- The CDC suggests that COVID-19 vaccines be made available to children as young as six months old.
- Last Monday, an FDA advisory panel agreed to approve both the Pfizer/BioNTech and Moderna COIVD-19 vaccinations for children aged six months to five years.
- Children under the age of five are the only age group that does not have access to COVID-19 vaccinations.
The Centers for Disease Control and Prevention announced that COVID-19 immunizations should be made available to children as young as six months old. Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, accepted the Advisory Committee on Immunization Practice’s proposal that children aged 6 months to 5 years receive the COVID-19 immunization this weekend.
The Food and Drug Administration stated last week that the Moderna and Pfizer/BioNTech COVID-19 vaccines for children under the age of five had been granted emergency use permission. The FDA’s independent vaccine advisory committee of 21 members unanimously recommended emergency authorization of both the Moderna and Pfizer/BioNTech COVID-19 vaccines for infants and children as young as six months.
What happens next?
The vaccine should be made available to young children soon now that the FDA has granted emergency use authorization and the CDC has backed the recommendation, implying that an extra 20 million children will be able to obtain the vaccination.
The federal government intended to begin the dissemination as soon as the vaccines were approved. As a result, doses could be accessible as early as this week at pediatrician offices and certain pharmacies. Some pediatricians’ offices, however, will be closed on Monday in observance of Juneteenth.
Parents can locate a vaccination location by contacting their pediatrician’s office, a local drugstore, or by visiting Vaccines.gov.
Committee emphasizes parent choice on vaccination
Dr. Peter Marks of the FDA addressed the discussion by emphasizing the impact of COVID-19 on younger children. Although children are less likely than adults to get serious illnesses from coronavirus infection, hospitalizations within this age group increased during the Omicron wave, according to Marks.
Furthermore, as of June 2, 442 children under the age of five had died in the United States as a result of COVID-19, according to data given at the meeting. “We have to be careful not to become numb” to pediatric COVID-19 mortality because they exceed deaths in older individuals, Marks added.
Several committee members applauded the vote to license these vaccines for younger children but stressed the importance of fully communicating the vaccines’ advantages and hazards to the public. “Families will now have a choice that they did not have previously,” said Dr. Michael Nelson of the University of Virginia School of Medicine, a committee member.
“I fully believe in the intellect of families to make the best decision for their family and children,” he continued, “especially when we provide clear recommendations based on the knowledge we have on hand about the risks and advantages.” Dr. Arnold Monto of the University of Michigan, chair of the committee, stated that implementing two vaccines with different regimens will be difficult.
One risk is that parents who opt for the Pfizer-BioNTech vaccine may fail to bring their children in for their third dose. During the discussion, Dr. Paul Offit of The Children’s Hospital of Philadelphia stated that the data submitted by the firms demonstrated that the protection provided by two doses is insufficient against Omicron. Parents should be aware that their child will not be entirely safeguarded until the third dose, he stressed.
The Pfizer-BioNTech vaccine
The Pfizer-BioNTech COVID-19 vaccine is currently available as a two-dose primary series for most Americans aged 5 and up, or three doses for those persons with impaired immune systems. For these age ranges, it is also available as a booster. The businesses asked the FDA in May to expand its usage to newborns and children aged 6 months to 4 years.
This would be a three-dose main series at one-tenth the adult dosage strength. The first two doses are administered three weeks apart, with the third dose administered at least eight weeks after the second. According to a briefing document issued by the FDA for the meeting, the businesses’ research revealed that the three-dose regimen produced an immunological response equivalent to that seen in those aged 16 to 25 who received two doses.
The vaccine’s efficacy against infection was evaluated by FDA experts to be 75.6 percent in children aged 6 to 23 months and 82.4 percent in children aged 2 to 4 years. All coronavirus cases in the research occurred in the United States when the Omicron variety was dominant.
Dr. Susan Wollersheim of the FDA stated during the conference that these efficacy estimates should be considered with caution due to the tiny number of coronavirus infections that occurred after the third dose — due to the short follow-up period. A longer follow-up period should provide a more accurate measure of efficacy, which the firms intend to do.
Given that the immune responses after three doses are comparable to those reported in older age groups, Dr. William Gruber of Pfizer stated during the meeting that he is sure that three doses will provide substantial protection against Omicron in younger children. According to the document, data from the studies also demonstrated that the vaccination was safe in younger children, with most side effects being mild to moderate.
Irritability, sleepiness, decreased appetite, and pain at the injection site was the most common side effects in children aged 6 to 23 months. The most prevalent side effects in children aged 2 to 4 years old were discomfort or redness at the injection site and exhaustion.
There were no reports of heart irritation (myocarditis or pericarditis), allergic reactions (anaphylaxis), or deaths associated with vaccination. Because myocarditis and pericarditis following COVID-19 vaccination are uncommon, extra monitoring will be required following vaccine approval to see whether this adverse event occurs in younger children.
Furthermore, given the short duration of the trial, it is unclear how long the protection provided by three doses will remain. However, given what has happened in adults after two doses, the FDA stated in the document that “a booster dosage will most likely be required in addition to the three-dose primary series.”
COVID-19 vaccine from Moderna is accessible to people aged 18 and up, as well as as a booster for that age range. On June 14, the FDA vaccine advisory group voted to recommend approval of the Moderna COVID-19 vaccine for children aged 6 to 17. The FDA and CDC will also need to approve this use.
On June 15, the FDA vaccine advisory group examined Moderna’s two-dose COVID-19 vaccination data for children aged 6 months to 5 years. This age group’s doses are one-quarter the strength of the adult dose and are administered four weeks apart. According to an FDA briefing sheet prepared for the conference, studies demonstrated that the Moderna COVID-19 vaccination generated a positive immunological response, similar to what was seen in young adults.
The vaccine’s predicted efficacy against infection was 36.8 percent in children aged 2 to 5 years old and 50.6 percent in children aged 6 to 23 months. These findings were obtained when Omicron was the prevalent variation. According to the document, its efficacy was comparable to two doses of the Moderna vaccine in adults during the Omicron wave. The meeting’s results also revealed that the Moderna vaccination was safe for younger children.
According to the document, side effects were “mainly mild to moderate in severity, often of short duration,” and occurred more frequently after the second dose than the first. Pain at the injection site was the most common side event across all pediatric age groups. Fever occurred in almost one-quarter of vaccinated youngsters, most frequently after dose two. High fevers were uncommon.
Irritability, weeping, and tiredness was often noted in children aged 6 to 36 months. Fatigue and headaches were frequently mentioned in older children. There were no reports of myocarditis or pericarditis linked to the vaccination. More research will be required to determine whether this uncommon side effect occurs in younger children.
There were no recorded deaths. Moderna will continue to track the children who have joined in the study and will provide them with a booster dose of either the existing vaccination or a newer one that is targeted to Omicron.
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