Regulatory Focus™ > News Articles > 2021 > 4 > Asia-Pacific Roundup: TGA investigating death linked to AstraZeneca vaccine

Asia-Pacific Roundup: TGA investigating death linked to AstraZeneca vaccine

Posted 20 April 2021 | By Michael MezherJoanne S. Eglovitch 

Asia-Pacific Roundup: TGA investigating death linked to AstraZeneca vaccine

Australia’s Therapeutic Goods Administration (TGA)’s Vaccine Safety Investigation Group (VSIG) announced that a 48-year-old woman who was vaccinated in New South Wales and admitted to the hospital died four days after receiving the vaccine.
 
The patient died of thrombosis with thrombocytopenia syndrome (TTS), or blood clots in the arteries and veins, that may be linked to the AstraZeneca vaccine. Officials says this is the third Australian report of a case of TTS following administration of the AstraZeneca vaccine.
 
In the latest case, the patient was administered the dose of the vaccine on 8 April, prior to the decision by TGA that the Pfizer vaccine was preferred for patients under the age of 50.
 
TGA says the review of the case has been “complicated” by the patient’s underlying medical conditions, including diabetes, other medical conditions as well as “atypical” features.
 
TGA reported that “despite the atypical clinical features and the negative antibody test, in the absence of an alternative cause for the clinical syndrome, VSIG believed that a causative link to the vaccine should be assumed at this time.”
 
To date, there have been at least 885,000 doses of the AZ vaccine administered. The agency estimates the overall risk of these rare blood clots is equates to a frequency of 1 in 295,000 who receive the vaccine.
 
TGA
 
India offers fast-track path for foreign made COVID vaccines
 
In a notice issued last week, India’s Central Drugs Standard Control Organization (CDSCO) said it will fast-track approvals of COVID-19 vaccines that have been authorized for emergency use by foreign regulators.
 
Under the order, vaccines authorized by the US Food and Drug Administration, UK Medicines and Healthcare products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency (PMDA) or by the World Health Organization via its emergency use listing (EUL) procedure are eligible for an accelerated review.
 
The move comes as India faces a severe second wave of COVID-19 cases and a limited supply of the three vaccines the country has authorized for emergency use: Bharat Biotech’s Covaxin, the Serum Institute of India’s Covishield and Russia’s Sputnik V.
 
To speed access to additional vaccines, India will allow applicants to conduct postapproval parallel bridging clinical trials in place of local clinical trials and make decisions on emergency use within three working days of receiving an application.
 
The notice also calls for a 7-day safety monitoring period for the first 100 recipients of any vaccine given a fast-track emergency approval before the vaccine is distributed more broadly.
 
CDSCO
 
India extends licenses for implantable devices, imaging equipment
 
To ensure continued access, India’s Ministry of Health & Family Welfare is extending the licenses to import or manufacture eight types of medical devices by up to six months for entities that have already submitted applications to central or state licensing authorities.
 
The eight types of devices include all implantable medical devices; CT scan, MRI and PET equipment; defibrillators; dialysis machines; X-ray machines; and bone marrow cell separators. All of the devices are subject to a 2019 notice that designated the devices as drugs as of April 2020.
 
However, importers and manufacturers of the devices have called for additional time to obtain licenses, citing procedural barriers, audits and testing requirements.
 
As such, importers and manufacturers’ existing licenses “shall be deemed valid and the importer/manufacturer can continue to import/manufacture the said device(s) up to 6 months from issue of this order or till the time, the Central Licensing Authority or State Licensing Authority, as the case may be, takes a decision on the said application, whichever is earlier.”
 
CDSCO
 
PMDA establishes RWD working group
 
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) this month stood up a new Real-World Data (RWD) working group in April tasked with overseeing the use of patient registry data and medical information databases for regulatory purposes.
 
The working group includes members from a dozen offices across the agency and is a successor to the agency’s Clinical Innovation Network (CIN) working group.
 
PMDA says the RWD working group will provide clarification on the general principles of RWD utilization and data reliability throughout the product lifecycle. The working group will also be active in disseminating administrative documents related to the use of RWD in Japan and overseas and developing use cases for RWD in regulatory applications.
 
PMDA
 
Other news:
 
China’s National Medical Products Administration (NMPA) announced the cancellation of three medical device registration certificates: Allergan’s silicone gel-filled breast implants, Changchun Bethune Medical Instrument’s disposable precision filter infusion set with a needle and Xuzhou Yijia Medical Equipment’s disposable infusion set with needle.
 
The Pharmacopoeial Discussion Group (PDG) reported that major technical revisions have been made to the chapters on X-Ray powder diffraction and the monograph for croscarmellose sodium, and that 28 of the 31 general chapters and 46 of the 60 excipient monographs on its current work program have been harmonized following recent teleconferences held on 6 November 2020 and 12 March 2021.

Australia’s TGA issued its half yearly performance snapshot for the period 1 July 2020 to 31 December 2020 tracking its progress made in some “priority” areas. The report noted that in the first six months of 2020, travel restrictions prompted by the COVID-19 pandemic required the reprioritization of all scheduled inspections, which resulted in delays of domestic re-inspections and overseas initial and reinspections.

 

© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe