COVID News: Moderna, AstraZeneca, Sanofi, GSK & MoreBy
The latest on COVID-19 vaccines/drugs and manufacturing from Moderna, AstraZeneca, Sanofi, GSK, Thermo Fisher Scientific, Novavax, Valneva, Dow, Sartorius, Südpack, USP, and the World Health Organization.
Manufacturing and supply of COVID-19 vaccines and drugs
Moderna, Thermo Fisher in Mfg Pact for COVID-19 Vaccine
Moderna and Thermo Fisher Scientific have formed a 15-year pact for large-scale US manufacturing of Spikevax, Moderna’s COVID-19 vaccine, and other investigational mRNA medicines in Moderna’s pipeline.
Over the past several years (as reported on February 23, 2022), Thermo Fisher has been partnering with Moderna to support its development pipeline with both clinical research and contract manufacturing services. This included the scale-up of aseptic fill–finish services and packaging of Moderna’s COVID-19 vaccine. Thermo Fisher will now provide dedicated capacity for a range of aseptic fill–finish services, including lyophilized and liquid filling. In addition, the Thermo Fisher will provide inspection, labeling and final packaging services.
Separately, Moderna announced a distribution service agreement with Adium Pharma, a Montevideo, Uruguay-based bio/pharmaceutical company, to support the commercialization of Spikevax across Latin America. The agreement covers 18 countries in Latin America, including Brazil, Mexico, Colombia, and Argentina.
Moderna has a commercial presence in 11 countries globally (Australia, Canada, France, Germany, Italy, Japan, South Korea, Spain, Switzerland, UK, US) and recently announced plans to increase its commercial footprint across 10 additional markets in Asia-Pacific (Hong Kong, Malaysia, Singapore, Taiwan) and Europe (Belgium, Denmark, the Netherlands, Norway, Poland, Sweden) in 2022.
FDA OKs Four Lots of AstraZeneca’s COVID-19 Vaccine
The US Food and Drug Administration (FDA) has found an additional four lots of AstraZeneca’s COVID-19 vaccine substance, manufactured at Emergent BioSolution’s facility in Baltimore, Maryland, to be acceptable for use and for potential export. The AstraZeneca vaccine is not authorized for use in the US, but the FDA says that these AstraZeneca lots, or vaccine made from the lots, may now be exported. At this time (as reported on February 18, 2022), the agency says it does not anticipate making any more determinations on additional AstraZeneca lots manufactured at the Emergent facility.
Source: US Food and Drug Administration
Novavax Ships COVID-19 Vaccine to EU
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, has begun shipping Nuvaxovid, its COVID-19 vaccine to European Union (EU) member states.
Novavax and the European Commission (EC) have an advance purchase agreement for up to 100 million doses of Nuvaxovid with the option for an additional 100 million doses (up to 200 million doses total). Through the second quarter, Novavax has received a commitment for orders from the EC totaling 69 million doses.
The EC granted conditional marketing authorization for Nuvaxovid to prevent COVID-19 in individuals 18 years of age and older. Novavax expects to submit its regulatory filing for a pediatric indication in adolescents aged 12 through 17 years of age to global regulatory authorities, including the European Medicines Agency, during the first quarter of 2022.
Separately, Health Canada, the pharmaceutical regulatory body of Canada, has granted authorization for Nuvaxovid to prevent COVID-19 in individuals 18 years of age and older.
Novavax and the Canadian government signed an advance purchase agreement for 52 million doses of Novavax’s COVID-19 vaccine, with the option for up to an additional 24 million doses, in January 2021. In February 2021, they established a memorandum of understanding to produce the vaccine at the National Research Council of Canada’s (NRC) Biologics Manufacturing Center in Montréal. Production is expected to begin later this year (2022).
Valneva Awarded $27 M for COVID-19 Vaccine, Other Vaccines
Valneva Scotland, a subsidiary of Valneva, a Saint-Herblain, France-headquartered vaccine company, has been awarded up to £20 million ($27 million) in research and development funding by Scottish Enterprise, Scotland’s national economic development agency.
The funding is comprised of two grants, which provide funding for manufacturing at the company’s site in Livingston, Scotland. The grants are expected to be received over the next three years (as reported on February 21, 2022), commencing March 2022.
The first grant of up to £12.5 million ($17 million) will support research and development related to the manufacture of VLA2001, Valneva’s COVID-19 vaccine candidate. The second grant of up to £7.5 million ($10 million) will support research and development connected to Valneva’s manufacturing processes for other vaccines.
Source : Valenza
Six African Countries Selected for mRNA Mfg. Support
The World Health Organization (WHO) reports that six African countries (Egypt, Kenya, Nigeria, Senegal, South Africa and Tunisia) will receive technology needed to produce mRNA vaccines.
The mRNA technology transfer hub was established in 2021 and is supported by WHO, the Medicines Patent Pool, a United Nations-backed public health organization, and the ACT-Accelerator/COVAX, a global initiative for equitable access to COVID-19 vaccines and therapeutics. Its goal is to support manufacturers in low- and middle-income countries to produce their own mRNA vaccines at scale and according to international standards. Primarily set up to address COVID-19, the hub has the potential to expand manufacturing capacity for other products as well.
The hub has already established mRNA vaccine production at laboratory scale and is currently scaling up and validating production at commercial scale. The mRNA technology transfer is hosted by three South African companies: Afreen Biologics, the South African Medical Research Council (SAMRC) and Biovar, a vaccine producer. Afreen is the entity mandated to establish mRNA vaccine production technology, SAMRC is providing the research, and Biovar manufacturing.
In addition, WHO has been working to establish a biomanufacturing workforce training hub that will train people from interested countries in scientific and clinical research and production. WHO says the training hub will be announced in the coming weeks (as reported on February 18, 2022).
Source: World Health Organization
Dow, Sartorius, Südpack in Bioprocessing Materials Pact
Dow, a chemical and materials science company, Sartorius, a provider of products and services for the life sciences, and Südpack, a producer of films and packaging materials, have formed a pact to support the manufacturing of bioprocessing bags, needed for the production and transportation of COVID-19 vaccines globally. The products will be manufactured by Sartorius, using Südpack polymer films made from Dow resins.
Updates on COVID-19 treatments and vaccines
Sanofi, GSK To Seek US, EU OK of COVID-19 Vaccine
Sanofi and GlaxoSmithKline (GSK) are in discussions with regulatory authorities, including the US Food and Drug Administration and European Medicines Agency, over the companies’ investigational COVID-18 vaccine. The companies plan to submit data from both booster and Phase III efficacy trials as the basis for regulatory applications.
The vaccine consists of Sanofi’s recombinant antigen and GSK’s pandemic adjuvant.
The companies report that that a global COVID-19 vaccine booster trial confirmed universal ability to boost neutralizing antibodies 18- to 30-fold across vaccine platforms (mRNA, adenovirus).
In the Phase III primary series trial, two doses of the Sanofi/GSK COVID-19 vaccine in seronegative populations demonstrated 100% efficacy against severe COVID-19 disease and hospitalizations, 75% efficacy against moderate or severe COVID-19 disease, and 57.9% efficacy against any symptomatic COVID-19 disease.
Sanofi and GSK report a favorable safety profile following both primary series and booster vaccinations.
USP Seeks Input on Draft Guidance on mRNA Product Quality
US Pharmacopeia (USP), a non-profit scientific and standards-setting organization, is seeking scientific input on new draft guidelines, Analytical Procedures for mRNA Vaccine Quality to support development of mRNA products.
USP and a group of mRNA experts have identified the need for analytical procedures and best practices to support quality assessments for mRNA vaccines and therapies in development pipelines for infectious diseases, cancer, cystic fibrosis, and other disorders.
To advance the draft guidelines, USP is calling on industry, academic and government experts with experience or interest in mRNA vaccines and technology to provide feedback on the methods and recommend additional information to support the understanding of mRNA quality. Initial feedback to this draft will be presented by USP at the World Vaccine Congress in March (March 2022).
Full details of the draft guidance can be found here.
Source: US Pharmacopeia