Asia-Pacific Roundup: India rejects Comirnaty EUA

RoundupsRoundups | 09 February 2021 |  By 

Pfizer has withdrawn its application for emergency use authorization (EUA) in India for Comirnaty, its COVID-19 vaccine with partner BioNTech, after the country’s COVID-19 Subject Expert Committee (SEC) recommended against its authorization.
After reviewing data presented by Pfizer at an SEC meeting on 3 February, the committee did not recommend that an EUA be granted, citing serious adverse events including anaphylaxis and palsy as well as the companies’ lack of safety and immunogenicity studies in the Indian population.
“Pfizer will continue to engage with the authority and re-submit its approval request with additional information as it becomes available in the near future,” the company said in a statement to Reuters.
The action ends the near-term prospect of bringing Comirnaty to the Indian market. Pfizer filed for EUA of the vaccine late last year, shortly before Serum Institute of India and Bharat Biotech did the same for their vaccine candidates. Serum Institute and Bharat received EUAs in the first week of 2021, somewhat controversially in the case of the latter company, but Pfizer had to wait another month to receive a decision (RELATED: Asia-Pacific Roundup: India approves AstraZeneca, Bharat Biotech COVID vaccines, Regulatory Focus 05 January 2021).
Pfizer continues to secure authorizations for Comirnaty in other markets. Last week, the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) became the latest regulatory agency to clear Comirnaty for use. Medsafe is also conducting a rolling review of Johnson & Johnson’s COVID-19 vaccine.
SEC Recommendations, Medsafe Notice
TGA seeks feedback on repurposing existing medicines
Australia’s Therapeutic Goods Administration (TGA) wants feedback on its proposal for simultaneous submissions for regulatory and reimbursement reviews in an effort to make it easier for companies to gain new indications for existing medicines.
The agency has supported the repurposing of medicines including tamoxifen in recent years but sees scope to increase the practice.
The consultation document notes several known challenges to repurposing, such as the fact the off-label use of many inexpensive medicines disincentivizes companies from seeking approval in new indications. The agency wants respondents to identify the main barriers to repurposing.
TGA has proposed several options to increase repurposing. The first idea is to reduce the regulatory burden for repurposing. Specifically, TGA is considering providing additional support, offering fee relief for programs with limited commercial potential and giving companies that win new indications exclusivity periods.
TGA also has proposed granting access to data on the real-world use of medicines in Australia and otherwise increasing the availability of information can facilitate drug repurposing as well as looking into what it can do when no sponsor is willing to pursue a new indication. Options include seeking non-commercial organizations that are willing to file, compelling a sponsor to make an application and approving the drug for use in the indication in the absence of a submission. Legislative changes would be needed to implement those options.
TGA is seeking feedback until 23 March.
TGA Consultation
TGA details continuing cost pressures in fee proposal
Increases in the amount of work TGA does that is not covered by user fees has added millions of dollars to its spending in recent years, according to the agency’s fees and charges proposal for fiscal year 2021-2022.
Like other regulators, TGA recoups the cost of the work it does for industry through fees and charges. However, the agency also performs other activities that do not directly serve a particular company.
TGA calculates it would need to increase industry fees by 3.6% to cover the additional spending. Yet, the agency would rather increase fees by the indexation factor, an approach that would amount to a roughly 1.1% rise in 2021-2022. TGA said an increase of 3.6% would be inconsistent with the established indexation practice and “may compromise certainty for sponsors and manufacturers.”
Spending on several fee-free services and activities has risen sharply in recent years. Legislative changes have increased patient demand for medicinal cannabis products through the special access scheme (SAS), leading to an anticipated cost of AU$2 million ($1.5 million) in the 2021-2022 fiscal year. TGA is also braced for the addition of e-cigarettes to the SAS pathway.
The change to mandatory reporting of medicine shortages has also added to costs. TGA spent AU$140,000 on medicine shortages in its 2017 to 2018 financial year. By the 2021 to 2022 reporting period, TGA expects to spend AU$2.3 million. Spending on compliance, enforcement and litigation is also set to rise from AU$5.7 million in 2017 to AU$12.3 million in 2021.
Direct government funding is increasing from AU$3.2 million in 2019 to AU$8.0 million in 2021 but the rise is too small to cover the additional AU$13 million in uncovered costs TGA is set to take on.
The agency is accepting feedback on the plans until 17 March.
TGA Consultation
Philippine FDA revises guideline on pharmaceutical cold chain management
The Philippine Food and Drug Administration (FDA) has updated its position on pharmaceutical cold chain management by adopting a set of international documents. FDA is bringing the changes into effect immediately due to the distribution requirements of products to address COVID-19.
COVID-19 vaccines and antibodies must be kept in controlled environments ranging from deep freezers through to standard refrigerators. FDA expects an “influx” of such time and temperature sensitive products, leading it to adopt a set of World Health Organization (WHO) texts on cold chain distribution.
The documents include WHO’s Technical Report Series on time and temperature sensitive products from 2011 and 2015. WHO published the reports to provide guidance and principal requirements on the safe storage and distribution of pharmaceutical products that need to be kept in cold chains.
FDA has adopted the 2011 and 2015 WHO annexes alongside a handful of supplements that address specific topics such as the design and procurement of storage of facilities. By reading and following the documents, distributors should be able to manage challenges including how to monitor and control the temperature and humidity at which products are kept.
FDA Guideline
Other News:
TGA has told a former Australian politician David Leyonhjelm to take down posts on Twitter about the use of the antiparasitic drug ivermectin for COVID-19. The posts were deemed to be noncompliant with advertising rules. TGA Notice


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