Two more potential coronavirus vaccines secured for Australia,
Federal Government says
The Federal Government has signed another two agreements to give Australia access to potential COVID-19 vaccines early next year.
Under the deals, Australia will get 40 million doses of the vaccine being developed by biotechnology company Novavax, and 10 million doses of the vaccine being produced by Pfizer and BioNTech.
Both vaccine candidates are currently in stage three clinical trials, and supplies will begin arriving in Australia in early 2021 — if they are proven safe and effective.
The new agreements mean Australia is in line to get access to 134 million doses of four different vaccines at a total cost of $3.2 billion.
Prime Minister Scott Morrison said there were no guarantees the vaccines would pass trials, but his Government's strategy puts Australia at the front of the queue.
"By securing multiple COVID-19 vaccines we are giving Australians the best shot at early access to a vaccine, should trials prove successful," Mr Morrison said.
"We aren't putting all our eggs in one basket and we will continue to pursue further vaccines should our medical experts recommend them."
Earlier this year, the Morrison Government signed a deal to get 33.8 million doses of the AstraZeneca/Oxford University vaccine and 51 million doses of the CSL/University of Queensland vaccine.
Those vaccines would be manufactured domestically, however, under the new deals, doses of the Novavax and Pfizer vaccines would be made offshore in the United States, Czech Republic, Belgium and Germany.
All four vaccines would likely require individuals to take two doses.
Health Minister Greg Hunt said Australia had invested in a range of vaccines including two protein vaccines, one mRNA, and a viral vector-type vaccine.
AstraZeneca/Oxford University vaccine
The AstraZeneca Oxford COVID-19 vaccine (ChAdOx1 nCoV-19 and also known as AZD1222) now undergoing Phase III clinical trials, has already undergone rigorous testing to ensure the highest standards of quality and safety. Now a team at Bristol University has used recently developed techniques to further validate that the vaccine accurately follows the genetic instructions programmed into it by the Oxford team. This novel analysis provides even greater clarity and detail about how the vaccine successfully provokes a strong immune response.
The findings, led by scientists at the University of Bristol and published on the pre-print server ResearchSquare, represent the most in-depth analysis of any of the COVID-19 vaccine candidates, going significantly above and beyond any regulatory requirements anywhere in the world.
Work on the vaccine, developed by researchers at the University of Oxford’s Jenner Institute and Oxford Vaccine Group, began in January 2020. Now undergoing Phase III clinical trials by the University of Oxford and AstraZeneca, the Bristol researchers’ focus was to assess how often and how accurately the vaccine is copying and using the genetic instructions provided by the Oxford team. These instructions detail how to make the spike protein from the coronavirus, SARS-CoV-2 that causes COVID-19.
The Oxford vaccine is made by taking a common cold virus (adenovirus) from chimpanzees and deleting about 20 per cent of the virus’s instructions. This means it is impossible for the vaccine to replicate or cause disease in humans, but it can still be produced in the laboratory under special conditions. By removing these genetic instructions there is space to add the instructions for the spike protein from SARS-CoV-2. Once inside a human cell the genetic instructions for the spike protein need to be ’photocopied’ many times – a process known as transcription. In any vaccine system, it is these ’photocopies’ that are directly used to make large amounts of the spike protein.
Once the spike protein is made, the immune system will react to it and this pre-trains the immune system to identify a real COVID-19 infection. So, when the person vaccinated is confronted with the SARS-CoV-2 virus their immune system is pre-trained and ready to attack it.
https://www.ox.ac.uk/news/2020-10-2...-programmed-genetic-instructions-independent#
CSL/University of Queensland vaccine
Global biotech company
CSL Limited will supply the Australian Government with 51 million doses of The University of Queensland’s COVID-19 vaccine candidate if it proves successful, under a heads of agreement announced today.
CSL expects the first tranche of doses to be available by mid-2021, with additional doses following in late 2021 and early 2022, if late stage clinical trials are successful.
The total number of vaccines ordered by the Government is based on a two dose per person regime.
CSL CEO and Managing Director Paul Perreault said CSL had invested significant resources in the rapid development and large-scale manufacture of the vaccine candidate - UQ-CSL V451.
https://www.uq.edu.au/news/article/...ement-australian-government-uq-vaccine-supply
The University of Queensland (UQ) CSL COVID-19 vaccine candidate (V451) combines the adjuvant technology MF59 to improve immune response, reduce the amount of antigen needed for each vaccine, and enable more doses to be manufactured more rapidly.
The UQ-CSL V451 developed a rapid response “molecular clamp” vaccine platform, a transformative technology patented by UniQuest, UQ’s technology transfer company that enables rapid vaccine design and production against outbreak viral pathogens.
Enveloped viruses have proteins on their surface that drive the fusion of the virus and host cell membranes, a key process in infection. These proteins are also the major target of a protective immune response.
Although they are able to induce an immune response, they are inherently unstable and can change shape when expressed on their own. This means that the immune response induced does not efficiently recognize the protein on the virus surface and so does not provide protection from subsequent infection.
UQ-CSL V451 has overcome this problem by using its proprietary “molecular clamp” technology that locks the unstable, prefusion version of the surface proteins in a form that allows the immune system to respond more effectively.
https://www.uq.edu.au/news/article/...ement-australian-government-uq-vaccine-supply
Novavax vaccine
GAITHERSBURG, Md., Sept. 24, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has initiated its first Phase 3 study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373, Novavax’ COVID-19 vaccine candidate. The trial is being conducted in the United Kingdom (UK), in partnership with the UK Government’s Vaccines Taskforce, and is expected to enroll and immunize up to 10,000 individuals between 18-84 (inclusive) years of age, with and without relevant comorbidities, over the next four to six weeks.
NVX-CoV2373 is a stable, prefusion protein made using Novavax’ recombinant protein nanoparticle technology that includes Novavax’ proprietary MatrixM™ adjuvant. The vaccine has a favorable product profile that will allow handling in an unfrozen, liquid formulation that can be stored at 2°C to 8°C, allowing for distribution using standard vaccine channels.
NVXCoV2373 is a vaccine candidate engineered from the genetic sequence of SARSCoV2, the virus that causes COVID-19 disease. NVXCoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigens and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVXCoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its the Phase 1 portion of its Phase 1/2 clinical trial, NVXCoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in two ongoing Phase 2 studies, which began in August; a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).
https://ir.novavax.com/news-release...hase-3-efficacy-trial-covid-19-vaccine-united
Pfizer vaccine
After extensive review of preclinical and clinical data from Phase 1/2 clinical trials, and in consultation with the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) and other global regulators, Pfizer and BioNTech have chosen to advance their BNT162b2 vaccine candidate into the Phase 2/3 study, at a 30
µg dose level in a 2 dose regimen. BNT162b2, which recently
received U.S. Food and Drug Administration (FDA) Fast Track designation, encodes an optimized SARS-CoV-2 full length spike glycoprotein (S), which is the target of virus neutralizing antibodies.
“Our selection of the BNT162b2 vaccine candidate and its advancement into a Phase 2/3 study are the culmination of an extensive, collaborative and unprecedented R&D program involving Pfizer, BioNTech, clinical investigators, and study participants with a singular focus of developing a safe and effective COVID-19 RNA vaccine. The Phase 2/3 study protocol follows all the U.S. Food and Drug Administration (FDA) guidance on clinical trial design for COVID-19 vaccine studies,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer. “The initiation of the Phase 2/3 trial is a major step forward in our progress toward providing a potential vaccine to help fight the ongoing COVID-19 pandemic, and we look forward to generating additional data as the program progresses.”
“Today, we are starting our late-stage global study, which will include up to 30,000 participants. We selected BNT162b2 as our lead candidate for this Phase 2/3 trial upon diligent evaluation of the totality of the data generated so far. This decision reflects our primary goal to bring a well-tolerated, highly effective vaccine to the market as quickly as possible, while we will continue to evaluate our other vaccine candidates as part of a differentiated COVID-19 vaccine portfolio,” said Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. “Many steps have been taken towards this important milestone and we would like to thank all those involved for their extraordinary commitment.”
https://www.pfizer.com/news/press-r...biontech-choose-lead-mrna-vaccine-candidate-0