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 65s crowd. This broader deployment has caused problems for clinical trials on other experimental shots.
Novavax’s Phase 3 trial of its COVID-19 candidate NVX-CoV2373 has received dropout requests from some participants aged 65 and older because New York has said it is vaccinating people of that age group now, reports The Washington Post.
One Long Island doctor told the Post that the pilot site he runs has received a “significant” number of calls to dazzle the study and that recruitment is becoming increasingly difficult as “people over the age of 65 suddenly become less interested. “
For the Phase 3 Prevent-19 trial launched by Novavax in late December, Maryland Biotechnology aims to enroll up to 30,000 volunteers at approximately 115 sites in the U.S. and Mexico. Of these, at least 25% of people are meant to be 65 years or older, a group at higher risk for severe COVID-19.
In a statement, Novavax states that the WaPo article does not match its actual experience. “Prevent-19 Phase 3 clinical trial continues to recruit participants at a rapid pace with more than 11,000 individuals enrolled, with less than 1% having so far requested to go unblinded,” the company said.
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Within the age group 65 or older, these people now make up about 20% of the entries, with a slightly higher percentage of dropout requests at 2%.
“Prevent-19 is overwhelmed, and we expect [to] has far more entries than are needed to show efficiency, ”the company added.
The company does have a separate trial in the UK, which has already enrolled more than 15,000 participants, with a data readout expected in the first quarter, according to a presentation by the company during the JP Morgan Healthcare conference last week. About 27% of the volunteers in the phase 3 trial 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 a designed version of the new coronavirus’ peak protein delivered on a nanoparticle formulation, adding the company’s own additive Matrix M to improve the immune response. The protein supplement system represents an established vaccination approach compared to mRNA, which has just seen its first product for widespread use in Pfizer-BioNTech’s Comirnaty (BNT162b2).
While the mRNA shots need to be transported under ultra-cold conditions, Novavax said the NVX-CoV2373 is stable at normal cooling temperatures of about 2 degrees to 8 degrees Celsius.
Novavax’s Phase 3 US trial was already delayed as it worked to iron out manufacturing details at the FDA, which asked the company to manufacture the Phase 3 clinical stock using commercial-scale processes and facilities.
With the help of Operation Warp Speed, the company has established a global supply chain and expects to have an annual capacity of more than 2 billion doses from this year. Its bulk drug manufacturing partners include Fujifilm, Baxter BioPharma and Korean SK Bioscience.