As more supplies of COVID-19 vaccines authorized by Pfizer-BioNTech and Moderna arrive, many states expand their reach beyond the elderly and move on to the crowd over 65 years old. This wider deployment has created some problems for clinical trials of other experimental shots.
Novavax’s Phase 3 trial of its COVID-19 NVX-CoV2373 candidate has received dropout requests from some participants age 65 or older, as New York said it is now vaccinating people in this group. of age, the Washington Post reported.
A Long Island doctor told the newspaper that the test site he managed has received a “significant” number of calls calling for them to stop blinding from the study and that recruitment is becoming more difficult because “of over and over again, people over the age of 65 became less interested. “
For the Novavax Phase 3 prevention trial, launched in late December, Maryland Biotechnology aims to enroll up to 30,000 volunteers in about 115 locations in the U.S. and Mexico. Of these, at least 25% of people are expected to be 65 years of age or older, a group with a higher risk of severe COVID-19.
In a statement, Novavax said the WaPo article did not match his actual experience. “The Prevent-19 Phase 3 clinical trial continues to enroll participants at a solid pace with more than 11,000 people enrolled, and up to 1% apply to be blind so far,” the company said.
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Within the age group of 65 or older, these people now account for approximately 20% of registrants, with a dropout rate slightly above 2%.
“Prevent-19 is over and we are waiting [to] they have many more registered than necessary to demonstrate effectiveness, ”the company added.
The company has an independent trial from the UK, which has already finished enrolling more than 15,000 participants, with a data reading scheduled for the first quarter, according to a presentation by the company at the JP Morgan Healthcare Conference last week. About 27% of the volunteers in this phase 3 trial are 65 years of age or older. The company confirmed that the time for reading the data remains unchanged.
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Unlike the mRNA technology used in Pfizer-BioNTech and Moderna dams, the Novavax candidate uses a designed version of the new peak coronavirus protein supplied in a nanoparticle formulation and adds the proprietary adjuvant of the company, Matrix M, to enhance the immune response. The protein adjuvant system represents a well-established vaccine approach compared to mRNA, which has just seen its first widely used product at Pfizer-BioNTech Comirnaty (BNT162b2).
Although mRNA traits must be transported in ultra-cold conditions, Novavax has said its NVX-CoV2373 is stable at normal cooling temperatures of about 2 to 8 degrees Celsius.
Novavax’s Phase 3 trial in the United States has already been delayed, as it was working to plan manufacturing details with the FDA, which has asked the company to produce the Phase 3 clinical supply through processes and facilities in commercial scale.
The company, with the help of Operation Warp Speed, has established a global supply chain and expects to have an annual capacity of more than 2 billion doses starting this year. Its bulk pharmaceutical manufacturing partners include Fujifilm, Baxter BioPharma and SK Bioscience of Korea.