The latest on COVID-19 vaccines/drugs and manufacturing from Pfizer, Moderna, Merck & Co., Daiichi Sankyo, BioNTech, Novavax, Inovio, and CSL.

Manufacturing and supply of COVID-19 vaccines and drugs

EU, Switzerland OK Booster of Moderna’s COVID-19 Vaccine
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) and Swissmedic, the national pharmaceutical regulatory agency in Switzerland, have authorized a booster dose of Spikevax, Moderna’s vaccine against COVID-19.

The EMA’s CHMP has concluded that a booster dose of Spikevax at the 50-µg dose level may be considered in people aged 18 years and older at least six months after completion of the primary series.

Swissmedic has authorized a booster dose of Spikevax at the 50-µg dose level in particularly vulnerable individuals 12 years of age and older, at least six months after completion of the primary series. Swissmedic also approved a third dose of Spikevax at the 100-µg dose level for people with a weakened immune system at least 28 days after the second dose.

Separately, Moderna has also signed a new memorandum of understanding (MoU) to produce up to 110 million doses of its COVID-19 to the African Union. Moderna says it is prepared to deliver the first 15 million doses in the fourth quarter of 2021, 35 million doses in the first quarter of 2022, and up to 60 million doses in second quarter 2022.

The company is also working on plans to allow it to fill doses of its COVID-19 vaccine in Africa as early as 2023, in parallel to building an mRNA vaccine manufacturing facility in Africa. This new MoU would be in addition to Moderna’s agreement with COVAX to supply up to 500 million doses of its COVID-19 vaccine from the fourth quarter of 2021 through 2022.

Source: Moderna (EMA), Moderna (Swissmedic), and Moderna (African Union)

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CSL Provides Mfg Update of AstraZeneca’s COVID-19 Vaccine
CSL reports it is committed to manufacture approximately 50 million doses of AstraZeneca’s COVID-19 vaccine, Vaxzevria. More than 20 million doses have already been produced for Australia and the Asia-Pacific region, and the company says it expects that the remaining production will be completed early next year (2022).

Source: CSL

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Updates on COVID-19 treatments and vaccines

EMA Starts Review of Merck & Co.’s Oral COVID-19 Drug
The European Medicines Agency (EMA) has initiated a rolling review for Merck & Co.’s molnupiravir, an investigational oral antiviral medicine, for the treatment of COVID-19 in adults. 

Molnupiravir is being developed by Merck & Co. in collaboration with Ridgeback Biotherapeutics, a Miami, Florida-based bio/pharmaceutical company. The companies formed a collaboration and licensing agreement in July 2020 to develop the drug under which Merck acquired exclusive global rights to develop molnupiravir and related molecules in collaboration with Ridgeback. Molnupiravir was invented at Drug Innovations at Emory LLC, a not-for-profit biotechnology company wholly owned by Emory University.

Earlier this month, Merck submitted an application for emergency use authorization (EUA) to the US Food and Drug Administration. The company says it is working to submit applications to other regulatory agencies globally.

In addition, Merck & Co. has asigned a licensing agreement with the Medicines Patent Pool (MPP), a United Nations-backed public health organization, to facilitate affordable global access for molnupiravir. This agreement will help create broad access for molnupiravir use in 105 low- and middle-income countries following appropriate regulatory approvals.

Source: Merck & Co. (EMA), Merck & Co. (MPP), and the Medicines Patent Pool

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Novavax Files for UK Authorization of COVID-19 Vaccine
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, has completed its rolling regulatory submission to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for authorization of its COVID-19 vaccine candidate.

Novavax has now completed the submission of all modules required by MHRA for the regulatory review of NVX-CoV2373, the company’s COVID-19 vaccine.

Novavax says it expects to complete additional regulatory filings in key markets, including Europe, Canada, Australia, New Zealand, the World Health Organization, and other markets globally shortly following the UK submission. In the US, Novavax expects to submit the complete package to the US Food and Drug Administration by the end of the year (2021).

Source: Novavax

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Daiichi Sankyo Updates Progress of COVID-19 Vaccine
Daiichi Sankyo plans to initiate a Phase II clinical trial in November 2021 and a Phase III clinical trial within FY 2021 of DS-5670, its mRNA COVID-19 vaccine in Japan with the aim for commercialization of DS-5670 in Japan within 2022. In addition, in order to initiate a clinical trial of a supplemental booster for the vaccine in January 2022, Daiichi Sankyo is continuing discussions with the Japanese Ministry of Health, Labour and Welfare, the Pharmaceuticals and Medical Devices Agency, and Japan Agency for Medical Research and Development.

Source: Daiichi Sankyo

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Inovio, Columbia in COVID-19 Health Initiatives
Inovio, a Plymouth Meeting, Pennsylvania-based bio/pharmaceutical company developing DNA-based immunotherapies for cancer and infectious diseases, has signed a non-binding memorandum of understanding (MoU) with Colombia’s Ministry of Health and Social Protection with the intent of protecting against COVID-19 and supporting broader health preparedness initiatives.

The MoU builds on recent regulatory authorization from Colombia’s INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos, or the National Food and Drug Surveillance Institute) to conduct a clinical trial in that country as part of the Phase III segment of its global Phase II/III trial, for INO-4800, Inovio’s COVID-19 vaccine candidate.

Source: Inovio