• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
    • Cardiovascular
    • Orthopedics
  • Wall Street Beat
    • Funding Roundup
    • Mergers & Acquisitions
  • Podcasts
    • DeviceTalks Weekly
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Job Board
    • Leadership in Medtech
    • Manufacturer Search
    • MedTech 100 Index
    • Videos
    • Whitepapers
  • DeviceTalks Tuesdays
    • DeviceTalks
  • Coronavirus: Live updates
Home » Report: FDA expanding AstraZeneca vaccine probe

Report: FDA expanding AstraZeneca vaccine probe

October 1, 2020 By Sean Whooley

AstraZenecaThe U.S. FDA is reportedly expanding its probe into a serious illness arising in the COVID-19 vaccine study from AstraZeneca (NYSE:AZN).

This news, reported by Reuters, follows last week’s statement from U.S. Health and Human Services Dept. Secretary Alex Azar that federal investigators are looking for “answers to important questions,” regarding the safety of patients involved in the trial operated by the United Kingdom-based company in collaboration with Oxford University.

In September, AstraZeneca voluntarily paused the U.S. trial after a standard review process was triggered so an independent committee could review safety data surrounding an unexplained illness that occurred in the UK Phase III trial for the AZD1222 vaccine candidate. The UK trial has since resumed, but the U.S. study remains on hold.

According to the Reuters report, that illness was believed to be a rare spinal inflammatory disorder known as transverse myelitis. The expanded investigation will reportedly observe data from earlier trials of similar vaccines developed by the same scientists.

The broadened investigation increases the possibility that the vaccine candidate could be delayed, with requested data expected to arrive this week, which would be followed by analysis from the FDA, Reuters reported. A source told the outlet that the FDA’s probe is not necessarily related to a belief that safety issues are related to the vaccines, but rather an indication that the administration is “being thorough.”

Oxford did not respond to Reuters’ request for comment, while the FDA declined to offer comment to the outlet on an experimental project.

In an emailed statement to MassDevice, an AstraZeneca spokesperson wrote:

“A standard review process triggered a voluntary pause to vaccination across all global AZD1222 trials on September 6 to allow review of safety data by an independent committee of a single event of an unexplained illness in one of the participants. Upon review of the independent committee’s recommendations, health authorities in the UK, Brazil and South Africa have confirmed trials in these countries are safe to resume.

“Regulators in each individual country determine when trials can start and they do this in their own time frame. We are continuing to work with the FDA to facilitate review of the information needed to make a decision regarding resumption of the US trial.”

The FDA did not responded to an additional request for comment from MassDevice.

AstraZeneca was one of nine companies whose CEOs signed a pledge last month which vowed to “uphold the integrity of the scientific process” as they pursue regulatory approvals of the first COVID-19 vaccines. The company has received $1.2 billion in government funding to develop the vaccine and deliver 300 million doses for the U.S.

 

This story was updated with a statement from AstraZeneca and may be updated further.

Filed Under: Clinical Trials, Featured, Pharmaceutical, Research & Development Tagged With: AstraZeneca plc, coronavirus, COVID-19, FDA

In case you missed it

  • The top 5 pharma firms by reputation
  • Famed marathoner uses Abbott glucose sensor for training
  • Medical device companies put $3.6 billion in docs’ pockets, study finds
  • DiaSorin to buy Luminex for $1.8B
  • Genentech wins FDA approval for Xolair prefilled syringe
  • FDA slaps Class I label on rapid infuser recall
  • Microsoft spending $19.7B on Nuance and its AI for healthcare providers
  • Memic raises $96M to support surgical robot with humanoid-shaped arm
  • Heater-Cooler suit against LivaNova revived
  • Cardiovascular Systems completes minority investment in CarePICS with option to buy
  • Zoll Medical acquires Respicardia
  • Medtronic has a serious recall of ICDs and CRT-Ds
  • Lyra Therapeutics touts results from chronic rhinosinusitis treatment trial
  • FDA issues EUA for single-use, OTC PCR COVID-19 at-home test
  • AI-aided colon cancer tech gets FDA nod
  • MedTech 100 roundup: Industry roars back
  • DTW Podcast: Herrera on how military lessons led to Medtech career; Ulmer ready to redo landmark FDA survey

RSS From Medical Design & Outsourcing

  • Medical device companies put $3.6 billion in docs’ pockets, study finds
    Medtech companies paid $3.62 billion for access to physicians — 10% more than drug companies did — from 2014 to 2017, according to new research. Device company payments to surgical specialists were significantly more tied to the surgeons’ Medicare billing than payments from drug companies to specialists, according to the study, which appears in the… […]
  • FDA slaps Class I label on rapid infuser recall
    The FDA today declared that the recall of an emergency infusion device kit is the most serious type. The recall covers three models of disposable sets made by Smisson-Cartledge Biomedical for its ThermaCor 1200 rapid infuser, which is used for fluid or bolus delivery. The system is made of a footswitch for hands-free fluid control,… […]
  • Cretex breaks ground on new plant north of Minneapolis
    Cretex Cos. last week broke ground on a new 245,000 ft2 medical device contract manufacturing plant in Brooklyn Park, Minn. Elk River, Minn.–based Cretex plans to complete facility construction by the end of the year. The company expects the facility by the end of 2022 to house its stamping, molding and tool design — and… […]
  • Resonetics to expand manufacturing in Costa Rica
    Resonetics announced today it has leased new manufacturing space in Costa Rica to more than double its production there. The space, in a building near its current site in the Coyol Free Zone business park in Alajuela, will be expanded and reconfigured to create a 45,000 ft² production site. The move comes after the company… […]
  • Are Black patients not getting LVADs as quickly as white patients?
    Researchers from the University of Missouri conducted a study that found disparities in treating Black and white patients with advanced heart failure. According to a news release, the study found that Black patients with advanced heart failure were more likely to receive a left ventricular assist device (LVAD) — a pump implanted into the chest… […]
  • Viant expands factory in Costa Rica
    Viant announced today that it has completed a major expansion of its medical device manufacturing facility in Heredia, Costa Rica. The company said it invested in the additional capacity to meet market demand for minimally invasive surgical devices, including energy-based devices. Begun in fall 2020, the expansion adds 14,000 ft² of ISO Class 8 cleanroom… […]
  • St. Jude Medical founder and his Medical 21 raise $3M
    Raising money for a startup company during a pandemic is no cakewalk, according to Manny Villafaña. But he did it. Medical 21, the latest venture for the founder of St. Jude Medical, has raised another $3 million in an equity offering, according to an SEC filing. The most recent round brings the Minneapolis-based startup’s total funding… […]
  • How can patient input improve clinical trials?
    The Medical Device Innovation Consortium (MDIC) has laid out some recommendations for improving medical device clinical trials with increased patient input. Having observed that clinical trial sponsors seldom refer to patient input — something the FDA issued guidance for in September 2019 — MDIC offered its view on increasing and using patient input to improve… […]
  • Orchid names new CFO
    Orchid Orthopedic Solutions (Holt, Mich.) announced this week that Matt Tharp has joined the company as chief financial officer. Tharp comes to Orchid from Ammega, where he held the role of CFO – Americas. He has more than 20 years of experience in supply chain, operations and finance and has held leadership roles at Midwest… […]
  • ICS establishes dedicated medical device practice
    Integrated Computer Solutions (ICS) is establishing a dedicated medical device practice amid increased demand for complex medtech. ICS said its work in the medical and life sciences markets has nearly doubled year-over-year as connected technologies drive innovation and transform healthcare. “There has been extraordinary innovation and growth in the medtech sector in recent years which… […]
  • SMC is expanding its Costa Rica facility
    SMC (Somerset, Wis.) recently announced that it will double the size of its Alajuela, Costa Rica facility to 120,000 ft2 this year. The additional space will enable SMC Costa Rica to provide increased contract manufacturing solutions, including assembly, injection molding and secondary operations. SMC plans to double the number of workers it has in the Central… […]

Primary Sidebar

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Medtech news in a minute?
We Deliver!

MassDevice Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

Tweets by @MassDevice
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion

MASSDEVICE

Subscribe to MassDevice
Advertise with us
About
Contact us

Add us on Facebook Follow us on Twitter Connect with us on LinkedIn Follow us on YouTube

Copyright © 2021 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy | RSS