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Government says serious adverse event will not delay launch of first covid-19 vaccine

Vials of AstraZeneca's COVISHIELD, coronavirus disease (COVID-19) vaccine are seen before they are packaged inside a lab at Serum Institute of India, in Pune, India, November 30, 2020. Picture taken November 30, 2020. REUTERS/Francis Mascarenhas (REUTERS)
Vials of AstraZeneca's COVISHIELD, coronavirus disease (COVID-19) vaccine are seen before they are packaged inside a lab at Serum Institute of India, in Pune, India, November 30, 2020. Picture taken November 30, 2020. REUTERS/Francis Mascarenhas (REUTERS)

  • Serum Institute’s Covishield is widely expected to be available for immunisation of front health workers starting as early as January
  • Covishield is originally developed by AstraZeneca and the University of Oxford, with the British company signing an agreement with Serum Institute for manufacturing 1 billion doses

The government on Tuesday said that the serious adverse event will not delay the launch of the country’s first covid-19 vaccine, despite widespread criticism over the lack of public disclosure of the acute neurological dysfunction in a 40-year old Chennai resident who participated in Serum Institute of India’s Covishield trial.

“The adverse event will not affect the timelines in any manner whatsoever," health secretary Rajesh Bhushan said on Tuesday.

Serum Institute’s Covishield is widely expected to be available for immunisation of front health workers starting as early as January.

On Saturday, the chief executive officer of the world’s largest vaccine manufacturer, Adar Poonawalla, said that the company plans to apply to the Drug Controller General of India for an emergency use license for the vaccine in about two weeks using the data from AstraZeneca’s phase 3 trial in the UK as well as the company’s own phase 2 and 3 bridging study in India.

Covishield is originally developed by AstraZeneca and the University of Oxford, with the British company signing an agreement with Serum Institute for manufacturing 1 billion doses.

The government plans to start vaccination using a priority list, with around 30 million frontline healthcare workers to be the first to get the vaccine, followed by other frontline workers like security personnel and transportation staff, and then the elderly and people with co-morbidities.

Poonawalla expects the rest of the population to be vaccinated only after March or April 2021.

The Pune-based firm will produce 1 billion doses, but not all of this capacity will be for Indians. Poonawalla has committed to reserve half of the doses for use in India.

Health minister Harsh Vardhan had in October said that the government plans to administer around 400-500 million covid-19 vaccines to 200-250 million Indians by July.

Serum Institute itself plans to start producing around 100 million doses every month starting February.

By March or April, three more vaccines could hit the market, provided they successfully complete the trials and get regulatory approvals.

Bharat Biotech, whose inactivated virus vaccine is currently in phase 3 trials, is expected to be the second vaccine to be launched, by March or April. Zydus Cadila is around the same time also expected to launch its three-dose DNA plasmid vaccine. The two indigenous vaccines are expected to provide more than 500 million covid-19 doses in 2021.

“Bharat Biotech, Zydus and Biological E are doing all stages of clinical development in India, so they will be slower," said Gagandeep Kang, a noted Indian scientist, who is currently the vice chairperson of Coalition for Epidemic Preparedness (CEPI) and professor at Christian Medical College (CMC), Vellore, Tamil Nadu. CEPI is a global non-profit aiding vaccine development as well as equitable access to the doses during the pandemic.

Russia’s Sputnik V, based on the human adenovirus platform, is expected around April 2021. Dr Reddy’s, which is the distributor of the vaccine in India, has started its trials on Tuesday.

If trials of these three vaccine candidates are successful as well and they receive regulatory approval, the target of 400-500 million doses could be achieved by July at least in terms of availability of doses.

After the vaccines are available, the next major challenge would be delivery of the doses. The National Expert Group on Vaccine Administration for Covid-19 (NEGVAC) in consultation with State Governments and all relevant stakeholders have prepared and presented a detailed blueprint of vaccine storage, distribution, and administration, officials in the union health ministry said. The Expert Group in consultation with the states is also working actively on vaccine prioritization and distribution of covid-19 vaccine.

The government has already said that database of healthcare and frontline workers, augmentation of cold chains and procurement of syringes, needles, etc. are in advanced stages of preparation for administering covid-19 vaccine at the first available opportunity. The Centre has also asked states to form committees for streamlining the process and increase acceptance of the vaccine among communities.

With covid-19 having a mortality rate of a little over 2% of the total number of cases, the focus of all covid-19 vaccines have been on safety of the doses.

“Safety is hard to predict and will be measured in clinical trials, but among the known platforms, recombinant proteins as in the vaccine being made by Biological E are probably the safest," Kang said.

Biological E’s vaccine last month started the phase 1 and 2 clinical trial of the vaccine, which it has licensed from US-based Baylor College of Medicine. The company expects the results of the first two phases of trial to be available by February.

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