FDA Panel Recommends Authorization Of Moderna’s COVID-19 Vaccine For Youth Aged Six To 17.
The Washington Post (6/14, McGinley, Shepherd) reports, “Independent advisers Tuesday unanimously urged the Food and Drug Administration to clear Moderna’s two-shot coronavirus vaccine for children 6 through 17 years old, paving the way for an agency authorization later this week.” An approval “from the FDA, followed by an endorsement by the Centers for Disease Control and Prevention, would give parents another choice of shots for school-age children and adolescents. The Pfizer-BioNTech vaccine already is available for children 5 through 17.” Because there is already a vaccine available for this age group, “having a second vaccine available might not translate into a big bump in vaccinations, at least in the 6-to-11-year-old age group, in which demand has been weak.” Therefore, “to increase uptake ‘really is going to require lots of one-on-one single conversations and educating providers and parents about the benefits,’ said Amanda Cohn, chief medical officer of the CDC’s National Center for Immunization and Respiratory Diseases.”
The New York Times (6/14, Weiland, LaFraniere) reports the FDA “will most likely follow the panel’s advice in the coming days, as it has done consistently during the pandemic, and grant authorization.” Moderna “first applied to cover 12- through 17-year-olds a year ago” but “federal health officials, concerned about possible links between the Moderna vaccine and a rare heart condition, myocarditis, delayed a decision.” Now, Moderna “says concerns about myocarditis have subsided after further research and real-world evidence. Federal health officials repeatedly addressed the risks of that side effect in the panel’s sessions.”
ABC News (6/14, Salzman, Haslett, Mitropoulos) reports that after the FDA decides “whether to issue an official emergency use authorization of the vaccine...the Centers for Disease Control and Prevention’s team of advisers will review Moderna’s data, and finally, CDC Director Rochelle Walensky will issue her recommendation.”
CNN (6/14, Howard) reports, “The vaccine advisers are scheduled to meet again Wednesday to consider amending the emergency use authorization of Moderna’s vaccine to include even younger children, ages 6 months through 5 years old.” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said, “These vaccines will essentially extend down to the younger age ranges of as low as 6 months. Obviously, the safety in this population is of paramount importance, and I think there’ll be a fair amount of discussion by the committee on this particular area.”
STAT (6/14, Feuerstein) reports experts on the panel discussed “the lack of ethnic diversity in Moderna’s studies of children, a stark contrast with the earlier studies conducted in adults.” Panelist Adam Berger, “a researcher at the National Institutes of Health, noted that when looking at the immune response in children 12 to 17, the data were based on hundreds of subjects who were white but only four who were Black.” Marks, in response, “said that although the trial fell short in terms of diversity, there has been no evidence that people of different ethnic backgrounds mount differing immune responses to the vaccine.”
FDA Scientists Say Pfizer-BioNTech’s COVID-19 Vaccine For Children Under Five Safe, Effective.
The Washington Post (6/12, McGinley) reports, “Food and Drug Administration staff said Sunday the coronavirus vaccine made by Pfizer and its German partner, BioNTech, for children younger than 5 is effective in producing a virus-blocking response and did not raise safety concerns, a prelude to a crucial review this week by the agency’s independent advisers.” This “analysis by FDA scientists was released ahead of a meeting Wednesday of the agency’s independent experts, who will consider a request for emergency use authorization for the Pfizer-BioNTech vaccine in the youngest children.”
The New York Times (6/12, LaFraniere) reports the FDA “said the data submitted by Pfizer and its German partner, BioNTech, suggests that three doses are more effective than two.” However, “the agency said it was hard to draw definitive conclusions because there were so few cases of Covid among the 1,415 children who received three doses of the vaccine during the clinical trial.”
FDA Scientists Say Moderna’s COVID-19 Vaccine For Children Aged Five And Under Safe, Effective.
The Washington Post (6/10, A1, McGinley) reported on its front page, “Scientists at the Food and Drug Administration on Friday said Moderna’s coronavirus vaccine for infants and young children was safe and effective, setting the stage for a review by the agency’s outside advisers Wednesday and a potential authorization by the end of the week.” Moderna “has asked the FDA for permission to use its vaccine in children 6 months through 5 years old.” The FDA “said the Moderna two-shot regimen for the youngest children met the main requirement set by regulators – that it generate an immune response at least as strong as the protection afforded young adults.”
The New York Times (6/11, LaFraniere) reported FDA advisors “are scheduled to meet next week to decide whether to recommend that the agency grant Moderna’s request for emergency authorization of its vaccine for children ages 6 months to 17 years.” The agency “cautioned that estimates of the efficacy of Moderna’s two-dose pediatric vaccine were based on relatively few cases of Covid-19.” Furthermore, “the agency also said that, like adults, pediatric recipients would probably require a booster shot to counteract the vaccine’s waning potency over time.”
Breakthrough Infections Have Become A Regular Occurrence Amid Nationwide Push For Boosters.
ABC News (6/9, Mitropoulos) says that “with the majority of the country vaccinated, and immunity gradually waning over time, once-scarce breakthrough infections – which the Centers for Disease Control and Prevention (CDC) define as when a fully vaccinated person gets infected with COVID-19 – have become a regular occurrence associated with the pandemic.” Last month, in an interview with CBS News, Dr. Anthony Fauci, the White House’s chief medical advisor, “acknowledged there has been an increase in the number of vaccinated people who are dying of COVID-19, many of whom are elderly, immunocompromised or have underlying conditions.” Fauci also “stressed that a large proportion – about a third of Americans – have not been fully vaccinated, while about half of eligible Americans are still unboosted with their first dose.” In a meeting with her advisors back in May, CDC director Dr. Rochelle Walensky said, “Only 38% of those 50 to 64 and 43% of those 65 and older have received a vaccine dose in the past six months. This leaves about 60% of older Americans without the protection they may need to prevent severe disease, hospitalization, and death.” She added, “We know immunity wanes over time, and we need to do all we can now to protect those most vulnerable.”