FDA Authorizes COVID-19 Boosters for Kids 5-11 as Cases Creep Up
On Tuesday morning, the FDA authorized a booster of Pfizer's vaccine for kids ages 5 to 11 years. The action comes as major cities are announcing a rise in cases.
While the demand for these boosters is unclear, given that only 30% of children in this age group have even received the initial two-dose schedule.
"While it has largely been the case that COVID-19 tends to be less severe in children than adults, the omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer term effects, even following initially mild disease," said FDA Commissioner Robert M. Califf, M.D.
"The FDA is authorizing the use of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age to provide continued protection against COVID-19. Vaccination continues to be the most effective way to prevent COVID-19 and its severe consequences, and it is safe. If your child is eligible for the Pfizer-BioNTech COVID-19 Vaccine and has not yet received their primary series, getting them vaccinated can help protect them from the potentially severe consequences that can occur, such as hospitalization and death," Califf said.
Pfizer Study: 110K More Lives Could Have Been Lost if Not for Vaccine
COVID-19 would have claimed over 110,000 more lives in 2021 if not for the Pfizer-BioNTech vaccine, according to a Pfizer-sponsored report on the first year of the U.S. vaccination program.
The data gathered was based on COVID-19 and post-vaccination results from the use of Pfizer and BioNTech's BNT162b2 (Comirnaty) vaccine. A combined Markov decision tree model evaluated the economic and clinical outcomes of using the vaccine compared to not using it in people ages 12 years and up.
The clinical benefits identified in the report included the number of symptomatic cases, deaths and hospitalizations averted and Quality Adjusted Life Years saved. Meanwhile, economic benefits were identified according to the amount of societal and healthcare cost savings from vaccine-preventable health outcomes.
The report found that Comirnaty had helped avert almost 9 million symptomatic cases, 700,000 hospitalizations and more than 110,000 fatalities. These translated to around $30.4 billion in direct cost savings in healthcare, $43.7 billion in savings from productivity loss and 1.1 million in discounted gains in terms of QALYs, according to the report.
The data is incomplete, as it does not include the impact of the highly contagious B.1.1.529 Omicron variant, which did not enter the U.S. until the end of 2021. The report notes that further study should be conducted to include its effects.
"This analysis shows that the Pfizer-BioNTech COVID-19 vaccine generated substantial gains in health outcomes and cost savings in the U.S. in 2021. It adds to the growing body of evidence demonstrating the societal benefit of the fast and extensive rollout of the vaccine in the US. It supports FDA and CDC recommendations for broad use of the vaccine, and highlights the opportunity to continue widespread uptake to prevent COVID-19 related disease and generate substantial benefits from a broad, patient-centric, societal perspective," the report said.
FDA Denies Antidepressant Drug For COVID-19
Meanwhile, in the current treatment landscape, the U.S. Food and Drug Administration declined to authorize the generic antidepressant drug fluvoxamine to treat COVID-19, citing a lack of evidence of its benefits against the SARS-CoV-2 virus.
The application for emergency use authorization was filed based on University of Minnesota professor Dr. David Boulware's observation that the drug may be effective in some patients. Fluvoxamine is a selective serotonin reuptake inhibitor (SSRI) that three trials in Brazil showed to have the ability to reduce hospitalizations and emergency department visits.
"Based on the review of available scientific evidence, the FDA has determined that the data are insufficient to conclude that fluvoxamine may be effective in the treatment of non-hospitalized patients with COVID-19 to prevent progression to severe disease and/or hospitalization. Therefore, FDA has determined that the criteria for issuance of an EUA are not met and is declining to issue an EUA covering fluvoxamine for the treatment of COVID-19 at this time," the agency wrote in its announcement.
Speaking to reporters, Dr. Boulware said he is disappointed with the FDA's decision, adding that the regulator used a different assessment method from what is usually used in evaluating proposed drugs from big pharmaceutical companies.
"The standard that they were holding for fluvoxamine was a different standard than the other big pharma trials, with Paxlovid and (Merck's) molnupiravir and the monoclonals. I was really quite disappointed that they did that," Dr. Boulware was quoted as saying.
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