Top 10 Companies Leading the Race of COVID-19 Vaccine

At Intellizence, we deliver market intelligence related to COVID-19 latest developments – Vaccines & Regulatory Approvals, Business Impact, Government Relief Programs, etc.,

Headquarter – Oxford, United Kingdom

• Type of Vaccine
  • • ChAdOx1, a chimpanzee adenovirus vaccine vector – one of the top contenders for the most suitable vaccine technology for the COVID-19 vaccine. Administered intranasally, a single dose of this  non-replicating virus can generate a strong immune response  

• Partnership and Alliance
  • • Partnered with Anglo-Swedish drugmaker AstraZeneca and Serum Institute of India on the global development and distribution of Oxford’s COVID-19 vaccine, if clinical trials prove successful
• Funding
  • AstraZeneca gets more than $1bn US BARDA investment to support the development and production of the vaccine developed at Oxford University’s Jenner Institute
  • Under Operation Warp Speed The U.S is partnering with drug maker AstraZeneca for at least 300 million doses of a coronavirus vaccine developed by the University of Oxford 
  • The phase III trial is funded by the US Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health, and led by AstraZeneca

• Clinical Trial Status
  • The Oxford Vaccine Centre COVID-19 Clinical Trial Phase 1 involving 1100 healthy adult volunteers in the UK. The study is to determine the efficacy, safety, and immunogenicity of the candidate
  • The results of the Phase I/II trial published today in the scientific journal, The Lancet, indicate no early safety concerns and induces strong immune responses in both parts of the immune system
  • The Phase I/II trial for the vaccine has been evaluated in more than 1,000 healthy adult volunteers aged between 18 and 55 years in a randomized controlled trial. The vaccine caused side effects, including fever, headaches, muscle aches, and injection site reactions, in about 60% of patients and all resolved themselves over the course of the study 
  • Phase III clinical trial in the US to assess the safety, efficacy, and immunogenicity of the potential vaccine has been initiated. Clinical trials are going on globally with late-stage Phase II/III trials ongoing in the UK and Brazil, South Africa, and planned trials in Japan and Russia. These, together with the US Phase III clinical trial will enroll up to 50,000 participants globally.
  • AstraZeneca has now adjusted the efficacy rate of its vaccine from 79% to 76%.
  • Positive high-level results from the PROVENT Phase III pre-exposure prophylaxis trial showed AstraZeneca’s AZD7442 achieved a statistically significant reduction in the incidence of symptomatic COVID-19, the trial’s primary endpoint.
  • AZD7442, a combination of two long-acting antibodies (LAAB), reduced the risk of developing symptomatic COVID-19 by 77% (95% confidence interval (CI): 46, 90), compared to placebo. The trial included 5,197 participants in a 2:1 randomization AZD7442 to placebo. The primary analysis was based on 5,172 participants who did not have SARS-CoV-2 infection at baseline.
• Pediatric ​Trials
  • ​AstraZeneca that had begun the study of its vaccine among 6- to 17-year-olds, has to stop the trial till further approvals.
• Vaccine Approval
  
  • AstraZeneca’s COVID-19 vaccine has been granted a conditional marketing authorization or emergency use in more than 50 countries, with the WHO EUL now accelerating the pathway to access in up to 145 countries through the COVAX Facility.
  • The Japanese Ministry of Health, Labour, and Welfare has recently granted the approval based on positive Phase III efficacy and safety data from the Oxford University-led clinical trial program in the UK, Brazil, and South Africa, and a Phase I/II trial in Japan.
    
    
• Blood Clotting Complications
  
  Scientists from Oxford University Hospitals NHS Foundation Trust and other institutions analyzed the first 220 cases of clotting reported in the United Kingdom.
  • Vaccine-induced immune thrombocytopenia and thrombosis (VITT) is a combination of blot clots and low platelet levels that has been labeled as a rare side effect of the COVID vaccines made by AstraZeneca.

 Oxford, Astrzeneca, clinical trial2, clinical trial1, Astrazeneca1

BioNTech – Mainz, Germany

Pfizer Headquarter – New York, USA

Fosun Pharma – Shanghai, China

• Type of Vaccine
  • BNT162 vaccine (mRNA vaccine)
• Partnership & Alliance
  • Entered into a multi‐year research and development (R&D) collaboration with the U.S. Big Pharma, Pfizer. BioNTech and Pfizer are ramping up manufacturing capabilities to further increase production capacity in 2020/2021.
  • In China, BioNTech-Pfizer is partnering with Fosun Pharma to jointly develop BNT162.
• Funding
  • Pfizer has committed to pay BioNTech $185 million upfront—including $72 million in cash and a $113 million equity investment—and up to $563 million in payments tied to achieving milestones. 
    
  • Fosun is making a $50 million equity investment and up to $85 million in additional upfront and milestone payments to BioNTech.
  • BioNTech will get $1.93 billion funding from the U.S. Department of Health and Human Services and the Department of Defense under the U.S. government’s Operation Warp Speed (OWS) program.
    
• Clinical Trial Status
  • The Phase 1/2 study is designed to determine the safety, immunogenicity, and optimal dose level of four mRNA vaccine candidates evaluated in a single, continuous study. Three of these candidates contain uridine-containing mRNA or nucleoside-modified mRNA, while a fourth vaccine candidate contains self-amplifying mRNA.
  • Phase 1/2. In human trials, the first participants were dosed at NYU Grossman School of Medicine and the University of Maryland School of Medicine. Clinical tests are ongoing in Germany and the U.S. 
  • The Phase 2/3 global study in up to 30,000 participants that started in July 2020, has to date enrolled more than 11,000 participants, including in areas with significant SARS-CoV-2 transmission.
  • The Phase 3 pivotal COVID-19 vaccine trial will have approximately 44,000 participants and also allows for the enrollment of new populations.
    
  • Phase 3 Trials –  Based on the first interim efficacy analysis, the mRNA-based vaccine candidate, BNT162b2, has demonstrated evidence of efficacy against COVID-19.
• Clinical Trial Results 
  • Vaccine candidate BNT162b2, has demonstrated the efficacy of 95% against COVID-19, in Phase III trials, with no serious safety concerns observed to date.
  • Will present their vaccine, BNT162b2, to the FDA’s independent vaccines advisory committee and the Centers for Disease Control’s Advisory Committee on Immunization Practices (ACIP) on Dec 10th.
  • Expected to produce globally up to 50 million doses in 2020 – and up to 1.3 billion doses by the end of 2021.
  • The Food and Drug Administration declared the Pfizer vaccine is safe and offers strong protection for younger teens based on testing of more than 2,000 U.S. volunteers ages 12 to 15. 
  • FDA expanded the emergency use authorization to include children as young as 12 years. Countries like Europe and Canada are also offering vaccination for teens in the 12-18 age bracket. They get the same dose as adults.
• Regulatory Approval
  • The U.K. regulator, MHRA, has authorized the supply of COVID-19 mRNA vaccine for emergency supply under Regulation 174. Pfizer-BioNTech is ready to deliver the first doses to the U.K. immediately.
  • The distribution of the vaccine in the U.K. will be prioritized according to the populations identified in guidance from the Joint Committee on Vaccination and Immunisation.
  • The U.S. Food and Drug Administration issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S.
• Pediatric Trials
  • Phase III trial on Adolescents – Pfizer Inc. and BioNTech Phase III trial on adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, demonstrated 100% efficacy and robust antibody responses, exceeding those recorded earlier in vaccinated participants aged 16 to 25 years old, and was well tolerated. The trial enrolled 2,260 adolescents.
  • Phase I/II/III study on Children – To further evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine in children 6 months to 11 years of age. The children are divided into three age groups: children aged 5 to 11 years, 2 to 5 years, and 6 months to 2 years.
  • Study on Children (Under 12 yrs) Pfizer will begin testing its Covid-19 vaccine in a larger group of children under age 12 after selecting a lower dose of the shot in an earlier stage of the trial. The study will enroll up to 4,500 children at more than 90 clinical sites in the United States, Finland, Poland, and Spain.
  • Phase 2/3 Study of Oral Antiviral Candidate –  Approximately 1,140 participants have been enrolled for this trial. The first participant has been dosed the oral antiviral to evaluate the safety and efficacy of PF-07321332. This is an investigational orally administered protease inhibitor antiviral therapy designed specifically to combat COVID-19 – in non-hospitalized, symptomatic adult participants who have a confirmed diagnosis of SARS-CoV-2 infection. These patients are not at increased risk of progressing to severe illness, which may lead to hospitalization or death.
  • Phase 2/3 Trials Result in Children 5 to 11 Years – Pfizer and BioNTech announce positive topline results from the pivotal trials of the covid-19 vaccine in children 5 to 11 years. The results from a Phase 2/3 trial showing a favorable safety profile and robust neutralizing antibody responses in children 5 to 11 years of age using a two-dose regimen of 10 µg administered 21 days apart, a smaller dose than the 30 µg dose used for people 12 and older. 
• FDA Full Approval
  •  The U.S. gave full approval to Pfizer and its partner BioNTech’s vaccine. The vaccine now carries the strongest endorsement from the Food and Drug Administration, which has never before had so much evidence to judge a shot’s safety. More than 200 million Pfizer doses already have been administered in the U.S. — and hundreds of millions more worldwide — since emergency use began in December.
  • Pfizer and BioNTech have submitted the Phase 1 safety and immunogenicity data to the US FDA to support the booster dose of the covid-19 vaccine. The study in individuals who received a third dose of the Pfizer-BioNTech vaccine (BNT162b2) show a favorable safety profile and robust immune responses.

Vaccine Distribution

Pfizer is a proven, reliable multinational vaccine producer, supplying vaccines to more than 165 countries. The company manufactures more than 200 million doses of Pfizer vaccines annually and is one of the largest sterile injectables suppliers in the world, producing more than 1 billion sterile units per year.

Pfizer, fierce biotech, Pfizer-press, Fosun

Moderna

Headquarter– Massachusetts, USA

A biotech startup pursuing the mRNA approach has recently reported some early results in COVID-19 research.

• Type of Vaccine 
  • mRNA-1273 is a novel lipid nanoparticle (LNP)-encapsulated mRNA-based vaccine that mimics the natural infection to stimulate an immune response.

• Partnership & Alliance 
  • Partnered with Lonza to produce one billion doses of mRNA-1273 annually.
  • Strategic partnership with the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, for the Phase 1 study.
    

• Funding
  • The Coalition for Epidemic Preparedness Innovations (CEPI) will fund Moderna to manufacture an mRNA vaccine against 2019-nCoV.
  • US Biomedical Advanced Research and Development Authority (BARDA)has committed $483 million in funds for trials.
  • The U.S. government has committed up to an additional $472 million. The funding would go for the Phase 3 study and development of its Covid-19 vaccine.
  • Under the  U.S. government program, Operation Warp Speed (OWS), Moderna will get funding of $1.6 Billion from the federal government.
    
• Clinical Trial Status
  • Moderna is the first company to begin human clinical trials of its vaccine candidate in the U.S.
  • The first US clinical trial of a Covid-19 vaccine candidate started at Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle in March 2020.
  • Phase I trial was completed in just 63 days with an enrollment of 45 healthy adult volunteers ages 18 to 55 years.
  • Phase 2 study on 600 participants is slated to begin depending upon Investigational New Drug (IND) acceptance by the FDA.
  • Phase 2 study with over 600 participants was initiated in early July.
  • Phase 3 randomized, placebo-controlled trial will include approximately 30,000 participants in the United States. The primary efficacy analysis of the Phase 3 study will be an event-driven analysis based on the number of participants with symptomatic COVID-19 disease.
  • Moderna has completed enrollment for the Phase 3 study of mRNA-1273.
• Clinical Trial Results
  • Vaccine candidate mRNA-1273 met its primary efficacy endpoint in the first interim analysis of the Phase 3 COVE study with a vaccine efficacy of 94.5%.
  • Intends to submit for an Emergency Use Authorization (EUA) with the U.S. FDA in the coming weeks and anticipate
    having the EUA informed by the final safety and efficacy data.
•  Regulatory Approval
  • The U.S. Food and Drug Administration issued an emergency use authorization (EUA) to the Moderna COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The Vaccine is to be distributed in the U.S. for use in individuals 18 years of age and older.
• Pediatric Trials
  • Moderna has started conducting vaccine trials including children as young as age 12. The study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA).
  • Phase 2/3 study called the KidCOVE study, of mRNA-1273, has enrolled 6,750 healthy pediatric participants less than 12 years of age, in the U.S. and Canada.
  • Phase 2 and 3 studies on participants between 12-17 years showed that the vaccine had an efficacy of 96 percent against symptomatic coronavirus infection.

Moderna, CEPI, Lonza, NIAID, clinical trials

Headquarter – Beijing, China

• Type of Vaccine
  
  PiCoVacc – Purified inactivated SARS-CoV-2 vaccine.
• Partnership & Alliance

Collaboration with several leading academic research institutes in China.

• Funding
  • Total funding of $15 million – Advantech Capital and Vivo Capital investing $7.5m each in Sinovac Research and Development.
    

• Clinical Trial Status
  • Phase 1 human clinical trial, a randomized, double-blinded, placebo-controlled study, for its vaccine candidate against COVID-19.
  • Phase II clinical trials of the inactivated SARS-CoV-2 vaccine have been approved by China’s National Medical Products.
  • Administration (NMPA) to evaluate the vaccine candidate’s safety and immunogenicity. Stage 2 of the vaccine trial has started with more than 1000 volunteers participating.
  • Phase III clinical trial has started and is to assess the efficacy and safety of the Adsorbed COVID-19 (inactivated) vaccine. manufactured by Sinovac in health care professionals. The study will be a double-blind placebo-controlled trial with participants randomly allocated 1:1 to placebo and vaccine arms. An estimated 8870 participants will be part of the trial.
    
  • The potential vaccine has passed the III phase clinical trial.
  • A large phase 3 trial in Brazil showed that two doses, administered at an interval of 14 days, had an efficacy of 51% against symptomatic SARS-CoV-2 infection, 100% against severe COVID-19, and 100% against hospitalization starting 14 days after receiving the second dose.

• Vaccine Approval

  • WHO has validated the Sinovac-CoronaVac COVID-19 vaccine for emergency use, giving countries, funders, procuring agencies, and communities the assurance that it meets international standards for safety, efficacy, and manufacturing.

pharmaceuticaltechnology, clinicaltrial, clinicaltrial2, Sinovac

Wuhan Institute of Biological Products

• Type of Vaccine
  
  • Inactivated SARS-CoV-2 – grown in culture using virus particles, bacteria, or other pathogens that lack disease-producing capability.
    
• Partnership & Alliance
  Wuhan Institute of Biological Products, part of state-owned China National Pharmaceutical Group (Sinopharm Group) and the Wuhan Institute of Virology, part of the Chinese Academy of Sciences.
• Funding
  • Sinopharm is investing approximately $142 million for vaccine research and development in two technological approaches Beijing Institute of Biological Products and the Wuhan Institute of Biological Products.
• Clinical Trial Status
  • Phase 1 and 2 clinical trials are underway in China. The study will evaluate the safety of the COVID-19 vaccine (Vero cells) in healthy people at different ages after inoculation with different doses of COVID-19 vaccine (Vero cells), and preliminarily explore the immunogenicity and persistence of the COVID-19 vaccine (Vero cells) in healthy people.
  • Both the first and the second phase of clinical trials of the vaccine has been approved by the National Medical Products Administration through a green channel.
  • Phase III clinical trial of its Covid-19 vaccine candidate has started at the Bahrain International Exhibition and Convention Centre (BIECC). The trial received approval from the National Health Regulatory Authority (NHRA) and has over 6,000 volunteers aged more than 18 years.
• Vaccine Approval
  • Sinopharm COVID-19 vaccine has been approved for emergency use by the WHO, and the vaccine can be rolled out globally. The Sinopharm vaccine is produced by Beijing Bio-Institute of Biological Products Co Ltd, a subsidiary of China National Biotec Group (CNBG). 

Clinical trial, Xinhuanet, trialsite news

Headquarter – MD, USA

• Type of Vaccine
  • NVX‑CoV2373, a stable, prefusion protein made using its proprietary nanoparticle technology, adjuvanted with Matrix M.
    

• Alliance & Partnership
  • Novavax will work with a U.S.-based biologics Contract Development Manufacturing Organization (CDMO) to manufacture the antigen component of NVX-CoV2373 for at least 10 million doses of vaccine It will also collaborate to scale up the production and manufacture of the Matrix-M adjuvant component of the vaccine.
• Funding
  • The U.S., Department of Defense (DoD) is to fund up to $60 million, to support Novavax in its production of several components of the vaccine that will be manufactured in the U.S.
  • Receives up to $388 Million Funding from CEPI for COVID-19 Vaccine Development and Manufacturing.
  • Gets $1.6Billion funding from the U.S. Operation Warp Speed
  • Bill & Melinda Gates Foundation providing a $15 million grant toward trial in South Africa.
    
    
• Clinical Trial
  • Clinical trial phase 1 is a randomized, observer-blinded, placebo-controlled trial designed to evaluate the immunogenicity and safety of NVX‑CoV2373, both adjuvanted with Matrix‑M and unadjuvanted.
  • The Phase 2 trial is expected to be conducted in multiple countries, including the United States, and would assess immunity, safety, and COVID‑19 disease reduction in a broader age range.
  • Started enrolment for the Phase II part of an ongoing Phase I/II clinical trial of its Covid-19 vaccine candidate, NVX-CoV2373.
    
• Clinical Trial Status
  • Novavax COVID-19 vaccine demonstrates 89.3% efficacy in UK Phase 3 trial. The primary endpoint of the UK Phase 3 clinical trial is based on the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline
  • Phase III trial in the US is still ongoing.
  • NVX-CoV2373, the vaccine candidate, has demonstrated a potent efficacy of 96.4% effective.
    Novavax expects to receive UK and US Food and Drug Administration (FDA) approval in Q2 2021 based on promising results from the final analysis of its phase III UK trial.

Novavax press, clinical trial, ir.novavax, Press Release, 

Beijing Institute of Biological Products/Sinopharm

• Type of Vaccine
  • • The inactive SARS-CoV-2 vaccine is designed to trigger an individual’s immune response.
• Partnership & Alliance
  • • • Beijing Institute of Biological Products, a unit of China National Biotech Group Co Ltd (CNBG) has collaborated with China National Biotec Group Company (Sinopharm).
        
• Funding
  
  • • Sinopharm is investing approximately $142 million for vaccine research and development in two technological approaches Beijing Institute of Biological Products and the Wuhan Institute of Biological Products.
    • Ministry of Science and Technology, China.

• Clinical Trial
  • China National Biotech Group Co Ltd (CNBG), the vaccine and bioscience unit of state-owned China National Pharmaceutical Group (Sinopharm Group), said on April 27 that its second inactivated vaccine targeting COVID-19 won clinical trial approval from China’s National Medical Products Administration.
  • Phase 1 and 2 clinical trials are going on and it is expected to move to Phase 3 soon.
• Clinical Trial Results 
  • Based on an interim analysis of data from its Phase III clinical trial, the vaccine has a protection rate of 79.34 percent against the disease.
  • Paediatric Trial
  • The UAE’s Ministry of Health and Prevention (MOHAP) has initiated a Sinopharm “immune bridge study” for children aged three to 17 years.
• Regulatory Approval
  • The United Arab Emirates approved a Sinopharm vaccine on 9th December.
  • The National Medical Products Administration, China approved on Dec 31 its first COVID-19 vaccine.
  • More than 4.5 million doses have already been administered as of Dec 15 using at least three different products – two developed by CNBG and one by Sinovac Biotech.

CHtrial, trialsitenews

Intellizence offers an AI platform for company & industry intelligence to help businesses to survive, sustain, and stay ahead.