US FDA pauses Novavax's trial of combo flu shot on safety concerns
Updates shares in paragraph 2
Oct 16 (Reuters) -The U.S. Food and Drug Administration has put Novavax's NVAX.O trial of an experimental COVID-flu vaccine combination on hold after one person who received the shot reported nerve damage, the company said on Wednesday.
Shares of the vaccine maker plunged about 20% to $10.13 in early trading.Novavax said it was working with the FDA to resolve the clinical hold on the trial of its combination shot and the standalone flu vaccine.
A participant enrolled in a mid-stage study of the vaccine reported symptoms of motor neuropathy, or damage to the nerve cells that control muscles or movement, last month.
The company said other trials of COVID-19 and flu vaccines had not shown any safety signal for motor neuropathy. It did not believe that it was established that the vaccine had caused the safety event, but was working to provide more information to the FDA.
"Our goal is to successfully resolve this matter and to start our Phase 3 trial as soon as possible," said Robert Walker, the company's chief medical officer.
Novavax's protein-based COVID vaccine is the biotech's only commercial product. The shot has failed to make a significant dent in the market share of early COVID-vaccine entrants such as Pfizer/BioNTech PFE.N, 22UAy.DE and Moderna MRNA.O.
In May, Novavax signed a licensing deal worth at least $1.2 billion with Sanofi, giving the U.S biotech firm much-needed liquidity. It also provided the French drugmaker a license to co-sell Novavax's vaccine in most countries and use the COVID shot along with its own flu vaccines to develop a combination shot.
Reporting by Bhanvi Satija and Leroy Leo in Bengaluru; Editing by Arun Koyyur and Anil D'Silva
Aloqador aktivlar
Eng oxirgi yangiliklar
Javobgarlikdan voz kechish: XM Group korxonalari har biri faqat ijro xizmatlarini koʻrsatadi va onlayn savdo platformamizdan foydalanish huquqini beradi, bu odamga veb-saytda yoki veb-sayt orqali mavjud boʻlgan kontentni koʻrish va/yoki undan foydalanishga ruxsat beradi hamda uni oʻzgartirishga moʻljallanmagan va uni oʻzgartirmaydi yoki kengaytirmaydi. Bunday kirish va foydalanish huquqi doimo quyidagilarga boʻysunadi: (i) Shartlar va qoidalar; (ii) Risklar haqida ogohlantirish; va (iii) Javobgarlikni toʻliq rad etish. Shuning uchun bunday kontent umumiy maʼlumot sifatida taqdim etiladi. Xususan, shuni esda tutingki, bizning onlayn savdo platformamiz mazmuni moliyaviy bozorlarda biror bitimni amalga oshirishga oid maslahat yoki taklif emas. Har qanday moliyaviy bozorda savdo qilish sizning kapitalingiz uchun jiddiy risk darajasini oʻz ichiga oladi.
Onlayn savdo platformamizda chop etilgan barcha materiallar faqat taʼlim/axborot maqsadlari uchun moʻljallangan va unda moliyaviy, investitsiya soligʻi yoki savdo maslahatlari va tavsiyalar; yoki bizning savdo narxlarimizning qaydlari; yoki har qanday moliyaviy vositalar bilan bitim tuzish maslahati yoki taklifi; yoki sizga kerak boʻlmagan moliyaviy reklama aksiyalari hisoblanmaydi
Har qanday uchinchi tomon kontenti, shuningdek XM tomonidan tayyorlangan kontent, masalan: fikrlar, yangiliklar, tadqiqotlar, tahlillar, narxlar va boshqa maʼlumotlar yoki bu veb-saytda joylashgan uchinchi tomon saytlariga havolalar umumiy bozor sharhi sifatida "boricha" taqdim etiladi va investitsiya maslahatini tashkil etmaydi. Har qanday kontent investitsiya tadqiqoti sifatida talqin qilinsa, siz bunday kontentni investitsiya tadqiqotlarining mustaqilligini ragʻbatlantirish uchun moʻljallangan qonun talablariga muvofiq moʻljallanmagan va tayyorlanmaganligini eʼtiborga olishingiz va qabul qilishingiz kerak, shuning uchun unga tegishli qonunlar va qoidalarga muvofiq marketing kommunikatsiyasi sifatida qaraladi. Mustaqil boʻlmagan investitsiya tadqiqoti va yuqoridagi maʼlumotlarga oid risk haqida ogohlantirishimizni oʻqib chiqqaningizga va tushunganingizga ishonch hosil qiling, unga bu yerdan kirish mumkin.
