The Moderna Covid-19 vaccine currently authorized for those 18 and older now has clinical trial results demonstrating efficacy in adolescents, data that the company said supports expanding use of the two-shot regimen to the younger age group.
Cambridge, Massachusetts-based Moderna said Tuesday it plans to submit regulatory filings early next month to health agencies globally seeking authorization of the messenger RNA vaccine in the 12 to 18 age group. Expansion of emergency use of the Moderna vaccine would provide another option for children, following the FDA’s authorization of the Pfizer/BioNTech Covid vaccine for those ages 12 to 15 in early May. Clinical trials evaluating both mRNA vaccines in children younger than 12 are currently enrolling patients.
The Moderna vaccine results announced Tuesday were from a Phase 2/3 study that enrolled more than 3,700 volunteers between the ages of 12 and 18. Those participants were randomly assigned to receive to receive either the Moderna vaccine or a placebo in two shots given 28 days apart. The main goal was to show an immune response over time that was no worse than the effect observed in Phase 3 tests of the vaccine in adults.
According to preliminary data from Moderna, after two doses, no Covid-19 cases were observed in the vaccine group compared to four cases reported in the placebo group. Cases were defined as patients having at least two of the symptoms characteristic of the disease and at least one positive test—the same definition that was used in the Phase 3 study that tested the vaccine in adults. Based on that definition, the vaccine was 100% effective starting 14 days after the second dose.
However, the lower Covid-19 incidence rate in children led the company to account for cases with milder symptoms. Therefore, clinical trial participants were also evaluated according to the CDC’s definition of Covid-19 cases, which requires only one symptom of the disease and a positive test. Based on that definition, after 14 days of a single shot of the vaccine, the efficacy rate in the younger group was 93%. Moderna said it plans to submit the clinical trial data to a peer-reviewed publication.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The Moderna vaccine was generally well tolerated by adolescents, leading to side effects consistent with what was observed in adults, according to the company. Those side effects included injection-site pain, fatigue, chills, and headache, which is consistent with the other Covid vaccines. Those problems were classified as mild to moderate and no major safety problems were reported.
The FDA has scheduled a June 10 meeting of the Vaccines and Related Biologics Products Advisory Committee to discuss the agency’s approach to authorizing Covid vaccines for adolescents. The meeting will also cover vaccination in children age 11 and younger. The virtual meeting will be open to the public, and the FDA is accepting electronic or written comments. Comments received by June 3 will be given to committee members. Any comments submitted after that date will be taken into consideration by the FDA. The agency has said that the committee will not be discussing specific products at the meeting.
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