The TGA decision authorizes the COVID-19 Vaccine AstraZeneca for use in Australia for the next two years. In that time, TGA expects AstraZeneca to provide it with longer-term safety and efficacy data from clinical trials and real-world assessments.
Real-world assessments of the rollout in Australia will provide more data on the merits of giving the two doses of the AstraZeneca vaccine 12 weeks apart. Phase 3 clinical trials were supposed to give the two doses closer together but some participants ended up waiting 12 weeks. The trials suggested the longer gap has no deleterious effects, leading the UK and World Health Organization to go with a 12-week schedule.
TGA has recommended the second dose be given 4-12 weeks after the first. With the Australian Technical Advisory Group on Immunisation recommending a 12-week schedule, most patients will only get the shots four weeks apart if they have imminent travel, chemotherapy, major elective surgery or another reason to go with the shorter gap.
The TGA statement on the provisional authorizations addresses the lack of clinical efficacy data on the use of the vaccine in people aged 65 years and older. Some European countries responded to the lack of data by recommending against the use of the vaccine in seniors. TGA is advising physicians to decide whether to immunize seniors on a case-by-case basis, factoring in “age, co-morbidities and their environment [and] taking into account the benefits of vaccination and potential risks.”
TGA shared the authorization of the AstraZeneca vaccine shortly before releasing a guide to advertising COVID-19 vaccines to the Australian public. The guide clarifies that advertisers cannot use self-developed materials about COVID-19 vaccines but may share content created by the Australian national, state and territories governments.
TGA granted provisional approval to Comirmaty in January.
On 16 February, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) granted special approval to Comirnaty – it is the first vaccine authorized in the country. The decision, which comes almost two months after Pfizer filed for approval, comes tied to a request for “intensive post-approval activities.”
The up to 20,000 healthcare workers who will receive the vaccine first will be followed for one month after getting the shot to gather data on symptoms and illnesses. In addition, a questionnaire will be conducted in the general population to assess post-vaccination health status. PMDA plans to release the post-approval data to the public.
TGA Notice, PMDA Notice, More
New Zealand seeks feedback on adopting new PIC/S Guide to GMPs
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is holding a public consultation on its proposed adoption of the updated PIC/S Guide to Good Manufacturing Practices (GMPs).
PIC/S, the Pharmaceutical Inspection Co-operation Scheme, adopted the latest version of its GMP guide in 2018. The update affected sections covering recalls, real-time release and other topics.
Medsafe has summarized the main changes to its current code, released in 2009. Since then, revisions have occurred – some minor, but others more substantive. Medsafe noted significant changes to the information on cross-contamination and starting materials, as well as the substantial expansion of the section on complaints and product recalls.
Medsafe is accepting feedback until 22 March. The agency plans to notify stakeholders of its final decision by 12 April, setting it up to use the new code as its terms of reference from 3 May. Medsafe plans to give the industry until 3 November to fully implement the code. From May to November, the agency will allow companies found to be deficient against the new code to propose a timeline for implementation of corrective actions. Medsafe accepts the timelines may be longer than is typical.
PMDA asks paclitaxel-coated device makers to review package inserts
Japan’s PMDA has asked manufacturers of paclitaxel-coated balloons and stents to assess whether the information on their package inserts reflects current understanding of the risks and benefits of the medical devices.
The risk-benefit profile of paclitaxel-coated devices was called into question by a 2018 meta-analysis that linked the products to an increased risk of two-year mortality. Subsequent studies have found no link between the cardiovascular devices and increased mortality.
Japan’s Ministry of Health, Labour and Welfare has supported research into the topic, leading to the release of a paper that found no significant difference in five-year mortality. Professional bodies in Japan responded to the paper by recommending that decisions about whether to use the devices should be made in consultation with patients and after getting informed consent.
PMDA wants the package inserts of paclitaxel-coated medical devices sold in Japan to reflect the new understanding of the outcomes associated with the products. As such, the agency has asked local health departments to tell companies to voluntarily assess their package inserts.
TGA releases clinical decision support software guide ahead of regulatory change
TGA has released draft guidance on clinical decision support software (CDSS). The publication comes days before TGA adopts a new approach to the regulation of CDSS and other software-based medical devices.
If a CDSS product meets the medical device definition, it must be included in the Australian Register of Therapeutic Goods (ARTG) unless otherwise exempt. CDSS products that are used to directly process or analyze an image or diagnostic output, to only provide or support a care recommendation or to replace the clinical judgment of a healthcare professional need registering in the ARTG.
TGA’s new guidance describes the criteria for exemption and presents a flowchart to help sponsors decide if a product needs adding to the ARTG. The guidance also gives examples of products that are and are not exempt. The examples explain why devices are not eligible for the exemption.
The new regulations take effect on 25 February.
Malaysia adds desktop review section to guidance on foreign GMP inspections
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has published updated guidance on foreign GMP inspections. The updated guidance introduces the concept of desktop assessments.
COVID-19 has stopped NPRA and its peers from inspecting overseas production facilities in person, leading agencies to explore ways of assessing sites remotely. NPRA has set out its thinking on remote assessments in the seventh version of its guide to foreign GMP inspections, which explains which facilities are eligible for desktop assessments and covers details of the process.
NPRA is limiting its desktop inspection program to small molecule production plants it has previously found to comply with GMPs in an earlier in-person inspection. The new and previously assessed drug products need to have the same dosage form.
There are no additional fees for desktop assessments. However, facilities that fail a desktop review will need to undergo an in-person inspection. Facilities can undergo two successful remote reviews, spaced two years apart, before needing to undergo another on-site inspection.