young children.
Marks stated, "Each lost child essentially fractures a family."
While endorsing vaccines, some panelists stated that they feel the risk of severe disease and death in young infants is negligible.
Dr. Cody Meissner of Tufts University stated, "Risks associated with vaccination are extremely low, but so are risks associated with COVID-19 for young children."
In evaluations provided before the full-day hearing, FDA reviewers concluded that both brands appear safe and effective for infants as young as six months. In both cases, side effects such as fever and exhaustion were generally mild and less common than in adults.
Despite employing the same technology, the two vaccinations are distinct. During a call with media earlier this week, vaccine experts warned that the shots had not been compared; thus, it is impossible to tell parents which is best.
Former FDA vaccine chief Dr. Jesse Goodman of Georgetown University stated, "You cannot directly compare vaccines."
If the FDA agrees with its advisors and approves the injections, there is one additional step. The Centers for Disease Control and Prevention advisers will vote on a formal proposal on Saturday. Vaccines might be accessible as early as Monday or Tuesday at doctor's offices, hospitals, and pharmacies if the CDC approves.
The Pfizer vaccination is for children aged six months to 4 years, while the Moderna vaccine is for children aged six months to 5 years.
The dose of Moderna's shots is one-fourth that of the company's adult shots. Two doses appeared to be sufficient to avoid severe sickness but were only 40 to 50 percent effective against milder illnesses. Moderna added a booster to its tests and plans to provide one in the future.
The Pfizer injections are only one-tenth the adult dose. During testing, Pfizer and its partner BioNTech determined that two doses did not provide sufficient protection, so a third was added during the omicron wave.
The data supplied by Pfizer revealed no safety issues and suggested that three injections were 80% effective at avoiding symptomatic coronavirus infections. However, this was based on only 10 cases of COVID-19; the computation could alter as the business continues to study other cases.
Noting that protection is poor after two Pfizer dosages, several advisors were concerned that some parents would avoid the third dose or wrongly believe their children are better protected between treatments, leaving them susceptible.
Dr. Archana Chatterjee of Rosalind Franklin University stated that parents must be educated "extremely cautiously" so that they are not deceived about what immunizations genuinely offer.
Tuesday, the same FDA panel approved Moderna's half-dose injections for children aged 6 to 11 and full-dose injections for adolescents. If FDA-approved, it would be the second-best alternative for these age groups. Currently, only Pfizer's vaccine is available.
The nation's vaccination campaign began in December 2020 with the release of adult vaccines from Pfizer and Moderna, with health care workers and nursing home residents being the first to receive vaccinations. Last year, adolescents and school-aged children were added.
Moderna stated in April that the company is also pursuing regulatory approval for infant vaccinations in countries outside the United States. According to the World Health Organization, 12 nations currently vaccinate children under 5 with alternative brands.
Health Canada stated in a statement to Global News on Wednesday that it is still assessing Moderna's vaccine for children under the age of 5, a process it claims is being "accelerated" alongside other COVID-19 studies. Late in April, Moderna submitted its application.
A spokesman for Health Canada stated, "Because the review is still ongoing, it is impossible to predict when a regulatory decision will be made."
In May, Dr. Bonnie Henry, the public health officer for British Columbia, hinted that the vaccine might be ready as early as late summer.
It is unknown in the United States how many parents want their youngest children immunized. According to some estimates, three-quarters of all children are currently afflicted. And just about 29 percent of children aged 5 to 11 have been vaccinated since Pfizer's vaccine became available in November of last year, a figure significantly below what public health authorities consider optimum.
According to Dr. Nimmi Rajagopal, a family medicine physician at Cook County Health in Chicago, she has been prepping her parents for months.
"Some are hesitant, while others are eager to get started," she said.