AstraZeneca Partners for COVID Vaccine Mfg; South Africa Suspends Rollout
AstraZeneca has added two additional manufacturing partners for its COVID-19 vaccine, respectively in Japan and Europe, with Daiichi Sankyo and IDT Biologika, a Dessau-Rosslau, Germany-based CDMO. Also, the South African government suspended the rollout of the vaccine in the country following an efficacy study that showed the vaccine did not prevent mild or moderate cases of Covid-19 caused by the coronavirus variant found in South Africa. The South African government subsequently updated its vaccine rollout plan and has secured dose of Johnson & Johnson’s and Pfizer’s COVID-19 vaccines.
Manufacturing pacts with IDT Biologika and Daiichi Sankyo
AstraZeneca and IDT Biologika are exploring options to accelerate output in Europe of AstraZeneca’s finished COVID-19 vaccine in the second quarter of 2021. The companies are also planning a joint investment to build additional drug-substance capacity at IDT Biologika’s production site in Dessau, Germany by building up to five 2,000-liter bioreactors capable of making tens of millions of doses of the vaccine per month. The new assets are slated to be operational by the end of 2022. Overall, IDT Biologika says it will spend a three-digit million-euro amount on the capacity expansion. The companies say the investment could also allow for the manufacture of other vaccines sharing a similar manufacturing process.
AstraZeneca’s/University of Oxford’s COVID-19 vaccine was granted conditional marketing authorization in the European Union in late January (January 2021) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. In addition to the EU, the vaccine has been granted conditional or emergency use authorization in a number of Latin American countries, India, Morocco, and the UK.
Under a separate pact, Daiichi Sanyko has entered into an outsourcing agreement to manufacture AstraZeneca’s COVID-19 vaccine in Japan. Daiichi Sankyo will use undiluted solutions provided by AstraZeneca to manufacture the COVID-19 vaccine, including vial filling and packaging. Daiichi Sankyo Biotech Company, a subsidiary of Daiichi Sankyo, will manufacture the vaccine.
Separately, Daiichi Sankyo says it continues its own work to advance research and development of a nafamostat inhalation formulation against COVID-19 as well as an mRNA COVID-19 vaccine.
South African government updates vaccine strategy
In a national address delivered this week (February 11, 2021), Cyril Ramaphosa, President of South Africa, updated the country’s COVID-19 vaccine plan following the country’s suspension of the rollout of AstraZeneca’s COVID-19 vaccine due to an efficacy study that showed that the vaccine was not effective against preventing mild or moderate COVID-19 cases against the emerging variant of the virus (501Y.v2) in South Africa.
“While it [the finding] should not delay the start of the vaccination program by much, it will affect the choice of vaccines and the manner of their deployment,” he said in his address. The first phase of its vaccination program, which is targeted at healthcare and other frontline workers, will now use Johnson & Johnson’s (J&J’s) COVID-19 vaccine, which has been shown to be effective against the 501Y.v2 variant.
The South African government has secured 9 million doses of the J&J vaccine. He said the first batch (80,000 doses) will arrive in the country next week (as reported on February 11, 2021) and further consignments will arrive over the next four weeks, totaling 500,000 doses of the vaccine.
In addition, the South African government has secured 12 million vaccine doses from the global COVAX facility, a global initiative aimed at equitable access to COVID-19 vaccines. This will be complemented by other vaccines that are available to South Africa through the African Union’s African Vaccine Acquisition Task Team facility as well. President Ramaphosa also said that Pfizer has committed 20 million vaccine doses of its vaccine commencing with deliveries at the end of the first quarter (first quarter 2021).
The procurement of the AstraZeneca vaccine was based on its proven efficacy before the discovery of the 501Y.v2 variant in South Africa.