As more supplies of Pfizer-BioNTech and Moderna’s authorized COVID-19 vaccines arrive, many states are expanding their reach beyond the elderly and into the over-65s. That wider rollout has caused some problems for clinical trials with other experimental shots.
Novavax’s Phase 3 study of its COVID-19 candidate NVX-CoV2373 has received dropout requests from some participants 65 or older, as New York said it now vaccinates people of that age group, The Washington Post reported.
A physician in Long Island told the Post that the trial site he was managing has received a “significant” number of calls requesting to be unblinded from the trial and that recruitment is becoming more difficult because “suddenly the over-65s became less interested.”
For the Phase 3 Prevent-19 trial that Novavax launched in late December, the Maryland biotech plans to enroll up to 30,000 volunteers at approximately 115 sites in the US and Mexico. Of those, at least 25% of people are intended to be 65 or older, a group at higher risk of severe COVID-19.
In a statement, Novavax said the WaPo article does not match the actual experience. “Prevent-19 Phase 3 clinical trial continues to enroll participants at a robust rate with more than 11,000 enrolled individuals, of which less than 1% have requested to be unblinded to date,” the company said.
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Within the age group 65 or older, these people now make up about 20% of the enrollees, with a slightly higher percentage of dropout requests, namely 2%.
“Prevent-19 is being overwhelmed, and we expect [to] have far more registrants than is necessary to demonstrate efficacy, ”the company added.
The company does have a separate UK trial, already completed with over 15,000 attendees, with a readout of the data in the first quarter, according to a company presentation at the JP Morgan Healthcare Conference last week. About 27% of the volunteers in that phase 3 study are 65 or older. The company confirmed that the timing for reading the data remains unchanged.
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Unlike the mRNA technology used in the Pfizer-BioNTech and Moderna shots, the Novavax candidate uses an engineered version of the novel coronavirus spike protein that is delivered on a nanoparticle formulation, adding the proprietary adjuvant of the company, Matrix M, to boost the immune response. The protein adjuvant system represents an established vaccine approach compared to mRNA, which just saw its first product of widespread use in Pfizer-BioNTech’s Comirnaty (BNT162b2).
Although the mRNA images must be transported in ultra-cold conditions, Novavax has said that the NVX-CoV2373 is stable at normal cooling temperatures of about 2 degrees to 8 degrees Celsius.
Novavax’s Phase 3 US trial had already been delayed because it worked to smooth out manufacturing details with the FDA, which has asked the company to produce the Phase 3 clinical facility using commercial-scale processes and facilities.
The company, with help from Operation Warp Speed, has established a global supply chain and expects to have an annual capacity of more than 2 billion doses as of this year. Its bulk drug manufacturing partners are Fujifilm, Baxter BioPharma and SK Bioscience from Korea.