Sanofi has entered into an agreement with Janssen Pharmaceutical NV and Janssen Pharmaceuticals, Inc., two of the Janssen Pharmaceutical Companies of Johnson & Johnson (J&J), to support the manufacturing of J&J’s single-dose COVID-19 vaccine.

Earlier this month (February 2021), J&J submitted an application for conditional marketing authorization to the European Medicines Agency and a request to the US Food and Drug Administration (FDA) for emergency use authorization (EMA). An advisory committee of the FDA is meeting on February 26, 2021 to review the EUA request. In addition, rolling submissions for the COVID-19 vaccine have been initiated in several other countries worldwide.

Once authorized, Sanofi will provide J&J access to its vaccine manufacturing plant in Marcy l’Etoile, France, to formulate and fill vials of the COVID-19 vaccine in 2021 at a rate of approximately 12 million doses per month.

Filing with the World Health Organization

J&J has also submitted a request for emergency use listing (EUL) to the World Health Organization (WHO) for its single-dose COVID-19 vaccine. The data package delivered includes interim efficacy and safety results from a Phase III trial. This marked the completion of the company’s rolling submission of clinical data to WHO.

The EUL procedure streamlines the process by which new or unlicensed products can be assessed for use during public health emergencies by governments and UN procurement agencies. The EUL process expedites access to such products in many countries and is also a prerequisite to supply vaccines to the COVAX Facility, a global mechanism for pooled procurement and distribution of COVID-19 vaccines in 190 participating countries, including 92 lower-income countries.

In December 2020, the company entered into an agreement in principle with Gavi, a global public health partnership, in support of the COVAX facility. J&J and Gavi expect to enter into an advance purchase agreement that would provide up to 500 million doses of the J&J vaccine to COVAX through 2022.

COVAX is the vaccines pillar of the Access to COVID-19 Tools Accelerator, which is co-led by the Coalition for Epidemic Preparedness Innovations, a public–private partnership focused on vaccine development against emerging infectious diseases, Gavi, a global public health partnership, and WHO.

Manufacturing and supply of other COVID-19 vaccines

Late last month (January 2021), Sanofi entered into an agreement with Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, to support the manufacturing and supply of more than 125 million doses Pfizer’s/BioNTech’s COVID-19 vaccine.

Separately, Sanofi is pursuing development of its own COVID-19 vaccines in partnership with other companies. It is collaborating with GlaxoSmithKline (GSK) on a COVID-19 vaccine candidate using the same recombinant protein-based manufacturing technology as one of its seasonal influenza vaccines, combined with GSK’s adjuvant platform. The companies initiated a new Phase II study in February 2021 that will evaluate the vaccine candidate with an improved antigen formulation in order to achieve high-level immune response across all age groups. If data are positive, a global Phase III study could start in the second quarter 2021. Positive results from this study would lead to regulatory submissions in the second half of 2021, with potential availability of doses in the fourth quarter of 2021.

Sanofi is also developing a messenger RNA (mRNA) COVID-19 vaccine in partnership with Translate Bio, a clinical-stage messenger RNA (mRNA) therapeutics company. A Phase I/II study is expected to start in the first quarter of 2021.

Source: Sanofi, Johnson & Johnson, and the US Food and Drug Administration