Pharma COVID Roundup: News from Moderna, Takeda, Merck & Co, J&JBy
The latest on COVID-19 vaccines/drugs, manufacturing, and testing from Moderna, Takeda, Merck & Co., J&J, AstraZeneca, Sanofi, Celltrion, and Thermo Fisher Scientific.
Manufacturing and supply of COVID-19 vaccines and drugs
Moderna, Takeda Report Findings Investigating COVID-19 Vaccine Recall
Takeda and Moderna have published a report of their investigation of foreign particles in unpunctured vials from a single lot of Moderna’s COVID-19 vaccine distributed in Japan by Takeda.
The lot was suspended on August 26, 2021 and voluntarily recalled on September 2, 2021. Two other lots manufactured in the same series were included in the suspension and voluntary recall as a precautionary measure.
The report provides details on the particle analysis, root cause, and health risk assessment conducted by Moderna, Takeda, the authorized distributor and marketing authorization holder of the vaccine in Japan, and Rovi Pharma Industrial Services, a Madrid, Spain-based CDMO of the vaccine. In addition, the report provides information based on a draft for-cause audit of Rovi, conducted onsite jointly by Moderna and Takeda.
In summary, the root cause, particle analysis, and health risk assessment established the following:
- The rare presence of 316-L stainless steel particles, observed in one of the recalled lots, presented no undue risk to patient safety and did not adversely affect the benefit/risk profile of the product.
- The most probable cause of the particles identified in one of the recalled lots is related to friction between two pieces of metal installed in the stoppering module of the production line.
- This was the result of incorrect assembly and was due to human error specific to visually misjudging the required 1mm gap between the star-wheel and the stopper.
The full investigation report can be read here.
Updates on COVID-19 treatments and vaccines
Merck & Co. Plans to File for Authorization for Oral COVID-19 Drug
Merck & Co. and Ridgeback Biotherapeutics, a Miami, Florida-based bio/pharmaceutical company, reported results on molnupiravir, an investigational oral antiviral agent being developed by the companies for preventing COVID-19.
The companies reported that molnupiravir reduced the risk of hospitalization or death at a planned interim analysis of a Phase III trial in at-risk, non-hospitalized adult patients with mild-to-moderate COVID-19.
At the recommendation of an independent data monitoring committee and in consultation with the US Food and Drug Administration (FDA), recruitment into the study is being stopped early due to these positive results. Merck plans to submit an application for emergency use authorization (EUA) to the FDA as soon as possible (as reported on October 1, 2021) based on these findings and plans to submit marketing applications to other regulatory bodies globally.
J&J Submits Data to FDA for Booster of COVID-19 Vaccine
Johnson & Johnson (J&J) has submitted data to the US Food and Drug Administration (FDA) to support use of a booster shot of its COVID-19 vaccine in individuals 18 years of age and older.
The submission includes recent results from a Phase III study that found a booster of J&J’s COVID-19 vaccine given 56 days after the primary dose provided 94% protection against symptomatic (moderate to severe/critical) COVID-19 and 100% protection against severe/critical COVID-19, at least 14 days post-booster vaccination.
Also, part of the submission is Phase I/IIa data showing that when a booster of the J&J’s COVID-19 vaccine was given six months after the single shot, antibody levels increased nine-fold one week after the booster and continued to climb to 12-fold higher four weeks after the booster. The vaccine, when given as a booster or primary dose, was generally well-tolerated.
The company plans to submit the data to other regulators, the World Health Organization (WHO), and National Immunization Technical Advisory Groups (NITAGs) globally to inform decision-making on local vaccine administration strategies, as needed.
Source: Johnson & Johnson
FDA To Hold Meeting To Consider COVID-19 Vaccine Booster Doses in Children
The US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee will meet on October 14, 2021 and October 15, 2021 to discuss the use of booster doses of Moderna’s COVID-19 vaccine and the Johnson & Johnson’s COVID-19 vaccine in children.
Both vaccines are currently authorized for emergency use to prevent COVID-19 in individuals 18 years of age and older. The committee will also hear presentations and discuss the available data on the use of a booster of a different vaccine than the one used for the primary series of an authorized or approved COVID-19 vaccine (i.e., heterologous or “mix and match” booster).
Source: US Food and Drug Administration
AstraZeneca Files for EUA for COVID-19 Antibody Combo
AstraZeneca has submitted a request to the US Food and Drug Administration (FDA) for an emergency use authorization (EUA) for AZD7442, its long-acting antibody (LAAB) combination, for prophylaxis of symptomatic COVID-19.
In August (August 2021), AstraZeneca reported positive results from a Phase III pre-exposure prophylaxis trial of AZD7442, indicating that AZD7442 reduced the risk of developing symptomatic COVID-19 by 77% compared to placebo. The trial accrued 25 cases of symptomatic COVID-19 at the primary analysis.
Preliminary in-vitro findings showed that AZD7442 demonstrates broad anti-COVID activity, and in particular neutralizes recent emergent SARS-CoV-2 viral variants, including the Delta and Mu variants, according to the company.
Discussions regarding supply agreements for AZD7442 are ongoing with the US government as well as other governments globally.
EMA Starts Review of Celltrion’s COVID-19 Drug
The European Medicines Agency (EMA) has started evaluating an application for marketing authorization for) Regkirona (regdanvimab) from Celltrion, an Incheon, South Korea-based bio/pharmaceutical company, to treat adults with COVID-19 who do not require supplemental oxygen therapy and who are at increased risk of progressing to severe COVID 19.
The EMA will assess the benefits and risks of Regkirona under a reduced timeline and could issue an opinion within two months (as reported on October 5, 2021) depending on the robustness of the data submitted and whether further information is required to support the evaluation.
Sanofi Reports First Results for Flu Vaccine with Moderna’s COVID-19 mRNA Booster
Sanofi reports positive interim results from the first co-administration descriptive study of Sanofi’s Fluzone High-Dose Quadrivalent vaccine with Moderna’s COVID-19 mRNA investigational vaccine booster dose.
The results show that the administration of the vaccines at the same visit had similar immunogenicity responses and a similar safety and tolerability profile compared to each vaccine administered individually.
Fluzone High-Dose Quadrivalent is a high-dose quadrivalent influenza vaccine, indicated for adults aged 65 and older in the US and Canada. It is also licensed under the brand name Efluelda in Europe where it is indicated for adults aged 60 and older.
News on COVID-19 testing
Thermo Fisher Launches Wastewater Isolation Kit for SARS-CoV-2 Surveillance
Thermo Fisher Scientific has launched the MagMAX Wastewater Ultra Nucleic Acid Isolation Kit, which provides an end-to-end solution for detecting SARS-CoV-2, the virus that causes COVID-19, from wastewater.
The kit is compatible with input volumes ranging from 200 µl to 500 mL and works with upfront concentration methods, including ultracentrifugation, precipitation, and filtration.
Source: Thermo Fisher Scientific