COVID-19 Vaccine Pipeline: Introduction

  • COVID-19 is an infectious disease caused by the coronavirus. COVID-19 began its outbreak in Wuhan, China in December 2019. The World Health Organization (WHO) declared COVID-19 as Public Health Emergency of International Concern on January 30, 2020.
  • COVID-19 is spreading rapidly across the globe and almost every country has reported notable number of cases as well as death due to this this infection
  • Till date, the U.S. has recorded highest number of COVID-19 cases with count of more than one million active cases and more than 60,000 deaths. In Europe, more than 1.4 million active cases of COVID-19 have been reported as of April 30, 2020 with Italy being the worst affected country in the region. Italy has reported around 200,000 Covid-19 cases and more than 27,000 deaths.
  • The most common symptoms associated with COVID-19 are fever, dry cough, tiredness, aches and pains, nasal congestion, sore throat; and diarrhea. In the beginning stages of the COVID-19 infections, the symptoms are very mild. According to the WHO, 1 out of every 5 COVID-19 patients becomes seriously ill and faces breathing problem.
  • No perfect treatment or cure is available to treat the disease till date and lots of research and development activities are being carried out by leading players operating in the biopharmaceutical market place and all are expecting some positive outcomes very soon
  • The WHO has facilitated and accelerated efforts on the development of COVID-19 vaccine on such a scale that was not ever seen before in history
  • Healthcare experts estimate that the fast tracked vaccine development process could take around 12 to 18 months to successfully reach the market

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COVID-19 Vaccine Pipeline: Clinical Trial Phase 2/3

  • The University of Melbourne and Murdoch Children’s Research Institute are testing Bacillus Calmette-Guerin (BCG) live-attenuated vaccine for COVID-19. According to a research article published in MedRxIV in April 2020, the people in countries with BCG vaccination program at childhood are less virulent to COVID-19 than that of people in countries without BCG vaccination program.
  • Researchers at Radboud University Medical Center (The Netherlands) have launched the phase-3 BCG-CORONA trial on March 31, 2020 and plan to enroll 1,500 healthcare workers to receive the BCG vaccine or placebo

Clinical Trial Phase 2

  • China-based biotech company Sinovac Biotech is developing COVID-19 vaccine candidate PiCoVacc. The company has claimed to have successfully tested the vaccine against COVID-19 in monkeys. The company is in talks with the World Health Organization to launch the phase-3 clinical trials in the region where the COVID-19 cases are rapidly spreading.
  • Massachusetts-based biotech company Moderna has developed the mRNA-1273 COVID-19 vaccine candidate. The mRNA-1273 is currently in phase-2 stage of clinical trial pipeline study and the USFDA has awarded the fast track designation for this candidate.
  • The China National Pharmaceutical Group (Sinopharm) is developing the inactivated vaccine candidate against COVID-19. The vaccine candidate has received the approval from the National Medical Products Administration and is currently in phase-2 of clinical trial pipeline studies.

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Clinical Trial Phase 1

  • China-based biotechnology company CanSino Biologics has used the adenovirus type 5 vector (Ad5) to develop novel COVID-19 vaccine. The preliminary safety data from phase-1 clinical trials is positive and it allowed the company to plan for phase-2 clinical trial studies.
  • The Oxford university’s Jenner Institute in collaboration with AstraZeneca is developing the ‘ChAdOx1 nCoV-19' coronavirus vaccine. The vaccine has shown the positive results on six rhesus macaque monkeys in March 2020. After the positive results from the initial trials on macaque monkey, the Oxford’s team is planning to test the vaccine on 6,000 people by the end of May 2020. If the clinical trials are successful in humans, then few million doses of the vaccine would be available by the end of September 2020.
  • The Serum Institute of India has planned to collaborate with Oxford University for the manufacture of vaccine if clinical trials are successful. The Serum Institute of India can produce 5 million doses of vaccine per month for the first 6 months and after that, the company can scale up to 10 million doses per month.
  • Inovio Pharmaceuticals is developing DNA vaccine INO-4800 against COVID-19.  The Inovio Pharmaceuticals and the International Vaccine Institute (IVI) in association with Korea National Institute of Health (KNIH) are conducting phase 1/2 clinical trials in Korea.
  • Pfizer Inc. and BioNTech have collaborated to develop COVID-19 vaccine candidate BNT 162.  The BNT-62 is currently under phase 1/2 clinical trial study. The human trials are also started with BNT 162 in the U.S.

Pre-clinical

  • A lot of companies are developing COVID-19 vaccine candidates in preclinical studies. Some of companies having vaccine candidates in preclinical studies are Novavax, CureVac, Generex Biotechnology, Vaxart, Medicago, Takis Biotech, Altimmune, and Johnson and Johnson.

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