Pharma COVID Roundup: News from AstraZeneca, Moderna, Thermo Fisher
The latest on COVID-19 vaccines/drugs, manufacturing, and testing from AstraZeneca, Moderna, Sk Bioscience, Inovio, Sinovac, the FDA, the World Health Organization, and Thermo Fisher Scientific.
Manufacturing and supply of COVID-19 vaccines and drugs
FDA OKs Certain Lots of AstraZeneca’s COVID-19 Vaccine from Emergent’s Mfg Facility
The US Food and Drug Administration (FDA) has found certain lots of AstraZeneca’s COVID-19 vaccine drug substance manufactured at the Emergent BioSolutions manufacturing facility in Baltimore, Maryland, to be acceptable for use for potential export.
The AstraZeneca vaccine is not authorized for use in the US, but these AstraZeneca lots, or vaccine made from the lots, can now be exported for use. The agency conducted a review of facility records and the results of quality testing performed by the manufacturer and reached its decision based on this review.
Source: US Food and Drug Administration
Updates on COVID-19 treatments and vaccines
Australia Authorizes Moderna’s COVID-19 Vaccine
The Australian Therapeutic Goods Administration (TGA) has granted provisional registration to Moderna’s COVID-19 vaccine in Australia for active immunization to prevent COVID-19 in individuals 18 years of age and older.
Delivery of Moderna’s COVID-19 vaccine to Australia is expected to begin in the second half of September (September 2021). The Australian government previously secured 10 million doses of Moderna’s COVID-19 vaccine for delivery in 2021, through a supply agreement announced in May 2021, which also included an option to procure 15 million doses in 2022.
Moderna has received emergency, conditional, interim or provisional authorization for use of its COVID-19 vaccine from health agencies in more than 50 countries and an emergency use listing from the World Health Organization. The TGA continues to evaluate an application for provisional registration of Moderna’s COVID-19 vaccine for use in adolescents aged 12 to 18 years.
WHO To Evaluate Three Drugs for Treating COVID-19
The World Health Organization (WHO) has announced the next phase of a global clinical trial evaluating potential COVID-19 treatments to include three new drugs for treating hospitalized COVID-19 patients: artesunate, imatinib, and infliximab.
The Solidarity PLUS trial is a platform trial among WHO member states. It involves thousands of researchers in over 600 hospitals in 52 countries to allow the trial to assess multiple treatments at the same time using a single protocol.
The three drugs—artesunate, imatinib and infliximab—were selected by an independent expert panel for their potential in reducing the risk of death in hospitalized COVID-19 patients. They are already used for other indications: artesunate is used for severe malaria, imatinib for certain cancers, and infliximab for diseases of the immune system, such as Crohn’s disease and rheumatoid arthritis. These drugs were donated for the trial by their manufacturers: Ipca (artesunate); Novartis (imatinib); and Johnson & Johnson (infliximab).
Source: The World Health Organization
SK bioscience Gets OK for Phase III Trial of COVID-19 Vaccine
SK bioscience, a vaccine developer and manufacturer based in South Korea, has received approval from South Korea’s Ministry of Food and Drug Safety for a Phase III trial for its COVID-19 vaccine candidate, GBP510.
SK bioscience is initiating the final stage of the clinical study with the goal of making it available in the first half of 2022. SK bioscience, the Korea Disease Control and Prevention Agency, and the International Vaccine Institute, a non-profit global organization for vaccines, recently signed a joint analysis agreement for the global Phase III trial.
Development costs of GBP510 are being supported by the Bill & Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations, a public–private partnership focused on vaccine development against emerging infectious diseases. The two organizations have been behind GBP510 since the initial development stage and have committed $214 million, among which about $173 million will be used for Phase III trial and other program activities. SK bioscience expects to use the funds for the Phase III clinical trial and approval process, the development of commercial processes geared for delivering hundreds of millions of doses yearly, the acquisition of relevant raw materials, and additional research and development against virus variants.
Source: SK bioscience
FDA OKs Dexamethasone as COVID-19 Drug
The US Food and Drug Administration (FDA) has approved an abbreviated new drug application (ANDA) for dexamethasone sodium phosphate injection as a treatment for COVID-19.
Dexamethasone injection is used to treat conditions such as arthritis, blood disorders, hormone disorders, allergic reactions, skin diseases, eye disorders, breathing problems, bowel disorders, cancer, and immune-system disorders.
Source: US Food and Drug Administration
Inovio, Sinovac To Evaluate Mixed Boosted Regimes of COVID Vaccines
Inovio, a Plymouth Meeting, Pennsylvania-based bio/pharmaceutical company developing DNA-based immunotherapies for cancer and infectious diseases, has received regulatory allowance in China for two clinical trials evaluating mixed boosted regimens of INO-4800, its COVID-19 DNA vaccine, and CoronaVac, a COVID-19 vaccine developed by Sinovac Biotech, a Beijing-based bio/pharmaceutical company.
Inovio is partnered with the trial-sponsor, Advaccine Biopharmaceuticals, and Sinovac for the studies, which will evaluate the safety, tolerability, and immunogenicity of heterologous prime-boost sequential immunizations using Inovio’s INO-4800 and Sinovac’s CoronaVac. Both studies, which will be conducted in China, are anticipated to begin this fall (fall 2021) and will involve healthy adult subjects 18 years of age or older.
Sinovac Reports Results for COVID-19 Vaccine Boosters
Sinovac Biotech, a Beijing, China-based bio/pharmaceutical company, reported positive data for the booster dose of its COVID-19 vaccine, CoronaVac, in which it induces strong immune response in adult and elderly populations.
The results indicated that a two-dose schedule generates good immune memory. A third dose given six to eight months after the second dose increased neutralizing antibody levels in adults and the elderly population
News on COVID-19 testing
Thermo Fisher Updates COVID Test for Select Variants
Thermo Fisher Scientific has updated its Applied Biosystems TaqMan SARS-CoV-2 Mutation Panel to detect the Delta and Lambda strains of SARS-CoV-2, the virus that causes COVID-19.
First launched in March 2021, the research panel enables laboratories to track known mutations by selecting from a menu of over 50 assays designed to screen for different variants.
Source: Thermo Fisher Scientific