'SII and Pfizer may get emergency authorisation of vaccine for Indian market'

Senior health expert and director professor and head of community medicine at Maulana Azad Medical College Dr Suneela Garg told ETV Bharat that Drug Controller General of India (DCGI) might give the approval for manufacturing and marketing of the Oxford vaccine after Serum Institute of India (SII) applied for emergency authorisation of its Covid19 vaccine to the country's drug regulator.

New Delhi: A day after Serum Institute of India (SII) applied for emergency authorisation of its Covid19 vaccine to the country's drug regulator, senior health expert and director professor and head of community medicine at Maulana Azad Medical College Dr Suneela Garg told ETV Bharat in an exclusive interview that Drug Controller General of India (DCGI) might give the approval for manufacturing and marketing of the Oxford vaccine.

"The advantage of SII is that it's a domestic company and they are the oldest producers of vaccines. The SII has already manufactured 40 million doses. In addition to this, in Phase 3 trial of its vaccine, we have not observed any serious side effects," said Dr Garg while highlighting that India is in a good position as far as trial and emergency authorisation of Covid19 vaccine are concerned.

Referring to the vaccine controversy involving SII, Dr Garg said that there was an initial claim of side effects. "But those claims have been proven wrong. It's a fact that at the beginning we can't ascertain the truth due to the character of the trial," said Dr Garg.

In fact, the DCGI has also not found any relation between the Covid19 dose given to the volunteer and his deteriorated health conditions.

It may be noted that Prime Minister Narendra Modi had recently visited the Covid19 vaccine manufacturing companies in three different locations and during a subsequent all-party meeting with political leaders, Modi has announced that India will be having "cheap and safe" vaccine ready in the next few weeks.

Significantly, a day before SII approached the drug controller general for emergency authorisation, Pfizer and AstraZeneca have also approached DCGI for emergency authorisation of its Covid19 vaccine in India. Pfizer has already got emergency authorisation from the government of the UK and Bahrain.

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The drug controller general Dr VG Somani has recently said that any foreign vaccine needs emergency authorisation for manufacturing and marketing will have to undergo human clinical trials of its vaccine.

The Pfizer asked for direct manufacturing and marketing approval in India. Another point concerning Pfizer is that this vaccine needs to be stored in minus 70 degrees centigrade.

"When Pfizer has applied for emergency authorisation, we have to see whether we can supply the vaccine to the masses under 70-degree centigrade. It may not be feasibly for everyone, but due to urgency of the situation we can cater for some, as we have such minus 70 degrees centigrade facilitation centres with our different medical colleges including AIIMS, Maulana Azad Medical College among others," said Dr Garg.

Officials privy to the development said that the drug controller general has also accelerated its review of Covid19 vaccine developed by Pfizer and SII for emergency use.

However, along with Covid vaccine candidate of SII and Pfizer, India has a few other options too.

"India is inching towards 1 crore number of Covid positive cases. Even as cases are declining, we are not sure whether we are completely going to do away with the virus. So, it's important at this stage to think about immunizing our population," added Dr Garg.

Highlighting that India has several vaccine options for Covid19 disease, Dr Garg said, "in the long run we have to rely on those vaccines which are indigenous, cost-effective with equal efficacy and at the same time they meet the safety standards."

India needs vaccine which is able to be kept with about 2 to 8-degree centigrade, she said.

The health experts do believe that Hyderabad based Bharat Biotech and Ahmedabad based Zydas Cadila can also provide effective Covid19 vaccine at the earliest.

"Bharat Biotech along with NIV, Pune and ICMR is making another vaccine which is COVAXIN and we do believe that it will be available soon," said Dr Garg. Bharat Biotech has already started Phase 3 clinical trial of its vaccine candidate.

Similarly, Zydus Cadila is also in stage 2 of the human clinical trials "which can also cater to India's needs."

Russian vaccine SputnikV in collaboration with India's Dr Reddy's Laboratories has commenced Phase 2 and 3 clinical trials in the country in association with Russian Direct Investment Fund (RDIF).

However, once the drug regulator gives emergency authorisation to any vaccine, the most critical issue that may come before the authorities is about vaccine distribution.

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For this, the Government of India has set up a national expert group of vaccine administration (NEGVAC) chaired by Niti Aayog member Dr VK Paul. Union Health Ministry Rajesh Bhusan is the co-chair of the task force.

Significantly, the task force has already chalked out a blueprint where it's has said that initially 30 crore Indians will be vaccinated at the first phase. The frontline health workers including doctors, nurses, ASHA workers, security personnel will be vaccinated first to be followed by senior citizens and people with co-morbidities.

"We need the proper distribution of the vaccine so that it can reach to the last mile. In this case, we will be using our existing 28,000 cold chain facility across India," health secretary Rajesh Bhushan has said.

These cold storage were the part of India's universal immunisation programme (UIP).

Government of India is also in talks with the private players for making use of their cold storage facilities for vaccine distribution.

"Yes, private players can definitely play a big role as far as cold storage and distribution of Covid19 vaccine is concerned," said Dr Giridhar Gyani to this correspondent.

To ensure that the vaccine reaches to the priority section of the society, the Health Ministry with the help of Ministry of Information and Communication Technology has also developed Covin app to trace and track every development on a real-time basis.

The Covin app will streamline data on Covid19 vaccine procurement, distribution, circulation, storage and dose schedule besides also notifying the first set of vaccine recipients when their shots have been scheduled.

"In Covin app there will be updated information on a real-time basis and it will definitely work in the right direction," said Dr Suneela Garg.

Recently, health secretary Rajesh Bhushan has also asked all state government and UTs to set up task force for overall monitoring of the vaccine distribution process.

The ministry has also asked the authorities in states and UTs to handle all possible side effects of vaccine administration.

In the communication made with the states and UTs recently, the Health Ministry has asked them to take steps to "strengthen adverse events following immunisation (AEFI) surveillance following Covid19 vaccination to maintain confidence in the safety of the vaccine."

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