At 5 am on January 12, three temperature-controlled trucks arrived at the Pune airport. Police and airport security in tow, they took a special route on the runway for their consignments to be loaded onto nine flights. Heading to 13 cities across India, these flights carried 5.6 million doses of the Covishield vaccine between them. It was the first batch of the much-awaited protection against the Covid virus, the first shots of which will be administered to some 30 million Indians for free, beginning January 16.

"Covid cases in India are declining, which is a good sign. Our vaccination drive will further help reduce transmission of the virus. Both Covishield and Covaxin, the vaccines approved for emergency use in India, have met all safety criteria," says Dr V.K. Paul, NITI Aayog member and chairman of the National Expert Group on Vaccine Administration for Covid-19. "In fact, 12 countries have approached us for Covid vaccines." Dr Paul adds that after nearly 10 days of dry runs across 33 states and Union territories, the country is fully geared up to vaccinate its entire 1.3 billion population against Covid-19, in what will arguably be the largest immunisation programme in the world.

India granted emergency use authorisation to Covishield, developed by AstraZeneca-Oxford and manufactured in the country by the Serum Institute of India, and Bharat Biotech's Covaxin on January 3. Covishield is a viral vector vaccine that uses a weakened version of a common cold virus found in chimpanzees. It encodes instructions for making proteins similar to that of the novel coronavirus to generate an immune response and prevent infection. Trials have shown it to have an average 70 per cent efficacy. Covaxin, on the other hand, has been derived from a strain of the novel coronavirus isolated by the National Institute of Virology (NIV), Pune. Bharat Biotech used this to develop an inactivated vaccine, which is still in phase 3 trials with efficacy not yet known.

A COLOSSAL EXERCISE

The Union ministry of health & family welfare (MoHFW) has issued guidelines to all states for the Covid vaccination programme. For the first phase, the Centre will procure and distribute the vaccines. States can then decide which vaccine to use in the subsequent phases. The guidelines mandate only one vaccine candidate per state to avoid confusion. From deciding the number of people to be vaccinated in the first phase to identifying transport and distribution points, states have had around two weeks to plan their vaccination drives.

The first lot of the Covishield vaccine gets ready for dispatch from Pune

In all states, health and frontline workers will be the first to receive the vaccine. Bihar, for instance, has enrolled around 1 million beneficiaries for the first two phases of vaccinating healthcare and frontline workers. Around 430,000 health workers will be immunised in the first phase. In the next round, frontline workers, including police, armed forces, home guards, civil defence and disaster management volunteers and municipal workers, will be covered. Once this is done, dates will be announced for the priority target group of 15-20 million people who are above 50 years of age or have co-morbidities. In Delhi, 5.1 million health and frontline workers will be the first to receive the vaccine while 425,000 people have been listed in Rajasthan. Around 407,000 health workers will be immunised in Madhya Pradesh and 267,000 in Chhattisgarh. Uttar Pradesh has announced figures for three phases of its vaccination drive: 800,000 health workers in the first phase, 1.6 million frontline workers in the second and 30 million people (above age 50 or having co-morbidities) in the third. West Bengal plans to vaccinate 10 million people in the next six months, with 600,000 covered in the first phase.

Vaccine dry run in Jammu

The states have drawn their individual plans for transporting, storing and administering the vaccines. In Telangana, the Covid vaccine will be administered at primary and community health centres and a chosen few private facilities. Over 10,000 nurses and ANMs (auxiliary nurse midwives) have been identified as vaccinators. "Robust preparations have been made across the state, which includes augmenting storage capacity, creating infrastructure for additional walk-in cold rooms and procuring vaccine vans for seamless transport," says Dr G. Srinivasa Rao, director of public health, Telangana.

In Bihar, the vaccines will be supplied to 10 regional vaccine stores using refrigerated vans and cold boxes. The state-level store in Patna and the regional stores together have a capacity for 5.1 million vials. Uttar Pradesh, which had a cold storage capacity of 80,733 litres for routine immunisation, required an additional capacity of 123,205 litres for the Covid vaccine drive. The state received massive support in this from the Centre. "The central government made available 224,242 litres of cold storage space. A total of 1,477 centres will be set up for Covid vaccination," says Alok Kumar, the state's principal health secretary. Each centre will have two vaccination teams, who will together cover 200-odd people in a day. About 300,000 people will be vaccinated per day. "We aim to finish the first phase within three days," says Kumar. Prashant Kumar, UP's additional director general of police (law and order), says the vaccine storage centres will be made as secure as EVM vaults after elections.

Rajasthan, which has had one of the lowest Covid counts in the past six months, has lined up two state-level vaccine stores, six regional vaccine stores, 34 district vaccine stores, 2,444 cold chain points and 1,300 ambulances for its drive. "We anticipate no problems in meeting our phase 1 targets. Subsequently, we will be able to reach most of our target population even in the remotest parts with the help of anganwadi workers," says Siddharth Mahajan, secretary, health, Rajasthan.

HICCUPS AHEAD

But reaching so many people in such a vast country isn't just a matter of procuring and distributing vaccines. A big concern is selection of the right vaccine. Some experts are worried about the efficacy of Covaxin, which is still in phase 3 trials. After a dry run in 28 districts, Chhattisgarh health minister T.S. Singh Deo expressed doubts over Covaxin. "There is no data on how long the effect of the immunisation will last. It is better to wait till the results are out," he says. West Bengal and Maharashtra are two other states to have put a question mark on Covaxin. "Covaxin works on the entire virus even if it has mutations. It is a good back-up option since Covid has various strains now. Phase 3 trials for more data are on," argues

Dr Paul. He adds that those who receive either of the two vaccines will be kept under observation at the vaccination centres for half an hour for potential side-effects.

Additionally, two parliamentary panels were set up on January 11 to review the country's Covid vaccination programme and its management. The panels will meet vaccine-makers, MoHFW officials and health experts to report on India's vaccine capacity and the plan for vaccine administration.

Vaccine candidates from Russia and Zydus Cadila are currently undergoing trials in India and might be approved for emergency use in the days ahead. The Pfizer vaccine, which has completed trials and is being used in the US, hasn't been granted approval in India. The vaccine has an efficacy of 90 per cent, far higher than of Covishield. But Indian officials say it is too expensive and prone to greater temperature sensitivity than the two vaccines approved so far. "Despite public health experts raising questions, we have very little clarity regarding the basis on which Covaxin was given approval and who was on the approval committee. Vaccines that have completed trials and are being used in other countries haven't been approved [in India], and we don't really know why since their efficacy is higher and proven," says Malini Aisola, healthcare expert and co-convenor of the All India Drug Action Network (AIDAN).

Of the two vaccines in India, only distribution of Covishield has begun. Each Covishield vial contains 10 doses. Being a live virus vaccine, chances of contamination are high if it is not stored at 2 to 8 degrees Celsius. Given the global shortage of vaccine vial monitors (VVMs), which indicate the temperature inside a vaccine vial, MoHFW has said that there is to be a no open vial policy-the vials will not have any expiry date or temperature monitor, but will not be used four hours after they have been opened. The onus of ensuring this will be on the vaccinators.

Though 170,000 vaccinators and 300,000 vaccination team members have been trained to use the vaccine vials, concern remains over how reliably the vials can be monitored without VVMs. "Vaccination on such a wide scale has never been attempted before, so it is hard to predict the outcome. Cold chain maintenance is crucial for live vaccines," says Virander S. Chauhan, scientist at the International Centre for Genetic Engineering and Biotechnology (ICGEB), New Delhi.

Since Covishield and Covaxin require two doses, real-time recording of data will be done through the CoWIN app, the platform for registering for Covid vaccination. This is to ensure that individuals get their second dose on time and receive two doses of the same vaccine. Dry runs have thrown up problems in data uploads in areas with poor internet connectivity. In Bihar, some ANMs were found to be struggling with using smartphones and uploading data. A training programme was launched for them. Uttarakhand chief secretary Om Prakash and Goa health secretary Amit Satija have raised internet connectivity issues at vaccine centres. "The dry runs were carried out to ensure that the actual vaccination takes place effectively. Feedback has been collected from the states and the problems will be fixed before the drive begins," says Dr Paul.

WILL PEOPLE TAKE THE VACCINE?

With many states aiming to vaccinate healthcare/ frontline workers and priority groups within six months, there is considerable hope of the Covid vaccines being available to the general public in the second half of the year. However, taking the shot is voluntary, even for healthcare workers. "Nobody will be forced to take the vaccine. We will vaccinate as many as are ready. The purpose is to reduce transmission of Covid," says Dr Balram Bhargava, the director general at the Indian Council of Medical Research (ICMR).

A December 2020 survey by LocalCircles, a community social media platform, among 18,000 people in 242 districts found nearly 70 per cent unwilling to take the vaccine. Within the health community itself, vaccine expert Dr Gagandeep Kang has said she will not opt for Covaxin until its efficacy is known. Among the politicians who followed suit are Shashi Tharoor and Akhilesh Yadav. "So much doubt has been raised over India's vaccine approval process. I would rather fly to a Gulf country and take the Pfizer or Moderna vaccine," says Chandni Ghosh, a teacher from New Delhi.

Ganesh Reddy, secretary of the NGO Citizens Foundation, says that while preparations seem afoot, the government may eventually involve social organisations to spread awareness about the importance of getting vaccinated . To counter public scepticism, Telangana has begun an awareness programme. On taking the first dose, beneficiaries are sent phone messages about the importance of completing the second dose. Uttar Pradesh is taking steps to prevent misinformation campaigns. "Police cyber teams in the districts have been put on the job of preventing rumour-mongering about the vaccine on social media," says UP ADGP Kumar.

Awareness drives alone may not help. Experts suggest involving private hospitals in the vaccination. "People still have very low trust in public healthcare. It is a result of years of neglect. Public trust is also low because of lack of transparency in the vaccine programme," says Dr Mira Shiva of AIDAN. The first few phases of Covid immunisation will most certainly be run through the public healthcare network in order to keep costs low and ensure equitable reach. In the long run, though, partnership with private players and approval for more vaccines might be necessary to build public confidence for the Covid vaccination drive.
with Amitabh Srivastava,

KNOW YOUR VACCINE

The top five vaccine candidates for India and what experts have to say about them:

COVISHIELD

Researched by: AstraZeneca and Oxford University

Manufactured by: Serum Institute of India

Type: Chimpanzee adenovirus vector-based vaccine

Efficacy*: 70% (based on phase 3 trial results)

Status in India: Approved for emergency use. Around 5.6 million vials shipped to 13 cities on Jan. 12

Expert take: "Live vaccines need to be stored at 2 to 8 degrees Celsius. This vaccine requires an efficient cold chain to avoid contamination. It has been tested on only 1,600 people in India, which is good to judge safety and immunogenicity* but is a small sample size for robust efficacy data."

-Dr Gagandeep Kang, Vaccine expert, Christian Medical College, Vellore

SPUTNIK V

Researched by: Gamaleya Research Foundation

Manufactured by: Hetero India

Type: Adenoviral vector-based vaccine

Efficacy: 91.4%

Status in India: Phase 3 trials on; interim analysis found it to be safe*

Expert take: "To make this vaccine, a gene from the adenovirus is removed and a gene with the code of a protein from Covid is inserted. This inserted element is safe and helps the immune system produce antibodies."

-Dr Shahid Jameel, Virologist and Director, Trivedi School of Biosciences, Ashoka University

COVAXIN

Researched by: Bharat Biotech with NIV, Pune and ICMR

Manufactured by: Bharat Biotech

Type: Inactivated vaccine

Efficacy: Not known

Status in India: Approved for emergency use

Expert take: "This vaccine type is time-tested and safe, but its efficacy is questionable at this stage. We lack data on how long the protection will last or how effective it will be."

-Virander S. Chauhan,

Scientist, International Centre for Genetic Engineering and Biotechnology, New Delhi

ZYCOV-D

Researched by: Zydus Cadila

Manufactured by: Zydus Cadila

Type: DNA vaccine

Efficacy: Not known

Status in India: Phase 1 and 2 trials on

Expert take: "DNA vaccines use genetically engineered plasmids-a type of DNA-that are coded with the Covid antigen to generate an immune response. Being a relatively new type of vaccine, more safety and efficacy data is needed."

-Virander S. Chauhan

PFIZER & BIONTECH

Researched by: Pfizer and BioNTech

Manufactured by: Pfizer and BioNTech

Type: mRNA

Efficacy: 95%

Status in India: Applied for emergency use authorisation

Expert take: "mRNA is a remarkable technology. It allows the body to produce the Covid antigen by introducing genetic instructions. But we need more time to be sure of its efficacy."

-Dr Shahid Jameel, Virologist and Director, Trivedi School of Biosciences, Ashoka University

COVID VACCINE FAQS

1. Does everyone need to take the Covid vaccine?

Only health and frontline workers will be vaccinated in the first phase. Vaccination is not mandatory for anyone but it is recommended.

2. Why take the vaccine if Covid cases in India are slowing down?

Immunisation cuts down viral transmission and reduces chances of a second Covid wave. Some vaccines also protect against Covid mutations.

3. Which vaccine should I opt for?

Only two vaccines are approved in India at the moment. Covishield has full safety/ efficacy data available while Covaxin is undergoing trials.

4. Are these vaccines safe?

Both vaccines have cleared safety tests. Minor side-effects, such as headache or swelling at the injection site, have been reported. Those receiving the vaccine will be kept under observation for 30 minutes.

5. How do I register for vaccination?

The CoWIN app helps register for a vaccine dose provided one is eligible for it.

6. How many vaccine doses will I need?

Both vaccines require two doses. The CoWIN app will help track the next vaccination appointment.

7. Who will administer the vaccine?

Around 175,000 health workers have been trained in India to administer the vaccine in the first phase.

8. Should I wait for more vaccine candidates to be available?

There is no certainty when more vaccines will be approved for use in India.

  • Safety: Vaccines undergo safety tests to note side-effects and how adverse reactions may be linked to dosage.
  • Immunogenicity: The ability of cells/ tissues to provoke an immune response. Only after all three trial phases of a vaccine can it be determined if the immune response is good enough to protect against a virus and how long the protection will last.
  • Efficacy: Statistical measurement of a vaccine's overall performance. For instance, 90 per cent efficacy would mean there is a 90 per cent chance the vaccine will protect an individual against the disease provided it is taken in routine circumstances. It is calculated in phase 3 of human trials by looking at the percentage reduction of the disease in the vaccinated group as against the unvaccinated group.



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