BOOKS/EXCERPT . The Covid-19 vaccine story

How Is the COVID-19 Vaccine Research Being Accelerated?

Generally, it takes years to develop and license a vaccine. Many factors determine its success or failure. The long period and unpredictable outcomes, at times, discourage vaccine research. During a pandemic, a vaccine is needed quickly. A number of approaches have been used to speed up vaccine research and development.

•• Rapid response platforms that use the information from virus sequence data to quickly design vaccines are being used. RNA and DNA vaccines may not have any licensed products for humans, but they have many years of development experience in humans. For viral vectors, two vaccines for Ebola were licensed in 2019 and 2020, showing that the platforms work.

•• National regulatory authorities (Central Drugs Standard Control Organisation, or CDSCO, in India, Food and Drugs Administration in the US) have worked with global partners and industry to create regulatory pathways for the development and testing of vaccines. It is reassuring that the national regulatory authorities have clearly stated that patient safety will not be compromised; no shortcuts will be made for clinical evaluation. Instead, the agencies have put pressure on themselves by radically reducing the amount of time for the review of documents.

•• Governments have funded large-scale efforts, instead of small piecemeal grants. Operation Warp Speed is probably the best-known global effort, but every vaccine-manufacturing country including India has had government support for new vaccine development.

•• Global cooperation and sharing have ramped up. In efforts coordinated by organizations like the WHO and CEPI, sharing of information and materials is being done at a level never seen before.

•• Clinical trials for efficacy testing are being designed to be large and conducted simultaneously, so that results can be obtained quickly. This is also because potentially in some programmes such as Operation Warp Speed and the Solidarity 3 study, it might be possible to do head-to-head comparisons of vaccines.

Till We Win: India’s Fight Against the COVID-19 Pandemic / Dr Chandrakant Lahariya, Dr Gagandeep Kang, Dr Randeep Guleria / Penguin Random House / Non-fiction / ₹299

Why Do We Need More than One Candidate?

The success rate at every stage of the preclinical and clinical trials is low. With regard to vaccines, out of every 100 vaccine candidates identified in an academic setting, only six will go on to become a vaccine. Therefore, the higher the number of vaccine candidates, the greater the chances of success.

Second, given the size of the world’s population and the fact that no one manufacturer will be able to make enough vaccine to be able to supply to every country, it is important to have many manufacturers to ensure enough vaccines and buffer, in case some problem in making or shipping vaccines is encountered. Third, many manufacturers means competition, and competition of equally good products lowers the price, which is good for less well-resourced countries who need to buy vaccines.

COVID-19 Vaccines and India

India is the largest producer (by volume or number of doses) of vaccines in the world, and provides vaccines to UNICEF which then distributes them in Africa, South America and Asia. For UNICEF to buy the vaccines, the vaccines have to be pre-qualified or approved for purchase by the WHO. The WHO’s approval process relies on the fact that the country which makes the vaccines has a national regulatory authority that meets the standards laid down by the WHO. India’s CDSCO has met these criteria and ensures that the vaccines made in India are of high quality and safe. Indian vaccine manufacturers, which have grown in number and capacity since they were established decades ago, have good and long experience with manufacturing in high volumes. However, they have only recently begun modest investments in research towards new vaccines. With a population of 138 crore, India needs local and indigenous production of the COVID-19 vaccine to ensure widespread availability.

The development and availability of the vaccine in India has been part of some of the early discussions on the country’s response to the COVID-19 pandemic. A national task force for vaccine research and development was set up in April 2020. The progress on the vaccines, both globally and in India, has been reviewed by high-level committees, and planning for delivery of the vaccines is ongoing. In early October 2020, the health minister announced a proposal to vaccinate 20 to 25 crore Indians by July 2021. In parallel with many such efforts around the world, discussions are on about the prioritization of target populations for initial vaccination.

Excerpted with permission from ‘Till We Win: India’s Fight Against the COVID-19 Pandemic’ by Dr Chandrakant Lahariya, Dr Gagandeep Kang and Dr Randeep Guleria published by Penguin Random House