Unfolding The COVID-19 Vaccine

The dawn of the New Year 2021 has brought new hope. 2020 has been a difficult year in many ways than one. The pandemic fatigue seems to have set in as people can be seen without masks at public places or using them improperly. Tourist destinations have been opened up and people have started thronging such places with their families, as is evident from the traffic jams witnessed on way to popular tourist spots. Receptivity to restrictions and lock downs has reduced all over the world and countries imposing lock downs are facing tough opposition from their citizens. In the midst of all this, the much awaited launch of the vaccine for COVID-19 has given new hope to the people as a possible way out of the pandemic.

On January 16, 2021 the Prime Minister of India launched the coronavirus vaccination drive in India through video conferencing. 3 lakh frontline healthcare workers will be covered in 3006 sites across the country on the first day. With 2,07,229 persons vaccinated on Day 1, India has achieved the highest Day 1 vaccination number in the world. 1.65 crore doses of Covishield and Covaxin vaccines will be administered in the first phase, the cost of which shall be borne by the Centre.

Let us have a look at the various aspects related to the coronavirus vaccine.

Scientific approval process -

For a vaccine to be fit for use, it has to pass a rigorous process of trials and approvals. At the experimental stage, the vaccine is put to three stages of clinical trials. After each phase of the trial, the results are made public. These are then published and subjected to peer review. Once one phase of trial gives desired results, then the trial is moved on to the next phase. After the phase III trials, the efficacy and safety of the vaccine is established. After that each country has its own drug regulatory agencies that give approvals before the said vaccine can be administered to the public. Smaller countries that do not have a regulatory agency or similar mechanisms in place, usually rely on the recommendations of World Health Organization (WHO).

Stages of Clinical trial for a Vaccine –

There are five stages in all that a newly introduced vaccine has to undergo. These are: -

1. Pre-clinical animal studies-

At this stage trials are done on animals to check the safety and toxicity of the vaccine.

1. Phase 1 Human trials-

Once the safety is established on animals, phase 1 trials are initiated on humans to test the safety, tolerability and toxicity on humans. This is conducted using different doses on a small number of healthy volunteers.

1. Phase 2 Human trials –

Once the safety is established in phase 1 human trials, phase 2 trials are initiated that test the ability of the vaccine to generate an immune response i.e., its immunogenicity.

1. Phase 3 Human trials –

Once the safety and immunogenicity is established then the phase 3 trials are initiated where in the volunteers are divided into two groups – one group receives the vaccine while the other group receives the placebo. This helps to test the efficacy of the vaccine in reducing the disease.

Usually, an efficacy of more than 50 percent is considered reasonable to introduce the vaccine for use in the general public.

1. Phase 4 (Post market surveillance) –

Once the vaccine is launched for administration to the general public, it is being tested in real life situations. Any adverse effects noticed – AEFI (Adverse Effects Following Immunization) have to be recorded by the manufacturer on a fact-finding sheet and reported periodically to the regulator.

Various vaccines in the fray -

The first candidate to get approvals after due scientific process is the Oxford University – Astra Zeneca vaccine that is being manufactured in India by the Pune based Serum Institute of India (SII). The SII is the world’s largest vaccine manufacturer. It is available by the name Covishield. The 10 member SEC (Subject Expert Committee) had recommended granting EUA (Emergency Use Authorization) to this vaccine. These recommendations were then assessed by the DCGI (Drug Controller General of India) who heads the CDSCO (Central Drugs Standard Control Organization), which is India’s drug regulator.

This vaccine is known globally as AZD1222. The technology used is based on use of a weakened and modified version of adenovirus (a common cold virus) that causes infections in chimpanzees and contains the genetic material of the Sars-CoV-2 virus spike protein. After the vaccination is given, the surface spike protein is produced, priming the immune system to attack the Sars-CoV-2 virus if it later infects the body. This vaccine has the advantages of storage and cost. It can be stored and transported at 2 degree C to 8 degree C for six months. Each dose is likely to cost around $3-4. Presently two different dosing regimes are being studied and efficacy varies accordingly. The efficacy is 62% when two full doses are administered 4 weeks apart. The efficacy is 90% when half a dose is given first followed by full dose. However the drug regulatory authorities in UK have rejected the latter regime.

Another vaccine in line is the Pfizer-Biotech vaccine. It is based on the mRNA technology. It has been granted emergency validation by WHO and was the first to be approved anywhere in the world. This will help countries around the world to quickly approve its import and distribution. It has an efficacy of 95%. However, the downside is the cost and storage requirements. It is likely to cost $20 per shot and needs to be stored at ultra cold temperatures -70-degree C.

Next is Moderna vaccine. It is also an mRNA vaccine that has been finalized by US’s National Institute of Health along with the US biotechnology company Moderna. It is even costlier at $25-37 per shot and needs to be stored at -20 degree C. It has an interim efficacy at 94.5%.

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Apart from these three vaccines with known efficacy, there are three more potential vaccines that are still at the trial stage and efficacy results will be known in early 2021.  The first among these is Bharat Biotech – ICMR developed Covaxin. It uses traditional inactivated virus platforms that work by neutralizing or inactivating live virus. It has been approved for emergency use in India as a backup to Covishied. It use has been approved in ‘clinical trial mode’ only as it is in phase III trials. Clinical trial mode means that the data currently available is not sufficient for it to be called full-fledged therapy. Efficacy results will be known by April 2021.

Another is Novavax’s NVX-CoV2373. It uses the tried and tested recombinant vaccine platform. It has shown high antibody response in early phase of clinical trial and efficacy will be known by February 2021.

Gujarat based Zydus Cadila’s ZyCov-D is a DNA vaccine. It is India made and India produced thus ensuring easy availability. However the phase III clinical trials have not yet started so its efficacy is unknown.

Easing of Norms  -

The Government of India has eased the restrictions on import and export of vaccine to ensure speedy clearance and distribution. The CBIC (Central Board of Indirect Taxes and Customs) has amended norms to facilitate the import and export of COVID vaccine through courier at locations where the Express Cargo Clearance System is operational.

Transportation of the vaccine –

The logistics part will be managed by a digital system called the Co-WIN vaccine delivery management system. It will help monitor and keep track of the storage and transport in real time. The vaccine will be transported from the manufacturer to the primary vaccine store by air. There are four primary vaccine stores in India, one each at Karnal, Mumbai, Chennai and Kolkata. These are called Government Medical Stores Depot (GMSD) and run by the Union Health Ministry. From here the vaccine will reach 37 state vaccine stores in refrigerated vans and shall be further dispatched to the district level vaccine stores. From here it shall be taken to the primary health centres or the session site, as applicable.

Co-WIN app-

It is an application brought in by the Centre government for digitally monitoring and executing the vaccination process. Co-WIN stands for COVID Vaccine Intelligence Network. It is a digital platform that will help the government coordinate the execution of the inoculations and help the health authorities to monitor the effects of the vaccine in real time. It is available for free on Google Play Store and Apple App Store.

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The district authorities will bulk upload the data of healthcare workers and other frontline workers onto the app. Further, each medical facility will also add details of persons working with them. The automated process will filter and remove the duplicate entries. Self registration is not allowed at the moment. It will be available in the later phases of implementation. The registered persons will get an SMS informing them of the time, date and venue of vaccination. The system will be updated once the vaccine is administered. Once this is done, the beneficiary will receive an acknowledgment SMS along with a QR-based certificate. In the Report Module, the authorities will prepare reports as to the number of vaccination sessions conducted along with details of beneficiaries.

Target group-

In the initial phase, the government plans to vaccinate 300 million people by July 2021, which includes four high risk groups, namely

1. healthcare workers
2. other frontline workers like police personnel
3. persons above 50 years of age
4. persons below 50 years of age but with associated co morbidities.

While the first two priority groups need not register on the Co-WIN app as there data will be auto populated by the respective organizations; the next two high risk groups have to get themselves registered. The government is largely relying on the electoral rolls data to identify this group.

Administration -

The vaccines have to be administered to the age group 18 years and above by an intramuscular shot. The first shot will be followed by a booster shot after four weeks. The beneficiary has to wait for 30 minutes after receiving the shot, at the centre itself for signs of any immediate adverse or allergic reactions. Further, SII has to follow up with the beneficiaries and closely monitor the post vaccination side effects after immunizations begin, and to submit a report every 15 days.

The Global Scenario –

Globally the US, UK, China, Canada and Israel are among the few countries that have already started vaccinating their populations. While Israel has achieved the highest proportion of population vaccinated at 11 %, China has administered to the highest in terms of volume – 4.5 million people have been vaccinated. Israel is aiming at achieving herd immunity while the UK is prioritizing its older population. Thus, different countries are following different strategies as per resources available and demographics.

Situation in India -

In India, 50% of the doses produced by SII will be split between India and Covax Facility, a WHO led pool to distribute vaccines to low- and middle-income countries. Astra Zeneca has reached a $750m agreement with Coalition for Epidemic Preparedness Innovations (CEPI) and Gavi (global vaccine initiative) to support the manufacturing, procurement and distribution of 300 million doses. This reflects its commitment to equitable distribution so that people in poor and middle-income countries also have access to the vaccine.

Do not lower the guard -

Introduction of the vaccine does not mean that one should lower the guard. Use of face masks, following respiratory etiquette, hand washing and social distancing have to be followed religiously. The reasons being;

1. The immune response begins to develop around two weeks after the booster dose has been given which means around six weeks after the first shot.
2. The vaccine has around 90% efficacy, which means around 10% of those receiving the vaccine will still be susceptible.
3. Considering India’s population, the priority group chosen is still small for the herd immunity to develop.
4. The virus is known to mutate which may affect the efficacy of the vaccine.
5. Research has shown that the antibodies, whether induced by natural infection or by vaccine, are known to last for six months. After that though a serious disease may be averted but not re infection.

 The challenges ahead–

1. Availability of adequate number of vials and syringes.

In 2021, the production of vials and syringes is likely to be expanded. Most vaccine manufacturers are also shifting to larger vials that can hold a greater number of doses to tide over any shortage of vials.

1. Ensuring strict adherence to temperature requirements during storage and transportation.

10 to 15 % of the vaccine stock is expected to be lost to wastage due to non/inadequate adherence to cold temperature requirements.

1. Making the vaccine accessible to the poor and middle income countries.

At present rich nations representing 14% of the world’s population have bought up 53% of the most promising vaccines so far. Among the top 10 countries in the world with the most doses of vaccine administered so far, 8 are advanced economies. The Bill & Melinda Gates Foundation in association with agencies like WHO, UNICEF, The World Bank etc. is assisting multilateral organizations like Gavi, the Vaccine Alliance in ensuring equitable distribution of COVID vaccines. It is supporting Covax – a WHO led initiative to pool resources from rich countries to help low- and middle-income countries gain access to the vaccine.

1. Emergence of new strains of the virus due to mutations.

It is another challenge that has an impact on the efficacy of the vaccine and the outcome of the pandemic. This calls for continuing scientific research while simultaneously ensuring adherence to the triple social vaccines – face mask, hand washing and social distancing.

1. Misinformation about the possible side effects of the vaccine.

This is another challenge as too much information circulating on social media about the possible side effects of the vaccine may lead to people hesitating to come forward to volunteer for the shot.

Last but not the least, one needs to understand that even though the world has produced a vaccine for corona virus, still any kind of complacency in using face masks and following other preventive practices has to be strictly avoided. Only then can the human race win this battle against the virus.

January 20, 2021.

(The views expressed are personal)