New Delhi: A top World Health Organization (WHO) official has batted for the government’s decision to include Covaxin in India’s Covid vaccination drive despite the absence of complete Phase 3 clinical trial data.
Speaking to ThePrint, Dr Poonam Khetrapal Singh, the WHO’s regional director for the South-East Asia Region, said “evidence could be limited during the early phases of Covid vaccine development”.
Countries, she added, “have the autonomy to issue emergency-use authorisations for any health product”.
Covaxin, India’s indigenous Covid-19 vaccine, is a collaboration between the Hyderabad-based Bharat Biotech, known for its low-cost vaccines, and the Indian Council of Medical Research (ICMR).
It was given a “conditional” emergency-use authorisation by the country’s apex drug regulator, the Drugs Controller General of India (DCGI), last month. It is one of two vaccines being administered as part of India’s Covid vaccination drive. The other is Covishield, which was developed by researchers at the Oxford University and the Anglo-Swedish firm AstraZeneca, and is being manufactured in the country by the Serum Institute of India (SII). This candidate has also received a conditional emergency-use authorisation.
Asked about the controversy surrounding Covaxin, Singh said, “In line with their national regulations and legislation, countries have the autonomy to issue emergency-use authorisations for any health product. Domestic emergency-use authorisations are issued at the discretion of countries.
“We recognise that, in early phases of Covid vaccine development, there could be limitations of evidence. The WHO supports the development of evidence to inform the use of vaccines,” she said. “We recommend ongoing research to inform optimisation, and safe and effective use of the new Covid vaccines.”
Also Read: Everything you need to know about Covaxin, India’s controversial Covid vaccine candidate
‘Cases declining in India but can’t let guard down’
Singh, the first woman to serve as the WHO’s regional director for the South-East Asia Region, assumed the post in February 2014. A former IAS officer with a two-decade career in the civil services, she is currently serving her second term in the position.
In her interview to ThePrint, she lauded India’s response against Covid-19 but urged caution. The pandemic, she said, is not yet over and the possibility of resurgence remains high.
“It is encouraging to see decline in Covid-19 cases. Over the past several months, we have seen how India has responded to the pandemic,” she added.
According to the latest data from the Union Ministry of Health and Family Welfare, the tally for active Covid-19 cases on a given day has remained below 1.5 lakh since 7 February.
Singh hailed India’s efforts to scale up capacities, and strengthen the implementation of core public health measures — to test, trace, isolate and treat.
“Simultaneously, Covid-19-appropriate behaviours — use of masks, hand hygiene, cough etiquette, and physical distancing — have been promoted,” she said.
However, she added, “Globally, whenever and wherever these measures have been implemented well, the number of cases has declined. Also, we have witnessed a resurgence whenever there has been a let-up in these measures.”
Even as Covid-19 vaccines are now being rolled out, she said, “we cannot let our guard down”.
“We need to do everything possible to keep Covid-19 transmission low. The longer we let the virus transmit anywhere, the higher the risk of variants,” she added.
Moreover, she said, testing must continue to keep a check on mutated strains.
“Along with vaccination, we must continue to use tested public health and social measures that have shown to work, even against the new variants,” she added.
Also Read: Covaxin a ‘buffet’ vaccine that can deal with mutations, others ‘a la carte’ — top virologist
‘Vaccine hesitancy was expected’
The introduction of Covid-19 vaccines has been accompanied by reports of hesitancy among some sections, including fears about the potential side-effects and safety of the shots.
According to Singh, vaccine hesitancy “was not unexpected initially”, but she sees the sentiment easing in the coming days.
“However, moving forward, we can expect a lot of positive sentiment towards vaccination, especially given the protection and return to normal life they could represent,” she said.
The WHO, she added, has been working with all the countries to prepare for Covid-19 vaccine rollout, and “vaccine safety” is an important aspect.
The UN health agency is keeping an eye on instances of adverse events following immunisation (AEFI), and expects the countries to submit related data for analysis, she added.
“While the WHO continues to support monitoring of Covid-19 vaccination rollout, the AEFI national committees (panels formed by different countries to monitor AEFI) are overseeing causality assessment and are expected to share data that will enable WHO to conduct an analysis in the long run,” she said.
Also Read: Covid vaccine hesitancy in India down by 7% since Dec, 3% to wait till 2022 to decide — survey
These are dangerous people to humanity.All big names of UN are sold
I agree with the statement of Yashapal 100 percent
It is unduely getting delayed for the covaxin to be available across the counter.Government regulation to control the distribution should be withdrawn in the earliest.
It may cause harm if the control over the availability of the same is not withdrawn, like testing of COVID .
Indian govt and medical officials have every right (really?) to make Indian citizens GUINEA PIGS for Covaxin trials…. That’s what they really mean!!!
No doubt it is the prerogative of the country to give any kind of authorisation to any drug but the regulators and the company had been shouting from the roof tops that all protocols will be strictly followed and then clinical mode authorisation was given. If the regulators and the Govt were pro active, Phase 3 trials could have been started by Oct ’20, all inoculations completed by Nov ’20 and preliminary results got by end Jan – mid Feb and no questions would have been raised.
Per the article, WHO representative said: “(Countries) have the autonomy to issue emergency-use authorisations for any health product.” Compare this to the paraphrasing in the title, “(India) has every right to”. Clickbaiting or bias?
The headline of the article and the contents do not match. What Ms Singh seems to be suggesting is barely that India’s legislation allows approval which we know because we already did it. There seem to be no statements backing the vaccine and it’s efficacy. Wonder if we are starting to move towards sensational headlines ourselves.
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