- Governments in several countries are securing early access of COVID-19 vaccine by signing deals with the frontrunners.
- ASX 200 biotech player, CSL Limited had signed two Heads of Agreement to manufacture and supply COVID-19 vaccine across Australia.
- Agreement with the Australian government to provide 51 million doses of University of Queensland’s vaccine to Australia.
- Another deal with AstraZeneca for the expected manufacture of ~30 million doses of vaccine candidate of the Oxford University AZD1222.
- The government of Australia shall provide funding to support the readiness of CSL to manufacture AZD1222.
Currently, more than 170 COVID-19 vaccine candidates are under development across the world, according to the WHO. 34 out of the 170 candidates are under clinical trials.
As soon as a safe & effective COVID-19 vaccine is discovered, COVAX facility shall facilitate the equitable access as well as the distribution of these vaccines to protect people across all countries. the WHO, GAVI and CEPI lead the COVAX facility. However, governments across several geographies are seeking early access of COVID-19 vaccine by signing deals with the frontrunners - companies that are in the late stage clinical trials with their respective vaccine candidates.
With this backdrop, we will discuss ASX 200 listed global biotech player CSL Limited which recently inked two deals to develop COVID-19 vaccine in Australia:
CSL Limited to manufacture ~81 million doses of two COVID-19 vaccine candidates
ASX 200 listed healthcare major CSL Limited (ASX:CSL) is all to manufacture two COVID-19 vaccine candidates after signing deals with the Australian government and UK-headquartered AstraZeneca (LON:AZN), respectively.
On 7 September 2020, CSL disclosed that the Company had signed two Heads of Agreement (HoA) to manufacture and supply COVID-19 vaccine across Australia.
- Agreement with the Australian government to supply 51 million doses of University of Queensland’s vaccine to Australia. The first doses are scheduled for release from mid-2021 once the clinical trials demonstrate positive results.
- Another agreement with AstraZeneca for the expected manufacture of ~30 million doses of vaccine candidate of the Oxford University AZD1222. CSL will supply first doses of AZD1222 to Australia likely by early 2021, after successful clinical trials.
Post this key announcement on 7 September 2020, CSL’s share price ended at A$282.130, up by 1.104%. The market capitalisation of CSL stood at A$126.9 billion with nearly 454.77 million shares trading on the ASX.
About CSL Limited
Biotech player CSL Limited is engaged in the development & delivery of innovative biotherapies along with influenza vaccines for protecting lives and support patients suffering from life-threatening diseases. CSL operates in three businesses- CSL Behring, CSL Plasma & Seqirus.
Let us discuss these two agreements in detail-
Agreement with Australian Government to manufacture University of Queensland’s COVID-19 vaccine candidate-
Currently, the University of Queensland is performing Phase 1 clinical trial of UQCSL V451 to assess the safety as well as immunogenicity in healthy subjects.
The number of total vaccines ordered by the government is based on a two-dose per person regime. Once the clinical trials are completed successfully, CSL anticipates the 1st tranche of doses to be accessible by mid-2021.
The HoA is between CSL Seqirus and the Australian government; CSL Seqirus will hold regulatory responsibility as the marketing authorisation holder. Vaccine production to support late-stage clinical trials has started at CSL’s biotech manufacturing facilities in Melbourne.
Results for UQ-CSL V451 from the pre-clinical and early clinical trials are promising. However, it is not feasible to predict the success level the candidate will demonstrate in late-stage clinical trials.
Once the Phase 1 clinical trials are completed successfully by the end of 2020, CSL shall take complete responsibility for the Phase 2b/3 clinical trial. Phase 2b/3 clinical trial is anticipated to begin in late 2020.
Agreement with AstraZeneca to manufacture Oxford/AstraZeneca’s COVID-19 Vaccine-AZD1222
AstraZeneca’s candidate is perceived as a frontrunner in the global race to deliver a potential vaccine for the deadly COVID-19 pandemic. With this agreement, Australia is set to receive the first batch of AZD1222 in early 2021.
CSL has completed a thorough evaluation of its capabilities & agreed with AstraZeneca for production of ~30 million doses of AZD1222. The vaccine candidate AZD1222 requires a two-dose/person regime. The manufacturing would be done at the Australian facilities of CSL.
Australian Government Shall Provide Funding to Support CSL’s Readiness to manufacture AZD1222
The government of Australia shall give funding to support the readiness of CSL to manufacture AZD1222. Therefore, the government helping to expand on-shore COVID-19 vaccine manufacturing capabilities of Australia.
This government funding will be used to establish at-risk components necessary to make the commercial production of a recombinant vector-based COVID-19 vaccine.
Moreover, funds will be used for the acquisition of equipment, recruitment, training & redeployment of personnel as well as retooling & reconfiguration of already existing manufacturing facilities.
AstraZeneca has established a separate commercial arrangement with the Australian government to supply its COVID-19 vaccine candidate to Australia after successful completion of clinical trials.
Moreover, successful manufacture & supply of Oxford/AstraZeneca’s vaccine AZD1222 under contract to AstraZeneca is subject to Australian regulatory authorisation.
CEO & Managing Director of CSL Paul Perreault stated-