Indian scientists have developed a candidate vaccine against the coronavirus disease that remains active after long-term storage at room temperature, raising hopes for novel vaccines that would not need low-temperature cold chain demanded by most vaccines.Researchers at the Indian Institute of Science, Bangalore, and collaborators in Faridabad and Thiruvananthapuram have designed a protein-based vaccine candidate formulation that they say looks promising and remains active at 37°C for over four weeks.Cold storage temperature for routine immunisation vaccines is typically 2 to 8°C and can be much lower for some vaccines.Their vaccine candidate uses a small fragment of the so-called spike surface protein of SARS-CoV-2, the virus that causes Covid-19, to stimulate the immune system into making neutralising antibodies against the virus. In studies in guinea pigs, the vaccine generated antibody levels comparable to those observed from several other vaccine candidates currently under clinical trials worldwide.Almost all vaccine candidates against SARS-CoV-2 under development need refrigeration or are in a frozen state before they are administered. Public health experts view the need for a low-temperature supply chain as a major challenge for vaccine delivery, particularly in the rural areas of low and middle-income countries.“The protein fragment we’ve used in our candidate vaccine elicits antibodies and it is stable at room temperature,” Raghavan Varadarajan, a senior scientist at the IISc molecular biophysics unit who led the research, told The Telegraph.The stability at 37°C for at least four weeks would be a major advantage in efforts to distribute a vaccine in rural areas that lack low-temperature storage facilities. Varadarajan and his colleagues published their findings in the Journal of Biological Chemistry on Thursday.The scientists have sought funding from the Indian government for downstream development — more exhaustive pre-clinical studies in animals and toxicity studies that are critical prerequisites ahead of human clinical trials.For the animal studies, the IISc group partnered with a Bangalore-based start-up Mynvax. The other collaborators are based at the Indian Institute of Science, Education and Research in Thiruvananthapuram and the Translational Health Science and Technology Institute, Faridabad.The researchers say the timeline for further development would hinge on funding. Accelerated pre-clinical and toxicity studies can typically take two to three months. The speed of efforts to develop vaccines against SARS-CoV-2 has been unprecedented. The very first vaccine candidate emerged only about two months after scientists had published the SARS-CoV-2 genome sequence.Three other vaccine candidates are already under clinical
trials in India — an inactivated vaccine from the Hyderabad-based Bharat Biotech,a DNA
vaccine from Ahmedabad-based Zydus Cadila and an adenovirus-based vaccine developed by
Oxford researchers.
On this background matrix, the present proposal aims to develop COVID vaccine at room
temperature considering three primary seasons of the state premonsoon (average temperature
380C), monsoon (average temperature 350C) and postmonsoon (average temperature 280C).
The ambient atmosphere also varies in terms of composition as recorded by scientists of
Techno India University, West Bengal.
Dear Abhijit,
There are protein preparations which are stable at room or fridge temperature. E.g. antibodies frequently are shipped lyophilized or dried, sometimes using additives. Thus, together with the vaccine, one could supply a vial of a sterile suitable solvent (saline, water, physiological buffer ...) that is added to dissolve the vaccine on site, just before injection.
While this principle in my experience usually works well for purified antibodies (that's how we are shipping them), it still has to be validated for each individual protein. Vaccines do not consist of pure antigens only, they also have adjuvants and other substances, so there is no guarantee that this process will work for protein based vaccines, but in my opinion, it's definitely worth exploring.
Development of a covid vaccine that can be stored at room temperature is of course possable. For instance the freeze drying of vaccines greatly increases their stability. In the case of liquid preparation that can cope with room temperature requires the development of a suitable formulation/stabiliser. This would require some r&d including appropriate stability tests/trials.Good luck with this important endeavour.
It is possible, but not easy or quick. Creation of room temperature/tropical temperature stable versions of common vaccines was the subject of a Gates Foundation "Grand Challenge" about 20 years ago. There is a fundamental tension between a good, protective antigen, its complexity, and its stability.
Till date its under trial - although IACS, Bangalore is approaching fast in this track
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