India COVID-19 vaccine updates — Oxford's potential coronavirus vaccine reports no side affect so far in vaccine trial at PGI Chandigarh

• According to the government, over 30 vaccine candidates are being developed in India.
  
• Serum Institute of India has entered phase II/III trials and is leading the vaccine development race in the country.
  
• Whereas, both Bharat Biotech and Zydus Cadila are conducting phase I/II human trials right now.
  
  

As India records over 1 million COVID-19 deaths, scientists in India are racing against time to develop an effective vaccine. There are 191 COVID-19 vaccine developments in the works around the world right now, and 41 of them are under clinical evaluation, according to the World Health Organisation.

According to the Indian government, over 30 vaccine candidates are being developed in India. Three of them are in the advanced stages of the trial, while four are in the pre-clinical development stage.

Serum Institute of India is leading the vaccine development race in the country. SII and the Indian Council of Medical Research (ICMR) are jointly conducting phase II/III trials of Oxford’s coronavirus vaccine in India.

Here are the latest developments on COVID-19 vaccines in India:
No major adverse side-effects reported so far in vaccine trial at PGI Chandigarh
The late phase trials of the Oxford-AstraZeneca vaccine, known as Covishield in India, are well underway at the Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, the institute said on Thursday

The officials at the premier institute told IANS that no adverse side-effects among the volunteers have been observed so far.

"Very few people developed fever or body ache post vaccine administration. It is expected and very normal after the vaccine dose is given. Nothing to get alarmed about," an official informed.

The institute is listed as one of the 17 trial sites for conducting the second and third phases of human clinical trials of the Coveshield vaccine.

The officials added that 53 participants in the trials have already completed seven days of post vaccination period without developing any major side-effects. They also informed that the institute has screened 97 volunteers till date and 65 of them have already been administered the first dose of the vaccine.

Indian-origin researchers use bovine adenovirus to develop coronavirus vaccine
Oct 8 (IANS) A team of Indian-origin researchers in the US is working to develop a unique Covid-19 vaccine that uses a bovine adenovirus that will protect all segments of the population, especially older adults.

Bovine Adenovirus, also known as BAdV, is a member of the Adenoviridae family that causes disease in cattle.

"Adenoviral vectors have emerged as a promising gene-delivery platform for a variety of therapeutic and vaccine purposes during the last two decades," said study author Suresh Kuchipudi from Penn State University in the US

Moderna to apply for real-time reviews for its COVID-19 virus in Europe: Reuters
US pharma giant Moderna said it will apply real-time reviews in Europe. It is in talks with European countries and is also planning to get approval from U.S. Food and Drug Administration. Real-time reviews will allow researchers to give feedbacks without waiting for studies to conclude, reported Reuters.

Government to map out cold chain storage facilities for COVID-19 vaccine delivery
With the likelihood of a vaccine against coronavirus being available within months, the government has begun a massive exercise to map out cold chain storage facilities to ensure the vaccine is delivered quickly across the country.

A national expert group is talking to public and private sector entities in the pharmaceutical sector, food processing industry and agro businesses as well as food delivery start-ups such as Swiggy and Zomato to identify cold storages or fridges at the taluka level that can stock and distribute the vaccine, sources with direct knowledge of the discussions said.

India's drug controller reject Dr. Reddy's proposal to test Russian coronavirus vaccine
India's drug controller has rejected Dr. Reddy's proposal to test Russian coronavirus vaccine in a large study stating early-age study to be small. An expert panel of Central Drugs Standard Control Organisation has asked Dr Reddy's to first conduct small study.

Previously, CDSCO asked Dr Reddy's Laboratories to submit a revised protocol for conducting both phase 2 and phase 3 human clinical trials for the Russian vaccine against COVID-19, Sputnik V, in India, sources said Monday.The Hyderabad-based pharmaceutical company had applied to the Drugs Controller General of India (DCGI) late last week, seeking permission to conduct phase-3 human clinical trials of the Russian vaccine.

India plans procure 400-500 million doses of vaccine for 25 crore people by 2021
Union Health Minister Harsh Vardhan said on Sunday that the Centre is working on plans to procure 400-500 million doses of Covid-19 vaccine, which will be administered to up to 25 crore people by July 2021.

He also indicated that the frontline workers and those having underlying health conditions are in the top priority list of the government for vaccine administration, saying that his ministry is currently preparing a format in which states will submit lists of priority population groups to receive the vaccine, especially health workers engaged in the management of Covid-19.

In India, three potential COVID-19 vaccines are under advanced clinical trials
According to ICMR, there are three potential COVID-19 vaccines under human trials — Bharat Biotech’s COVAXIN, Oxford’s Covishield, and Zydus Cadila’s ZyCoV-D. Serum Institute of India has already begun phase III trials of Oxford’s vaccine candidate at 17 sites across the country. Whereas, both Bharat Biotech and Zydus Cadila are conducting phase I/II human trials right now.

India likely to approve potential COVID-19 vaccine with 50% efficiency

The Indian drug regulator, Central Drugs Standard Control Organization, earlier this week, said it is planning on approving the COVID-19 vaccine that can protect 50% of the participants in phase III human trials.

“To ensure that a widely deployed COVID-19 vaccine is effective, the primary efficacy endpoint point estimate for a placebo-controlled efficacy trial should be at least 50%," the Central Drugs Standard Control Organization (CDSCO)

The Health Ministry also launched a portal on September 29 that will provide important information on vaccine development, ongoing clinical trials and progress made - both locally and globally.

Previously, World Health Organization (WHO) chief Tedros Adhanom Ghebreyesus has lauded Prime Minister Narendra Modi's assurance that India will use its vaccine production capacity in helping nations fight COVID-19. WHO chief said that the pandemic can be defeated only by mobilising resources for common good.

The Indian government is optimistic about getting a COVID-19 vaccine by the start of 2021. Moreover, the Ministry of Health and information believe they’ve sufficient funds to distribute COVID-19 vaccines in the country.

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