COVID News: Moderna, CEPI, Valneva & MoreBy
The latest on COVID-19 vaccines/drugs and manufacturing Pfizer, BioNTech, Moderna, Novavax, Bharat Biotech, ExcellGene, and Valneva. Highlights below.
Manufacturing and supply of COVID-19 vaccines and drug
* Novavax Ships COVID Vaccine to US Gov’t
* Valneva To Supply 1.25-M Doses of COVID-19 Vaccine to EU
Updates on COVID-19 therapeutics and vaccines
* Pfizer, BioNTech Initiate Phase II Trial for Bivalent COVID Vaccine Against Omicron Variant
* EMA Recommends Moderna’s COVID-19 Vaccine Booster in Adolescents
* CEPI, Bharat Biotech, & Others In Pact for Variant-Focused COVID-19 Vaccine
Manufacturing and supply of COVID-19 vaccines and drugs
Novavax Ships COVID Vaccine to US Gov’t
Novavax, a Gaithersburg, Maryland-based vaccine company, has shipped doses of its COVID-19 vaccine to US government’s designated distribution centers. The US Food and Drug Administration granted emergency use authorization for the vaccine to individuals 18 years or older earlier this month (July 2022).
The US Centers for Disease Control and Prevention will allocate doses to US states, including state and local distribution centers, federal pharmacy partners, and federally qualified health centers, and the ability of those entities to order doses was slated to start on Monday, July 25., 2022.
Valneva To Supply 1.25-M Doses of COVID-19 Vaccine to EU
The European Commission (EC) has approved an amended purchased agreement with Valneva, a Saint-Herblain, France-based vaccine company, for 1.25 million doses of Valneva’s COVID-19 vaccine in 2022 with an option to purchase an equivalent quantity later this year (2022).
Last month (June 2022), the EC notified Valneva of its intent to terminate the original purchase agreement signed in November 2021, which provided that Valneva supply up to 60 million doses of its vaccine in 2022 and 2023. The EC provided Valneva the opportunity to provide an alternate plan, which is reflected in the amended purchase agreement. The amended purchased agreement will be signed after a mandatory five-day period (as reported on July 20, 2022) during which European Union (EU) member states can opt out.
The first vaccine doses will be delivered to participating EU member states (Germany, Austria, Denmark, Finland, and Bulgaria) in the coming weeks (as reported on July 20, 2022). Valneva will retain inventory for potential additional supply to these EU member states should demand increase and, in parallel, aim to deploy approximately 8 to 10 million doses of remaining inventory into international markets. Given that the vaccine’s shelf life is expected to reach up to 24 months over time, Valneva says it is seeking to deploy these doses in the next six to twelve months (as reported on July 20, 2022).
Updates on COVID-19 therapeutics and vaccines
Pfizer, BioNTech Initiate Phase II Trial for Bivalent COVID Vaccine Against Omicron Variant
Pfizer and BioNTech have initiated a Phase II study to evaluate a bivalent COVID-19 vaccine candidate, BNT162b5, which covers both the original SARS-CoV-2 virus and an Omicron variant. The vaccine candidate consists of RNA-encoded prefusion spike proteins incorporating a SARS-CoV-2 ancestral strain (wild-type) and an Omicron variant. The enhanced spike protein encoded from the mRNAs in the companies’ original COVID-19 vaccine has been modified with the aim of increasing the magnitude and breadth of the immune response against COVID-19.
This is the first of multiple vaccine candidates with an enhanced design that the companies plan to evaluate as part of a long-term scientific COVID-19 vaccine strategy. The new vaccine candidate, BNT162b5, will be evaluated in a US-based study enrolling approximately 200 participants between 18 and 55 years old who have received one booster dose of a US-authorized COVID-19 vaccine at least 90 days prior to their first study visit.
EMA Recommends Moderna’s COVID-19 Vaccine Booster in Adolescents
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended a variation to Moderna’s conditional marketing authorization to include a booster dose of Spikevax, the company’s COVID-19 vaccine, at the 50-µg dose level for adolescents (12–17 years) at least three months after completion of the primary vaccination series.
Spikevax was previously authorized for individuals six years of age and older, and a booster dose for people aged 12 years and older.
CEPI, Bharat Biotech, & Others In Pact for Variant-Focused COVID-19 Vaccine
The Coalition for Epidemic Preparedness Innovation (CEPI), a public–private coalition that develops vaccines against infectious diseases, is supporting a consortium to develop vaccines against SARS-CoV-2 variants of concern and other beta-coronaviruses. Partners in the consortium include Bharat Biotech, a Hyderabad, India-based bio/pharmaceutical company, ExcellGene, a Monthey, Switzerland biologics CDMO, and the University of Sydney in Australia.
CEPI will provide up to $19.3 million in funding to develop a variant-focused SARS-CoV-2 vaccine candidate for Phase I clinical trials. Bharat Biotech, the University of Sydney, and ExcellGene will generate and screen a library of chimeric spike proteins to identify cross-reactive antigen structures that recall past and possibly future variants. An entirely new “chimeric” spike antigen complex, different from any protein of existing SARS-CoV-2 variants, will be generated. It is expected that such a trimeric spike protein, composed of combined mutations that characterize virus variants of concern from 2020–2022, will induce a wider range of cross-reactivity against historic or future variants than any of the individual virus variants did before.
Source: ExcellGene and Bharat Biotech