NEW YORK — In an effort to keep reining in the pandemic, the Biden administration will invest $1 billion to quadruple the national supply of at-home COVID-19 tests by December. In addition, it is expanding the number of free community-based test sites to 30,000 nationwide, including 20,000 in pharmacies.
The White House’s announcement of the funding followed closely on the heels of the Food and Drug Administration’s announcement that it had approved the Acon home test, an antigen test that provides results in less than 15 minutes.
“We will have a 200 million test supply by December,” said Jeff Zients, COVID-19 coordinator, during a White House press briefing. “At the same time we are increasing the supply of at-home tests we are expanding access to free testing. Every American, no matter their ZIP code, can access free testing.”
Meanwhile, the fight against the pandemic is poised to enter a new phase, as Pfizer Inc. and BioNTech SE applied to the FDA for clearance to administer their vaccine to children ages 5 to 11. If the bid receives prompt approval, the vaccine could be available in doctors’ offices, schools and some pharmacies by Halloween.
The FDA has scheduled a review of the manufacturers’ data by a panel of outside experts for October 26. The agency usually follows such panel recommendations, though it is not required to.
Pfizer-BioNTech filed the application following late trials of their vaccine in 2,268 child volunteers showed that it safely generated a robust immune response, with antibody levels similar to those in young adults. The companies began filing data with the FDA last month in support of a regimen of two 10-microgram doses, which is one-third of the adult dose.
If approved, the Pfizer-BioNTech vaccine will be the first available in the United States for children younger than 12. Approximately 28 million children from 5 to 11 years old are estimated to be eligible for an approved vaccine. The Pfizer-BioNTech vaccine is available to children ages 12 to 15 under Emergency Use Authorization.
While the overall rates of cases and hospitalizations have begun to ebb, infections among children have surged, particularly in states and regions with low adult vaccination rates. According to the American Academy of Pediatrics, more than 5.7 million children have been infected with COVID since the outbreak began last year.
“With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against COVID-19,” Pfizer stated in a tweet. “We’re committed to working with the FDA with the ultimate goal of helping protect children against this serious public health threat.”
Schools and public health departments are expected to play a major role in the vaccination of elementary-school-age children since they already perform other immunizations. However, the cold storage requirements for the Pfizer-BioNTech vaccine could present challenges. Pharmacies that have been administering the Pfizer-BioNTech medication, including booster shots, are already equipped to store the vaccine.
Elsewhere on the vaccine front, Merck & Co. revealed positive results from its late-stage clinical trials of an experimental anti-COVID-19 pill, molnupiravir that they are developing with Ridgeback Biotherapeutics (see story, page 51). Other drug manufacturers testing their own anti-COVID pills are Pfizer and Roche Holding AG and its partner, Atea Pharmaceuticals.
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