Asia-Pacific Roundup: India seeks more data on AstraZeneca COVID vaccine

RoundupsRoundups | 15 December 2020 |  By 

India’s Subject Expert Committee (SEC) has asked to see additional data on AstraZeneca’s COVID-19 vaccine before deciding whether to grant emergency use authorization (EUA). The Central Drugs Standard Control Organization (CDSCO) wants to see immunogenicity data from patients in the UK and India and safety data beyond the 14 November cut-off shared with it to date.
Serum Institute of India, which is partnered with AstraZeneca on ADZ1222, a viral vector vaccine, put an EUA proposal to SEC at a meeting last week. The proposal was supported by interim safety data from an Indian Phase 2/3 clinical trial, plus interim safety and efficacy from the global late-phase program.
SEC has agreed to consider data from multiple countries but found gaps in the evidence presented at the meeting. The CDSCO committee wants Serum to submit updated safety data, as well as immunogenicity data from clinical trial sites in the UK and India.
Serum, working with its partners at AstraZeneca and the University of Oxford, can handle those data requests itself. However, the third request to come out of the meeting is out of Serum’s hands. SEC wants to see the outcome of the UK Medicines and Healthcare products Regulatory Agency’s assessment of the application before making its own decision on the EUA. 
The request for more data by SEC follows a period of public scrutiny of results on the COVID-19 vaccine developed by AstraZeneca and Oxford. While Moderna and Pfizer ran single pivotal trials of at least 30,000 people, Oxford sponsored smaller national trials that featured two different vaccine regimens and a wide range of times between the first and second doses.
SEC’s request for additional data provides an early glimpse of how regulators may approach Oxford’s pooled analysis. The vaccine has begun the rolling review process in territories including the UK and European Union, setting the stage for conclusive regulatory verdicts on the vaccine in the coming weeks.
Pfizer was due to present data on its COVID-19 vaccine, which has emergency authorization in countries including the UK and US, at the SEC meeting. However, SEC said Pfizer has asked for more time before making its presentation.
SEC was able to review results on Bharat Biotech’s coronavirus vaccine. Bharat Biotech presented a proposal for EUA alongside interim safety and immunogenicity data from a Phase 1/2 clinical trial. SEC has asked to see safety and efficacy data from an ongoing Phase 3 clinical trial.
CDSCO Update
TGA finds no causal link between antidepressants, rising youth suicide rates
Australia’s Therapeutic Goods Administration (TGA) found insufficient evidence to conclude there is a causal link between antidepressant use and youth suicide, according to its own investigation. TGA will to continue probing the association with new analyses.
The US Food and Drug Administration (FDA) added a boxed warning to antidepressants about the suicide risk in young adults in 2004. TGA decided to take a fresh look at the topic after a review article posted in July postulated that antidepressants are a driver of rising youth suicides in Australia.
TGA’s assessment identified perceived shortcomings of the review article, including uncontrolled confounding, and reviewed prescribing data. The data showed prescribing rates in young people rose steadily from 2013 to 2019. Suicide rates rose over the same period, although there is year-to-year fluctuations and differences between age groups and genders.
“These complexities are important to consider when studying the relationship between antidepressants and suicide deaths. Aggregated trends are useful to generate hypotheses but are not a sufficient base for making causal statements,” TGA wrote in the report.
The Advisory Committee on Medicines said the warnings and precautions carried by antidepressants sold in Australia are adequate. Considering that conclusion and the lack of evidence for a causal link, TGA has opted against proposing regulatory changes. Rather, TGA has written to medical bodies to request they provide additional guidance on the use of antidepressants in young people. TGA also plans to review additional data on the link between antidepressants and suicide next year. 
TGA Report
TGA posts guidance on declarations of conformity for low-risk devices and tests
TGA has released guidance on the declaration of conformity process for manufacturers of Class I medical devices and in vitro diagnostics. The document describes how to complete a declaration that manufacturers use to show their compliance with essential safety and performance principles.
Australian regulations require a device manufacturer to complete the declaration of conformity and share it with the sponsor. The sponsor needs to include the declaration in its requests for Class I products to be added to the Australian Register of Therapeutic Goods. TGA’s guidance mainly covers what is expected of manufacturers.
The guidance walks through the process of completing the declaration of conformity, explaining details such as how to handle the naming of items within system or procedure packs and the list of technical documentation required.
TGA Guidance
Malaysia’s NPRA sets June deadline for updating routine nitrosamine testing
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has given metformin and ranitidine manufacturers until 30 June to update routine testing for nitrosamine impurities in their products and active ingredients.
NPRA wants manufacturers to assess the risk of nitrosamine contamination throughout the product lifecycle and update their specifications in light of any resulting changes. Manufacturers will need to share details of the updated specification through variation applications. NPRA has listed a range of variation types that may be relevant to the updates required.
The NPRA document also addresses the requirements for companies seeking to bring new metformin and ranitidine products to market. NPRA lists the sections of the application that are relevant to the risk of nitrosamine impurities and describes what companies need to do.
For example, in the section on specifications NPRA lists the maximum daily limits for nitrosamine impurities. Skip testing is only justified if levels are consistently less than 30% below the limit and the root cause is known and well understood. NPRA wants manufacturers to test whichever is higher of 10% of annual batches or three batches per year.
NPRA Notice
New Zealand starts review of antiseptic soothing cream following TGA action
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has begun a review of the benefits and risks of an antiseptic cream that contains bufexamac. Medsafe’s review follows TGA’s decision to remove bufexamac-containing medicines from the market.
TGA took the action after concluding the risk of serious skin reactions, coupled to doubts about efficacy, resulted in an unacceptable benefit-risk balance. Responding to the action, Medsafe is set to perform its own review and has asked the sponsor of the cream, Multichem NZ, to provide evidence of its safety and efficacy. Medsafe may impose restrictions on use or ban the product outright.
The review comes nine years after Medsafe reviewed bufexamac-containing products in response to their withdrawal from the European market due to concerns about allergic contact dermatitis. At that time, a Medsafe committee recommended stopping the use of bufexamac in dermatitis, rash and hives. The Multichem cream is used to treat bites, stings, itches, minor burns and sunburn.
Medsafe Notice
Other News:
Singapore’s Health Sciences Authority (HSA) has granted interim authorization to the COVID-19 vaccine developed by BioNTech and Pfizer. HSA evaluated the vaccine under a rolling review and in consultation with two groups of experts. BioNTech and Pfizer must continue to gather longer-term data on the vaccine and seek full approval when they have sufficient evidence. HSA Notice


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