A health worker prepares a needle to inject the 'Gam-COVID-Vac', also known as 'Sputnik V', COVID-19 vaccine, developed by the Gamaleya National Research Center for Epidemiology and Microbiology and the Russian Direct Investment Fund (RDIF), during a trial at the City Clinic #2 in Moscow, Russia.(Bloomberg)
A health worker prepares a needle to inject the 'Gam-COVID-Vac', also known as 'Sputnik V', COVID-19 vaccine, developed by the Gamaleya National Research Center for Epidemiology and Microbiology and the Russian Direct Investment Fund (RDIF), during a trial at the City Clinic #2 in Moscow, Russia.(Bloomberg)

Pune hospital starts Sputnik V phase two trials, volunteers under observation

The hospital is one of the first in the state to administer the vaccine for its phase two trials.
Hindustan Times, Pune | By Steffy Thevar, Pune
UPDATED ON DEC 06, 2020 07:25 PM IST

City’s Noble Hospital administered Russia’s Sputnik V vaccine to combat Covid-19 disease to 17 volunteers over the past three days. Volunteers are currently under observation for any medical symptoms, according to hospital authorities.

The vaccine was also one of the first in the world to be registered as a measure against Covid-19 disease and had gained world attention after the Russian president Vladimir Putin claimed its safety. The hospital is one of the first in the state to administer the vaccine for its phase two trials.

The hospital had administered the dose to 17 volunteers who came to the hospital over the past three days. Dr HK Sale, executive director of Noble Hospital, said, “This is the phase two trial of the vaccine and is probably the first in the country to administer it to volunteers. We will keep observing the volunteers for the next few days and report it to the sponsors.” Although the vaccine has been manufactured by the Russian Ministry of Health, it is being manufactured and distributed in India by Hyderabad-headquartered Dr Reddy’s Laboratories.

Another doctor at Noble Hospital, said, “We have got a protocol for administering the vaccine which has certain conditions, including the age of the volunteer which needs to be above 18 years of age. The volunteers need to be healthy which means they should not have any comorbidities. Also, we will only collect the samples from the volunteers for antibodies and Covid-19 testing which would be tested by Dr Reddy’s, who are the sponsors for this vaccination. Two doses of the vaccine would be given and we have 17 volunteers with us who were administered the vaccine in the past three days after we scrutinised the candidates.”

The volunteers were selected randomly and now will be followed up for the next few days. The volunteers have been given an online form to fill in if they notice any symptoms. The doctors also said that the volunteers would be followed up telephonically for flu-like symptoms. The doctors said, “The storage temperature of the vaccine is minus 20 degrees Celsius till it is injected. It has to be thawed and liquified before it is injected. This is the second vaccine undergoing trials in Pune.”

IMA expresses concerns

The Indian Medical Association (IMA) has expressed concern over the fact that even if the vaccine comes out in December and is approved by the ICMR, the inoculation or the administering of the vaccine would be only possible in the next 2-3 months. The IMA listed several problems in the country, including the need to maintain a cold chain throughout from the manufacturing site to the vaccination centre and that any disruption in the cold chain would make the vaccine ineffective. The mRNA vaccines need to maintain the temperature around minus 25 degrees to minus 70 degrees in some of the vaccine types.

In India, the additional conditions would be of transport vehicles with the facilities to maintain the required temperature and currently the government does not have such facilities and may require outsourcing it, which will take quite some time, as per the IMA. The government hospitals, primary health centres and sub-centres will have to install refrigeration cold stores maintaining such low temperature levels. At present in India there are not many such facilities and the state government is planning to install it and it will take a minimum of 2-3 months for that, said IMA.

“The additional challenges would be providing 24x7 electricity to deep freezing machinery. To inoculate 130 crore of the Indian population, government staff will not be sufficient and the government may need to employ additional staff or will have to outsource it to private hospitals. Considering all these points, we feel that even if the vaccine is available in December 2020, the inoculation drive may not begin for the next 2 to 3 months,” said officials of the IMA.

The IMA in its letter states that the government may take a decision to provide the vaccine at select metros, but again it will create discontent in the masses especially from rural India.

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