Regulatory Focus™ > News Articles > 2021 > 3 > Asia-Pacific Roundup: TGA reports positive COVID vaccine safety data, backs use of AstraZeneca jab

Asia-Pacific Roundup: TGA reports positive COVID vaccine safety data, backs use of AstraZeneca jab

Posted 16 March 2021 | By Nick Paul Taylor 

Asia-Pacific Roundup: TGA reports positive COVID vaccine safety data, backs use of AstraZeneca jab

Real-world evidence and monitoring have not detected new safety concerns in Australia’s COVID-19 vaccination campaign, according to a report from the country’s Therapeutic Goods Administration (TGA) which was followed quickly by a statement about international reports of blood clots in recipients of AstraZeneca’s vaccine.
The COVID-19 immunization campaign in Australia is currently fairly small by global standards, with around 164,000 vaccinations as of 14 March. As it stands, TGA is yet to see any new safety signals.
TGA has received reports of the death of vaccine recipients but none of the events are thought to be linked to the jab. As in most other countries, many people vaccinated in Australia so far are older and have pre-existing medical conditions. TGA is continuing to review the deaths, factoring in the individual’s health at the time of vaccination, but the evidence and experience in other countries suggests immunization is unlikely to have played a causal role.
With other countries administering far more vaccines, TGA is reviewing safety reports from its international peers to keep track of potential issues.
TGA noted that it had not yet received reports of blood clots in recipients of COVID-19 Vaccine AstraZeneca at the time of its statement and has not provided an update indicating any have arrived since then. Based on the available evidence, including knowledge that blood clots can occur naturally, TGA has opted to allow vaccinations with the AstraZeneca product to continue.
COVID-19 Vaccine AstraZeneca last month joined Comirnaty (Pfizer/BioNTech) in receiving provisional approval in Australia.
TGA Notice, More

India lifts restrictions on Bharat COVID vaccine after seeing efficacy data

The Central Drugs Standard Control Organization (CDSCO) of India has lifted restrictions imposed in conjunction with the emergency authorization of Covaxin, Bharat Biotech’s COVID-19 vaccine.
CDSCO cleared the vaccine for emergency use before the generation of Phase 3 efficacy data. Given the lack of key evidence on the vaccine at the time of approval, CDSCO only signed off on its use in “clinical trial mode”. The All India Institute of Medical Sciences criticized the term as “ambiguous” but local media reports suggest that in practice it meant recipients needed to sign consent forms.
Now, acting on the recommendation of the COVID-19 expert committee, CDSCO has lifted the clinical trial mode requirements. The action means Covaxin now has the same regulatory status as the AstraZeneca vaccine sold by Serum Institute of India as Covishield. 
The expert committee made the recommendation after reviewing interim efficacy data from a Phase 3 clinical trial of Covaxin. Bharat released the data earlier this month, revealing 36 cases of COVID-19 in the placebo group and seven cases in the Covaxin arm. The interim analysis puts the estimated efficacy of the vaccine at 81%. 
In recommending the end of clinical trial mode, the expert committee told Bharat to continue the Phase 3 as per the protocol. The committee also asked Bharat to update its prescribing information and fact sheet to reflect the change in regulatory status. 
SEC Recommendations

India’s NPPA bows to pressure to change medical device pricing request

India’s National Pharmaceutical Pricing Authority (NPPA) has revised its request for information on the pricing of medical devices after receiving feedback from companies and industry associations.
NPPA made the request last month. At that time, NPPA asked manufacturers and importers of all 24 non-scheduled medical devices to submit price-related information “duly certified by practicing Chartered/Cost Accountant” within 21 days. NPPA last asked producers of non-scheduled devices for pricing information in 2017, at which time 19 types of product were subject to the request.
The request for pricing information on the expanded list of non-scheduled medical devices met with pushback. NPPA received requests to grant the industry more time to submit the information and to waive the requirement for the submissions to be certified by accountants.
After meeting with industry associations last week, NPPA has acquiesced to the requests. Companies now have until 15 April to submit the requested information. NPPA also permitted information to be certified by the chief financial officer of a company, rather than an accountant, but emphasized “that the onus of the authenticity of the data submitted shall rest with the company concerned.”
NPPA Notice

TGA seeks feedback on guide to assessing conformity assessment bodies

TGA has requested feedback on a guide to assessing conformity bodies that review medical devices. The International Medical Device Regulators Forum (IMDRF) created the guidance to harmonize the global premarket review process.
The guidance is part of a series of IMDRF documents intended to “establish a common set of requirements to be used by Regulatory Authorities for the recognition and monitoring of entities that perform regulatory reviews of medical devices.”
In the 34-page draft document, IMDRF discusses the criteria for assessing conformity bodies. IMDRF is proposing that regulatory authorities that identify nonconformities when assessing the bodies use its system to grade the severity of the problem. The most severe grade is reserved for repeat failings and “possible fraud, misrepresentation or falsification of evidence.”
Other topics addressed in the guidance include the formulation of remediation plans by bodies that do not conform to the criteria and the verification of the effectiveness of corrections and corrective actions.
IMDRF is accepting feedback until 19 April.
TGA Notice, IMDRF Guide

Japan’s PMDA releases guidelines on pharmacokinetic models

The Pharmaceuticals and Medical Devices Agency (PMDA) has released English-language guidance on the use of physiologically based pharmacokinetic (PBPK) modeling.
Japan’s PMDA created the guidance, which was published in Japanese late last year, in response to a rise in the use of PBPK models to investigate drug interactions, predict pharmacokinetics in children and determine the optimum dose and regimen. The approach enables drug developers to generate evidence to support marketing authorizations through mathematical models.
To support the appropriate use of analyses, PMDA has created guidance that describes the content of PBPK reports, including details such as the assumptions applicants should report in relation to the methodology.
Through the guidance, PMDA aims to “ensure the consistency of data submitted to the regulatory authority, to facilitate timely decision-making in clinical trial consultations and regulatory reviews, etc., and to standardize the content of PBPK model analysis reports for the appropriate provision of information.” The guidance applies to analyses performed throughout the product lifecycle.
PMDA Guidelines

Other news:

TGA has approved updated storage conditions for Comirnaty, the COVID-19 vaccine developed by Pfizer/BioNTech. The vaccine now can be kept at around -20°C for up to two weeks, including during transportation. The change, which follows a similar action in the US, could make it easier to get the vaccine to communities in remote parts of Australia. TGA Notice


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