Asia-Pacific Roundup: TGA makes Moderna’s Spikevax the first fully registered COVID vaccine

Australia’s Therapeutic Goods Administration (TGA) has upgraded Moderna’s COVID-19 vaccine to full registration, making Spikevax the first COVID-19 vaccine to transition from provisional to full registration in Australia.

TGA granted provisional approval to Spikevax in August 2021, eight months after regulatory agencies in North America cleared the vaccine for use. AstraZeneca, Johnson & Johnson and Pfizer all beat Moderna to market in Australia, but Spikevax has made up ground since then. Moderna racked up a series of label expansions for use in children and as a booster in 2021 and 2022.

Now, TGA has converted almost all aspects of the provisional registration to full authorization. Spikevax is fully registered for use as a primary vaccination course in people aged 6 years and up and as a booster shot in individuals aged 12 years and up. The only use case that remains provisional is the vaccination of infants aged between 6 months and 6 years.

It is unclear whether the revised regulatory status of Spikevax will have any impact on the Australian vaccine market. The Australian Technical Advisory Group on Immunisation now recommends the use of the bivalent forms of Moderna’s Spikevax and Pfizer/BioNTech’s Comirnaty that protect against the original strain of SARS-CoV-2 and either the BA.1 or BA.4/5 subvariants of omicron. Moderna’s bivalent vaccines are still covered by provisional registration decisions.

TGA granted full registration of the original version of Spikevax after reviewing long-term follow-up data from multiple studies that confirmed the safety and efficacy of the vaccine. These studies showed that recipients of the COVID-19 vaccine had “a continued immune response” after a two-dose primary series and booster dose, TGA said. No new safety concerns were identified.

The full registration is a rare example of Moderna reaching a COVID-19 vaccine regulatory milestone in Australia ahead of Pfizer. Across the pandemic, from its original provisional registration in 2021 through to the clearance of its BA.4/5 vaccine in January, Pfizer has typically received regulatory decisions from TGA before Moderna.

TGA began reviewing Moderna’s application for full registration in January.

TGA Notice

Pakistan freezes fees for major pharmaceutical, medical device regulatory services

The Drug Regulatory Authority of Pakistan (DRAP) has published a consolidated notification for regulatory fees that keeps the rates for major regulatory services unchanged from the level set in 2021.

Facing rising inflation that is increasing their costs, some regulatory agencies have enacted significant, across-the-board increases to their fees. The European Medicines Agency (EMA), for example, recently increased its fees by 10.4%. The economic situation in Pakistan is particularly challenging, with inflation up 47% in the latest data.

In the consolidated notification published last week, DRAP reiterated the regulatory fees set out in a text from 2021. The fee for the grant of a drug manufacturing license continues to range from Rs. 45,000 to Rs. 150,000 ($159 to $529), depending on the type of production performed at the facility. Similarly, the rate for the grant of drug registration still ranges from Rs 30,000 to Rs. 150,000 ($106 to $529).

DRAP Notice

TGA seeks feedback on scheduling psychoactive drug used in indigenous cultural ceremonies

TGA is holding a public consultation into the proposed scheduling of a psychoactive drug that is used in indigenous cultural ceremonies. The applicant is proposing to schedule the ingredient, which is found in mushrooms, as a high-risk poison except when used under the overview of a medical practitioner.

The ingredient, ibotenic acid, is a psychoactive constituent of Amanita species of mushrooms. According to a consultation text prepared by TGA, the ingredient is used in indigenous cultural ceremonies and is not specifically scheduled in the current Poisons Standard.

TGA is seeking feedback on a split scheduling for the ingredient. The applicant is proposing to include ibotenic acid in Schedule 7, reflecting the belief it is a hazardous psychedelic neurotoxin that should be tightly controlled. However, seeing scope to use the ingredient in medical research, the applicant has also requested that it is included in Schedule 4 when used therapeutically under medical supervision.

Interest in the therapeutic applications of ibotenic acid stem from evidence that it and muscimol, a pharmacologically active substance generated after the ingredient is partially metabolized in the body, are isoxazole derivatives that resemble the neurotransmitters glutamate and GABA, respectively. The molecules may have “effects such as euphoria, disorientation, agitation and occasionally seizures.”

TGA is accepting feedback until 17 May.

TGA Notice

Japan updates list of drugs that may cause abuse to cover more codeine-based medicines

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has shared details of changes to the list of drugs that may cause abuse. In a translation of a Ministry of Health, Labour and Welfare document, the regulator reveals that Japanese officials have extended the scope of the list to cover more medicines.

Under the original list, Japan only classed codeine and dihydrocodeine as drugs that may cause abuse when used in some types of cough medicine, specifically antitussive and expectorant products. Similarly, the entry for methylephedrine was limited to “oral solutions among antitussive and expectorant drugs.” The update removes those limitations.

Now, codeine, dihydrocodeine and methylephedrine are included on the list without qualifying notes that limit the application of the rules to certain types of products. All six ingredients, the others being ephedrine, bromovalerylurea and pseudoephedrine, are now listed without caveats.

The changes follow an analysis of Japanese health data that found cases of dependence are not limited to antitussive and expectorant drugs containing dihydrocodeine and/or methylephedrine. Rather, there is evidence of dependence to combination cold remedies containing the same ingredients. The data led Japan to gather feedback on revising the list last year and ultimately to the changes shared by PMDA.

PMDA Notice

DRAP gives marketing authorization holders more time to update finished product specifications

Pakistan’s DRAP has given the holders of pharmaceutical and biological drug registrations more time to update their finished product specifications and validated testing procedures.

Last month, DRAP said it would give the industry 30 days to provide the information as part of its roll out of the Pakistan Integrated Regulatory Information Management System, an online system for processing information related to the licensing, registration and inspection of pharmaceutical and biological drugs (RELATED: Asia-Pacific Roundup: Japan revises postmarket safety controls ahead of launch of generic lenalidomide, Regulatory Focus, 21 March 2023).

Now, “keeping in view the practical difficulties,” DRAP has changed its deadline. Drug registration holders now have until 9 June to submit the requested information. DRAP plans to close the portal used to update the information beyond that date “and afterwards, no request shall be entertained.” Fees may apply to companies that miss the deadline.

DRAP Notice

Asia-Pacific Roundup: TGA makes Moderna’s Spikevax the first fully registered COVID vaccine

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