Coronavirus vaccine update: Russia will test Sputnik-V on 40,000 people; J&J announces largest human trials

Johnson & Johnson, one of the leading contenders to develop a vaccine for novel Coronavirus, has said it planned to test its vaccine on about 60,000 people during the phase-3 trials, This makes it the biggest human trial planned for a potential Coronavirus vaccine till now. Other leading contenders like Moderna and Pfizer plan to enrol about 30,000 volunteers for phase-3 trials of their candidate vaccines, which has already begun.

Johnson & Johnson said it hoped to begin the phase-3 trials from September, and it was trying to enlist up to 60,000 healthy people above 18 years of age. The trials are supposed to be carried out at about 180 locations in the United States, Mexico and Brazil.

“We can confirm that planning and recruitment is underway for our phase-3 programme, which is subject to interim data of the phase-1/2 trials and approval of the regulators. Our phase-3 programme is intended to be as robust as possible, could include up to 60,000 participants and will be conducted in places with high incidence rates,” Reuters quoted a J&J spokesperson as saying.

Amidst criticism, Russia says will test its vaccine on 40,000 people

Russia has said it planned to test its already-approved vaccine, which has been named Sputnik-V, on 40,000 people in phase-3 trials. Russia had approved the vaccine developed by Moscow’s Gamaleya Institute on August 11, even without phase-3 trials. The vaccine had only undergone accelerated phase-1 and phase-2 human trials.

Facing global criticism for pushing through its vaccine without testing it adequately, Russia has been on a publicity overdrive to minimise the damage. It has launched a special website for the vaccine, where it seeks to provide all information and data related to the vaccine.

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On Thursday, the Russian Direct Investment Fund (RDIF), a sovereign wealth fund that is supporting the development of Sputnik-V vaccine, put out a detailed statement in which it listed reasons why the questions being raised about the vaccine were unfounded and why the vaccine was safe for public use.

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In the same statement, RDIF also announced that the vaccine would enter phase-3 clinical trials next week, during which it would be tested on more than 40,000 people at over 45 locations. RDIF said these trials were “previously planned” and were supposed to take place “post-registration” of the vaccine with the Russian drug regulator.

In a separate interaction with journalists, Denis Logunov, deputy director for scientific work at Gamaleya Institute, said that the Russian vaccine had only been granted a “conditional registration certificate” by the country’s drug regulator, and that meant it was obligated to undergo phase-3 clinical trials, according to a news report.

Hunt for Coronavirus vaccine: The story so far

• More than 160 vaccine candidates in pre-clinical or clinical trials
• 30 of them in clinical trials
• Six in final stages, phase-III of human trials
• At least eight candidate vaccines being developed in India. Two of these have entered phase -II trials after completing phase-I.

(As on August 20; source: WHO Coronavirus vaccine landscape of August 20, 2020)

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