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Nitesh Kumar Sahoo

New Delhi: The Union Health Ministry on Friday said that the Covid-19 vaccine will be safe and effective but could show minor side effects like fever and pain at the injection site, adding that taking its shot will be voluntary.

The comment comes at a time when questions are being raised at the safety and efficacy of the vaccine being developed at a phenomenal rate. According to a recent survey, nearly 70 per cent people are hesitant to take the vaccine fearing its side-effects.

Allaying the fear, the Health Ministry said, "Covid-19 vaccines will be introduced only when their safety is proven. The vaccines will be safe and effective but may have minor side effects like fever, pain, etc. at the injection site. These effects can happen in any vaccine."

States have been directed to start making arrangements to deal with any Covid-19 vaccine-related side-effects as one of the measures towards safe vaccine delivery among masses, the ministry said in a statement.

The ministry clarified this in a series of frequently asked questions on Covid-19 vaccine and responded to questions like is the vaccine scheduled anytime soon, how long it takes for the antibodies to develop and if it was necessary for a recovered person to take the vaccine.

Recently, Health Secretary Rajesh Bhushan said that 'adverse' reactions cannot be ruled out when vaccination starts. Such events have also been seen in some cases with Pfizer-Biontech's Covid vaccine in the UK.

The UK government had asked people with significant history of allergies to not take the vaccine.

In a sign of relief, vaccinated people will be monitored for thirty minutes pursuant to getting the shots for any adverse event, according to recently released guidelines for the mass vaccination drive.

Besides this, the ministry said that getting vaccinated for Covid-19 will be voluntary, while underlining that the vaccine introduced in India will be as effective as any vaccine developed by other countries.

It further stated that it was advisable to receive a complete schedule of the anti-coronavirus vaccine irrespective of past history of infection with COVID-19 as this will help in developing a strong immune response against the disease.

As many as eight Covid-19 vaccine candidates are under different stages of clinical trials which could be ready for authorization in near future, including three indigenous vaccines.
It includes AstraZeneca and Oxford university developed and Serum Institute of India manufactured Covishield; Covaxin by Bharat Biotech Limited; ZyCoV-D by Zydus Cadila and Russian vaccine candidate Sputnik-V.
The list also contains NVX-CoV2373 by SII, HGCO19 by Geneva, and two unlabeled vaccines -- Recombinant Protein Antigen-based vaccine by Biological E Limited; and Inactivated rabies vector platform by Bharat Biotech.

In the FAQs, the ministry asserted that vaccine trials are under different stages of finalization. The government is geared to launch a vaccine soon.

Covid-19 Vaccination: Can India Deliver That Shot To All?

As the wealthy nations like the US and the UK begin vaccinating their public, the road ahead for India does not look very rosy as both Pfizer-BioNTech and Moderna vaccines currently making headlines are yet to reach the country owing to a host of factors including scarce supply, tricky transport and an absence of proper cold chain.

For over 130 crore Indians, two promising vaccines -- Astrazeneca and Oxford university developed and Serum Institute of India (SII)-manufactured Covishield, and Covaxin by Bharat Biotech Ltd are still a distant dream owing to factors not in the control of the manufacturers or the government.

Sanjay Rai, who is the principal investigator (PI) of Covaxin trial, told IANS on Friday that the rollout of Covaxin may get delayed as the All India Institute of Medical Sciences (AIIMS), where its Phase-III human clinical trial is underway, is struggling to find takers of the trial shots.

However, Dr Harshal R Salve, Associate Professor at Centre for Community Medicine at AIIMS told IANS on Friday that hopefully, we will see approval for an appropriate vaccine in a month or so by a competent regulatory authority.

"In Phase 1, India is planning to vaccinate 30 crore people healthcare workers, frontline workers such as military professionals, police force, disaster management workers and people with existing diseases aged more than 60 years," Salve said.

India has the world's largest immunization programme in the world with beneficiary of more than 60 million annually.

According to Salve, India has also demonstrated outreach and decentralised delivery of public services during general elections.

"These experiences will help India roll out the Covid-19 vaccination at the mass level. The use of IT is crucial in tracking and implementation of individual-level vaccination. However, administration of vaccine should be kept as a voluntary exercise and should not be made mandatory," Salve stressed.

However, due to scarce data on the Covid-19 vaccination and its mass-level efficacy globally, nothing can be predicted at this crucial moment.

An analysis by Duke University's 'Launch and Scale Speedometer', which is updated every two weeks, shows India has made deals for 1.6 billion doses of three global vaccine candidates upon them being ready and certified for use.

Globally, 10.1 billion doses were reserved even before any candidate was approved for market, showed the data.

"Countries with manufacturing capacity, such as India and Brazil, have been successful in negotiating large advance market commitments with leading vaccine candidates as part of the manufacturing agreements," according to Duke University's 'Launch and Scale Speedometer'.

Dr Neha Gupta who is infectious diseases specialist at Medanta Hospital in Gurugram said that the potency of vaccines depends upon the temperature at the storage level.

"Cold chain needs to be properly maintained. The government needs to keep a designated staff for the mass vaccination of healthcare workers, elderly population and patients with common comorbidities like hypertension, COPD (chronic obstructive pulmonary disease), diabetes and cardio-cerebrovascular disease," she told.

The stark reality is that many countries including India may opt to use less protective Covid-19 vaccines that are more affordable and available instead of waiting for better, costlier shots.

But even the lowest reported efficacy so far, for the AstraZeneca-Oxford vaccine, could powerfully curb Covid-19's toll.

"If you'd asked me a year ago if we had the opportunity to deliver billions of doses of a vaccine that had 60 per cent, 70 per cent efficacy, we would have been delighted by that prospect," said Richard Hatchett, who heads the Coalition for Epidemic Preparedness Innovations, in an article in the prestigious journal Science this week.

The Serum Institute of India, the world's largest producer of vaccines, could boost supplies globally.

"It has signed contracts with the US biotech Novavax to make roughly 1 billion doses of its candidate, which is just about to start a large efficacy trial. And it will supply COVAX with up to 200 million doses of the AstraZeneca-Oxford and Novavax vaccines for low- and middle-income countries," according to the article.

To avert vaccine inequality, the Covid-19 Vaccines Global Access (COVAX) facility has been set up by the World Health Organisation (WHO) and its partners to help purchase and distribute proven vaccines.

But COVAX is strapped for cash and its impact remains to be seen.

"If in the first six months, Western Europe and the United States are the only regions that are vaccinating people, and other parts of the world are not being vaccinated until the end of 2021, then I think we're going to have a very, very tense global situation," infectious disease researcher Jeremy Farrar, who heads the Wellcome Trust research charity, was quoted as saying.

The truth is that current estimates depend on vaccine production running smoothly, and already, Sanofi Pasteur and Novavax have run into manufacturing delays.

"Many factors can trip up a vaccinemaker, including shortages of raw materials, equipment, or glass vials. In 2009, the pandemic flu vaccine was delayed because the influenza virus poorly replicated in eggs".

India has entered a critical stage and an absence of a vaccine for long will only create confusion and further deter millions from taking that elusive shot.

(With IANS Inputs)

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