Pharma COVID Roundup: News from Roche, Moderna, Merck & Co., and GSKBy
The latest on COVID-19 vaccines/drugs, manufacturing, and testing from Roche, Moderna, Merck & Co., GSK, CureVac, Gristone, CEPI, and Thermo Fisher Scientific.
Manufacturing and supply of COVID-19 vaccines and drugs
Roche Reports Shortages for COVID-19 Drug
Roche’s Genentech has announced a global shortage of the supply of Actemra (tocilizumab), a drug for treating rheumatoid arthritis and authorized as a treatment for COVID-19, for at least the next several weeks (as reported on August 16, 2021).
In a statement released by the company on August 16, 2021, Roche’s Genentech reported that the rise of the COVID-19 Delta variant and the slowing of vaccination rates in the US has led to high of COVID-19 hospitalizations in certain areas of the US. “This new wave of the pandemic has led to Genentech experiencing an unprecedented demand for Actemra IV—well-over 400% of pre-COVID levels over the last two weeks alone and it continues to increase,” the company said in its August 16, 2021 statement.
Genentech says it has taken several actions, including allocating all Actemra IV formulations (80-, 200- and 400-mg vials), dropping shipping medicine directly to hospitals and clinics in COVID-19 hotspots, and collaborating with distributors and shipping carriers to find logistics solutions.
Despite these actions, the company says it is experiencing a temporary stockout of Actemra IV in the US for 200-mg and 400-mg SKUs, as of August 16, 2021. The company currently also has a short supply of the 80-mg SKU and expects a stockout by the end of the week (as reported on August 16, 2021).
The company says it currently (as of August 16, 2021), have a supply of subcutaneous Actemra available, which is indicated to treat rheumatoid arthritis and several other inflammatory-related conditions although it says the supply situation continues to evolve. Subcutaneous Actemra is not authorized for the treatment of COVID-19 patients under the FDA’s emergency use authorization.
Genentech says it expects the next scheduled replenishments to arrive by the end of August (August 2021). “However, if the pandemic continues to spread at its current pace, we anticipate additional periods of stockout in the weeks and months ahead,” the company said in its statement.
Moderna, Canadian Gov’t Revise Supply Pact for COVID-19 Vaccine
Moderna, a bio/pharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, has revised its supply agreement with the Canadian government for up to 105 million doses of Moderna’s COVID-19 vaccine and its booster vaccine candidate, if authorized, for delivery through 2024.
The agreement provides for 20 million COVID-19 vaccine doses each year in 2022 and 2023, with an option for an additional 15 million COVID-19 vaccine doses each year. For 2024, the agreement provides an option for up to 35 million COVID-19 vaccine doses.
Updates on COVID-19 treatments and vaccines
Merck & Co. Initiates Rolling Review of COVID Drug with Health Canada
Merck & Co. has initiated a rolling submission to Health Canada, the national pharmaceutical regulatory agency of Canada, for molnupiravir, an investigational oral antiviral agent for treating mild-to-moderate COVID-19.
Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics, a Miami, Florida-based bio/pharmaceutical company.
The rolling submission process was accepted under Canada’s Minister of Health’s Interim Order, which allows for the review of early safety, quality and efficacy data while later-stage clinical trials take place. Merck says that further findings from the ongoing molnupiravir development program will be shared with Health Canada as they become available. Health Canada will make a decision when all necessary evidence has been submitted and reviewed.
Source: Merck Canada
GSK, CureVac Report Preclinical Results for mRNA COVID-19 Vaccine
GlaxoSmithKline (GSK) and CureVac, a Tubingen, Germany-based clinical-stage biopharmaceutical company developing messenger ribonucleic acid (mRNA) therapeutics and vaccines, have reported preclinical data evaluating their mRNA COVID-19 vaccine candidate, CV2CoV, in a SARS-CoV-2 challenge study in non-human primates, compared to CureVac’s first COVID-19 vaccine candidate, CVnCoV.
The companies reported that the preclinical study provides evidence for strongly improved immune responses with CV2CoV, which was jointly developed by CureVac and GSK, compared to CureVac’s CVnCoV. The companies also reported that the data also demonstrate high protective efficacy of CV2CoV in animal models during the SARS-CoV-2 challenge study.
Additionally, the companies reported that higher antibody neutralizing capacity was observed with CV2CoV across all selected variants, including the Beta, Delta and Lambda variants.
Gritstone, CEPI in $20.6 M Funding Pact for COVID 19 Vaccine
Gritstone bio, an Emeryville, California-based bio/pharmaceutical company developing immunotherapies, has entered into a funding agreement of up to $20.6 million with the Coalition for Epidemic Preparedness Innovations (CEPI), a public–private partnership focused on vaccine development against emerging infectious diseases, to advance the development of Gritstone’s COVID-19 vaccine program with an initial focus in South Africa.
Gritstone’s vaccines include self-amplifying mRNA (SAM) to deliver multiple antigens (spike protein plus additional sequence from non-spike genes) providing the potential for immunity against variants of SARS-CoV-2, the virus that causes COVID-19.
Under the agreement, CEPI will provide up to $20.6 million to support a Phase I clinical trial in South Africa, including manufacturing of clinical trial materials as well as supporting preclinical studies and optimization of manufacturing processes.
The Phase I study will evaluate the program’s SAM vaccine in naïve, convalescent, and HIV+ patients. The funding will also support preclinical studies, scale-up and formulation development. The study will evaluate two different SAM vaccine constructs that each target both the spike protein and other SARS-CoV-2 targets and are designed to drive both robust B and T cell immune responses. The trial is expected to initiate before the end of 2021.
CEPI and Gritstone bio have agreed that the vaccine candidate will be made available to the COVAX Facility for procurement and allocation, if proven to be safe and effective. The COVAX Facility seeks to provide equitable access to COVID-19 vaccines for all countries that wish to participate.
News on COVID-19 testing
FDA Grants Emergency Use Authorization for Thermo Fisher’s COVID-19 Assays
The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for two of Thermo Fisher Scientific’s COVID-19 assays.
The TaqPath COVID-19 Fast PCR Combo Kit 2.0 and the TaqPath COVID-19 RNase P Combo Kit 2.0 are designed with increased target redundancy to compensate for current mutations and emerging SARS-CoV-2 variants. Both PCR-based kits use an updated design from the original TaqPath assays by targeting eight different genes across three regions of the virus that causes COVID-19.
Source: Thermo Fisher Scientific