Vaccine research work for Covid 19 began in January with the deciphering of the SARS-CoV-2 genome. The first vaccine safety trials in humans started in March. Many countries are trying to produce a vaccine, and as of now there are nearly one hundred vaccines being developed all over the world.
Historically, it has taken between two to ten years to do research and develop a vaccine to be made available for universal use. But due to the urgency of the severe spread of the disease and consequent loss of lives, there is a dire need of a vaccine.
Modern scientific advances have helped. Many research institutions and vaccine producing companies have been able to develop these in the short span of the last 10 months, and of these a few vaccines are in late stage clinical trials.
After permission of the authority the phase two trials are launched. This phase is a randomised controlled trial with a placebo group. A placebo is a substance that has no therapeutic effect, but is used as a control in testing new drugs.
This is done to assess whether the vaccine is safe and whether there is an immune response, and to determine the dose and the immunisation schedule.
When the phase two trials are satisfactory and there are no major side effects, the vaccine will go for phase three trials. In this phase, the vaccine is used on a large number of volunteers, 20,000 to 40,000 people.
Also in this phase, the safety profile, the immune response, the duration and the length of protection of the vaccine are evaluated.Generally, the manufacturing companies set up the production units after the approval of the vaccine by the authorities concerned. In view of the urgency of the requirement, drug-making companies are setting up the manufacturing capacities simultaneously even as the trials are going on.
COVAXIN is India’s indigenous Covid-19 vaccine which Bharat Biotech is developing in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV). This indigenous, inactivated vaccine is being developed and manufactured in Bharat Biotech’s BSL-3 (Biosafety Level 3) high containment facility.
Recently it has been approved for phase three trials by ICMR. ZYCOV-D is another Indian vaccine being developed by Zydus Cadila. It is a plasmid DNA vaccine and Zydus has commenced Phase II trial. Covishield is the Indian name for a vaccine being developed by Oxford University in association with the pharma giant AstraZeneca. This Oxford-AstraZeneca vaccine is expected to be one of the first from international pharma giants to secure regulatory approval.
The news that older people get an immune response from this vaccine is very encouraging because the immune system weakens with age and older people are those most at risk of dying from the virus. Oxford and AstraZeneca have licenced the Serum Institute of India (SII) to manufacture the vaccine in India. SII and ICMR are jointly conducting a Phase II and III, observer-blind, randomized, controlled study to determine the safety and immunogenicity of Covishield vaccine.
It is a matter of pride that JSS Hospital and Medical College (JSS Academy of Higher Education and Research) in our city is one of the few advanced medical centres in India that has been selected by ICMR for conducting trials of this vaccine.
Pfizer, Johnson and Johnson, Novavox and Moderna are some of the pharma majors whose vaccines are in advanced trials in the USA. Till now five or six vaccines in phase three trials are likely to be available for universal use in 6 to 18 months. But even when the vaccines are available, there are many logistical hurdles.
If everyone in the world has to be vaccinated, eight billion doses are required. They require investment for vaccine production and ancillaries like packaging material, glass vials and syringes and the cold chain, and require hundreds of billions of dollars investment worldwide.
As the vaccine becomes available, every nation has to have a policy of its equitable distribution, irrespective of financial status. Every country has to define a policy as to who will get the vaccine first.The World Health Organisation has not yet issued guidelines for this purpose.
In the coming months, we all hope to have good news about a vaccine for Covid-19. But if and when we have an effective vaccine, we must also use it effectively. In time, as production increases, we want all people everywhere to have access to vaccines.
But initially, when supply is limited, priority must be given to vaccinating essential workers and those most at risk — including older people and those with underlying conditions.
In other words, the first priority must be to vaccinate some people in all countries, rather than all people in some countries. Let us hope and pray there will be a vaccine soon to deliver us from this killer disease of Covid-19.
(The writer works at NSS, CHSE, Odisha, and lives at E-237, GGP Colony, Bhubaneswar. Mob: 9437616497)