Tuesday 24 November 2020

Top 10 Covid 19 Vaccine Drugs Manufacturing Companies and Institution.....


According to the WHO COVID-19 vaccine landscape document, ten companies are in various stages of clinical trials and over a hundred companies are in preclinical stages.....


 

The top ten companies that are leading the race of COVID-19 Vaccine are CanSino Biological, Moderna, SinoVac, University of Oxford, BioNTech, BioNTech, Novavax, Wuhan Institute of Biological Products, Inovio Pharmaceuticals, Beijing Institute of Biological Products/Sinophar, and Chinese Academy of Medical Sciences.  

At Intellizence, we deliver market intelligence and competitive intelligence about companies working on Coronavirus  ( COVID-19) vaccines by monitoring various business signals like Alliance & Partnerships, Funding, Clinical Trial stages, Regulatory Approvals status, etc.

University of Oxford

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 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.
  •         By June 2020 a combined Phase II and Phase III trial will begin involving another 5,000 volunteers.
  •         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.
  •         The University will trial a new testing technology that aims to identify asymptomatic individuals with the coronavirus.
  •         After a pause, the clinical trials of the ChAdOx1 nCov-2019 Oxford coronavirus vaccine have restarted in the USA following the trials restarting in the UK, Brazil, South Africa, and Japan.


Oxford, AstraZeneca, clinical trial2, clinical trial1

 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 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.


     

Moderna, CEPI, Lonza, NIAID, clinical trials

Inovio Pharmaceuticals

Headquarter – Pennsylvania, USA

Inovio Pharmaceutical, a US-based startup is committed to powering a new way forward in DNA medicines to save and protect lives worldwide.

    Type of Vaccine

  •         INO-4800, a DNA based plasmid COVI-19 vaccine with electroporation.


    Partnership & Alliance

  •         Manufacturing partnership with the German Richter-Helm BioLogics, to support large-scale manufacturing of INOVIO’s investigational DNA vaccine INO-4800.
  •         Collaboration with the International Vaccine Institute (IVI) and the Korea National Institute of Health (KNIH) for a Covid-19 vaccine trial.

    Funding

  •         Funding of $17.2 million by the Coalition for Epidemic Preparedness Innovations (CEPI).
  •         $5 million funding from the Bill & Melinda Gates Foundation for advancement and manufacturing of INO-4800.
  •         $71 million funding from the U.S. Department of Defense (DoD).

    Clinical Trial Status

  •         Got FDA clearance to begin the clinical development of potential DNA vaccine INO-4800 in April.
  •         Phase 1 clinical trial is underway to evaluate the safety, tolerability, and immunogenicity of INO-4800 administered intradermally followed by electroporation in healthy volunteers.
  •         Phase II trials undergoing in China and South Korea.


Gates foundation, CEPI, clinical trials arena, clinicaltrial, Inovio

Cansino Biologics

Headquarter – Tianjin, China

Cansino is a biotechnology company dedicated to vaccine research and development. It is one of the lead contenders in the global race for an approved vaccine product. The biotech company has been granted the first patent approval from the Chinese government in Beijing for its COVID-19 vaccine called Ad5-nCOV.

    Type of Vaccine

  •         Non-Replicating Adenovirus Type 5 (Ad5-nCoV) Vector.

    Partnership & Alliance

  •         Alliance with the government-backed Academy of Military Medical Sciences’ Institute of Biotechnology, and PLA of China.  
  •         A co-development agreement with Canada’s Precision NanoSystems on COVID-19 Vaccine. Canada has as of August 27th terminated the CanSino Biologics Ad5-nCoV clinical trial.


    Clinical Trial Status

  •         Phase I clinical trial is underway to evaluate the safety and tolerance for recombinant novel coronavirus vaccine (adenoviral vector) in healthy adults (18 – 60 years).
  •         Currently running a Phase II clinical trial in Wuhan and will enroll 500 healthy participants.
  •         A Phase 1/2 trial has been approved to begin in Canada
  •         Phase III trials have started in September to evaluate the efficacy, safety, immunogenicity in healthy adults aged 18 years old and above. The trial will have over 40000 participants.


Clinicaltrial, biospace, clinicaltrial2

 Sinovac

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.


pharmaceuticaltechnology, clinicaltrial, clinicaltrial2, Sinovac

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.


Pfizer, fierce biotech, Pfizer-press, Fosun

 

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 to preliminarily explore the immunogenicity and persistence of 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.




 

Novanax

    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 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.




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 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.



Chinese Academy of Medical Sciences

  •     Type of Vaccine

             Inactivated SARS-CoV-2 Vaccine

  •     Partnership & Alliance

             Institute of Medical Biology

  •     Clinical Trial


     

  •         The phase Ia/IIa trials are designed to evaluate the safety and immunogenicity of different doses of the Inactivated SARS-CoV-2 Vaccine inoculated with different immunization schedules based upon the randomized, double-blind, and placebo-controlled principle.
  •          Phases I, II, and III clinical trials with PiCoVacc, as well as other SARS-CoV-2 vaccine candidates, are expected to begin later this year.
  •         The phase-2 trials, which further evaluate the immunogenicity and safety of the vaccine in humans, have started in the southwestern province of Yunnan. Nearly 200 volunteers aged between 18 and 59 received the vaccine in West China Second University Hospital in Sichuan Province.


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

No comments:

Post a Comment