Pharma COVID Roundup: News from Lilly, GSK, Moderna, Fujifilm, CureVacBy
The latest on COVID-19 vaccines/drugs and manufacturing from Lilly, GSK, Moderna, Fujifilm, Novavax, CureVac, the Serum Institute of India, Bharat Biotech, and others.
Manufacturing and supply of COVID-19 vaccines and drugs
Serum Institute of India, Bharat Biotech To Increase COVID-19 Vaccine Production
Serum Institute of India, a Pune, India-based vaccine manufacturer, and Bharat Biotech, a Hyderabad, India-based biopharmaceutical company, have separately announced the scaling up of production of COVID-19 vaccines.
Serum Institute of India is scaling up its COVID-19 vaccine production to accelerate India’s vaccination drive as announced by India’s Ministry of Health and Finance Ministry.
For the next two months (as reported on April 21, 2021), the company says it will address limited capacity by scaling up vaccine production. The company reports 50% of its capacities will be served to the Indian government for its vaccination program, and the remaining 50% of the capacity will be for state governments and private hospitals.
Separately, Bharat Biotech is scaling up manufacturing capacity to produce approximately 700 million doses of Covaxin, its COVID-19 vaccine candidate, annually, with capacity expansion already implemented across multiple facilities in Hyderabad and Bangalore, India.
The company says manufacturing partnerships are being explored with its partners in other countries that have prior expertise with commercial-scale manufacture of inactivated viral vaccines under biosafety containment.
To further increase capacities, Bharat has partnered with Indian Immunologicals (IIL) to manufacture the drug substance for Covaxin. The technology transfer process is underway (as reported on April 20, 2021), and IIL has capabilities to manufacture inactivated viral vaccines at commercial scale and under biosafety containment.
Covaxin has received emergency use authorizations in several countries with authorization for another 60 countries in process. Authorization has been obtained from Mexico, Philippines, Iran, Paraguay, Guatemala, Nicaragua, Guyana, Venezuela, Botswana, Zimbabwe and are in process in the US and several European countries.
Source: Serum Institute of India, Bharat Biotech (expansion), and Bharat Biotech (Phase III results)
Moderna, Israel in New Supply Pact for COVID-19 Vaccine
Moderna, a biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, has announced a new supply agreement with Israel for 2022 for its COVID-19 vaccine.
Under the agreement, Israel retains an option to purchase doses of one of Moderna’s variant-specific vaccine candidates, subject to regulatory approval. This announcement follows two earlier agreements between Israel and Moderna to supply a total of 10 million doses of its COVID-19 vaccine. The Israeli Ministry of Health authorized Moderna’s COVID-19 vaccine on January 4, 2021.
Hualan Biological Bacterin To Produce Russia’s COVID-19 Vaccine
Hualan Biological Bacterin, a division of Hualan Biological Engineering, a biopharmaceutical company and influenza vaccine manufacturer in China, has entered into an agreement with Russian Direct Investment Fund (RDIF), a sovereign wealth fund in Russia, to produce more than 100 million doses per year of Sputnik V, a COVID-19 vaccine developed by Russia’s Gamaleya National Center of Epidemiology and Microbiology.V.
The produced volume will allow providing vaccination to over 50 million people. RDIF and Hualan Biological Bacterin aim for long-term cooperation for the production of the vaccine.
Source: Hualan Biological Bacterin
CEPI, African Union in Pact for Vaccine R&D, Mfg
The Coalition for Epidemic Preparedness Innovations (CEPI), a public–private partnership focused on vaccine development against emerging infectious diseases, and the African Union Commission have signed a memorandum of understanding to strengthen ties between the organizations and the Africa CDC, a specialized institution of the African Union responsible for the prevention and control of diseases in Africa, to enhance vaccine R&D and manufacturing in Africa.
This collaboration forms a major part of CEPI’s longer-term epidemic and pandemic strategy, which was announced in March 2021. As part of this strategy, CEPI aims to work with low-income and middle-income countries to develop the infrastructure and expertise to undertake the epidemiological and clinical studies needed to advance vaccine development, support technology transfer, and develop national and regional manufacturing capacity that will enable these countries to take full ownership of their national health security.
Source: Coalition for Epidemic Preparedness Innovations and African Union Commission
Kintor Pharmaceutical, Visum in Pact To Expand COVID-19 Treatment Mfg
Kintor Pharmaceutical, a Suzhou, China-based clinical-stage biopharmaceutical company, has entered into a strategic partnership with Hainan Visum Pharmaceutical, a Haikou City, China-based pharmaceutical company, to expand the manufacturing of proxalutamide, a potential COVID-19 treatment.
Kintor Pharmaceutical is completing Brazilian clinical trials of proxalutamide for treating COVID-19 patients with mild or moderate symptoms and COVID-19 patients with severe symptoms.
Kintor Pharmaceutical also announced that its investigational new drug application for a Phase III clinical trial of proxalutamide for COVID-19 patients has been approved by the US Food and Drug Administration.
Source: Kintor Pharmaceutical
Updates on COVID-19 treatments and vaccines
FDA OKs Lilly’s Request to Revoke Authorization for COVID-19 Drug
The US Food and Drug Administration (FDA) has granted Eli Lilly and Company’s request to revoke the emergency use authorization (EUA) for bamlanivimab 700 mg alone. Lilly made this request due to the evolving variant landscape in the US and the full availability of bamlanivimab and etesevimab together as a COVID-19 treatment.
Lilly and the US government have also modified their contracts to ensure adequate supply of etesevimab to be used together with bamlanivimab.
The company says all vaccination sites in the US have access to obtain doses of etesevimab for administration with bamlanivimab, which together neutralize more of the emerging COVID-19 variants in the US than bamlanivimab alone. Lilly is not requesting the withdrawal of emergency authorization for bamlanivimab alone in any other jurisdiction at this time.
Lilly, in collaboration with Amgen, expects to manufacture sufficient supply of bamlanivimab and etesevimab together to meet global supply needs. Going forward (as reported on April 16, 2021), Lilly will only submit bamlanivimab administered with etesevimab together for authorization globally with a full transition expected by June 2021.
Source: Eli Lilly and Company and the US Food and Drug Administration
EU, Australia Begin Rolling Review of GSK’s, Vir’s COVID-19 Drug
The European Medicines Agency (EMA) has started a rolling review of VIR-7831, a monoclonal antibody for the treatment COVID-19, from GlaxoSmithKline (GSK) and Vir Biotechnology, a San Francisco-based clinical-stage biopharmaceutical company. The Australian Therapeutic Goods Administration (TGA) has also granted VIR-7831 a provisional determination.
The EU review is being carried out by the EMA’s Committee for Human Medicinal Products (CHMP) and will provide EU-wide recommendations for national authorities who may take evidence-based decisions on the early use of the medicine, ahead of any formal marketing authorization application.
Additionally, the TGA has granted VIR-7831 a provisional determination. The granting of a provisional determination means that the TGA has made a decision that GSK is now eligible to apply for provisional registration for the treatment in the Australian Register of Therapeutic Goods (ARTG). Provisional determination is the first step in the process and does not mean that an application has or will be made, or that the treatment will be provisionally approved for inclusion in the ARTG.
Source: GlaxoSmithKline, Vir Biotechnology, the European Medicines Agency, and the Australian Therapeutic Goods Administration
Swissmedic Initiates Rolling Review of CureVac’s COVID-19 Vaccine
CureVac, a Tubingen, Germany-based clinical-stage biopharmaceutical company developing messenger ribonucleic acid (mRNA) therapeutics and vaccines, has initiated the rolling review process for the authorization of its COVID-19 vaccine candidate, CVnCoV, to Swissmedic, the Swiss pharmaceutical regulatory agency.
In early February (February 2021), the Swiss federal government and CureVac signed a contract for the supply of five million doses of the vaccine. The contract is based on the delivery agreement between the European Commission and the company.
CureVac’s COVID-19 vaccine candidate is currently in late-stage clinical testing. In February 2021, the company started a rolling review with the European Medicines Agency for the vaccine and expects the potential authorization for use in the European Union in the second quarter of 2021.
Source: CureVac and Swissmedic
Fujifilm Initiates Phase III Trial for Influenza Drug as COVID-19 Drug
Fujifilm Toyama Chemical has initiated a new Phase III clinical trial in Japan for its anti-influenza drug, Avigan (favipiravir) in patients infected with COVID-19.
Fujifilm Toyama Chemical initiated a Phase III clinical trial for Avigan in Japan in March 2020, targeting COVID-19 patients with non-severe pneumonia. Since the primary endpoint had been met with the statistically significant differences in the clinical trial, the company filed an application for partial changes to manufacturing and marketing approval matters of Avigan.
Novavax To Participate in University of Oxford Mixed COVID-19 Vaccine Study
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, has announced its participation in a newly expanded investigator-initiated Phase II clinical trial to be conducted by the University of Oxford and supported by the UK Vaccines Taskforce to evaluate COVID-19 vaccines.
The study will compare the immune-system responses from those who receive a heterologous regimen to those who receive a homologous regimen and will assess potential for flexibility in the delivery of COVID-19 vaccines. The UK Medicines and Healthcare products Regulatory Agency and the UK’s Joint Committee on Vaccination and Immunization will formally assess the safety and efficacy of any new vaccination regimen before it is made available to the public.