Serum, Bharat Biotech to start trial of Covid-19 vaccine

SERUM Institute of India and Bharat Biotech are expected to pursue late stage clinical trials of intranasal Covid-19 vaccines in the coming months once they receive regulatory approval, India’s health minister said on Sunday.

Dr Harsh Vardhan said the late stage trial generally involves thousands of participants, sometimes 30,000 to 40,000.

Of the vaccines currently in phase third trials, all are administered by injection, according to the World Health Organization (WHO).

India’s coronavirus infections rose by another 61,871 over the past 24 hours, data released on Sunday showed, although the health ministry said it is seeing a trend of steadily declining active cases.

The Indian Council of Medical Research (ICMR) said it will revisit its protocol for Covid-19 treatment after the WHO found some of the commonly used drugs, including remdesivir, had little or no impact on a patient’s chances of surviving, local media reported earlier on Sunday.

The Russian Direct Investment Fund (RDIF) and India’s Dr Reddy’s Laboratories Ltd have received renewed approval to conduct late-stage clinical trials in India of the Russian Covid-19 vaccine, the sovereign wealth fund said on Saturday.

Large-scale trials of the Sputnik V vaccine in India were first announced and then knocked back by Indian regulators, who said the scale of Phase I and II trials conducted in Russia earlier this year was too small, requesting that they be repeated.

Following a new agreement, India will now carry out an adaptive phase II and III human clinical trial involving 1,500 participants, RDIF, which is marketing the vaccine abroad, said on Saturday.

Under the deal, Dr Reddy’s will conduct the clinical trials and, subject to approval, distribute the finished vaccine in India. RDIF will supply 100 million doses to Dr Reddy’s.

Russia, the first country to grant regulatory approval for a novel coronavirus vaccine, is also conducting Phase III trials of Sputnik V in Belarus, Venezuela and the United Arab Emirates.

RDIF has reached agreements with Indian manufacturers to produce 300 million doses of the shot.

A Phase III trial involving 40,000 participants is currently underway in Moscow, with 16,000 people having already received the first dose of the two-shot vaccine.

Interim results are expected to be published in early November.

Indian regulators have agreed to incorporate data, provided by Russia on a weekly basis, from the Moscow trial, a source close to the deal told Reuters.

Russia has also reached an agreement with the biotechnology department of India’s Science and Technology Ministry to use its laboratories as a base for the Indian clinical trial, the source said.

Calling for full preparedness to ensure speedy access to Covid-19 vaccines for every citizen, Prime Minister Narendra Modi on Saturday suggested developing a vaccine delivery system on the lines of conduct of polls and disaster management while involving all levels of government and citizen groups.

Chairing a meeting to review the Covid-19 pandemic situation and the preparedness of vaccine delivery, distribution, and administration, the prime minister also noted a steady decline in the daily cases and the growth rate. At the same time, he also cautioned against any complacency at the decline and called for keeping up the efforts to contain the pandemic.

He insisted on continued social distancing and Covid-appropriate behaviour such as wearing the mask, regularly washing hands and sanitation, especially in the wake of upcoming festival season.

In a statement, the PMO said three vaccines are in advanced stages of development in India, out of which two are in Phase II and one is in Phase-III. It further said Indian scientists and research teams are collaborating and strengthening the research capacities in neighbouring countries such as Afghanistan, Bhutan, Bangladesh, Maldives, Mauritius, Nepal and Sri Lanka.

There are further requests from Bangladesh, Myanmar, Qatar and Bhutan for clinical trials in their countries. To help the global community, the prime minister further directed to reach out to the entire world, instead of limiting to immediate neighbourhood, in providing vaccines, medicines and IT platforms for vaccine delivery system.

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.

The Expert Group, in consultation with states, is working actively on prioritisation and distribution of the vaccine. Modi further directed that keeping in view the geographical span and diversity of the country, the access to the vaccine should be ensured speedily.

He stressed that every step in the logistics, delivery, and administration should be put in place rigorously.

‘It must include advanced planning of cold storage chains, distribution network, monitoring mechanism, advance assessment, and preparation of ancillary equipment required, such as vails, syringes etc,’ the statement said.

The prime minister further directed that ‘we should make use of experience of successful conduct of elections and disaster management in the country.’