As more supplies of authorized COVID-19 vaccines from Pfizer-BioNTech and Moderna arrive, many states are expanding their reach beyond the elderly and the population over 65. This broader implementation created some problems for the clinical trials of other experimental injections.
Novavax’s phase 3 trial of its candidate COVID-19 NVX-CoV2373 received withdrawal requests from some participants aged 65 and over, as New York said it is vaccinating people of that age group, The Washington Post reported.
A Long Island doctor told the Post that the trial site he administered received a “significant” number of calls asking not to be blind to the study and that recruitment is getting more difficult because “suddenly, people over 65 years were less interested. “
For the Prevent-19 phase 3 study, Novavax launched in late December, Maryland biotech plans to enroll up to 30,000 volunteers at about 115 locations in the US and Mexico. Of these, at least 25% of people are 65 years of age or older, a group at higher risk for severe COVID-19.
In a statement, Novavax said the WaPo article did not correspond to his real experience. “The Prevent-19 phase 3 clinical trial continues to enroll participants at a robust pace, with more than 11,000 individuals enrolled, with less than 1% requesting the non-blind so far,” said the company.
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In the age group of 65 and over, these people now represent about 20% of those enrolled, with a slightly higher rate of abandonment requests, at 2%.
“Prevent-19 is defeated, and we hope [to] it has many more subscribers than necessary to demonstrate effectiveness ”, added the company.
The company has a separate test in the UK, which has completed registration for more than 15,000 participants, with a data reading expected 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 study are 65 or older. The company confirmed that the time for reading the data remains the same.
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Unlike the mRNA technology used in the Pfizer-BioNTech and Moderna shots, the Novavax candidate uses a engineered version of the new peak coronavirus protein delivered in a nanoparticle formulation and adds the company’s proprietary adjuvant, Matrix M, to increase the immune response. The protein-adjuvant system represents 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 the mRNA shots must be carried in ultracold conditions, Novavax said his NVX-CoV2373 is stable at normal refrigeration temperatures of around 2 degrees to 8 degrees Celsius.
Novavax’s phase 3 test in the United States has already been postponed as it was working to work out the 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 more than 2 billion doses starting this year. Its bulk drug manufacturing partners include Fujifilm, Baxter BioPharma and SK Bioscience from Korea.