Fear and hope

As India prepares to roll out world’s largest vaccination drive, adverse reactions to Covid-19 vaccination in other countries have raised some concerns about its safety. Experts and volunteers, however, says these fears are unwarranted

Aditi Tandon

Tripta Vasudev is not particularly vaccine skeptic but she would rather wait for the first wave of Covid-19 vaccinations to be over before volunteering for a shot.

“How do we know the vaccines are safe? All our lives we have been told it takes years to develop safe vaccines. Now two vaccines have been approved in less than a year of the Covid-19 outbreak. I have my worries,” says the 62 year old who falls in the priority group that the Centre has listed for initial rounds of Covid-19 inoculation expected to roll out this week.

A watch out for side effects

Ever since the UK became the first country on December 12, 2020, to approve the Pfizer-BioNTech Covid-19 vaccine, people have been watching out for news of potential side effects.

Vaccine confidence took the first big hit earlier in January with the news of a nurse in Portugal dying within 48 hours of getting the Pfizer shot. Soon afterwards, a UK nurse said she had contracted Covid-19 while waiting for the second dose of the vaccine.

With clouds of disinformation hovering on the Covid-19 vaccine horizon, the Indian authorities are rushing against time to boost people’s confidence in the two approved vaccines – Serum Institute of India’s Covishield and Bharat Biotech’s COVAXIN.

Covishield (an Oxford University/AstraZeneca vaccine) has shown over 70 pc safety, immunogenicity and efficacy in the UK trials and comparable safety in a bridging study on 1,600 Indians. The other approved made-in-India COVAXIN is, however, yet to conclude phase-3 trials, triggering fears over its efficacy.

Leading researcher Gagandeep Kang’s recent remarks that she would not take COVAXIN until efficacy data was available have exacerbated the fears, prompting other scientists to fill information gaps.

Fears unwarranted, say experts

“All three sets of data – safety, immunogenicity and efficacy – are required to approve vaccines in non-emergency situations. In a pandemic situation, the Indian laws allow the regulator to grant restricted emergency-use approval based on safety and immunogenicity data while phase-3 trials to judge efficacy are on,” says Balram Bhargava, chief of ICMR, Bharat Biotech’s collaborator on COVAXIN, rejecting fears.

India’s New Drugs and Clinical Trial Rules (March 19, 2019) allow treatment of phase-2 immunogenicity data as a surrogate for efficacy data.

“If remarkable efficacy is observed with a defined dose in the phase-2 clinical trial of investigational new drug for the unmet medical needs of serious and life threatening diseases in the country, it may be considered for grant of market approval by the central licensing authority based on phase-2 clinical trial data,” state the Rules, explaining why COVAXIN has been approved for use in clinical trial mode (all participants would be closely tracked).

Be that as it may, fears persist on the ground alongside hope.

Volunteers vouch for safety

A host of health and frontline workers, who took part in COVAXIN trials, vouch for its safety. They have urged people to shun hesitancy.

Paramedic Dhanesh Kumar, a native of Bharatpur, is happy to be part of COVAXIN’s ongoing phase-3 trials and has received the first dose on December 31. The second is due on January 28.

“I felt no tenderness, swelling, pain or fever. I am proud to have participated in the trials to boost public confidence in the safety of an Indian vaccine. Fear of the unknown is normal but I can guarantee that COVAXIN will work. It posed no safety issues in phase-1 and 2 trials and the third phase is also going very well,” says Kumar.

The first to receive Covid-19 vaccine shots, health and frontline workers will be essential to the success of Indian vaccine effort which Prime Minister Narendra Modi has termed “the largest drive in the world.”

Needed a positive communication strategy

The government is working to record beneficiary testimonials as part of Covid-19 Vaccine Communication Strategy prepared by the Health Ministry.

The strategy will address vaccine eagerness and vaccine hesitancy and use WhatsApp to spawn a web of pro-jab messaging.

“WhatsApp groups — ministerial, professional and community-based involving corporate partners, schools, parent groups, resident welfare associations, self help groups — will be used to boost vaccine confidence,” says the document.

Vaccine trial participants are also keen to aid the confidence-building effort.

AIIMS New Delhi nursing officer Mansingh Jat, a trial volunteer, says many of his friends have mixed feelings of fear and hope about the shots.

“A positive communication strategy is a must. I can say from my experience that there were no side effects of the COVAXIN trials. I even believe the vaccination should be compulsory,” Jat argues with experts now saying 70 per cent population would need to be covered to achieve the herd immunity needed to resume normal lives.

Positive experiences of trial volunteers play a huge role in this process with the Ministry planning to make many of the shot recipients ambassadors of the Indian vaccine story.

Sreejith G, a nursing officer, part of ongoing COVAXIN trials at AIIMS, New Delhi, says vaccine is India’s only option to go back to old, normal times.

“I did not feel any adverse events in the trial. People must trust science and researchers. The vaccine is our only hope for normalcy,” he says at a time when the Government admits to vaccine uptake being the top challenge to the inoculation drive that will cover 30 crore people in phase one by July.

The effort is huge as it means vaccinating five crore people a month and 15 lakh a day.

EXPERT QUOTEs

Rajib Dasgupta, Chairperson, Centre of Social Medicine and Community Health, JNU

“The Centre-led Covid-19 vaccination initiative is being carried forward by the states. This is an unprecedented campaign globally and nationally. The first set of dry runs, by and large smooth, presented minor issues such as space constraints, network connectivity and technical challenges with the CoWIN portal. These will be fixed. There is a well laid-out plan to generate demand in sync with the prioritisation strategy – health workers, other frontline staff, those above 50 and those with co-morbidities. But there are several unaddressed issues — product’ related concerns like vaccine research results, efficacy, prioritisation issues — such as why immune-compromised children should not be a priority and most critically potential adverse effects given that these are new vaccines with fast-tracked approvals. Social media must be used to address concerns and misinformation must be checked. Digital wildfires are a real threat. The crash of the poultry industry during February-March 2020 due to rumours linking Covid-19 to poultry consumption is a case in point.”

VACCINE Q/A: AIIMS NEW DELHI CHIEF RANDEEP GUERIA

Q: Are Indian vaccines safe?

A: Yes, Indian vaccines have been licensed only after the regulatory bodies studied safety and efficacy data. Indian vaccines are as effective as any other approved Covid-19 vaccine in the world

Q: Who can get the shot once the roll out starts?

A: In the first phase, one crore health workers and two crore frontline workers will get the vaccine followed by 27 crore people aged 50 and above and those aged below 50 with co-morbid conditions. Others will get the vaccine gradually as supplies come

Q: Do I need to get vaccinated?

A: Covid-19 vaccine is voluntary but it is advisable to receive the shot and both doses 28 days apart. Those with a history of Covid-19 must get vaccinated for better immunity. Those with co-morbid conditions must absolutely get vaccinated. Those with current Covid-19 infection should wait for 14 days post recovery to get the vaccine. While Covishield is licensed for use in people aged 18 and above, COVAXIN has been tested in people aged 12 and above.

Q: Can we take any of the two COVID vaccines?

A: No. It is advisable to take two doses of the same vaccine as the vaccines are not interchangeable.

Q: When will I get protected?

A: Protective antibodies will normally develop 14 days after the second dose.

Q: Will there be any side effects?

A: All vaccines can have side effects like mild fever, body aches, pain at the site of vaccination. These get resolved in few days. Half-an-hour rest and watch is recommended post vaccination. The government has readied a block-level plan to address adverse events following immunization.

Q: Can I buy the vaccine from the market?

A: No. The vaccines are currently not available in the market and are only available through the government in a priority setting. Registration on Co-WIN platform is a must for vaccination. Photo IDs are needed for online registration. General populations can register once the government announces a second phase of vaccination.

Q: Can India handle the world’s largest vaccination drive?

A: Yes. India already runs a well-oiled annual Universal Immunisation Programme (UIP) to vaccinate 26 million newborns and 29 million pregnant women. The UIP experience and experience of elections on booth levels will be used for Covid-19 vaccine delivery.

Box

INDIA’S VACCINE PREPARATIONS

• 1.7 lakh vaccinators trained so far; 3 lakh vaccination team members trained; each vaccine team per site to have five members.

• 29,000 cold points, 240 walk-in coolers, 70 walk-in freezers, 45,000 ice-lined refrigerators, 41,000 deep freezers, 300 solar refrigerators to be used.

• All states/UTs ready with state steering committees and state task forces to monitor vaccine movement.

• All 734 districts ready with district task forces.

• 23 ministries identified for social mobilisation against rumour mongering.

• Guidelines for estimation of electrical and non-electrical cold chain equipment issued.

• Guidelines for management of last cold chain points and session sites issued.

• States have identified at least one Adverse Events Following Immunisation (AEFI) centre per block to handle side effects of vaccination; each session site to be linked to AEFI centre.

Box 2

Digital vaccine delivery platform co-win/features

* Allows electronic allocation of vaccine session sites.

* Aadhar authentication to prevent malpractices.

* Creation of unique health IDs (under the National Digital Health Mission) for willing beneficiaries.

* Sends SMS in 12 languages to registered beneficiaries about date and location of vaccination.

* Sends QR code-based digital certificate to beneficiaries who have completed both doses of the vaccine.

* Has a provision for a free DigiLocker for beneficiaries to store their electronic vaccination certificate.

Box 3

ROLLOUT TESTING

Dec 28-29: Co-WIN field tested in four states in the first pilot dry run (Punjab, Assam, Andhra Pradesh and Gujarat).

Jan 2, 2021: First national dry run in 125 districts at 285 session sites.

Jan 8: Second national dry run in 736 districts across 33 states and UTs; Co-WIN tested at three sites per district.

Jan 11: Prime Minister to hold a virtual meeting with CMs to discuss COVID vaccinate rollout.