Clinical human trials begin for COVID-19 vaccine in China
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CEPI expands collaboration to develop COVID-19 multi-variant vaccine
February 8, 2022
OSLO, Norway, SHANGHAI and KUNMING, China; 8 February 2022: CEPI, the Coalition for Epidemic Preparedness Innovations, today announced that it will expand its collaboration with Shanghai Zerun Biotechnology Co., Ltd. (Zerun Bio) and its parent company Walvax Biotechnology Co., Ltd. (Walvax), a public company listed on the Shenzhen Stock Exchange (300142.SZ) to advance the development of a COVID-19 variant vaccine. CEPI will invest up to an additional USD$8.15 million to support a Phase I/II clinical trial in Mali which will evaluate the safety and immunogenicity of Zerun Bio’s prototype and multi-variant vaccine candidates. This will be the first clinical trial of the multi-variant vaccine, which has the potential to provide protection against a broad range of COVID-19 variants.Including this latest funding, CEPI has now committed up to USD$25.1 million to this vaccine development partnership to support preclinical studies, early-stage clinical trials, process optimization and manufacturing scale-up of prototype and multi-variant vaccines. Results from a Phase I/II study of the prototype vaccine candidate, funded by CEPI, demonstrate that the product has a good safety profile and promising immunogenicity data. The data indicate that the prototype vaccine candidate induced a high level of immune response in adult subjects after two doses of vaccination, and the clinical serum demonstrated a good cross-neutralization effect on Beta and Delta strains. Preclinical studies showed that the multi-variant vaccine developed through the same technology platform also demonstrated a broad spectrum of cross-neutralization results for multiple Variants of Concern, including Alpha, Beta, Gamma, Delta, and Omicron, as well as for the prototype strain. The data from these studies will be submitted for publication in a peer reviewed journal shortly.
Enabling equitable access
CEPI, Zerun Bio and Walvax are committed to enabling global equitable access to this COVID-19 vaccine. Under the terms of the agreement, it is anticipated that vaccine output funded by CEPI’s investment will be procured and allocated through the COVAX Facility, which aims to deliver equitable access to COVID-19 vaccines for all participating countries, at all levels of development.
Zerun Bio’s commercialization plant for COVID-19 vaccines in Daxing District, Beijing, China, is expected to be put into use in 2022, enabling Zerun Bio to produce commercial volumes of COVID-19 vaccine.
This press release is also available in Chinese.
—ENDS—
CEPI expands collaboration to develop COVID-19 multi-variant vaccine
OSLO, Norway, SHANGHAI and KUNMING, China; 8 February 2022: CEPI, the Coalition for Epidemic Preparedness Innovations, today announced that it will expand its collaboration with Shanghai Zerun…
100days.cepi.net
JSCh
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Breakthrough Discoveries on Novel Features of Omicron Variant and An Anti-Omicron Antibody JMB2002
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Abogen and Walvax is developing Omicron specific version of their mRNA vaccine ARCov to ARCoV-Omicron.
In a letter to the editor to Nature journal Cell Research, titled
Rapid development of an updated mRNA vaccine against the SARS-CoV-2 Omicron variant
published on 14 Feb 2022.
From the last paragraph,
Overall, our data presented here clearly demonstrate that a third dose of ARCoV would probably lead to a sharp increasement in neutralization antibodies not only against the WT SARS-CoV-2 but also the newly Omicron variant. Homologous booster vaccination with ARCoV represents a rational strategy in response to the Omicron emergency. More importantly, the continuously evolving SARS-CoV-2 calls for the most flexible and deployable mRNA vaccine platform. Starting from the Omicron RBD sequence, it took 32 days to obtain the first set of immunogenicity results from animal studies (Fig. 1i), and clinical grade vaccine will be ready in less than 3 weeks. As ARCoV-Omicron was produced under the same procedure and release specification as its original version ARCoV,14 ARCoV-Omicron can be stored at refrigerator temperature for at least 6 months. To our knowledge, this is the first mRNA vaccine candidate against the Omicron variant that has been validated in animals. We are approaching to clinical trials to test the safety and efficacy of ARCoV-Omicron.
JSCh
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Friday, 18 February 2022, 14:37 HKT/SGT
V-01 as a Sequential Booster Can Produce Good Protection against Omicron ---- Latest Phase III Data of COVID-19 Vaccine by Livzon Pharma
HONG KONG, Feb 18, 2022 - (ACN Newswire) - Global pandemic control is still facing enormous challenges after more than two years since the outbreak of the COVID-19. Following the Delta and Beta variants, Omicron variant emerged at the end of 2021, and its enhanced infectivity has cast a shadow over the global COVID-19 control. Recently, Omicron quickly spread in Japan and South Korea, and the number of newly confirmed cases in South Korea has exceeded 90,000 for two consecutive days. Although COVID-19 vaccine booster shots have been administered across the globe since 3Q2021, vaccine efficacy is shown to vary among vaccine products, and it is crucial to find and apply a vaccine with stronger protection against Omicron.
Livzon Pharmaceutical Group Inc. ("Livzon"), a long-established pharmaceutical company dedicated to research and development of innovative product, has developed a recombinant protein COVID-19 vaccine (the "V-01 vaccine") leveraging their recombinant protein technology platform since 2021.
It is reported that the V-01 vaccine is a COVID-19 recombinant protein vaccine jointly developed by Livzon MabPharm Inc. ("Livzon MAB") and the Institute of Biophysics, Chinese Academy of Sciences (the "Institute"). To date, Livzon MAB has conducted two global Phase III clinical trials in multiple countries, including (1) two doses of V-01 as basic immunization scheme, and (2) V-01 as a sequential booster for people who have received two doses of inactivated vaccine 3 to 6 months earlier. This is the only global Phase III clinical trial of sequential boosting immunization of the COVID-19 vaccine that have been approved by the regulatory authorities of multiple countries.
On February 16, Livzon has completed the interim analysis of the Phase III clinical trial for the sequential booster protocol, and released key data from this trial. According to the results disclosed, the person-year incidence rates of the V-01 sequential booster (after two doses of inactivated vaccine) group vs. the group who have only received two doses of inactivated vaccine were 6.73% and 12.80%, respectively, which showed a significant statistical difference (P=0.0012); and the absolute vaccine efficacy of the V-01 sequential booster was 61.35%, which is also shown to be significantly superior. The absolute vaccine efficacy after V-01 sequential booster has met World Health Organization's (WHO) standards.
Sixty valid genotype sequencing samples in this trial were confirmed to be Omicron using first-generation genotype sequencing of SARS-CoV-2 virus (the rest of samples are in the process of second-generation sequencing), indicating that V-01 sequential booster can produce good protection against Omicron infection. This is the first COVID-19 vaccine in the world of which the Phase III trial interim results have been disclosed since the Omicron outbreak.
Additionally, the Phase II trial results showed that V-01 had excellent immunogenicity and safety; and the overall incidence of adverse events was lower in the elder group than that of the younger adult group in comparison.
According to the company, the manufacturing of V-01 is well established in China with stable raw material supply and adequate reserves, ready to provide for global market once launched. The production line of Livzon MAB has been approved by the Guangdong Food and Drug Administration, and the vaccine production license has been granted. It is also disclosed that a workshop with an annual bulk product capacity of 3.5 billion doses is up and running at Livzon MAB, and the annual production capacity of formulated product has reached 1.5 billion doses.
With 71.32 million confirmed infected cases and 5.85 million cumulative deaths worldwide, the development and application of a safe and effective COVID-19 vaccine is urgent as the virus is spreading and mutating rapidly. Livzon, as a member of the Chinese Vaccine Research and Development Team, is in the process of obtaining EUA (Emergency Use Authorization) and conditional marketing approval for V-01 vaccine domestically and abroad, so as to provide a more robust and clinical-proven option for continuous immunization boosting for general public and to contribute to the global pandemic control efforts
JSCh
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Li et al. (https://rdcu.be/cH8ql) show prophylactic and therapeutic effectiveness of a new bispecific monoclonal antibody against SARS-CoV-2 in mice and non-human primates. Also see our News and Views (https://rdcu.be/cH8rJ) about this and related work from James E. Crowe Jr.
www.nature.com
Bispecific antiviral neutralizing antibodies are twice as nice - Nature Immunology
Increasingly, human monoclonal antibodies have been deployed against COVID-19, but combinations are typically needed for recognition of diverse viral variants. Bispecific antibodies could make the task of manufacturing and delivering combinations more efficient.
www.nature.com
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The findings of a study in @Nature shed new light on the receptor engagement and antibody neutralization/evasion of Omicron and may also inform design of broadly effective SARS-CoV-2 vaccines. https://go.nature.com/3ppcTX0
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