By Dr Edward Nazareth
Jan 6: Finally we in India will be getting the vaccines against COVID 19 virus soon. The Drug Controller General of India (DCGI), the India’s national drug regulator, gave emergency approval to use COVID 19 vaccines manufactured in India by Serum Institute of India and Bharat Biotech.
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The approval is ‘on an emergency basis’ and ‘for restricted use’ in the country.
Emergency use authorization (EUA)
In most of the countries, all medical products-medicines, vaccines, diagnostic tests, medical devices and all such materials related to be used on humans require the approval of a regulatory authority before they can be used. In India, the regulatory authority is the ‘Central Drugs Standard Control Organisation (CDSCO)’.
For medicines and vaccines the approval is granted after the assessment of their safety and effectiveness. This is based on data from clinical trials. The trials are done in different stages and the approval is required at every stage of the trials. Naturally this takes a long time. Approval is not given unless the authorities are convinced that the product is absolutely safe and effective. In emergency situations, like the current one, regulatory authorities grant interim approvals if there is ‘sufficient evidence’ that the medical product is safe and urgently required.
In the US, the Food and Drug Administration (FDA) grants ‘emergency use authorization’ only after it is satisfied that the ‘known benefits outweigh the known risks of the vaccine’. This is done only after efficacy data from the final trials were submitted. The EUA is not given based on earlier results of the trial; even if they show that the vaccine is safe.
The experts are of the opinion that India’s drug regulations do not have provisions for ‘emergency use authorization’, and the process is not clearly defined or consistent. Despite this, two vaccines are given ‘emergency use authorization’ simultaneously. Of these the vaccine manufactured by Serum Institute of India ‘Covishield’ had published its data and is known to be relatively safe. Whereas the trial reports of ‘Covaxin’ the vaccine manufactured by Hyderabad based Bharat Biotech is not yet available. The company’s managing director Krishna Ella had assured after the approval that the company’s vaccine was safe and the company was conducting trials in more than 12 countries apart from India. The final data will be available probably by two or three months from now. Many of the experts have expressed concern over the approval given to ‘Covaxin’. Only approval to ‘Covishield’ was expected, and the approval to ‘Covaxin’ is a mystery.
In the United States and United Kingdom, the first doses of the vaccine were administered within a day or two of the approval of Pfizer-BioNTech and Moderna vaccines. In India too, the process is likely to start soon. While no concrete timelines are known now, it can be reasonably expected that the mass vaccination programme will begin within a week.
Difference between Covishield and Covaxin
Though these vaccines are against a single virus-COVID19, the vaccines are not the same. The people who need protection against the infection are required to receive two doses of the same vaccine. One who gets the first dose of Covishield cannot take second dose of Covaxin or vice versa. The vaccines are entirely of different types.
Covishield has been developed by the Oxford University scientists in collaboration with the pharmaceutical company AstraZeneca. This vaccine is manufactured in India by Serum Institute at Pune. Covishield is manufactured using a common cold virus from chimpanzees; about 20 per cent of the parts from the original virus are removed. In the gap obtained in this process, the surface protein- spike protein of the COVID19 virus is filled. It may be compared to grafting of saplings to produce a new plant of good yield. Here a virus is produced that looks like COVID19 virus, but is not harmful. Once inside a human body, these viruses do not produce sickness, but the human body is likely to produce antibodies. Next time, when real COVID19 virus attacks, these antibodies are expected to eliminate the viruses.
It is recommended to take two full doses of the vaccine, with a gap of around 4-6 weeks between two doses. The vaccine can be stored at temperatures between 2°C and 8°C. Its efficacy is said to be 62% to 70%.
Covaxin is India’s first indigenous vaccine against Covid-19.There is no foreign collaborators. .Bharat Biotech has developed Covaxin in association with the Indian Council of Medical Research (ICMR) and the National Institute of Virology, Pune (NIV). The ‘Covaxin’ vaccine is developed using traditional method. In this method, the dead COVID19 viruses — called “inactivated” in medical language are used. As they are inactivated, the viruses are not capable of infecting people or replicating on its own inside the body of a person after being injected. The human body may recognize the dead viruses and produce antibodies to eliminate live viruses if the person gets infected later.
It is said to have a strong immune response and the ability to neutralize the COVID19 viruses in the laboratory studies. The largest clinical trial on 25,800 subjects is planned, including few with comorbid conditions. The vaccine will be administered in two doses and stored at 2-8° degrees Celsius. The vaccine will be probably cheaper than all other vaccines.
Who will receive the vaccines in India?
The vaccination program is likely to start from 13th January 2021.The entire vaccination drive will be voluntary. There is no force or statutory requirement of vaccination as of now. In the future, vaccination might become one of the requirements for certain people in particular category. For example anyone taking an international flight may have to take vaccination well in advance. So far, no such regulations are in force.
The central government has announced that first preference will be the people who are in the forefront of India’s battle against COVID19 virus. These are healthcare workers, second in priority are policemen and other frontline workers. The government has informed that the vaccine will be administered to them for free. The third in the line will be the people above the age of 50 with co-morbid conditions. The government aims to complete this first phase of vaccinations to these groups by August 2021. At present it is not known when rest of the people will get the vaccine in India.
It is not yet known who will receive which of the two-Covishield or Covaxin. Mean times there are other firms who also will be ready with their products in the coming months. The DCGI has approved the Cadila Healthcare Ltd to conduct Phase 3 clinical trials of its ZyCoV-D vaccine candidate for Covid-19. The Pfizer vaccine and Russia’s Sputnik V vaccines are likely to be approved for use in India in the coming weeks.
Will the vaccine available for purchase?
Poonawalla, the CEO of Serum Institute had informed to media that the first 100 million doses of the vaccine were being sold to the Indian government at a “special price” of 200 rupees per dose, after which prices would be higher. The vaccine will be sold on the private market at Rs.1, 000 per dose.
In India government sponsored vaccination schemes for children are available free of cost in most of the government hospitals and primary health centers. Simultaneously these vaccines are also given at a cost in the private firms-hospitals and clinics. Similarly, it is possible that soon the private firms will be able to sell the COVID 19 vaccines to the prospective users. The price will be known later.
Safety and efficacy of COVID19 vaccines
Most of the people are concerned about the side effects of COVID19 vaccines than their efficacy. Like earlier vaccines, the approved COVID 19 vaccines are relatively safe. Most of the side effects of COVID 19 vaccination are comparable to other vaccinations. The most common side effect is soreness at the site of injection. Other side effects include fatigue, headache, muscle aches, chills, joint pain, and possibly some fever. These symptoms usually last for 24 to 48 hours, and not more than a few days. The side effects were more frequent after the second dose in the vaccine trials. These side effects are typical of the inflammation induced by vaccines and are a sign of the body’s immune response to the vaccine.
The efficacies of the vaccines vary in the clinical trials. The efficacy may be entirely different when the vaccines are used for general public on a larger basis. At present the Covishield is known to be 62% to 70% effective. It means if full two doses of vaccines are taken, chances of getting sickness from COVID 19 infection may be 30% to 38%. It means, if 100 people who have taken full two doses of the vaccine are exposed to COVID19 virus, 30 to 38 of them will get infection.
The efficacy of other approved vaccine, Covaxin is not yet known. However, Bharat Biotech MD Krishna Ella has assured that Covaxin is “200 per cent safe”.
Whether two doses of vaccine give life time protection?
At present most of the experts are not able to answer this question. No one knows how long the protection from the vaccination will last. The protection someone gets from an infection by the virus is called natural immunity. The natural immunity varies depending on the disease, and it varies from person to person. Since this virus is new, it is not known how long natural immunity might last. Current evidence suggests that reinfection with the virus that causes COVID-19 is uncommon in the 90 days after initial infection.
It is not known how long the immunity after vaccination will last. If immunity from real infection doesn’t last long, the immunity after vaccination also may not last for long. More data about these may be available in the coming months.
COVID19 vaccines and common man
As per now, the healthy person below the age of 50 years will not get the COVID19 vaccines from the government for at least for another 7 to 8 months unless he/she is a health worker or frontline worker. By that time the vaccines will be used on priority basis as explained above and more details about the need, efficacy and side effects will be known.
If one is above the age of 50 and having co-morbid conditions, vaccination is better and safer than getting the real infection. The real infection can be life threatening. Compared to this the side effects of the vaccine are minimal and not lethal as per the clinical trial reports.
For the general public, most important would be to verify the truth in the messages and information about the vaccine and vaccination in the social media. Already plenty of wrong information about vaccination is in circulation.
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