Covid-19 vaccines in final stage: Russia to test Sputnik-V on 40,000 people, J&J plans 60,000 phase-3 trials
Johnson & Johnson has announced biggest sample size for phase-3 clinical trial. The company said that it hopes to test its vaccine on about 60,000 people before finally rolling it in the market.
New Delhi: Amid the race for developing Covid-19 vaccine, a couple of multi-national companies are in final stages of the human trial. Having crossed 1st and 2nd phase of trials successfully, they have now planned extensive trials on huge sample size.
Russia was the first nation to develop vaccine for Covid-19 and it also got it approved by Moscow’s Gamaleya Institute on August 11. The vaccine was approved after completion of Phase-I and Phase-II trial. However, its vaccine named Sputnik-V has announced Phase-III trial on 40,000 people.
In similar move, Johnson & Johnson has announced biggest sample size for phase-3 clinical trial. The company said that it hopes to test its vaccine on about 60,000 people before finally rolling it in the market.
“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,” J&J spokesperson was quoted by Reuters as saying.
However, it’s trials will be limited to 3 nations only – US, Mexico and Brazil, apparently the two most affected countries.
Other MNCs who are among the leading contenders for Covid-19 vaccine include Moderna and Pfizer. Both of them have announced plans to enrol about 30,000 volunteers for phase-3 trials of their vaccines.
India’s Serum Institute initiatives Phase 2,3 trial
Meanwhile, Indian pharmaceutical giant Serum Institute of India has initiated the phase 2, 3 clinical trials to evaluate the safety and immune response of its coronavirus vaccine candidate on healthy Indian adults.
A total of 1,600 eligible participants of more than or equal to 18 years of age will be enrolled in the study, which will be conducted on 17 sites in India.
Of the total 1,600 eligible participants, 400 participants will be part of the immunogenicity cohort and will be randomly assigned in a 3:1 ratio to receive either COVISHIELD or Oxford/AZ-ChAdOx1 nCoV-19, respectively.
The remaining 1,200 participants from safety cohort will be randomly assigned in a 3:1 ratio to receive either COVISHIELD or Placebo, respectively.