The latest on COVID-19 vaccines/drugs and manufacturing from Pfizer/BioNTech, Moderna, and Univercells. Highlights below.

Manufacturing and supply of COVID-19 vaccines and drugs
* Univercells Partners for COVID-19 Vaccine Mfg in Africa
Updates on COVID-19 therapeutics and vaccines
* FDA Authorizes Moderna’s, Pfizer’s/BioNTech’s COVID Vaccines for Younger Children 

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Manufacturing and supply of COVID-19 vaccines and drugs

Univercells Partners for COVID-19 Vaccine Mfg in Africa
Univercells, a provider of biomanufacturing technologies and services, and Afrigen Biologics, a Cape Town, South Africa-based biotechnology company, have formed a collaboration for the production of mRNA COVID-19 vaccines in Africa. 

Afrigen Biologics will host the new collaboration at its sites in Cape Town, South Africa. Afrigen hosts the World Health Organization’s Global mRNA Vaccine Technology Transfer Hub and is working to facilitate production of mRNA vaccines at more than 15 designated manufacturing sites in low- and middle-income countries (LIMs) globally. The agreement, and the eventual vaccine produced, will build on the expertise developed through the hub.

In addition, the collaboration intends to create a new model of manufacturing for mRNA vaccines. Quantoom Biosciences, a Univercells company, is developing a mRNA production technology that encompasses all the steps of RNA production, from sequence construct to large-scale production with a system to allow for distributed and de-centralized manufacturing to facilitate scale-up and production to LIMs. The companies will work with eTheRNA, a Niel, Belgium-headquartered company specializing in mRNA technology and production, including mRNA construct design and optimization, lipid nanoparticle (LNP) formulations, and process development and manufacturing for mRNA drug substance and LNP final product formulation technologies. The COVID vaccine produced on the Univercells system is being designed to have improved thermostability.

Source: Univercells

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Updates on COVID-19 vaccines and drugs

FDA Authorizes Moderna’s, Pfizer’s/BioNTech’s COVID Vaccines for Younger Children
The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to both Moderna’s and Pfizer’s/BioNTech’s respective COVID-19 vaccines for children as young as 6 months old. Now, both vaccines are available to individuals 6 months or older.

For Pfizer’s/BioNTech’s COVID-19 vaccine, the FDA amended the companies’ EUA to include use of the vaccine in individuals 6 months through 4 years of age. The vaccine had been authorized for use in individuals 5 years of age and older. For Moderna’s COVID-19 vaccine, the FDA amended the company’s EUA to include use of the vaccine in individuals 6 months through 17 years of age. The vaccine had been authorized for use in adults 18 years of age and older.

Pfizer’s/BioNTech’s vaccine was authorized for a three 3-µg dose series for children 6 months to less than 5 years of age. The companies plan to submit requests for authorization of their COVID-19 vaccine in this age group to other regulators globally, including the European Medicines Agency in early July (July 2022). Pfizer and BioNTech say that they will begin shipping 3-µg pediatric doses as directed by the US government.

Moderna’s COVID-19 vaccine is authorized in young children ages 6 months through 5 years of age at a dose level of 25 µg, a 50-μg two-dose regimen for children ages 6 through 11 years old, and a 100-μg two-dose regimen for adolescents aged 12 through 17 years old. Moderna’s COVID-19 vaccine will be available for children and adolescents at select vaccination sites in the coming days (as reported on June 17, 2022).

Source: Pfizer, BioNTech, Moderna, FDA

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