Takeda, IDT, Catalent in Mfg Pacts for J&J’s COVID-19 VaccineBy
Takeda Pharmaceutical, IDT Biologika, a Dessau-Rosslau, Germany-based CDMO, and Catalent have formed manufacturing pacts for Johnson & Johnson’s (J&J) COVID-19 vaccine. Also, the World Health Organization (WHO) has issued an emergency use listing for the vaccine.
Takeda Pharmaceutical and IDT Biologika mutually agreed to use capacity at IDT that was previously reserved for Takeda’s dengue vaccine candidate, TAK-003, to manufacture J&J’s COVID-19 vaccine. At the end of a three-month period, the capacity will be returned to Takeda to resume manufacturing for the planned launch of Takeda’s dengue vaccine, subject to regulatory approvals. IDT Biologika is now using capacities at its Dessau site to fill and package J&J’s COVID-19 vaccine.
With this agreement, Takeda is now supporting global access to three different COVID-19 vaccines. Takeda previously announced partnerships for COVID-19 vaccines in Japan with Novavax and Moderna. With Novavax, Takeda will receive a manufacturing technology transfer from Novavax and will be responsible for the development and commercialization based on manufacturing capacity of more than 250 million doses. Takeda will also import and distribute 50 million doses of Moderna’s COVID-19 vaccine as part of a joint partnership with Moderna and the Japanese government.
IDT Biologika is producing J&J’s and AstraZeneca’s COVID-19 vaccine and is developing its own COVID-19 vaccine together with the German Center for Vaccine Research
Separately, Catalent has expanded a partnership with J&J whereby Catalent Biologics will increase its manufacturing capacity for large-scale commercial supply of J&J’s COVID-19 vaccine at Catalent’s manufacturing facility in Anagni, Italy, including vial-filling, inspection, labeling, and packaging services.
The companies had previously agreed to dedicate an existing vial-filling line at the Anagni facility. As part of this expanded agreement, Catalent will accelerate the qualification and scale-up of an additional high-speed vial-filling line that is expected to be operational in the fourth quarter of 2021, to support the production of J&J’s vaccine through late 2022.
WHO issues emergency use listing
Additionally, the World Health Organization (WHO) has issued an emergency use listing (EUL) for J&J’s COVID-19 vaccine to prevent COVID-19 in individuals 18 years of age and older.
The EUL procedure streamlines the process by which new or unlicensed products can be assessed for use during public health emergencies by governments and United Nations procurement agencies. The EUL process expedites access to such products in many countries around the world and is also a prerequisite to supply vaccines to the new 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, J&J entered into an agreement in principle with Gavi, a global 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 J&J’s vaccine to COVAX through 2022 (as reported on March 12, 2021).
J&J also received interim authorization from WHO’s Strategic Advisory Group of Experts (SAGE) on Immunization. SAGE advises WHO on global vaccine and immunization policies and its recommendations on the use of vaccines supplied through the COVAX Facility.
In addition to WHO, J&J’s COVID-19 vaccine has received emergency use authorization by the US Food and Drug Administration, conditional marketing authorization from the European Commission, and an interim order authorization in Canada. Additional rolling submissions have been initiated in several countries worldwide.