'Cautious' hope

Every sunrise brings new hope. Such is also the case with the dark winter of Covid that we may now start emerging from in the new year with the wait for a vaccine finally coming to an end. The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) recently approved the proposal of Serum Institute of India (SII) for granting emergency use authorisation license for Oxford-AstraZeneca's Indian version COVID-19 vaccine that will be sold under the name Covishield. It is expected that the vaccination drive using the existing stock of Covishield would be launched on January 14.

The second good news for the people of the country came on the second day of the new year as the SEC also approved the proposal of Bharat Biotech for granting permission to indigenously-developed Covaxin for restricted use in an emergency situation in public interest as an abundant precaution in clinical trial mode, especially in the context of infection by mutant strains.

The approval of two vaccines for use is certain to be a big leap forward for the country that has recorded over 1.5 lakh deaths and the second-highest case count after America. In addition to these two already approved vaccines, the SEC has also granted permission for conducting phase three clinical trial protocol to Cadila Healthcare.

As per experts, the pace of vaccine development for this pandemic is unprecedented. Vaccine development is typically a time-taking process and it takes over five years (generally speaking) to complete all the process required for effective and error-free vaccine development. Drug regulators validate a vaccine/drug only after validating all the trial data of phase one, phase two and phase three with the final phase being conducted on humans.

But it is important to take note of the fact that this expedited pace of development has also created many doubts regarding the efficacy and safety of the vaccines. To assuage this hesitancy and control the harmful spread of misinformation at this stage, it is essential to heed expert advice and get the right set of facts.

Weighing in

Will the vaccine bring an end to COVID-19 in India? No. This is what renowned epidemiologist Dr Raman Gangakhedkar said when asked about the post-vaccination outcome. "This is just the beginning of the vaccination campaign. How can we say that as at the initial stage when the plan now is to vaccinate only 30 crore people ?" he said.

As per Gangakhedkar, medical council, those who are working in the government sectors would be auto-registered, while others would have to register themselves through Co-WIN app by uploading a certificate from any general medical practitioner.

As per the ICMR's Director-General Dr Balram Bhargava, if we are able to vaccinate a 'critical mass' of people, and break that virus transmission, then we may not have to vaccinate the entire population. Until we reach this critical mass, social distancing and masking measures will remain just as relevant, even if certain people have been vaccinated.

Moving on to the pace of development becoming a cause for concern, it is important to acknowledge that India is not alone in this conundrum. Vaccine approval has been fast-tracked all over the world at this point, a move that has divided the experts.

In case Serum Institute of India's Covishield, the vaccine has been approved for emergency use on the basis of human trial data of UK as the SII has not conducted "enough" human clinical trials in India. It is worth noting that the AstraZeneca vaccine has already been used to innoculate over 40,000 people in Britain, further validating its safety.

The "successful" approval story of Covaxin is not different from Covishield as the vaccine, which has been developed with the support of Indian Council of Medical Research (ICMR), has not yet completed phase three trial on humans.

Commenting on the Government's 'rush' for vaccine approval, noted community medicine expert Ritu Priya, who is a professor at the Centre of Social Medicine Community Health, Jawaharlal Nehru University, raised her doubts over safety and efficacy of the two approved vaccines. However, the JNU professor put Covishield above Covaxin as the Indian version of Oxford AstraZeneca has been tested in Britain while Covaxin has not yet completed phase three trial.

"The concerns of safety and efficacy would remain the same. The plus point with the Covishield is that it has been tested in the UK, which is not the case with Covaxin as we haven't yet seen any data of the indigenously developed vaccine in the public domain," the JNU professor told Millennium Post.

Questioning the views of volunteers appearing as a subject for human trial of Covaxin, Priya said, "It's very obvious that a volunteer becomes a part of the trial as the participant has faith in the vaccine, which does not mean that it's the community trend. The behavioural pattern of community is different from any particular participant."

Priya also raised an important issue of doctors and health workers not willing to get vaccinated due to the rush in vaccine development. "We have seen reports saying that about 20 per cent doctors and nurses in the US not willing to get vaccinated as the vaccine has been released in a rush without going through adequate study procedures," she said.

The JNU Professor suggested that the Government should not rush the delicate procedure. "The Government must allow sufficient time for safety as the vaccine would be administered to masses of healthy people which may have some side effects. So we have to follow the basic ethics of public health of being completely safe. Thus, it would be advisable for the Government to wait for such data prior to launching the full campaign."

Rejecting the comments of the JNU professor, Dr Rajni Kant, a senior scientist at ICMR, said, "The Drug Controller has set the standard. It approves any vaccine only after analysing the safety and efficacy of the vaccine. There is no doubt about the safety of both the vaccines."

"Both the vaccines have gone through small and large animal studies. The phase one and phase two studies are conducted for safety issues only," said Kant, who is currently working as Director, ICMR-Regional Medical Research Centre (RMRC), Gorakhpur with additional charge of head, Division of Research Management, Policy, Planning and Coordination (RMPPC) at ICMR headquarters.

"When noted people like member Niti Aayog VK Paul are ready to get vaccinated publically that means there is no safety issue with the two vaccines. Sometimes it happens that persons having some medical issues exhibit side effects after vaccination, which is very common. Experts are working on to address this issue," he said, adding that no serious adverse effects of the vaccine has been reported so far and there would be some normal post-vaccination effects such as mild fever, stiffness, headache etc., which are very common side-effects of any vaccination process.

On logistical aspects of the vaccination drive such as delivery and cold-chain management, the ICMR official said, "The delivery management is in the domain of Union Health Ministry and states and as far as cold-chain management is concerned, the country has the required infrastructure for vaccine storage and transportation as the approved two vaccines can be transported at fridge temperature (two to eight degrees) in comparison to the vaccines of Pfizer and Moderna as their storage requirement is upto -70 degrees."

"As far as the cold-chain infrastructure is concerned, there is not going to be any challenge in the country for the vaccination drive of both the vaccines. There would be no change in the efficacy of vaccines even it transported to remotest areas of the country," he said.

Agreeing with the views of Dr Kant, AIIMS nursing officer Kanisk Yadav, who has volunteered himself as a participant for Covaxin, said that the ICMR-developed vaccine is totally safe and effective in managing COVID-19.

Yadav, who is working a motivator, is working tirelessly to convince participants by addressing their anxiety for the vaccine's safety. "Till now, I have enrolled about 50 participants for the vaccine trial. I found the most of the participants, who came at AIIMS for vaccination, were not even aware of the factual findings. Their questions were all rumour-based," he told Millennium Post.

"I got vaccinated first so that I should have the authority to advocate about the vaccine. When I told participants that I have taken the vaccine and have not developed any side-effects as well as any COVID-19 symptoms, they took it positively and participated in the drive," he said.

"During the counselling the questions that I faced from participants, including highly educated individuals, were based on the myths being in circulation on social media. Some of them asked that it may imbalance the gene structure, while others raised their apprehensions that it may activate HIV-AIDS virus in the body," he said.

"In response to all such rumour-based queries, I just countered their questions by asking evidence to validate their claims which they fail to produce. Creating awareness about the safety and efficacy of vaccine is a challenging task and I'm on it with the sole objective of making our country a Covid-free nation," Yadav said.

Highlighting yet another key challenge, a noted researcher Dr Anant Bhan said, "The COVID-19 vaccination drive is going to be very different from any other ongoing drive as this new vaccine has to be provided to several groups, including pregnant women and children. The drive would require human resources in abundance to reach all target populations."

Aside from such concerns, there are many others as well which the scientific community is itself not in a position to definitively answer. Take for instance the much-discussed concern of just how vaccine immunity will last. The answer, for the most part, is that it is too early to make a precise comment on the same. No country, India included, has prioritised such studies. A few preliminary studies have been carried out in regards to the Moderna and Pfizer vaccine that have suggested that vaccine immunity from two shots would give atleast three months of immunity. There are caveats to that, however. Smaller studies have shown that antibody counts do decrease in these three months as well. While no conclusive evidence has obtained, there are indications that antibody counts may go down faster in advanced age groups. This is not to say that a reduced antibody count would significantly compromise the ability to protect against the virus. It is important to note that these observations are based on preliminary data from very limited test groups. As worldwide vaccination campaigns kick-off, it is important for such data to be shared and analysed to give a better picture of the same. India's vaccination drive will start from January 16.

Another difficult question that cannot be answered at this point is just how long it would take for a global vaccination campaign to fully pushback the virus. It is important to note here that the WHO has expressed the opinion that COVID-19 will never fully go away. Even after we succeed in controlling it, COVID-19 is likely to become endemic in certain parts of the world, just as is the case with similar coronaviruses. It is also important to note that humanity does have some experience with mass vaccination campaigns as we, for the most part, successfully eradicated deadly diseases like smallpox and polio through combined global efforts. But it is precisely those efforts that tell us that vaccination campaigns are long and complicated at this scale, often taking decades as new challenges rise up and are addressed. While we may have come together and pulled off the development of multiple vaccines in this short span of time, there simply exists little scope of the same for the actual process of getting vaccines into the arms of close to eight billion people worldwide. There are multiple problems to face with the disparity of related infrastructure and the wealthiest nations hogging initial vaccination batches being just some of them. Then there is the problem of the virus mutating even as the vaccination campaign is carried out. For now, the major vaccine makers have all reported that their respective vaccines seem to be equally effective with the new England strain of the virus. Experts have also additionally noted that it is very unlikely for RNA viruses to actually get deadlier with mutation with most, in fact, getting weaker even if they become more infectious. That said, it is not impossible for these 'genetic mistakes' to come together by some freakish change and create a virus variant that is more resistant to the current set of vaccines. This is why the scientific community is already engaged in sequencing all the variants of the virus so that they may stay ahead of any particularly worrying trends.

All this serves to offer a glimpse at the truly significant task ahead of India and the rest of the world as it struggles to contain not only the pandemic but the wave of misinformation that accompanies it. Despite the many challenges, JNU professor Ritu Priya maintains that the entire endeavour is doable so long as there is political will. "When the Government can make a financial outlay for the Central-Vista project, the same urgency and purpose can also be brought to bear for the mammoth vaccination drive."

WHO WILL GET COVID-19 VACCINE

The Government has identified three high-risk groups for vaccination on priority. The first group includes healthcare and frontline workers, the second group will be persons over 50 years and persons with comorbid conditions and the third group will all those who would need it;

The COVID-19 vaccine is not mandatory. It's voluntary;

COVID-19 recovered patients would also be vaccinated;

COVID-19 infected individuals would not be allowed to get

vaccinated;

All eligible beneficiaries will be informed about health facility for vaccination and its scheduled time through their registered mobile number;

A photo identity card is must for vaccine registration and

vaccination';

Individuals without any photo identity card will not be registered for vaccination;

A beneficiary will receive SMS on their mobile number about due date, place and time of vaccination after registration;

After all doses of vaccine are administered, a QR code-based certificate will be issued to beneficiaries on their mobile number;

Beneficiary will have to rest at the vaccination centre for at least 30 minutes after COVID-19 vaccine;

Cancer, diabetes, hypertension, etc patients will have to get

COVID-19 vaccination;

After first dose of vaccine, the second dose will be administered 28 days later and protective levels of antibodies would be developed two weeks after receiving the second dose.

Views expressed are personal