Novavax delays U.S. COVID-19 vaccine trial again, now sees start in the coming weeks

▴ Novavax delays U.S. COVID-19 vaccine trial again, now sees start in the coming weeks
Vaccine maker Novavax Inc said on Monday it has pushed back the start of a U.S.-based, late-stage trial for its experimental COVID-19 vaccine and now expects it to begin in the coming weeks instead of November.

Vaccine maker Novavax Inc said on Monday it has pushed back the start of a U.S.-based, late-stage trial for its experimental COVID-19 vaccine and now expects it to begin in the coming weeks instead of November.

It is the second time that Novavax, which already has a late-stage UK trial underway, has rescheduled the Phase 3 trial after first flagging an October start, hampered by issues in scaling up it's manufacturing.

Novavax plans to use vaccine material produced at a commercial scale for the trial in the United States and Mexico and has been working closely with the U.S. Food and Drug Administration to greenlight the use of the vaccine made at a North Carolina plant.

The company also said it has completed enrollment for its 15,000 participant UK trial and expects interim data as soon as the first quarter of 2021.

It has previously said that the UK trial could be the basis for some global regulatory approvals.

More than 25% of enrollees in the UK trial are over the age of 65, while a large proportion of volunteers had underlying co-morbid medical conditions generally representative of the population.

Novavax is also running a fully enrolled Phase 2b trial in South Africa, which has 4,400 volunteers including 245 who are medically stable, HIV-positive participants. Efficacy data from that trial could also be available in the first quarter of next year.

Tags : #NewYork #UnitedStates #Novavax #Covid19Vaccine #Covid19 #CoronaVirus #USFDA #UKTrial #PhaseIIITrial #HIV-PositivePatients

Related Stories

Loading Please wait...

-Advertisements-




Trending Now

Cipla Eyes Eli Lilly Partnership to Tap Growing Demand for Obesity Drugs in IndiaMay 13, 2024
Setback for Organ Transplantion: First Human to Receive Pig Kidney DiesMay 13, 2024
Why AstraZeneca is Withdrawing the Covid-19 Vaccine Globally: Explained May 13, 2024
Achieving Healthier Lifestyles: Understanding India's New Dietary GuidelinesMay 11, 2024
The Link Between Childhood Sleep and Adult Psychosis: A Critical AnalysisMay 11, 2024
Uncovering Immunization Gaps: Insights into Measles Vaccination Challenges in IndiaMay 11, 2024
Unlocking New Horizons: Gene Therapies for Hearing Loss and BlindnessMay 10, 2024
Kerala Health Alert: West Nile Fever Cases Confirmed in Thrissur, Malappuram, and KozhikodeMay 10, 2024
Managing Health in the Heat: Demand for Medications Surges in IndiaMay 10, 2024
Sudhamukti Ayurvedic Medicine by OJSP: A New Era in Diabetes ManagementMay 10, 2024
The Role of Genetic Profiles in Alzheimer’s Therapy: APOE4 and Treatment ResponsesMay 08, 2024
Assessing Covishield Safety: Indian Research Offers Reassurance Amidst Rare Side Effect DiscussionsMay 08, 2024
Quadria Capital Invests $102 Million in NephroPlus to Boost Dialysis Services Across AsiaMay 08, 2024
Reducing Stigma, One Story at a Time: Media's Role in Mental HealthMay 07, 2024
When Your Body Makes Beer: Exploring the Curious Case of Auto-Brewery SyndromeMay 07, 2024
Hair Today, Gone Tomorrow: Why Guys Go Bald Before Marriage May 07, 2024
Menopausal Transitions and Mental Health: UCL Study Highlights Increased Depression RiskMay 07, 2024
Vasavi Club of Buddhapurnima organised #GoVote, a vote awareness driveMay 06, 2024
Vasavi Club of Buddhapurnima organised #GoVote, a vote awareness driveMay 06, 2024
Harnessing AI for Early Alzheimer's Disease Diagnosis: IIT Indore's BreakthroughMay 06, 2024