The latest on COVID-19 vaccines/drugs and manufacturing from AstraZeneca, Moderna, CSL Seqirus , Arcturus Therapeutics, and CanSino Biologics. Highlights below.

Updates on COVID-19 Vaccines and Therapeutics
* AstraZeneca Gets Full EU OK for COVID-19 Vaccine Booster
* Japan OKs Partial Change to Authorization for Moderna’s Bivalent COVID-19 Vaccine Booster
* CanSino Biologics Launches Inhaled COVID-19 Vaccine in China
* CSL, Arcturus Therapeutics In Pact for mRNA Vaccine Technology

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Updates on COVID-19 Vaccines and Therapeutics

AstraZeneca Gets Full EU OK for COVID-19 Vaccine Booster
The European Medicines Agency (EMA) has granted AstraZeneca’s COVID-19 vaccine, Vaxzevria, full marketing authorization in the European Union. The vaccine had been previously granted a conditional marketing authorization. The full marketing authorization covers the use of Vaxzevria in both a primary vaccination series and as both a heterologous (with an approved mRNA COVID-19 vaccine) or homologous (all the same vaccine) third dose booster.

Source: AstraZeneca

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Japan OKs Partial Change to Authorization for Moderna’s Bivalent COVID-19 Vaccine Booster
Japan’s Ministry of Health, Labor and Welfare has granted Moderna approval for a partial change to a new drug application for its Omicron-targeting bivalent COVID-19 booster, mRNA-1273.222 (Spikevax Bivalent Original/Omicron BA.4-5) in adults 18 years and older.

Spikevax Bivalent Original/Omicron BA.4-5 contains the company’s original COVID-19 vaccine, Spikevax, and a vaccine candidate targeting the Omicron variant BA.4-5. The new booster joins Moderna’s Omicron BA.1 variant targeting vaccine, mRNA-1273.214, which was approved in Japan in September 2022.

Spikevax Bivalent Original/Omicron BA.4-5 is indicated as a booster dose for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.

Source: Moderna

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CanSino Biologics Launches Inhaled COVID-19 Vaccine in China
CanSino Biologics, a Tianjin, China-based bio/pharmaceutical company, has received approval from the Joint Prevention and Control Mechanism of the State Council of China for the company’s inhaled COVID-19 vaccine, Convidecia Air, to allow the vaccine to be included in Shanghai’s booster vaccination program that started October 26, 2022. This marks the first rollout of the company’s inhaled COVID-19 vaccine. An intramuscular-delivered version of the vaccine received conditional marketing authorization in China in February 2021.

Source: CanSino Biologics

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CSL, Arcturus Therapeutics In Pact for mRNA Vaccine Technology
CSL Seqirus, a vaccine company and subsidiary of the Australian bio/pharmaceutical company, CSL, and Arcturus Therapeutics, a San Diego, California-based RNA medicines and vaccines company, have entered a collaboration and license agreement for Arcturus’ self-amplifying mRNA (sa-mRNA) vaccine platform technology.

Arcturus has developed a COVID-19 vaccine candidate and has recently reported results from a large Phase III vaccine efficacy study that showed that the vaccine met primary and secondary endpoints for preventing infection and severe disease with a favorable safety and tolerability profile.

CSL Seqirus produces influenza vaccines across its global manufacturing network, which includes facilities in the US, UK, and Australia. CSL is also growing its R&D footprint and is investing in a new facility located in Waltham, Mass. that will support the company’s R&D portfolio, with a focus on the sa-mRNA technology platform. This facility will serve as an R&D center for current and future vaccine design and collaborations with external partners.

CSL said the collaboration with Arcturus will help it develop and commercialize enhanced vaccines for influenza and multi-pathogen pandemic preparedness and that the collaboration also provides a pathway to offer a COVID-19 booster.

Source: CSL