Fast-tracking the ideal way for developing the vaccine
The pandemic has created unprecedented partnerships among experts, national and international agencies and national governments to fast-track the process of vaccine development. The COVAX initiative, part of WHO’s Access to COVID 19 Tools Accelerator is working towards expediting availability of vaccines and treatment under the Coalition for Epidemic Preparedness Innovations (CEPI). Realtime information on COVID 19 vaccine is available at https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-vaccine-tracker. More than 150 vaccines are under trial, very few of them including AstraZeneca (UK), Moderna (US), Sputnik V (Russia), CanSino Biologicals (China) etc. are in advanced phase 3 trial. Sputnik V is perhaps the first vaccine to be registered in a country. The accelerated process of vaccine development has got many concerned about the vaccines’ safety and efficacy. I must say, never in the history of the world, any vaccine has been developed in a year or two. Remember, we still don’t have vaccines against malaria and HIV, despite decades of scientific efforts. But science has progressed in all these years.
India is a major global player in vaccine trials and manufacture with its own indigenous vaccine Covaxin (Bharat Biotech) and at least three more vaccines in advanced states of trial. All major vaccines companies are approaching India for collaboration in production of their vaccines.
Earlier scientists took many years to understand the structure of the virus that helps to develop the vaccine against a pathogen, COVID-19 virus has a different story to tell. If I clearly remember, in January this year when scientists had deciphered the structure of the corona virus 19 (COVID 19) and identified parts of virus that can be used to develop the antibodies in the vaccine. At this speed, I’m confident and hopeful that the safe and effective vaccine will soon reach the world.
No compromise on safety and efficacy
It is noteworthy, that unlike many public-health interventions, immunization has been successful to provide significant and extremely cost-effective improvement in human health. We have successfully eradicated Smallpox and are on the verge of seeing the end of another infection, Poliomyelitis with the help of vaccine against these diseases. Billions of doses of vaccine are utilized annually with millions of lives saved. The safety and efficacy, however, are the determinants of any successful vaccine to control and prevent infectious diseases.
There are more than 150 vaccines developed across the world that are undergoing clinical trials to examine their safety and efficacy against COVID 19. Let’s understand, what does a vaccine go through in the preclinical followed by three phases of the clinical trials? Taking an example of Sputnik V- it is based on a technological platform using human adenoviruses and has cleared the safety phase. After preclinical trial in animals for safety and phase 1, 2 and 3 clinical trials, there were no major adverse effects barring light and mild pain at the point of injection, or headache muscular pain and fever. This vaccine has been developed by Gamaleya institute. Gamaleya is a trusted institute as it had developed vaccine against Ebola based on the similar platform six years ago. In addition, every country examines the data on safety and efficacy of a vaccine developed in another country and conducts phase 3 clinical trial. Only after the trial results are critically examined, it is approved for use. India has approved clinical trial of this vaccine in the country. The vaccine against Ebola was developed using similar approach was widely used to combat Ebola in Africa.
There are very few vaccines like Sputnik V that have had the advantage of more human volunteers in the preliminary process of phase II that proves the efficacy of the vaccine to be up to the mark so far. Like for instance, the level of neutralizing antibodies after vaccination is 1.5 times higher than of patients who have been infected with coronavirus. We will be in a better position to comment after we get data from the phase II and III trial as directed by the Drug Controller General of India. Among the vaccines undergoing clinical trials today, the Lancet study, the most trusted medical journal has published the results of the phase 1/2 results of Sputnik V conducted based on safety and efficacy and said that no adverse effects were found and the vaccine showed good human response. The vaccine encouraged a strong immune response in 76 respondents in all. We need data from bigger sample size, which should be available when data from phase 3 trials is made public.
Prevention must continue even after vaccine arrives:
As we know that no vaccine is 100% effective and it will take a long time to reach 100% eligibles, we are constantly advised to maintain physical distancing, use mask and handwashing/sanitization on a regular basis. The vaccine is the most effective tool along with other preventive measures. Scientists may not have cracked the vaccine for HIV, but the fact remains that the vaccines for polio, chickenpox, measles, hepatitis B and mumps have made them a very rare phenomenon today whereas, other medical interventions like treatment didn’t prove to be as effective.
The importance of vaccine can be gauged from the fact that countries including India have preordered 3.8 billion doses and negotiation are on for another 5 billion. Despite all these efforts, it will only be early 2012 when vaccination can start and we may a sizable coverage of population with vaccine only in 2022 and 2023. Hence there must be no slackening in other preventive measures.
The article has been authored by Dr. Sanjiv Kumar, Chairperson of the Indian Academy of Public Health and Indian Alliance of Patients Group, Former Senior Advisor at UNICEF and Former Director at IIHMR