In a move that parents across the country are looking forward to, Moderna announced Thursday that it has applied for FDA authorization for its two doses of COVID-19 vaccines for children 6 months to 2 years of age and 2 years to under 6 years of age.
If the Food and Drug Administration issues an emergency authorization (EUA) for the vaccines, these will be the first such vaccines available to the age groups in the now nearly two-and-a-half-year-long pandemic. Parents of young, ineligible children have anxiously awaited the availability of such vaccines, especially as much of the country tries to put the pandemic behind them, even as cases of the extremely contagious omicron subvariants continue to rise.
“We are proud to share that we have submitted our EUA submission for authorization for our early childhood COVID-19 vaccine,” said Stéphane Bancel, CEO of Moderna, in a statement Thursday morning. “We believe that mRNA-1273” [the COVID-19 vaccine] will be able to safely protect these children from SARS-CoV-2, which is so important in our ongoing fight against COVID-19 and will be especially welcomed by parents and carers.”
In March, Moderna announced the highest clinical trial results that the vaccines for the two young age groups met their primary goals in the trial: They both produced high levels of neutralizing antibodies that matched or exceeded the levels seen in adults ages 18 to 25 years, which corresponds to the established effectiveness.
Because the trial was underway during the towering ommicron wave, Moderna was also able to roughly calculate the vaccine’s effectiveness against infection, even though the trial was not designed to do so in the first place. As expected, compared to the omicron variant — which can evade vaccine-derived immunity — the vaccines were found to be about 44 percent effective in children 6 months to 2 years of age and 37.5 percent effective in those 2 years to under 6 years of age. .
Omicron roller coaster
In today’s announcement, Moderna noted that those efficacy estimates include results of at-home COVID-19 testing. When instead they included only COVID-19 cases confirmed positive by lab RT-PCR testing, efficacy improved slightly for infants, increasing to 51 percent (with a 95 percent confidence interval of 21 to 69) over 6 months. months to 2 years. For children ages 2 to under 6, the efficacy estimate remained at 37 percent (with a 95 percent confidence interval of 13 to 54).
“These efficacy estimates are comparable to adult vaccine efficacy estimates against Omicron after two doses of mRNA-1273.” [vaccine]the company notes.
Now that the filing is with the FDA, parents will likely keep a close eye on how the regulator handles the filing. Last week, Politico reported that FDA officials are considering delaying review of Modern’s submission pending data from Pfizer and BioNTech on their early childhood vaccine. The officials reportedly think it would be “less confusing” if the two vaccine options were made available to parents at the same time. Top infectious disease expert Anthony Fauci later confirmed that the FDA is considering waiting until the summer, likely June, to review and approve the vaccines.
Pfizer and BioNTech’s vaccine for children under 5 has been a roller coaster ride, starting in December when the companies announced that two doses failed the primary goal of generating antibody levels in young children comparable to levels seen in adults. . The companies are now testing a third dose, with data expected in June.
Huge impact
Parents and other experts have been critical of plans to delay the review of Moderna’s vaccines. That includes former FDA commissioner and current Pfizer board member Scott Gottlieb. “When the Moderna application is ready and the Pfizer application is not, I think the FDA should and should consider this separately,” Gottlieb said: in an interview last Sunday on CBS’ Face the nation†
Gottlieb also revealed that he doesn’t expect the Pfizer-BioNTech vaccine to outperform in terms of vaccine effectiveness — in fact, he doubts their three-dose vaccine will be 50 percent effective against symptomatic omicron infections in the studies. “It is possible,” he said, “[but] I don’t think that will be the case, because I don’t think there will be enough symptomatic cases in that dataset to evaluate.”
The disclosure only raises more questions about why the FDA would consider delaying Moderna’s two-dose vaccine if Pfizer-BioNTech’s three-dose regimen may not provide better protection. Gottlieb and other experts have argued that the vaccines are urgently needed to provide basic protection in an age group of children who are not protected against serious illness and long-term COVID.
As Harvard emergency medicine doctor Jeremy Faust said on Twitter:Get protected faster, that’s what it’s all about… pending the actual data, we will vaccinate our 4-year-old as soon as possible, and that will have a huge impact on how we live our lives.”
