A persevering global effort has fostered the development of several vaccine candidates as a hope to alleviate the world from the terror of the acute crisis which has taken 1.5 million lives worldwide. Several pharmaceuticals have emerged with promising vaccine prospects and are expected to receive regulatory approval over the next few weeks. If all goes as planned, India’s drug regulator, Drugs Controller General of India (DCGI) may also authorize emergency use for the top vaccine candidates in the weeks to come.
Top Vaccine Candidates That Are Seeking To Receive Regulatory Approval in India
AstraZeneca-Oxford COVID-19 vaccine (Covishield)
British-based AstraZeneca and Oxford’s vaccine candidate has remained persistent in the vaccine race right from the initial days. Pune-based Serum Institute of India (SII) has been testing this vaccine in India for the last few months and is now seeking regulatory approval for its emergency use authorization (EUA).
The AstraZeneca-Oxford vaccine recorded a success rate of 62.1% in its double dosing regimen as published in the journal The Lancet. However, the pharmaceutical reported that some accidental single dosing regimen in the study recorded a peculiar jump to 90% efficacy. The overall success rate for the interim analysis stands at 70.4% by combining results from the two dosing regimens.
The initial availability will be for the private market for bulk supply, after which it will be available for individuals. If everything goes as planned, the vaccine is expected to enter the open market from March or April next year.
Earlier, Adar Poonawalla, CEO of SII, had stated that the vaccine could be available at a cost of somewhere between Rs. 500 and Rs. 600 per dose in pharmacies. However, more recently, Business Standard reported that SII is in talks with the Government to seal the supply deal and the price is expected to be set at Rs. 250 per dose.
As reported by SII, this vaccine has to be stored at 2 to 8 °C, which is quite feasible as compared to the other vaccine prospects.
Pfizer-BioNTech COVID-19 Vaccine
American pharmaceutical, Pfizer Inc. and German biotechnology company, BioNTech SE are also in the vaccine race with their mRNA-based vaccine candidate which has emerged to be one of the top vaccines in the lot in terms of efficacy. Pfizer has already received clearance in western countries such as the United Kingdom and Bahrain. On 10th December, Pfizer also received an endorsement from US FDA’s advisory panel for emergency use of the vaccine. Pfizer’s Indian arm has also sought clearance from the DCGI for EUA of its vaccine candidate in India.
Pfizer and BioNTech reported that the third phase of clinical trials was concluded with an overall efficacy of 95%. The report also stated that efficacy for adults over 65 years of age stood at about 94%.
However, even as the UK commenced inoculation of its citizens with this vaccine, a major concern arose when four volunteers who received the vaccine shots in trials developed a medical complication called Bell’s Palsy which caused facial paralysis symptoms. UK’s drug regulator also warned its citizens with a history of severe allergic reactions to medicines, food or vaccines from taking the vaccine shot. The statement came after two of the health workers who received the approved vaccination on Tuesday suffered adverse reactions.
Pfizer has estimated to produce 50 million doses by the end of this year and 1.3 billion doses in 2021. Notably, Pfizer has neither committed supplies to India nor initiated any trials in the country.
Albert Bourla, CEO of Pfizer, stated that there will be tiered pricing for middle-income countries like India. In the US, the vaccine will cost $19.50, “the price of an average meal”, said Bourla.
Pfizer’s vaccine has to be stored at a temperature of -70 °C. However, the company is working on a new formulation which will hopefully be able to avoid this requirement and can work with feasible storage such as simple refrigeration.
Shayana, Administration Officer at Vaccine Point, a Vaccine Distributor based in Madurai, told The Electronics:
“Although maintaining the required temperature is quite challenging, it can be achieved with ultra-cold chain storage. Many distributors have a data logger system to keep track of the temperature.
However, distributors who do not have the Ultra Low Temperature (ULT) cold rooms cannot achieve this storage requirement with ease. On the contrary, maintaining vaccines in the range of 2-8 °C is easy and we are already storing some at that temperature.”
Moderna’s COVID-19 Vaccine
Another American biotech company called Moderna has pioneered an mRNA-based vaccine candidate. Moderna is seeking EUA for its vaccine candidate from the FDA.
Moderna’s vaccine candidate could achieve efficacy of 94.1% based on the results from the late-stage trials.
If the FDA approves this vaccine’s EUA, the inoculation could commence before Christmas in the US. Moderna expects to have about 20 million doses for the US by the end of this year.
Moderna’s CEO, Stephane Bancel, stated that a single dose of vaccine will cost Rs.1850 ($25) to Rs. 2730 ($37).
Moderna’s vaccine candidate reportedly remains stable at 2 to 8 °C for a period of 30 days. The vaccine remains stable up to six months when stored at -20 °C.