A year has passed since the first novel cases Coronavirus
Infections were detected in the Chinese province of Wuhan. In this period, the global scientific community together with government regulators have opened new paths to develop and test vaccines against COVID-19 that can end the pandemic.
These efforts have begun to bear fruit as some of the major vaccine candidates have shown promise in preventing both the severity of the COVID-19 disease and the infection itself. Closer to home, human clinical trials on different vaccines have come a long way, although interim data on them are not yet available.
What are these candidate vaccines being tested in India, and what are the challenges in using them? What vaccines have shown promise internationally? News18 delves into the advancements of these vaccines.
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How many vaccines are undergoing clinical trials in India?
Currently, five vaccine candidates are in clinical trials in India and are in different stages of trials. These include vaccines developed by the University of Oxford – AstraZeneca, Bharat Biotech, Cadila, Biological E – Baylor College of Medicine and the Gamaleya Research Institute, Moscow.
Which companies have partnered with foreign-based vaccine developers?
Indian vaccine manufacturers, pharmaceutical companies and biotech companies have signed agreements with overseas-based vaccine developers. These agreements range from conducting clinical trials and manufacturing vaccines, as in the case of the Serum Institute of India, to becoming domestic partners for the sake of clinical trials and for distribution, in the case of doctor’s laboratories. Reddy and the Sputnik V vaccine from Russia.
Serum Institute of India (SII), Pune, has signed agreements with Oxford-AstraZeneca, Codagenix and Novavax to manufacture their vaccines. IBS is mass-manufacturing the Oxford-AstraZeneca vaccine and, according to Bloomberg News, is expected to produce 100 million injections by the end of the year. SII is also a domestic partner of Oxford-AstraZeneca to conduct clinical trials in the country.
Hyderabad-based Biological E Ltd., US-based Dynavax Technologies Corporation, and Baylor College of Medicine, a health sciences university in Houston, Texas, have partnered to COVID-19 vaccine candidate. Biological E has also signed an agreement with Janssen Pharmaceutical for the latter’s candidate vaccine, according to the Biological E website.
Pharmaceutical giant Dr Reddy’s Lab, another Hyderabad-based company, has partnered with the Russian Direct Investment Fund (RDIF) to conduct phase 2 and phase 3 clinical trials of the Sputnik V vaccine developed by the Research Institute. Gamaleya.
What is the progress made in clinical trials?
Bharat Biotech Ltd and the Indian Council for Medical Research began phase III trials of Covaxin on November 16 at 25 centers in India and will involve the administration of injections to 26,000 volunteers. The company claimed that it is the largest clinical trial in India for a COVID-19 vaccine.
Volunteers will receive two intramuscular injections approximately 28 days apart.
IBS and ICMR finalized registration for the Covishield Phase III vaccine that was developed in Pune with a master seed from Oxford-AstraZenenca. ICMR is funding the clinical trial site fees. IBS has already manufactured 40 million doses of the vaccine, under the at-risk manufacturing and storage license from DCGI, ICMR and the company announced last week. The Covishield phase III trials will involve 1,600 participants according to the Clinical Trials Registry – India.
Ahmedabad-based Cadila Healthcare is currently completing phase II trials on more than 1,000 volunteers at nine sites, while Dr. Reddy’s lab will soon begin an adaptive phase II and III trial of the Russian-developed Sputnik V vaccine. . Biological E began Phase I and II combined testing of its vaccine just days ago.
Have any of the Indian vaccines released interim results yet and which ones are likely to finish the trials first?
None of the Indian companies have published interim results. Data for Phase III of the Oxford-AstraZeneca vaccine are expected in December. If the data is positive, the SII will likely request an early use authorization for Covishield. IBS-ICMR and Bharat Biotech-ICMR are likely to finish their phase III efficacy trials earlier than others in India.
What are the challenges involved in the storage and implementation of these vaccines?
The logistical challenges faced by the Center in administering the vaccine include cold chain systems for proper transportation and storage. Once approved, the vaccines would have to be transported to hospitals and other designated vaccination sites by airplanes, refrigerated trucks and coolers during last-mile delivery. Proper cold chain facilities are imperative to prevent the vaccine from becoming ineffective in warmer temperatures.
Also, in hospitals and designated vaccination sites, there will be a great need for vials, syringes, gauze pads, and alcohol swabs to administer the injection. Storing the vaccine at specific temperatures will be a major hurdle as the disputed candidate vaccines have different storage requirements. Storage problems are also compounded, some of these vaccines are double-dose injections
For example, Covishield, the Oxford vaccine developed by IBS in Pune and Johnson and Johnson – Biological E vaccine requires storage at 2 to 8 degrees Celsius. On the other hand, the Sputnik V, Moderna and Pfizer-BioNTech vaccines require storage at temperatures below -18, -20 and -70 degrees Celsius during transport. Moderna vaccine can be stored at refrigerator temperature for 30 days.
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