COVID News: Moderna, Pfizer, Gilead & More
The latest on COVID-19 vaccines/drugs and manufacturing from Moderna, Gilead Sciences, AstraZeneca, Pfizer, BioNTech, Novavax, and Codexis. Highlights below.
Manufacturing and supply of COVID-19 vaccines and drugs
* Gilead, EU In Procurement Agreement for COVID-19 Drug
* AstraZeneca To Supply Switzerland 1,200 Doses of COVID-19 Drug
* Codexis To Supply Biocatalyst for Pfizer’s COVID-19 Drug
* Novavax, SK bioscience Extend COVID-Vaccine Mfg Pact
Updates on COVID-19 therapeutics and vaccines
* Canada, Australia OK Moderna’s COVID-19 Vaccine in Young Children
* Pfizer, BioNTech Submit Omicron Vaccine Candidate to EU
Manufacturing and supply of COVID-19 vaccines and drugs
Gilead, EU In Procurement Agreement for COVID-19 Drug
Gilead Sciences and the European Commission have signed a new joint procurement agreement for Gilead’s Veklury (remdesivir), a drug to treat COVID-19, covering participating member states of the European Union (EU) and the European Economic Area, which includes the EU countries and also Iceland, Liechtenstein, and Norway. The agreement covers purchases of Veklury over the next 12 months with an option to extend the agreement for an additional six months. The new agreement follows the expiration of the original agreement signed in October 2020.
Source: Gilead Sciences
AstraZeneca To Supply Switzerland 1,200 Doses of COVID-19 Drug
Switzerland’s Federal Office of Public Health has contracted with AstraZeneca to purchase just over 1,200 doses of the company’s Evusheld (tixagevimab co-packaged with cilgavimab), an antibody combination used to prevent and treat COVID-19. This is the second contract by the Swiss government with the pharmaceutical company to reserve this product.
Source: Switzerland Federal Office of Public Health
Codexis To Supply Biocatalyst for Pfizer’s COVID-19 Drug
Codexis, a Redwood City, California-based provider of biocatalyst and enzyme engineering technology, has entered into an agreement with Pfizer for the supply of a proprietary enzyme used to manufacture an intermediate for nirmatrelvir, an active pharmaceutical ingredient in Paxlovid, Pfizer’s COVID-19 drug.
Source: Codexis
Novavax, SK bioscience Extend COVID-Vaccine Mfg Pact
Novavax, a Gaithersburg, Maryland-based vaccine company, and SK bioscience, a Gyeonggi, South Korea-based pharmaceutical company, have extended their partnership with Novavax, for the manufacturing and supply of Novavax’s COVID-19 vaccine targeting Omicron variants and in prefilled syringes.
The companies signed an agreement for the technology transfer of Novavax’ COVID-19 variant antigen materials so that SK bioscience can manufacture the vaccine substance targeting COVID-19 variants, including the Omicron BA.5 subvariant.
In addition, the companies have signed an agreement to manufacture and supply the vaccine in a prefilled syringe. SK bioscience will begin work this year (2022) to enable the manufacturing process for commercial supply of the vaccine in prefilled syringes in 2023.
Source: Novavax and SK bioscience
Updates on COVID-19 therapeutics and vaccines
Canada, Australia OK Moderna’s COVID-19 Vaccine in Young Children
Health Canada, the pharmaceutical regulatory agency of Canada, and the Therapeutic Goods Administration (TGA), Australia’s pharmaceutical regulatory agency, have approved, and granted provisional registration, respectively, for the use of Moderna’s mRNA COVID-19 vaccine, Spikevax, in children aged six months to five years. Health Canada and the TGA previously approved the vaccine in individuals six years of age and older.
The primary series of the vaccine for children six months to five years is completed in a two-dose series of 25-µg per dose over one month, the same primary dosing schedule as adults, adolescents, and children over five years of age.
Source: Moderna (Canadian Approval) and Moderna (Australian Registration)
Pfizer, BioNTech Submit Omicron Vaccine Candidate to EU
Pfizer and BioNTech have completed a submission to the European Medicines Agency for an Omicron-adapted bivalent COVID-19 vaccine candidate, based on the BA.1 sub-lineage, for individuals 12 years of age and older.
The companies’ previously announced safety, tolerability and immunogenicity data from a Phase II/III trial found that a 30-µg booster dose of the Omicron-adapted bivalent vaccine candidate elicited what the companies characterized as a “superior” immune response against Omicron BA.1 as compared to the companies’ current COVID-19 vaccine.
Pfizer and BioNTech previously shared these data with the US Food and Drug Administration (FDA) to support a potential variant-adapted vaccine and continue to submit additional data as advised by the agency.
