When things seem to be getting normalised, reports started coming in of three schools in Ghaziabad, Noida being shut after 18 students were found infected with COVID-19 and the overall cases going up in Delhi and Mumbai. While it is understood that 'cases' alone do not indicate illness, the alarm has been sounded yet again.

Though India has been able to administer over 195.07 crore COVID-19 vaccines, a sizable population below the age of 12 are yet to be vaccinated. The vaccination for the age group 12-14 years was started on March 16 and so far, more than 3.51 crore adolescents have been administered with the first dose of COVID-19 vaccine (as on June 12). A few of the vaccines are in the pipeline to be launched, however, apart from COVISHIELD and COVAXIN none of the other vaccines has been able to make its mark in the Indian market.

Though there have been very less cases of deaths due to COVID in recent days, the XE variant of coronavirus has triggered fresh concerns about a new wave. Amidst these scenarios, the need has risen to go for booster doses, the need for more new vaccines and to approach the unvaccinated to get them jabbed.

According to Former Food and Drug Administration (FDA) Associate Commissioner Professor Peter Pitts, vaccinations are what got us where we are today. Vaccinations keep us safe as individuals and as part of society. If we step back and strive to understand, BA.2 variant data is what we see isn’t a surge in the pandemic, but the new realities of COVID-19 as an endemic.

The vaccine scenario

Vaccinating a large and diverse population as in India is inherently complex, although India has experience in running highly successful children's immunisation programmes. It also has a reputation for producing large amounts of different life-saving vaccines of high quality and at a lower cost.

The Government of India had set a target of vaccinating 100 per cent of the population by December 2021, however, the magic figure could not be achieved. Things were better as compared to the US and the UK where the vaccine hesitancy was more and is still so.

Says Dr Virander Chauhan, Distinguished Visiting Professor, Institutions of Eminence, University of Delhi, and Founder ETI, “By and large, India’s COVID-19 vaccination programme has been very successful, although, the country was somewhat behind other countries in rolling out vaccines for the population below 18.”

Dr Anup R Warrier, Head - Infectious Diseases and Infection Control, Aster DM Healthcare - India Units says, “We have done exceedingly well to vaccinate the majority of the population with at least two doses of the vaccine. Newer data suggest that the protection against death and hospitalisation lasts much longer than previously believed with just the two doses. Thus, while we will strive to complete the boosters for the eligible population, we are in a much safer zone compared to what we were a year ago.”

Though a majority of the Indians have faith in COVID-19 vaccines, it seems all the excitement has fizzled out like it was two years back when the coronavirus stuck. COVISHIELD and COVAXIN became the most popular ones and were administered the most to the Indians.

Saizen Global Insights and Consulting in collaboration with HEAL Foundation have conducted INDIA VAX-SCENE Survey on vaccine perception in February 2022. Over 90 per cent of Indians believe the vaccine's role is vital in fighting against COVID-19 and 85 per cent of Indians consider COVID-19 vaccines to be safe and effective.

Dr Swadeep Srivastava, Founder, HEAL Foundation says, “The survey has revealed one more thing that unvaccinated people have higher concerns, and effective healthcare communication is the key to addressing their half-cooked information and convincing them to go for the vaccination without hesitation at the earliest.”

GOQii's India Fit Report 2022 recently conducted a 'COVID-19 Trust in Vaccines and Vaccination’ survey with over 10000+ users. The report mentions how 91 per cent of Indians feel vaccination will protect them from COVID-19.

Is there a need for more vaccines?

Though COVISHIELD and COVAXIN have vaccinated a majority of the Indian population, the Government of India has approved vaccines from Moderna and Johnson and Johnson, which are not so popular in the Indian market. Even the Sputnik V from Russia, which underwent clinical trials in India, couldn’t make its mark in the Indian market. Even Covaxin trials for those below the age of 12 have been conducted, however, the efficacy is not clear.

Even India recently began administering precaution doses of COVID to above 18 years of age. The Technology Development Board (TDB), Ministry of Science & Technology has supported Hyderabad-based startup Sapigen Biologix for the development and commercialisation of two novel vaccines – the Intranasal COVID-19 Vaccine.

The Drugs Controller General of India (DCGI) has recently approved US-based Novavax and Serum Institute of India’s (SII) emergency use authorisation (EUA) for Novavax's protein-based COVID-19 vaccine for adolescents aged ≥12 to <18 years in India. The vaccine, also known as NVX-CoV2373, is manufactured and marketed in India by SII under the brand name Covovax and is the first protein-based vaccine authorised for use in this age group in India.

Jabs against recommendations

The government some time back announced that Hyderabad-based Biological E’s Corbevax will be used to vaccinate 12-14-year-olds in the country. The approval is for use as a booster dose, but as a standard two-dose vaccine for 12-14-year-olds only. The DCGI gave an emergency use nod to "Corbevax" in children between the ages of 12 and 18 years, however, the National Technical Advisory Group (NTAGI) seemed to differ from the stand taken by the government and a member of the working group of NTAGI went on to say that NTAGI did not give any recommendation to the Centre on a vaccine for children below 15 years of age. Experts have raised concerns over the vaccine's efficacy and safety data which are not in the public domain.

According to Dr Subhrojyoti Bhowmick, Clinical Director, Academics and Research Depts, Peerless Hospital, Kolkata, “I do not believe that there is a need for more vaccines although we have a larger portion of our population below 12 years of age which has not been vaccinated and no approved vaccine exists for the same.”

Opposed to scientific data

The Central Drugs Standard Control Organisation (CDSCO) has consistently failed to support its own approvals and has lacked transparency in public health matters. On some occasions it has even maintained an uncanny silence where it is supposed to make its mark clear.

The World Health Organisation (WHO), on April 2 has suspended the supply of Bharat Biotech’s Covaxin through the UN agencies after finding issues with the good manufacturing practices. It has led to confusion among many who have taken COVAXIN and questions are being raised on how CDSCO and DCGI could approve certain vaccines when the vaccine data is not in place.

We are all aware about the controversy pertaining to Molnupiravir, the first oral anti-covid drug and in January, 2022, Dr Balram Bhargava, Director General, the Indian Council of Medical Research (ICMR), then said, "The drug (Molnupiravir) has major safety concerns'. The issue was raised after DCGI and CDSCO approved the drug in the last week of December. It may also be noted that CDSCO had granted permission to 13 Indian pharma companies.

A study conducted by University of Virginia Health, US reveals emerging differences in COVID-19 infection rates in recipients of different vaccines. The study also finds that older recipients of the Pfizer vaccine generated fewer antibodies than did younger recipients, but this wasn’t the case for Moderna, where age did not appear to be a factor.

Cases like this are many. In the Indian context, the Health Ministry should have taken proactive steps to report adverse events due to vaccines, among adults and children and provide a clear picture to the citizens rather than fueling doubt and apprehension among many.

On one hand we are celebrating on achieving certain targets while on the other ignoring the fact that there may be serious health hazards for many who have taken certain vaccines for COVID-19. A glaring oversight is the lack of easy accessibility and informed consent of Adverse Events Following Inoculation (AEFI) reported so far.

Much ado about nothing?

Companies are in a rat race to launch new vaccines and currently, they are being charged. It will be a challenging task for the government to insist on its population going in for the booster dose, let aside a sizable population yet to be vaccinated. Also, numerous vaccines are in the pipeline and time will say whether these are required knowing that the virus is slowly becoming endemic.

As a virologist, Dr Gagangdeep Kang, rightly points out that India has data on COVID deaths but there are no statistics to establish which vaccine prevents hospitalisations. Data is important because we need to be prepared for future pandemics. Data will give us an idea about what needs to be done next.

Sanjiv Das
sanjiv.das@mmactiv.com