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As more and more stocks of authorized COVID-19 vaccines from Pfizer-BioNTech and Moderna arrive, many states are expanding their reach beyond the elderly and those over 65. This wider deployment created problems for the clinical trials of other experimental images.
Novavax’s Phase 3 trial on its COVID-19 candidate NVX-CoV2373 has received discontinuation requests from participants 65 years of age or older, as New York has said it is now vaccinating people in that group of age, The Washington Post reported.
A doctor from Long Island told the Post that the trial site he ran had received a “significant” number of calls asking to no longer be blinded from the study and that recruitment was growing. difficult because “suddenly, people over 65 have become less interested”.
For the phase 3 Prevent-19 trial that Novavax launched in late December, the Maryland biotech aims to recruit up to 30,000 volunteers at around 115 sites in the United States and Mexico. Of these, at least 25% of people are believed to be 65 or older, a group that is at higher risk for severe COVID-19.
In a statement, Novavax said the WaPo article does not reflect his actual experience. “The Prevent-19 Phase 3 clinical trial continues to enroll participants at a sustained rate with more than 11,000 people enrolled, less than 1% of whom have requested to be terminated blind to date,” the company said.
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Within the 65 and over age group, these people now represent about 20% of registrants, with a slightly higher dropout rate of 2%.
“Prevent-19 is overkill and we are planning [to] have many more registrants than necessary to demonstrate their effectiveness, ”the company added.
The company has a separate trial in the UK, which has already completed 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. About 27% of the volunteers in this phase 3 trial are 65 years of age or older. The company has confirmed that the timing of this data reading remains unchanged.
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Different from the mRNA technology used in the Pfizer-BioNTech and Moderna injections, the Novavax candidate uses a technical version of the advanced protein of the novel coronavirus delivered on a formulation of nanoparticles, and adds the company’s proprietary adjuvant, Matrix M, to improve the immune response. The protein-adjuvant system represents a well-established vaccine approach over mRNA, which has just seen its first product for widespread use in the Pfizer-BioNTech Comirnaty (BNT162b2).
While mRNA injections must be transported under ultra-cold conditions, Novavax said its NVX-CoV2373 is stable at normal refrigeration temperatures of around 2 to 8 degrees Celsius.
Novavax’s Phase 3 trial in the United States has already been delayed as it worked to fine-tune manufacturing details with the FDA, which asked the company to produce the Phase 3 clinical supply using processes and commercial scale installations.
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 as of this year. Its bulk drug manufacturing partners include Fujifilm, Baxter BioPharma and SK Bioscience in Korea.
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