Vaccine update: India readies five sites for vaccine trials

New Delhi: The world is watching with bated breath as the top coronavirus vaccine contenders race towards the finish line. Moderna, Oxford University-AstraZeneca and Pfizer-BioNTech that are spearheading the search for a COVID-19 vaccine have advanced to the final stages of the trial.

India, which is one of the vital pieces of this puzzle, has also identified five sites for the trials of the Oxford-AstraZeneca vaccine, according to Department of Biotechnology (DBT) Secretary Renu Swarup.

This is an essential step because it is necessary to have data within the country before the vaccine is administered to Indians, Swarup said. The Serum Institute of India, the largest vaccine maker in the world, has been chosen by Oxford and its partner AstraZeneca to manufacture the vaccine once it is ready.

Trials results for the first two phases were published earlier this month.

According to Swaroop, the DBT is part of any Covid-19 vaccine effort in India "… whether it is funding, whether it is facilitating the regulatory clearances or whether it is giving them access to different networks which exist within the country".

Speaking about the Moderna vaccine, infectious disease expert Anthony Fauci said that Moderna's progression into the final states is one of the country's best efforts. He said data from the final stages would emerge in November-December and said that despite the speed of the development, there would be no compromise at all regarding the safety of the COVID vaccine.

Moderna is part of the US' Operation Warp Speed that is aiming to speed up the vaccine process. The other three are Oxford-AstraZeneca, Johnson & Johnson and Novavax.

The World Health Organisation said that coronavirus is the worst health emergency the organisation has seen since its regulations came into force in 2005.

"This Thursday marks six months since WHO declared COVID-19 a public health emergency of international concern. This is the sixth time a global health emergency has been declared under the International Health Regulations, but it is easily the most severe," said WHO Director-General Tedros Adhanom Ghebreyesus at a press conference.

Latest vaccine developments

Oxford University-AstraZeneca: Phase 3 trials of the COVID vaccine candidate have already begun in Brazil. Now the government has chosen five sites in India for the third and final phase of trials of the candidate. The details of the sites have not been disclosed.

The Oxford vaccine is being manufactured by Serum Institute of India. The manufacturer had earlier sought permission for the first two phases of trials in the country from DCGI. The third phase of trials would be conducted in India including 10,000 volunteers.

Moderna: The company has launched a 30,000-subject trial for regulatory approval and widespread use by the end of the year. The first large study of a coronavirus vaccine began on Monday morning in Savannah. The volunteers have been picked from diverse backgrounds. The COVID vaccine is backed by a $955 million government funding and would be tested at 89 US sites.

If the trial is successful, the company would release 500 million doses by 2021. The early results of the trials would be available in November-December. The Moderna coronavirus vaccine is being developed with National Institutes of Health (NIH).

Pfizer-BioNTech: US drugmaker Pfizer and German company BioNTech have said that they have begun their late-stage human trials for their coronavirus vaccine. Like Oxford-AstraZeneca, the COVID-19 vaccine trials would include 30,000 subjects globally.

The trials would be conducted across 120 sites globally including 39 US states. If approved the vaccine would be forwarded for regulatory review as early as October. The makers plan to supply up to 100 million doses by end of 2020 and 1.3 billion doses by end of 2021.

Bharat Biotech: The coronavirus vaccine trial for the company's candidate COVAXIN has started in Odisha's Institute of Medical Sciences (IMS) and SUM Hospital. The selected volunteers will be given two doses within a gap of 14 days. The volunteers need to be healthy and disease-free and can screen themselves through a simple questionnaire available at the website.

The trials for COVAXIN are also underway in AIIMS Delhi, Post-Graduate Institute of Medical Sciences in Rohtak, Nizam's Institute of Medical Sciences (NIMS) in Hyderabad, SRM Medical College Hospital and Research Centre in Kancheepuram and two private hospitals in Uttar Pradesh - Prakhar Hospital in Kanpur and Rana Hospital and Trauma Centre in Gorakhpur.