Pharma COVID Roundup: News from Moderna, Pfizer, Regeneron, and TakedaBy
The latest on COVID-19 vaccines/drugs and manufacturing from Moderna, Pfizer, Roche, Takeda, Regeneron Pharmaceuticals, and Sinovac.
Manufacturing and supply of COVID-19 vaccines and drugs
Takeda, Japan Gov’t Expand Supply Pact for Moderna’s COVID-19 Vaccine
Takeda and Japan’s Ministry of Health, Labour and Welfare (MHLW) have agreed to purchase and distribute an additional 50 million doses of Moderna’s COVID-19 vaccine and its updated variant booster vaccine candidate, if authorized, to begin delivery in 2022.
This new supply agreement is in addition to the prior agreement for 50 million doses in 2021, which brings the total number of doses under both pacts to be supplied in Japan to 100 million doses. Moderna is responsible for the manufacture and supply of its COVID-19 vaccine candidate, and Takeda, with the support of the MHLW and Moderna, is responsible for all import, local regulatory, development and distribution activities in Japan for these additional 50 million doses beginning in 2022.
Pfizer/BioNTech in Mfg, Supply Pact with Biovac for COVID-19 Vaccine
Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, have signed a letter of intent with The Biovac Institute (Biovac), a Cape Town, South Africa-based bio/pharmaceutical company, for Biovac to manufacture Pfizer’s/BioNTech’s COVID-19 vaccine for distribution within the African Union.
Biovac will perform manufacturing and distribution activities within Pfizer’s and BioNTech’s global COVID-19 vaccine supply chain and manufacturing network, which includes more than 20 manufacturing facilities. To facilitate Biovac’s involvement in the process, technical transfer, on-site development, and equipment installation activities will begin immediately (as reported on July 21, 2021).
Pfizer and BioNTech expect that Biovac’s Cape Town facility will be incorporated into their vaccine supply chain by the end of 2021. Biovac will obtain drug substance from facilities in Europe, and manufacturing of finished doses will begin 2022. At full operational capacity, the annual production will exceed 100 million finished doses annually. All doses will exclusively be distributed within the 55 member states that make up the African Union.
To date (as reported on July 21, 2021), Pfizer and BioNTech have shipped more than one billion COVID-19 vaccine doses to more than 100 countries or territories globally. The companies are working with global governments as well as global health partners with the aim to provide two billion doses to low- and middle-income countries in 2021 and 2022–one billion each year. This includes an agreement to supply 500 million doses to the US government at a not-for-profit price, that the US government will, in turn, donate to the African Union and the COVAX 92 Advanced Market Commitment countries as well as a direct supply agreement with the COVAX facility for 40 million doses. The COVAX Facility is a global initiative for equitable access to COVID-19 vaccines
Updates on COVID-19 treatments and vaccines
FDA Grants Priority Review for Pfizer’s/BioNTech’s COVID-19 Vaccine BLA
The US Food and Drug Administration (FDA) has granted priority review designation for the Pfizer’s/BioNTech’s biologics license application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older.
The FDA assigned a Prescription Drug User Fee (PDUFA) goal date of January 2022 to the PDUFA deadline for priority review. The review of the BLA has been ongoing, and the agency says it intends to complete the review in advance of the PDUFA goal date.
Pfizer and BioNTech completed the rolling submission of the BLA in May (May 2021). The application includes clinical data from a Phase III clinical trial, where the vaccine’s efficacy and favorable safety profile were observed up to six months after the second dose.
In May (May 2021), the FDA expanded the emergency use authorization of the Pfizer’s/BioNTech’s COVID-19 vaccine to include individuals 12 through 15 years of age. The companies intend to submit a supplemental BLA to support licensure of the vaccine in this age group once the required data six months after the second vaccine dose are available.
Source: BioNTech and the US Food and Drug Administration
Japanese Gov’t OKs Roche’s/Regeneron’s COVID-19 Antibody Cocktail
Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved the antibody cocktail, casirivimab and imdevimab, from Regeneron Pharmaceuticals, a Tarrytown, New York-based biopharmaceutical company, and Roche for the treatment of patients with mild-to- moderate COVID-19 via intravenous infusion.
Regeneron invented REGEN-COV and is collaborating with Roche to increase global supply of the antibody cocktail, with Roche primarily responsible for development and distribution outside the US. In December 2020, Chugai Pharmaceutical, a member of the Roche Group, obtained development and exclusive commercialization rights in Japan from Roche and is working with the Japanese government to ensure an appropriate and timely supply of the antibody cocktail.
Outside Japan, the antibody combination has been authorized for emergency use or temporary pandemic use in additional territories and regions, including in the European Union, the US, India, Switzerland, and Canada. It is also undergoing rolling review by the European Medicines Agency (EMA) and was granted a scientific opinion by the EMA’s Committee for Medicinal Products for Human Use supporting its use as a treatment option for patients with confirmed COVID-19 who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-19.
Sinovac Reports Results for COVID-19 Vaccine in Adolescents
Sinovac, a Beijing, China-based bio/pharmaceutical company, reports positive results for its COVID-19 vaccine, CoronaVac, among adolescents.
The company reported results from a Phase II study on a group of participants ranging from three to 17 years of age that showed that, three months after two doses of the vaccine, seroconversion rates for a low-doses group and a medium-doses group were 98.9% and 100%, respectively, indicating that the vaccine was stable and showed good immunogenicity among adolescents.
CoronaVac was approved for emergency use in China for the population aged three through 17 years old in May (May 2021). Sinovac’s COVID-19 vaccine was approved for use in the population of 12 to 17 years of age by Indonesian authorities in June 2021.