The results of the global phase 2/3 clinical trial of the clover new crown candidate vaccine show that the protective effect of the Delta variant strain is 79%

A total of more than 30,000 adult and elderly subjects were enrolled in the "SPECTRA" Phase 2/3 clinical trials on four continents around the world.

Chengdu, China and Oslo, Norway, September 22, 2021/PRNewswire/ - Shamrock Biopharmaceutical Co.

Clover Biology Zhejiang Changxing Biological Base

The “SPECTRA” clinical trial enrolled more than 30,000 adult and elderly subjects (18 years and older) worldwide, spanning 4 continents and covering 31 in 5 countries (Philippines, Brazil, Colombia, South Africa and Belgium) The research center is one of the most comprehensive clinical trials of new crown vaccine candidates so far

"When our'SPECTRA' clinical trial subjects were enrolled, it coincided with the rapid spread of global new coronavirus variants and Delta becoming the main strain of the global epidemic

Clover Biology Zhejiang Changxing Production Base

Dr.

CEPI CEO Dr.

Shamrock Biology Chengdu Laboratory Work Scene

The "SPECTRA" clinical trial is a 1:1 randomized, double-blind, and placebo-controlled Phase 2/3 clinical trial to evaluate the protective efficacy, safety and immunogen of SCB-2019 (CpG 1018/aluminum adjuvant) against the new coronavirus Sex

Protective efficacy results: "SPECTRA" clinical trial reached primary and secondary endpoints

The cumulative time of the new coronary pneumonia cases in the final protection effectiveness analysis is from April 28 to August 10, 2021

DNA sequencing data of 146 strains were obtained from 207 new coronavirus cases, 100% of which were mutant strains, and no cases caused by the original new coronavirus strain were observed

Protective efficacy against severe cases of new coronary pneumonia, cases requiring hospitalization and deaths: No hospitalization and severe cases of new coronary pneumonia caused by any strains were observed in the vaccine group

Protective efficacy against moderate to severe cases of new coronary pneumonia: The protective efficacy against moderate to severe new coronary pneumonia caused by any strain is 83.

Protective efficacy against new coronary pneumonia cases of any severity: The protective efficacy of preventing any severity of new coronary pneumonia caused by any strain is 67.

Protection effectiveness for high-risk populations: Although participating countries are in the period of universal vaccination during the "SPECTRA" clinical trial, the enrollment of elderly subjects is affected to a certain extent, but there are 5 cases in subjects 65 years of age or older.

Results of protection effectiveness: Vaccines significantly reduce the risk of previously infected people suffering from new coronary pneumonia again

As the new crown virus continues to spread globally, it is becoming more and more important to evaluate the protective efficacy and safety of the new crown vaccine in previously infected people

Among the subjects randomly enrolled in the "SPECTRA" clinical trial, 49% of subjects were seropositive at baseline (previously infected) before enrollment

For previously infected people, the new crown vaccine candidate SCB-2019 (CpG 1018/aluminum adjuvant) reduces the risk of new crown pneumonia (re-infection) caused by any strain by 64.

The clover bio-new crown vaccine candidate SCB-2019 (CpG 1018/aluminum adjuvant) is the first vaccine to show significant protection against new coronaviruses (including the Delta strain) in a randomized double-blind clinical trial involving previously infected people
.

Safety results: The safety of the vaccine is good.
Compared with placebo, there is no significant difference in the incidence of systemic adverse events.

SCB-2019 (CpG 1018/aluminum adjuvant) has good safety
.
Severe and serious adverse events in the trial were rare, and they were evenly distributed in the vaccine group and the placebo group
.
Collective local adverse events are mostly mild and transient pain at the injection site, and the frequency of occurrence decreases after the second dose of vaccination
.
For all the collected systemic adverse events monitored in the trial (fatigue, headache, muscle pain, joint pain, loss of appetite, nausea, chills, fever), no significant differences were observed between the vaccine group and the placebo group
.

During the entire "SPECTRA" clinical trial, the independent "Data & Safety Monitoring Board (DSMB]) conducted multiple and continuous reviews of safety data, and it has never been suspended or suspended due to safety issues.
Revise the clinical trial
.

For more detailed data on the final analysis of the "SPECTRA" clinical trial, please refer to the official website of Clover Biology
.
The research results will also be submitted to peer-reviewed journals for publication
.

Clover Biology plans to submit conditional marketing approval applications to various drug regulatory agencies around the world (including China National Medical Products Administration/ Center for Drug Evaluation, European Medicines Agency and World Health Organization) in the fourth quarter of 2021
.
After obtaining the conditional marketing approval, Clover Biological expects to launch the first batch of new crown vaccine candidate SCB-2019 (CpG 1018/aluminum adjuvant) products before the end of 2021
.
As previously announced, once approved to be included in the World Health Organization (WHO) Emergency Use List (EUL), Clover Bio will provide up to 414 million doses of new crown vaccine candidates globally through the "New Coronary Pneumonia Vaccine Implementation Plan" (COVAX mechanism)
.

About SPECTRA

"SPECTRA" is a 1:1 double-blind, randomized and placebo-controlled clinical trial study to evaluate the protective efficacy, safety and immunogenicity of SCB-2019 (CpG 1018/aluminum adjuvant) in the Philippines and Brazil , Colombia, Africa and Belgium are carried out in 31 research centers, and a total of more than 30,000 subjects (18 years and older) have been enrolled in the Phase 2/3 clinical trial
.
The subjects completed two doses of SCB-2019 (CpG 1018/aluminum adjuvant) vaccination or placebo injections (21 days apart)
.
The protection efficacy and safety results are reviewed by the independent Data and Safety Monitoring Board (DSMB), and all cases of new coronary pneumonia in the protection efficacy analysis are determined by the independent Endpoint Adjudication Committee (EAC)
.
The "SPECTRA" clinical trial was sponsored by Clover Biology and funded by CEPI
.
 

About the study endpoint

The main endpoint of the "SPECTRA" clinical trial is: adult and elderly subjects (18 years and older) have no previous evidence of new coronavirus infection (serological baseline negative), and at least 14 days after the second dose of vaccination, it can prevent PCR-confirmed, any Severity (mild, moderate, or severe) with symptomatic new coronary pneumonia
.
The standard of statistical success is that the protective effect reaches the 95.
72% confidence interval (95.
72% CI), and the lower limit is >30%
.

The results obtained for the pre-set key secondary endpoints: Adult and elderly subjects (18 years and older) have no previous evidence of new coronavirus infection (baseline seronegative), and the second dose of vaccination can prevent PCR diagnosis at least 14 days after vaccination.
, Moderate to severe and severe new coronary pneumonia
.
The criterion of statistical success is that the protective effect reaches the 97.
86% confidence interval (97.
86% CI), and the lower limit is >0%
.

About SCB-2019 (CpG 1018/aluminum adjuvant)

Clover Bio-New Crown Vaccine Candidate SCB-2019 (CpG 1018/aluminum adjuvant) is expected to become one of the first recombinant protein COVID-19 vaccines to be commercialized in the world through the COVAX mechanism
.
Using the Trimer-Tag™ (protein trimerization) technology platform, Clover Biology developed the SCB-2019 antigen, which is a stable trimeric fusion protein based on the SARS-CoV-2 virus (original strain) S protein ( S-Trimer™)
.
Clover Bio's new crown vaccine candidate is composed of SCB-2019 antigen combined with two adjuvants: Dynavax (Nasdaq:DVAX) CpG 1018 adjuvant and aluminum hydroxide (aluminum adjuvant)
.

About Clover Bio

Clover Bio is a global biopharmaceutical company in the clinical trial stage, dedicated to the development of innovative vaccines and biological therapies
.
Trimer-Tag™ is a technology platform for the development of new vaccines and biological therapy products.
Relying on this technology platform, we have become a new crown vaccine development company and developed the new crown vaccine candidate SCB-2019 (CpG 1018/aluminum adjuvant) to solve the new crown virus.
The new coronary pneumonia pandemic
.
For more information, please visit the company's official website and follow the company's LinkedIn LinkedIn
.

Clover Biological Forward-Looking Statement 

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Forward-looking statements are based on our current expectations and assumptions about our business, economy and other future conditions
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We do not guarantee that these expectations and assumptions will be confirmed
.
Since forward-looking statements involve future conditions, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict
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Our performance may differ materially from the results envisaged in the forward-looking statements
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They are neither statements of past facts nor guarantees or guarantees of future performance
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Therefore, we remind you not to rely excessively on any such forward-looking statements
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Any forward-looking statements we make in this article are only opinions as of the date they are made
.
Factors or events that may cause our actual performance to differ from time to time may appear, and it is impossible for us to predict all of these factors or events
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In accordance with the requirements of applicable laws, rules and regulations, we do not undertake any obligation to update any forward-looking statements due to new information, future events or other reasons
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This cautionary statement applies to all forward-looking statements contained in this document

About CEPI (Innovation Alliance for Epidemic Prevention)

CEPI is an innovative partnership organization that unites public, private, charitable and non-governmental organizations.
It was established at the World Economic Forum in Davos in 2017.
Its mission is to develop vaccines to prevent and control future epidemics
.
Before the outbreak of the new crown, CEPI’s work focused on the development of vaccines against Ebola virus, Lassa virus, Middle East respiratory syndrome coronavirus, Nipah virus, Rift Valley fever virus and Chikungunya virus - there are more than 20 A candidate vaccine against these pathogens is under development
.
CEPI also invests in innovative platform technologies for the rapid development of vaccines against unknown pathogens (Disease X)
.

During the current COVID-19 pandemic, CEPI has initiated a number of vaccine programs to protect against SARS-CoV-2 and its variants, focusing on vaccine development speed, production capacity, and product availability
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These vaccine development projects use the rapid response technology platform developed by CEPI's existing and new partners before the emergence of the new crown virus to promote the clinical development of a diverse portfolio of safe and effective new crown vaccine candidates, and to distribute these vaccines globally through COVAX
.

CEPI has formulated a five-year plan roadmap of US$3.
5 billion.
The goal is to shorten the development time of the new crown vaccine to 100 days, develop a universal vaccine against the new crown and other β-coronaviruses, and establish candidate vaccines against known and unknown pathogens" Library"
.
The plan can be found at: http://
.

Follow our news page for the latest updates
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Follow us via @CEPIvaccines, @DrRHatchett and LinkedIn
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About the "New Coronary Pneumonia Vaccine Implementation Plan" (COVAX)

COVAX provided vaccine support for the Acceleration Plan for Acquiring New Coronary Pneumonia Tools (ACT).
It was co-sponsored by CEPI, the Global Alliance for Vaccines and Immunization (Gavi) and the World Health Organization (WHO), and is committed to working with key implementing partners, UNICEF and developed countries Cooperate with vaccine manufacturers in developing countries and the World Bank
.
COVAX is the only global project that cooperates with governments and companies.
This project will ensure that the new crown vaccine can be provided to high-income and low-income countries on a global scale
.