New Delhi-based biotechnology company Panacea Biotec Limited has partnered with US-based Refana Inc in the development, manufacturing and distribution of an experimental coronavirus disease (Covid-19) vaccine.
Panacea Biotec is working on product development and commercial manufacturing of an inactivated whole virus vaccine against Sars-CoV2, the virus that causes Covid-19.
An inactivated whole virus vaccine uses a weakened or inactivated virus to trigger a lasting immune response against the infecting pathogen. It is a tried and tested platform, and examples of such vaccines include polio vaccine, smallpox vaccine, rotavius vaccine against diarrhoea, and rabies vaccine, among others.
It’s a tried and tested vaccine platform, and many existing vaccines, such as those for measles and polio, are made in this way.
The firm will produce at least 500 million doses of the experimental vaccine, of which 40 to 45 million doses will be ready by January next year.
“We have completed proof of concept studies in the US and the results suggest a possible broader neutralising ability against the Sars-CoV-2 virus strain, which means that even if the virus mutates in future, the vaccine will be effective,” said Rajesh Jain, managing director, Panacea Biotec.
“Over the next four weeks, we are going to develop this vaccine in our labs in Delhi and Punjab and after regulatory toxicology studies and animal pre-clinical studies, we hope to start the phase one human trials by October. By August, we will start the cGMP (current good manufacturing practices) process so that we can start trials in October and thereafter, scale up for Phase 3 trials,” said Jain, who announced the collaboration with Refana Inc on Wednesday.
{{/usCountry}}“Over the next four weeks, we are going to develop this vaccine in our labs in Delhi and Punjab and after regulatory toxicology studies and animal pre-clinical studies, we hope to start the phase one human trials by October. By August, we will start the cGMP (current good manufacturing practices) process so that we can start trials in October and thereafter, scale up for Phase 3 trials,” said Jain, who announced the collaboration with Refana Inc on Wednesday.
{{/usCountry}}Refana Inc is a US-registered private corporation led by Dr Phillip Schwartz, who is its chief scientific and medical adviser, and also the founder and president of NASDAQ-listed EnteraBio, according to Panacea Biotec.
“Trials can happen in any country, today is day zero, we haven’t decided whether it will be in the US and India. By December-January next year, our target is to produce approximately 40-45 million doses and by that time, the phase one results will be out,” he said.
The vaccine maker launched the world’s first fully liquid hexavalent vaccine in 2017 called EasySix , which is a six-in-one shot that protects against diptheria, tetanus, pertussis, hepatitis B, haemophilus influenzae type b, and polio. It is also developing a new tetravalent dengue vaccine that works against all four strains of dengue virus, and pneumococcal conjugate vaccine against childhood pneumonia, among others.
Panacea Biotec is the fifth biotech company from India to join global efforts on the development of a vaccine against Covid-19. There are at least 130 vaccines in various stages of development, of which 10 are in advanced stages of development, according to data from the World Health Organisation. Of the 10 vaccines, four are inactivated vaccines, all of which are being developed in China.
“Whole inactivated viral vaccines have a higher probability of being safe and efficacious, given their long history and better understanding of their mechanism of action. The intramuscular/sub-cutaneous (injected in the fatty tissue under the skin, instead of a 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,” said Jain.
“We have a propriety product to inactivate the whole virus and our formulation also carries a propriety adjuvant to address safety issues. Multiple doses will be needed because we are using the whole virus, which has the ability to prevent infection over time. For that to happen, we need to maintain immunogenicity (ability to provide immune response) at a particular level,” said Jain.
“Adjuvants, which are substances that enhance the body’s immune response to an invading pathogen, and make lower doses viable, which make them safe without compromising protection. At least a dozen groups are working on adjuvanted vaccines against Covid-19 globally, and some have committed to making licensed adjuvants available for use with novel Covid-19 vaccines developed by others,” said Dr Nirmal K Ganguly, former director general of the Indian Council of Medical Research.
Since it’s a tried and tested vaccine platform, scalability is not an issue, and neither is transportation and distribution as the vaccine can be stored at 2-8 degrees Celsius, according to Jain.
After the announcement, the price of Panacea Biotech shares jumped 20% in morning trading on India’s National Stock Exchange on Wednesday morning.
Hyderabad-based vaccine maker Bharat Biotech has three vaccine candidates using two different platforms in the works, including one that uses an existing nasal flu vaccine, and two that use the deactivated rabies vaccine to deliver the Sars-CoV2 genetic material into the body to induce it to produce an immune response.
University of Oxford and AstraZeneca’s adenovirus vaccine is in late-stage trials. Serum Institute of India (SII), the world’s largest vaccine manufacturer, has invested $100 million in a manufacturing facility and is production in two months following its tie-up with UK-based AstraZeneca to mass produce the University of Oxford vaccine for India and other low-and-middle-income countries. “Till the trials are completed successfully for safety and efficacy, vaccines will not be distributed either in India or anywhere else in the world,” Adar Poonawalla, CEO, Serum Institute of India, said on Tuesday.
SII also partnered with US biotech firm Codagenix for a vaccine using a weakened virus that doesn’t cause disease, but triggers an immune response, and with Austrian biotech company, Themis Bioscience, for a vaccine that uses the measles virus as a vector to inject an antigen or protein of SARS-CoV-2.
Zydus Cadila in Ahmedabad and India Immunologicals in Hyderabad have also entered partnerships to develop Covid-19 vaccines.