Asia-Pacific Roundup: TGA provisional determination for Moderna’s bivalent COVID vaccine

RoundupsRoundups | 03 May 2022 |  By 

Australia’s Therapeutic Goods Administration (TGA) has granted provisional determination to a bivalent Moderna COVID-19 vaccine that is designed to protect against the original, wild-type strain of SARS-CoV-2as well as the Omicron variant.
Moderna began developing bivalent vaccines as SARS-Cov-2 started taking hold in parts of the world. The vaccines use two pieces of mRNA, one encoding for the spike protein of the original strain, another encoding for the spike protein of the variant, to generate immune responses that are effective against more forms of the virus.
Last month, Moderna delivered clinical data on a bivalent vaccine targeting the Beta variant but has switched gears now that Omicron is the dominant variant around the world. Phase 2/3 data on the Omicron bivalent jab are due midyear.
Ahead of that, TGA has granted provisional determination to Moderna for the investigational vaccine, referred to in the statement as Spikevax Bivalent Zero/Omicron. TGA based its decision on a set of eligibility criteria that include the presence of evidence of a plan to submit a comprehensive clinical dataset and the seriousness of the COVID-19 pandemic.
The provisional determination clears Moderna to file for provisional registration in Australia. Moderna has six months to make the application before the provisional determination expires. The Australian government’s contract with Moderna includes 15 million doses of a variant-specific vaccine that are scheduled for delivery this year.
TGA Notice
TGA seeks feedback on reclassifying psilocybin, MDMA for mental health use
TGA is considering partly down-scheduling psilocybin and MDMA to enable their use in the management of treatment-resistant mental illness in medically controlled environments.
Currently, psilocybin and MDMA  are schedule 9 compounds. Australia puts compounds in schedule 9 (prohibited substances) because of their potential for abuse or misuse, making it illegal to produce, own, sell or use the compounds except if needed for medical or scientific research, and then only with tight restrictions.
TGA considered a request to put psilocybin and MDMA in schedule 8 when used in some circumstances in 2020, only to decide to retain the current classification late last year. Now, the same applicant has made another request to reclassify the compounds, augmented by new evidence.
In the case of MDMA, the applicant has cited a randomized, double-blind, placebo-controlled Phase 3 clinical trial of MDMA-assisted therapy for severe post-traumatic stress disorder that was published in July. The study found the therapy was “highly efficacious” and “safe and well-tolerated.”
For psilocybin, the applicant is now drawing two additional studies. One is a published Phase 2 study indicating that secondary outcomes “generally favored” psilocybin over escitalopram; the other, a Phase 2b study (unpublished) showing “rapid and sustained” response in treatment-resistant depression, according to a company statement.
If TGA grants the request, psilocybin and MDMA will remain prohibited schedule 9 compounds in most circumstances. However, the agency will create new entries in schedule 8, which features controlled drugs that are covered by special rules and may be prescribed by authorized healthcare professionals who may need a special permit. The schedule 8 entries will cover the molecules’ use as part of psychotherapy in specific circumstances.
TGA is accepting feedback until 27 May. The feedback will inform an interim decision by the scheduling delegate, which TGA expects to release for further comment in September.
TGA Consultation
Philippine FDA changes guidance on applying to study COVID interventions
The Philippine Food and Drug Administration (FDA) has revised the process for applying to study vaccines and treatments for COVID-19. Applicants will file directly with FDA and simultaneously send submissions to their designated Research Ethics Committee (REC) or Single Joint Research Ethics Board (SJREB).
FDA published guidance on applying to run COVID-19 studies in the Philippines in 2020 to give sponsors a fast track to regulatory clearance. Most of that guidance remains in place but, after a meeting of the Inter-Agency Task Force for the Management of Emerging Infectious Diseases, certain changes have been made. The updated guidance features a new paragraph on ethics committees and boards.
“The Sponsor or CRO shall simultaneously submit an application to their designated REC or to the SJREB for multi-site studies with at least one [Department of Health] hospital involved. The Sponsor and/or CRO shall follow the existing guidelines of Philippine Health Research Ethics Board and SJREB relative to the conduct of COVID-19 related clinical trials in the Philippines. The decision of the REC/SJREB shall be provided to the FDA,” the guidance states.
Other aspects of the submission process have changed, too. Applicants will file directly with FDA, which will perform a pre-assessment of their submissions. The pre-assessment step was absent from the original workflow. After adopting the extra step, FDA pushed back the assignment of regulatory reviewers by one day, although it is still aiming to grant clinical trial approvals by day 30.
FDA Notice
Pakistan posts final guidelines on therapeutic good import and export permissions
The Drug Regulatory Authority of Pakistan (DRAP) has finalized its guidelines on imports and exports of therapeutic goods.
DRAP released a draft for consultation late last year, leading to the publication of the final text last week. The guidance applies to commercial and non-commercial imports and exports of any therapeutic good. DRAP created the guidelines to elaborate the requirements and documentation, determine eligibility and describe the responsibilities of the entities involved in the processes.
“The main objective of these guidelines is to provide legal and regulatory requirements to importers and exporters of therapeutic goods, enabling them to comply with the applicable drug laws for import and export of therapeutic goods. These guidelines specify the format and content of the relevant applications and procedures to receive necessary authorizations or permissions by DRAP,” the guidelines state.
DRAP Notice
India extends deadline to submit FDC applications because of COVID pandemic
India’s Central Drugs Standard Control Organization (CDSCO) has given manufacturers of some fixed-drug combinations (FDCs) covered by state licenses more time to seek authorization at the national level.
The original deadline for making the submissions has now passed. However, CDSCO has received calls to extend the deadline because of the COVID-19 pandemic. The agency granted the requests for more time last week, extending the deadline for making the submissions out to the end of October. The change will benefit manufacturers of rational FDCs that lack the proper clearances.
CDSCO’s extension of the deadline continues a saga that has already run for years. India originally moved to remove hundreds of FDCs from the market on the grounds that they featured irrational combinations of active ingredients. Further assessments determined some of the combinations to be rational, creating a need for a pathway for manufacturers of legitimate FDCs that lacked the proper licenses.
CDSCO Notice
Other news:
DRAP CEO Asim Rauf has met with the World Health Organization country representative Palitha Gunarathna Mahipala to promote bilateral cooperation. DRAP Notice


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