Covid-19’s spread in schools has many anxious parents clamoring for a pediatric vaccine, leading the FDA to call for caution, urging parents not to ask clinicians to vaccinate their kids with shots authorized or approved for older age groups.
“Children are not small adults – and issues that may be addressed in pediatric vaccine trials can include whether there is a need for different doses or different strength formulations of vaccines already used for adults,” the FDA said Friday.
Vaccines from Pfizer/BioNTech, Moderna, and Johnson & Johnson—the three that were first to receive emergency authorization in adults—are currently being evaluated in children. The shot from Pfizer and BioNTech shot appears to be the one closest to an FDA filing. Citing unnamed health officials, Reuters reported that the two companies are expected to have enough data for submission by the end of September. Those officials said an emergency authorization decision could be made within three weeks of a submission.
The Reuters story came after BioNTech executives reportedly told German news site Der Spiegel that the company is preparing to seek approval for its Covid-19 vaccine across the world for use in children. They added that clinical trial results in children five to 11 year of age will be available in coming weeks.
In its announcement about the status of pediatric Covid vaccines, the FDA said it aims to complete regulatory review of vaccines “as quickly as possible, likely a matter of weeks rather than months.” But that speedy review will depend on the timeliness and completeness of the submitted from companies.
The FDA said it wants to see a follow-up period of about two months for at least half of the clinical trial participants in order to monitor for safety. The FDA had asked the same for the three vaccines currently authorized in adults. After that follow up period and completion of the data analysis, the companies can proceed with a regulatory submission, either an emergency use authorization or a biologics license application (BLA) seeking full approval. The Pfizer/BioNtech vaccine is the only one that has full FDA approval, an August decision that covers those 16 and older.
The FDA left the door open for a meeting of the Vaccines and Related Biological Products Advisory Committee, the same independent body of clinicians and health experts that provided input for the three authorized vaccines. Such a hearing was not required for the authorization of the Pfizer/BioNTech vaccine in those age 12 to 16. But the vaccine tested in that age group was the same dose that was tested in adults. The FDA noted that pediatric clinical trials are assessing the need for different doses or different strengths of the vaccines that are already available for adults.
In other Covid-19 vaccine, drug, and diagnostics news from the past week…
- Kaleido Biosciences received an FDA warning letter for its experimental microbiome product, which the company has been evaluating as a way to supplement the care of Covid-29 patients. The regulator said that the company conducted a clinical trial without submitting an investigational new drug application. The company contends it did not need to make that filing because its product is a medical food, not a drug.
- Brii Biosciences said it would commit $100 million toward regulatory filings and commercialization of its combination antibody drug. The announcement followed the company’s recent report of encouraging Phase 3 clinical data, a 78% reduction in the relative risk of hospitalization and non-hospitalized death compared to a placebo.
- Not all Covid antibody drug candidates are faring well. The FDA declined Humanigen’s emergency use authorization request for lenzilumab, a drug it developed as a treatment for the cytokine storm immune response that can develop in hospitalized patients. According to the Burlingame, California-based company, the FDA said it was unable to conclude that the drug’s benefits outweigh its known and potential risks.
- Drug manufacturing company National Resilience struck an agreement with Moderna to manufacture drug substance for the biotech’s messenger RNA vaccine. No terms were disclosed. Resilience said it will make the drug substance at its Mississauga, Ontario for global distribution.
- The Bill & Melinda Gates Foundation’s strategic investment fund is taking a $35 million equity stake in Exscientia to begin a partnership focused on developing new antivirals. The alliance will focus initially on developing broad-spectrum coronavirus drugs. Exscientia uses artificial intelligence to discover, design, and develop drugs. The company will match the Gates Foundation’s investment through operations and funding for third-party work.
- In a move to expand its portfolio of PCR tests, Roche struck a deal to acquire TIB Molbiol Group, a developer of assays for infectious diseases. The two companies have collaborated for more than 20 years, and Roche said the purchase follows TIB Molbiol’s quick work developing SARS-CoV-2 detection tests in the pandemic’s early days.
Photo: Bill Oxford, Getty Images
