FDA decides to suspend clinical trial due to safety issues
Moderna is the fastest… Phase 3 positive results
The development of Novavax‘s combined COVID-19/flu vaccine has been put on hold.
According to the pharmaceutical industry on the 18th, the U.S. Food and Drug Administration (FDA) decided on the 16th (local time) to suspend the clinical trial plan application for Novavax’s COVID-19/influenza (flu) combination vaccine and influenza-only vaccine candidates.
This clinical hold is due to a serious adverse event (SAE) of motor neuropathy, a nerve disease that controls muscles, reported in one phase 2 participant outside the United States who received the vaccine in January last year. The clinical trial ended in July of last year.
The clinical hold could affect the timing and data of Phase 3 clinical trials of the combination vaccine.
“We do not believe causality has been established for this adverse event, but we will work quickly to fulfill the FDA’s request for additional information,” said Dr. Robert Walker, Novavax’s chief medical officer. “The plan is to start phase 3 as soon as possible,” he said.
A combo vaccine that can simultaneously prevent COVID-19 and the flu is expected to have great benefits in this multi-demic era. There are expectations that it will cause a paradigm shift if released, but development is difficult and research data from each pharmaceutical company is conflicting.
The mRNA (messenger ribonucleic acid)-based influenza/COVID-19 combination vaccine being developed by Pfizer of the U.S. and BioNTech of Germany also achieved one of the main goals of clinical trials in August, but failed to achieve the other, leaving homework to be done.
Moderna in the U.S. announced in June that it had confirmed positive results from clinical trials of its combination vaccine, and is expected to speed up commercialization. In the phase 3 trial of ‘mRNA-1083’, the primary evaluation indicators were met and the combined vaccine was found to induce a higher immune response than the existing licensed vaccine.
mRNA-1083 consists of components of Moderna’s influenza vaccine candidate mRNA-1010 and COVID-19 vaccine candidate mRNA-1283.
At the time, Moderna CEO Stephane Bancel said, “We need to consult with regulators, but our goal is to get approval in the fall of 2025.”
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