Moderna vax approval continues apace


Critical laboratory materials” arrive in country as hopes build for availability of new vax alternative

With the wider vaccine focus on the paucity of Pfizer’s Comirnaty and the abundance of the much-avoided AstraZeneca, work to get Moderna’s mRNA vaccine into play locally is quietly moving ahead behind the scenes.

The weekend before last AJP learned that what the Therapeutic Goods Adminstration (TGA) has confirmed as “critical laboratory materials” arrived from Moderna, allowing for batch release testing of its vaccine Elasomeran, which has become one of the main Pfizer alternatives in many developed nations.

Batch release testing involves reviewing batch-specific manufacturing information and targeted testing and includes a range of tests including assessments for composition, identity, potency, purity and potential contamination with microorganisms.

 

According to a TGA statement confirming the arrival, TGA laboratories has been working with Moderna for the early supply of the critical laboratory materials “to ensure laboratory testing methods will be in place to undertake batch release assessment of Elasomeran once a registration decision is made”.

“This preparatory laboratory work is occurring in parallel with the clinical evaluation of the evidence submitted by Moderna,” the TGA has said in another context.

Just over a month ago the TGA granted Elasomeran “provisional determination” and a deal has been struck, pending provisional registration by the Australian Register of Therapeutic Goods (ARTG), for the US company to supply a total of 25 million doses starting later this year.

According to the TGA, “the agreement is for 10 million doses of the current vaccine to be delivered in late 2021, and 15 million doses of booster or variant-specific versions of the vaccine to be delivered in early 2022”.

Though there had been some speculation this parallel prepatory lab work might have meant faster delivery of the Moderna vaccine than has been officially been acknowledged, the TGA poured water on this, saying “the timeline for delivery of the Moderna vaccine has not changed or altered since the agreement between the Government and Moderna on 13 May 2021”.

But the TGA said while its normal procedure was to undertake assessment for either provisional or general determination when all the relevant information had been delivered by sponsor, applications for COVID-19 vaccines were being treated “with the greatest priority”.

“For COVID-19 vaccines, the TGA is accepting rolling data to enable early evaluation of data as it comes to hand,” it said, confirming that it had received an application for provisional registration of Elasomeran on 8 July.

Assuming it receives regulatory approval, the Moderna vaccine would initially consist of two doses taken 28 days apart.

With the phasing out of Astra Zeneca’s vaccine by the end of September to “request only” status, Moderna would be prioritised along with Pfizer, with 600,000 per week of Moderna’s vaccine anticipated to be administered once approved.

Also under consideration is if the Moderna vaccine can be administered to children as young as 12.

Moderna is one of three as-yet unreleased COVID-19 vaccines currently undergoing TGA evaluation, along with Janssen/Johnson & Johnson’s viral vector vaccine and Novavax’s protein vaccine.

 

 

 

 

 

 

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