Panacea Biotec Limited, a New Delhi based Biotechnology Company has tied up with US-based Refana Inc. in the development, manufacturing, and distribution of coronavirus disease (COVID- 19) vaccine. Panacea Biotech is working on product development and commercial manufacturing of an inactivated whole virus vaccine against Sars- Cov2, the virus that caused COVID- 19. The collaboration with Refana Inc. was announced on Wednesday, June 10, 2020. Refana Inc. is the US- registered private corporation led by Dr.Philip Schwartz, who is its chief scientific and medical adviser and also the founder and president of NASDAQ.
An inactivated whole virus vaccine uses a weak or inactivates virus to activate a lasting immune response against the infected pathogen. It is a tried and tested platform, such vaccines present in the market which includes polio vaccine, smallpox vaccine, rotavirus vaccine against diarrhea, and rabies vaccine. The company is likely to produce 500 million doses of the experimental vaccine of which 40 to 45 million doses will be ready and available by January next year.
Rajesh Jain, the managing director of Panacea Biotec said, “We have complete proof of concept studies in the US and the results suggest a possible broader neutralizing ability against the Sars- Cov-2 virus strain, which means that even if the virus mutates in future, the vaccine will be effective.”
Over the next four weeks vaccine will be developed in the labs of Delhi and Punjab and after regulatory toxicology studies and animal pre-clinical studies, the phase one human trial will be started by October. By August the Current Good Manufacturing practices will start so that the phase one trial could be started in October and after that scale up to Phase 3 trials. Jain said, “Trials can happen in any country, today is day zero, we haven’t decided whether it will be US or India. By December or January, our target is to produce 40- 45 million doses and by that time Phase1 results will be out.”
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Panacea Biotec is the fifth company from India that is tying up globally to develop a vaccine to fight COVID- 19. There are at least 130 vaccines in different stages of development, out of which 10 are in an advanced stage, according to the report given by WHO. Out of these 10 vaccines, 4 are inactivated vaccines, all of which are being developed in China. In the long history of whole inactivated viral vaccines, they have a higher probability of being safe and efficient and have a better understanding of their mechanism of action. Jain said, “the intramuscular/ subcutaneous (injected in fatty tissue under the skin, instead of the vein) mode of administration makes it easy to use and this vaccine has the potential to become the vaccine of choice for the global fight against COVID- 19.”
They need a propriety product to inactivate the whole virus and the formulation carries a decent adjuvant to address safety issues. Multiple doses will be needed as a whole virus is being used, which can prevent infection over a longer time. And for all these to happen the scientists need to maintain immunogenicity at a particular level. After the announcement, shares of Panacea Biotec rose 20 percent to Rs.202.80 in morning trading on India’s National Stock Exchange on Wednesday morning.
The maker of vaccine earlier in 2017 invented the world’s first fully liquid hexavalent vaccine called the EasySix, which is a six- in- one- shot that prevents against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenza type b, and polio. They are also trying to develop a tetravalent dengue vaccine that works against all four strains of dengue virus, and the pneumococcal conjugate vaccine against childhood pneumonia, among others.