实验参与者报告了运动神经病变的症状，即控制肌肉或运动的神经细胞受损。诺瓦瓦克斯指出，流感/新冠联合疫苗的其他试验没有显示出任何导致运动神经病变的安全信号，他们不相信疫苗与患者的神经损伤有既定的联系，但正在努力向FDA提供更多信息。After a severe motor neuropathy event occurred in a trial participant, the Food and Drug Administration (FDA) of the USA suspended the company's "influenza/COVID-19 combination vaccine" clinical trial. Novavax claims to be working with the FDA to address the clinical hold on its combination vaccine and stand-alone influenza vaccine trials.
On Wednesday, Eastern Time, the American vaccine manufacturer $Novavax (NVAX.US)$ announced that after a trial participant experienced a severe motor neuropathy event, the Food and Drug Administration (FDA) of the USA suspended the company's "influenza/COVID-19 combination vaccine" clinical trial. This news led to Novavax's stock price plunging by more than 20%. As of the close, $Novavax (NVAX.US)$ dropped by 19.44%, to $10.15.
In addition to the influenza/COVID-19 combination vaccine, another standalone influenza candidate vaccine's new drug application has also been halted by the FDA. It is reported that the phase 2 trial of Novavax's influenza/COVID-19 combination vaccine was completed in July 2023, but trial participants reported severe adverse events in September of this year.
The trial participants reported symptoms of motor neuropathy, where neurons controlling muscles or movements are damaged. Novavax points out that no other trials of the influenza/COVID-19 combination vaccine have shown any safety signals leading to motor neuropathy. They do not believe there is an established connection between the vaccine and the patients' nerve damage, but are working to provide more information to the FDA.
Novavax claims that it is working with the FDA to address the clinical hold on its combined vaccine and standalone influenza vaccine trials.
Chief Medical Officer of Novavax, Robert W. Walker, stated: 'Our goal is to successfully resolve this issue and start our phase 3 trial as soon as possible.'
It is not yet clear how much of an impact this will have on Novavax's combined influenza/COVID-19 vaccine, but it is undoubtedly a major setback. As global demand for its COVID-19 vaccine sharply declines, the company is rushing to bring new products to the market.
Reportedly, Novavax's recombinant protein vaccine is the company's only commercial product. Just last month, the FDA approved Novavax's updated COVID-19 vaccine to better address the current prevalent strains and provide more options for Americans.
Public health officials believe that for those who do not want to receive mRNA COVID-19 vaccines, Novavax's protein-based COVID-19 vaccine offers another valuable option.
The Centers for Disease Control and Prevention (CDC) in the USA recently advised that now is the best time to receive all recommended vaccines as flu season is approaching. Therefore, it is recommended that people receive the latest version of the COVID-19 vaccine and the influenza vaccine, as this is the best way to protect themselves.
Currently, Cisco, Fujitsu, LM Ericsson Telephone, Nokia Oyj, HPE, NEC, Juniper Networks, Ciena, Volkswagen, and Western Digital are in the project. In addition, there are several larger projects underway: 1) Amazon Inferentia ASIC, expected to launch in 2025; 2) Microsoft Maia, expected to launch in 2026.$Pfizer (PFE.US)$and $Moderna (MRNA.US)$ The flu/covid combination vaccine has entered the late-stage trials, but pfizer's combination vaccine has performed poorly in late-stage trials, which may delay its launch.
Editor/Rocky
