Viruses are persistent and hazardous entities that remain inactive and hidden in the host body for as long as decades, further mutating into even more infectious entities. Thus, when the right opportunity presents they can shift from animals to human species causing the biggest havocs such as the Covid-19 resulting from the deadliest virus of the year SARS-CoV-2 since November, 2019.
Since then this virus has been creating havocs around almost 200 countries shattering their economies and overall workings. With the upcoming second wave of Covid-19 infection, further lockdowns and the unending wait for vaccines we still struggle from this threat for almost a year.
Perhaps, in this time of stress the only hope lies on the vaccine. We all are aware that researchers have been trying to decode this Covid-19 puzzle to arrive towards a safer and feasible vaccine. The pace of the vaccine development in the past 10 months has been moving successfully towards better results to finally put an end to this ‘new normal’.
India, a country very well known as a vaccine hub of the world has a very eminent role to play in the manufacturing and distributing of vaccines on a global scale. As a matter of fact while we see various candidates all over the world participating in the vaccine development, our country is also not sitting idly and has been investing time and money in the vaccine trials as well.
Apart from Bharat Biotech’s vaccine, the Serum Institute of India (SII) has been involved in partnership with the University of Oxford and AstraZeneca whose vaccine ChAdOx1, is also in its Phase-III trials. Further Serum Institute of India has also partnered with other companies such as Novavax, Codagenix and SpyBiotech for vaccine development wherein the testing by Novavax has also reached its Phase-III trials.
With each day passing bringing us closer to the one when we find out the vaccine, there poses another big problem for countries such as ours wherein the task of distributing the vaccines to 1.3 billion people would need the country’s Universal Immunisation Program (UIP) infrastructure. Considering the situations of the developing countries who are poorer in infrastructure and income, poses a big trouble of a rising war for the vaccines leading to unequal distribution.
Even though the vaccine developing candidates have pledged to price the vaccines at reduced market rates, the varying pricing along various countries would undoubtedly result in a huge shortcomings in the demand supply chain. As far as India is concerned, the best solution for this unending crisis lies best in abiding to Covid-19 guidelines such as maintaining social distancing norms, usage of face masks and sound hand washing techniques.
The Good News!
Amidst all this, the good news is that the vaccine might come to the markets anytime from the end of 2020 to the mid of 2021.
- Sputnik V which was initially known as Gam-Covid-Vac developed by Gamaleya Research Institute in Moscow and approved by the Ministry of Health of the Russian Federation on August 11, 2020. However people have expressed concerns over the vaccine and its safety as it is yet to enter Phase-III clinical trials.
- EpiVacCorona in Russia has been given regulatory approval but also yet to enter Phase-III clinical trials.
Regulatory Authorities
The Covid-19 crisis has shown the world various new ventures, one of them being a public-private partnership namely Operation Warp Speed, a joint venture of several US federal government departments such as Health & Human Services, Agriculture, Energy, etc. This venture has nominated 3 vaccine candidates in order to fund the Phase-III trials namely Moderna’s mRNA-1273, University of Oxford and AstraZeneca’s AZD1222, and Pfizer and BioNTech’s BNT162.
Further the COVAX initiative by the World Health Organization indicates its aim to work with vaccine manufacturers to offer low cost Covid-19 vaccines to the world. The companies such as Inovio, Moderna, CureVac, Institut Pasteur/Merck/Themis, AstraZeneca/University of Oxford, Novavax, University of Hong Kong, Clover Biopharmaceuticals, and University of Queensland/CSL are part of this initiative.
Present Scenario
Considering the world scenario, the Food and Drug Administration of USA has given out certain guidelines regarding the vaccine trials stating that any company into trials would have to first provide data from the placebo controlled trials showing their vaccine being at least 50% effective on Covid-19 so as to be authorized for use.
However, the European agency for drug regulation states that the EU would approve a vaccine even with less than 50% efficacy. The following are two major candidates involved in Covid-19 vaccine trails from Phase I-III along with those in preclinical stages of development and research.
Oxford vaccine by AstraZeneca and the University of Oxford.
AstraZeneca have started conducting global trials to assess the efficacy of their COVID vaccine specimen. Although AstraZeneca’s vaccine trials have been surrounded by criticism, ever since they revealed that the lower dose regime of the vaccine that had shown much higher efficacy. It was actually not by design of the vaccine but an error in dosing of the participants in the UK and Brazil. This has raised serious concerns on adherence to trials protocols and transparency of data.
In the midst of this criticism, AstraZeneca has told the press that they are likely to go ahead with fresh global trails. This is so as to assess if the lower dosing regime actually sticks to the 90% efficacy that they have reported. However, these trials will be conducted on a small set of people considering that the efficacy of the vaccine has already been established. So, the hopes are strong that this will not delay the approval in the UK and the European countries, while approval of the same in the US is yet under question. Moreover, this is a concern if AstraZeneca’s approval for the vaccine that was expected by mid of December gets delayed, its after effects will cause delay of approvals for India as well.
AstraZeneca’s vaccine is supposedly best suited for the Indian conditions in terms of pricing and cold chain logistics. Serum Institute of India has partnered with AstraZeneca to conduct trials for the two full doses in India on over 1600 participants. SII is also aligning the Indian regulatory filings along with that of the United Kingdom. So any delay in the fillings of the UK will affect the delays in India.
Pfizer and BioNTech
Pfizer and BioNTech on December 02, 2020 announced that Medicines & Healthcare Products Regulatory Agency (MHRA) in the U.K. has granted them with a temporary authorization for emergency use of their COVID-19 mRNA vaccine (BNT162b2), against COVID-19. This development marks a breakthrough scientific achievement in order to combat the ongoing pandemic crisis with the granting of Emergency Use Authorization following a worldwide Phase 3 trial. Thus, the good news is that the company is ready to deliver the first doses to the U.K. immediately giving a positive hope for the population worldwide.