BREAKING: FDA authorizes Pfizer and Moderna COVID-19 vaccines for children as young as six months old
The FDA has authorized COVID-19 vaccines for children as young as six months old, manufacturers announced Friday morning.
The expected move comes after the Food and Drug Administration’s (FDA) top advisory panel voted to recommend both the Pfizer and Moderna vaccines for approval earlier this week.
Now, the Centers for Disease Control and Prevention (CDC) will be left to greenlight the shots ahead of their targeted rollout date on June 21. A CDC advisory panel is scheduled to meet over the weekend.
The move makes America the nation with the youngest eligible COVID-19 vaccine age, an odd move as data points to children suffering limited risk from the virus and vaccine uptake among children aged five to 13 being low.
According to CDC data, children make up 0.1 percent of the nation’s total deaths from the virus and are also less likely to suffer a severe case or hospitalization from Covid.
‘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,’ Dr Robert Califf, commissioner of the FDA 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.’
Pfizer revealed preliminary data last month showing the vaccine was 80 percent effective at preventing infection from Omicron, though the efficacy rate may change as more trial participants need to be infected before the figures can be finalized.
The Pfizer jab will come in three doses, unlike the two dose standard set for older age groups. It will also be only three micrograms, a tenth of the size of the standard adult dose, and a third of dosage for children five through 12.
The switch was made towards the end of last year when early data showed that only two doses of the jab provided little protection against the virus.
Moderna will use a two-dose jab for young children, with each shot being 25 micrograms – a fourth the size of its adult sized shots.
In clinical trials, the Moderna shot was 40 to 50 percent effective at preventing mild infection from the virus.
‘We are thrilled that the FDA has granted Emergency Use Authorization of Moderna’s COVID-19 vaccine for children and adolescents, particularly for our vulnerable, youngest children,’ Stephane Bancel, CEO of Moderna, said in a statement.
Both of the shot’s were deemed safe and effective by both the FDA and by a panel of outside advisors, known as the Vaccines and Related Biological Products Advisory Committee (VRBPAC).
‘In addition to making certain the data for these vaccines met FDA’s rigorous standards, the agency’s convening of an advisory committee was part of a transparent process to help the public have a clear understanding of the safety and effectiveness data supporting the authorization of these two vaccines for pediatric populations,’ Dr Peter Marks, the FDA’s top regulator, said in a statement.