As more supplies of PVizer-BioNTech and Moderna COVID-19 vaccines arrive, many states expand their coverage beyond the elderly and reach the crowd of 65 people. This wider release has created some problems for the clinical trials of other experimental photographs.
The Novavax Phase 3 trial of its COVID-19 NVX-CoV2373 candidate received dropout requests from some participants age 65 or older because New York said it now vaccinates people in that age group, reported The Washington Post.
A Long Island doctor told the Post that the trial site he managed had received a “significant” number of calls asking not to be blinded by the study and that recruitment was becoming increasingly difficult because ” once people over the age of 65 became less interested ”.
For Phase 3 Prevent-19, a Novavax trial launched in late December, Maryland Biotechnology aims to enroll up to 30,000 volunteers at approximately 115 sites in the US and Mexico. Of these, at least 25% of people are intended to be 65 years of age or older, a group at higher risk of severe COVID-19.
In a statement, Novavax said the WaPo article did not match his actual experience. “Prevention-19 phase 3 of the clinical trial continues to register participants at a strong pace, with over 11,000 people enrolled, with less than 1% requesting not to be blind so far,” the company said.
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Within the age group of 65 years or more, these people now represent about 20% of those enrolled, with a slightly higher dropout rate of 2%.
“Prevent-19 is overwhelmed and we expect it [to] they have many more enrollees than necessary to demonstrate effectiveness, ”the company added.
The company has a separate study from the UK, which has already completed the enrollment of more than 15,000 participants, with a data reading expected in the first quarter, according to a presentation by the company at the JP Morgan Healthcare Conference last week. Approximately 27% of the volunteers in this phase 3 study are 65 years of age or older. The company confirmed that the schedule for reading the data remains unchanged.
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Unlike the mRNA technology used in Pfizer-BioNTech and Moderna photographs, Novavax candidate uses a technical version of the spike protein of the new coronavirus delivered on a nanoparticle formulation and adds the company’s proprietary adjuvant, Matrix M, to boost the immune response. The protein-adjuvant system is a well-established vaccine approach compared to mRNA, which has just seen its first product for widespread use in Pfizer-BioNTech’s Comirnaty (BNT162b2).
While mRNA photos must be transported in ultracold conditions, Novavax said the NVX-CoV2373 is stable at normal refrigeration temperatures of about 2 degrees to 8 degrees Celsius.
The Novavax Phase 3 study in the US has already been delayed because it worked to eliminate manufacturing details with the FDA, which asked the company to produce the Phase 3 clinical supply using commercial-scale processes and facilities.
The company, with the help of Operation Warp Speed, has established a global supply chain and expects to have an annual capacity of over 2 billion doses starting this year. Its bulk drug production partners include Fujifilm, Baxter BioPharma and SK Bioscience in Korea.