India in talks with Russia on ‘unverified’ COVID-19 vaccine

Indian serostudies do not talk about neutralising antibodies, says ICMR DG  

By Banjot Kaur
Published: Tuesday 25 August 2020
India in talks with Russia on ‘unverified’ COVID-19 vaccine. Photo: Pixabay

India is talking to Russia for purchasing its novel coronavirus disease (COVID-19) vaccine, Sputnik V, the Union government said on August 25, 2020.

“Initial details have been shared. More details are awaited,” Rajesh Bhushan, secretary at the Union Ministry of Health and Family Welfare (MoHFW) said in a press conference. However, he did not qualify anything beyond this. 

Russia had registered Sputnik V on August 12, 2020. Experts across the globe have been very sceptical about this vaccine. Any vaccine has to complete three phases of trials on humans before getting a nod from the drug regulator of a country for public use.

However, Phase-3 of the trial for the Russian vaccine is yet to take off. The third phase assesses the efficacy and safety on tens of thousands of study participants. 

The World Health Organization (WHO) has not approved of the vaccine yet and still terms it as a vaccine ‘candidate’ and not a ‘vaccine’.  In fact, it is not even privy to the results of the first two phases. 

“We have started discussion with the Russian authorities to learn more about the vaccine candidate. We have requested them to share the data on efficacy and safety,” Soumya Swaminathan, WHO’s chief scientist said at a virtual press conference on August 25.

“We understand it has undergone preliminary human studies… Phase-3 would be a real test of the efficacy,” she added.

Bhushan did not specify why India initiated talks, what convinced the Indian government about safety and efficacy and whether it would wait for the results of phase-3. News reports have suggested some 20 countries expressing interest in Sputnik V, with a few like the Philippines announcing it would conduct its own phase-3 trial on the product

The MoHFW also made it clear it won’t not give any opinion on conducting Joint Entrance Examination (JEE) and National Eligibility cum Entrance Test (NEET) for engineering and medicine aspirants respectively. The aspirants would take the exam in September.

“The Supreme Court has already given a decision. We will not comment on that. However, we would provide a standard operating procedure for conducting these examinations,” Bhushan said.

On serosurveys

No serosurvey conducted in India so far has said anything about neutralising antibodies of the sampled population, Indian Council of Medical Research (ICMR) Director-General Balram Bhargava said at the conference.

Different serosurveys conducted in different parts of India, from Pune to Delhi, Mumbai and Ahmedabad, have come out with different seropositivity rates ranging from 17 per cent to 51 per cent.

They indicate the spread of infection as well as the prevalence of antibodies in the sampled population and whether the antibody prevalence would lead to herd immunity or not. However, all of them so far, have also assessed the prevalence of IgG antibodies, as Bhargava said.

Not all antibodies are neutralising ones which actually fight against the virus. 

ICMR, on the other hand, also did a round of serostudies and its preliminary results were announced in June. However, the detailed data has yet not been published in any journal for which, ICMR has been criticised by several experts.

“We will be definitely publishing this week,” Bhargava said replying to a query. He said ICMR will undertake a second round of serosurveys and the exercise will end by the first week of September. 

The ICMR DG gave a detailed presentation about how India had scaled up testing from a test a day to ten lakh tests. However, a breakdown of what proportion were antigen tests and what were RT-PCR, was hard to come by. The sensitivity of the latter is more than the former.

As many as 30-40 per cent of the total tests being confuted are antigen tests, Bhargava replied. 

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