Experts say that while the new coronavirus that hit planet Earth in December 2019 created an unprecedented crisis for humanity, the response of researchers, medical scientists and pharmaceutical companies in trying to discover a vaccine is also unprecedented. Under normal circumstances, the process of discovering, testing and producing a vaccine takes 5 to 10 years thanks to the associated high failure rate. Therefore, the probability of having an effective COVID-19 vaccine within a year of the pandemic invasion is incredible news that speaks volumes about continued efforts, dedication, 24-hour supervision, utilization of special funds, and the global coordination put into that. According to the World Health Organization, there are currently about 200 candidate vaccines, of which 44 are in various stages of human clinical trials, and some are about to be approved by regulators. Indeed, this would be another great glory of the human quest if a safe and effective vaccine were actually found and prepared for public use in the coming months or even weeks.
China had been the first victim of the pandemic and therefore Chinese researchers did their best to find a vaccine. Their vaccine, called CoronaVac, was in fact approved for emergency use within the country in August 2020, of course, without completing phase 3 clinical trials. The results of the phase 2 human trial showed that the vaccine produced antibodies that could neutralize 10 strains of the SARS-CoV-2 virus without serious adverse reactions. This vaccine could be available for distribution at any time.
Russia became the first country to register a COVID-19 vaccine, Sputnik V, in August 2020, approving it for general use within the country, of course, without completing Phase 3 trials in humans. Has already claimed 92% efficacy, revised to 95% now. and final tests are underway in several countries, Russia says the vaccine is being exported, including India.
Another major vaccine being jointly developed and tested by US pharmaceutical giant Pfizer and Germany’s BioNTech is in final clinical trials and has claimed 95% efficacy based on interim data. The companies are likely to apply for emergency use authorization from US regulators in mid-December 2020, and the vaccine could be available in markets late next month subject to approval.
Moderna, a US Pharma vaccine, is also in the final stages, and has already claimed to be 94.5% effective based on provisional data. It will likely apply for emergency use authorization a few days later than Pfizer-BioNTech.
AstraZeneca, a vaccine developed by the University of Oxford and co-developed by the Serum Institute of India (SII), has shown an average efficacy rate of 70% for phase 3 trials with a probability of this rising to 90%. The vaccine has been shown to trigger an immune response in all age groups, particularly and most significantly in the elderly age group under 70 years. The Covishield vaccine developed by SII is already priced at around USD 13 (Rs 1,000) for two doses, and SII has been in the process of manufacturing 100 million doses this year.
Janssen, the pharmaceutical wing of Johnson and Johnson, is also developing a vaccine that is in the final phase of human trials after a pause in October 2020 due to illness in one of the participants. With both mono-dose and two-dose regimens, final trials of the vaccine are underway worldwide with up to 60,000 participants, and interim data show that the vaccine induced a robust immune response and was well tolerated.
Covaxin, a vaccine being developed by Bharat Biotech in India in collaboration with the Indian Council of Medical Research (ICMR), is also in the final phase of clinical trials and the company says they expect at least a 60% efficacy rate in the prevention of coronavirus. infection. Although the ICMR had hoped to launch the vaccine by February 2021, Bharat Biotech sets a more practical launch date of mid-2021.
Typically, a regulator approves a vaccine if it is found to be at least 50% safe and effective, and therefore there should be no difficulty getting all these late-stage vaccines licensed or approved. However, experts around the world insist that the results of phase 3 trials do not necessarily indicate a safe and effective vaccine, because it is not possible for a vaccine to take into account all kinds of side effects induced in humanity, regardless the size of your volunteers. . They say it’s critical to monitor the safety and efficacy of a vaccine long after it’s been released, and there can be no certainty, even for years.
Pricing and storage requirements for the vaccines deployed are among other concerns. Pfizer-BioNTech and Moderna are priced high at $70 and $39 for the two required doses, respectively. Additionally, Pfizer-BioNTech requires storage at minus 70 degrees Celsius, while Moderna requires -19 C. Both of these factors make these vaccines difficult to obtain for poor and developing countries. Hopefully AstraZeneca and its Indian counterpart Covishield would be cheaper and it has been confirmed that they can be kept in normal refrigeration temperatures. Sputnik V is also likely to be available at much lower prices, and Russian researchers have been testing a process to convert liquid Sputnik V into a dry white mass that can be stored at normal refrigeration temperatures of 2 C to 8 C and administer. This method is called lyophilized doses.
The willingness of citizens around the world to get vaccinated against COVID-19 is another factor to consider. At the moment the figures reveal low levels of will. However, once a vaccine is shown to be safe and effective, readiness will improve. In addition, people in the medical and essential services sectors are always the priorities. With the second wave of the pandemic affecting several countries around the world, we have no choice but to hope for the best, that one of the vaccines that may arrive at any moment finally proves to be safe and effective in the long term.