New Delhi: There are no plans to announce the results of phase one of the Covaxin trials on 15 August, ThePrint has learnt.
Phase one of the Covaxin trials — the Covid-19 vaccine being developed by Bharat Biotech and the Indian Council of Medical Research (ICMR) — are still underway in at least eight of the 12 trial sites, with phase two expected to begin in the first few weeks of September.
The Covaxin trials became a point of controversy last month when ICMR chief Dr Balram Bhargava wrote a letter addressed to the 12 sites, telling them the ICMR hoped to “launch the vaccine for public health use latest by 15 August 2020 after completion of all clinical trials”.
The ICMR later clarified that the purpose of the letter was to expedite the trial process so results of phase one could be ready by 15 August.
Bharat Biotech, however, has denied having prepared an announcement related to the vaccine trials for Saturday.
“We have not prepared any document or announcement regarding the vaccine for tomorrow,” a senior official of the firm which handles media relations for Bharat Biotech told ThePrint.
The 12 vaccine trial sites are AIIMS Delhi, AIIMS Patna, Gillurkar Multispeciality Hospital (Nagpur, Maharashtra), the Institute of Medical Sciences and SUM Hospital (Bhubaneshwar, Odisha), Jeevan Rekha Hospital (Belgaum, Karnataka), King George Hospital (Visakhapatnam, Andhra Pradesh), Nizam’s Institute of Medical Sciences (Hyderabad, Telangana), PGIMS (Rohtak, Haryana), Prakhar Hospital (Kanpur, Uttar Pradesh), Rana Hospital and Trauma Center (Gorakhpur, Uttar Pradesh), Redkar Hospital and Research Centre (Goa), and SRM Hospital & Research Center (Kancheepuram, Tamil Nadu).
Trial sites still in phase 1
Phase one of the trial includes two doses of the vaccine at 14-day intervals, with follow-up tests on days 28 and 42 to check for antibodies. As many as 375 volunteers were administered the vaccine across all 12 trial sites.
ThePrint reached the principal investigators of all 12 trial sites by phone, but was able to speak to nine of them. Of them, only one said they had completed phase one of the trial.
“We have finished phase 1 of the trial and we have sent our data to both ICMR and the Drugs Controller General of India (DCGI). Now we are waiting for further instructions from Bharat Biotech on how to proceed to phase 2,” said Dr Jitendra Kushwaha, principal investigator at Prakhar Hospital.
The hospital administered the second dose of the vaccine on 31 July.
The other eight trial sites administered the second dose during the second week of August and are observing the participants for the mandated two-week period.
ThePrint reached AIIMS Patna, King George Hospital and Rana Hospital and Trauma Center through phone calls, but they went unanswered.
“We have given the second dose today. We have to monitor the patients’ antibody levels now. So far, we have recorded no adverse effects,” Dr Amit Bhate, principal investigator at Jeevan Rekha Hospital said.
Sanjay Rai of AIIMS Delhi said phase 2 would not begin until phase 1 comes to an end. “Since most sites have administered their second dose today, phase 1 will only be completed by the end of August and phase 2 can only begin in early September,” he said.
Effects of the trial so far
Of the nine principal investigators ThePrint spoke to, four said participants developed a mild fever after being administered the vaccine.
“One person reported some mild pain at the point of the injection site and a mild fever. But the side effects went the next day,” said Dr Savita Verma of PGIMS.
Another participant from Gillurkar Multispeciality Hospital in Nagpur developed a mild fever which subsided within an hour. Participants from AIIMS Delhi and Prakhar Hospital also developed mild fevers.
It is significant to note that no adverse effects have been reported in any of the trial sites. Mild symptoms such as fever and pain at the point of injection are common, said the doctors.
“The vaccine has been safe. No adverse effect has been reported. Even the point of injection pain, which is normal in vaccines, has been very mild,” said Dr Kushwaha of Prakhar Hospital.
‘Hopeful’ of a vaccine by year-end
Vaccines usually take years to develop before they are launched for general public use. However, based on how the trial has gone so far, the principal investigators are hopeful the vaccine will be ready by the end of this year.
“Vaccine trials take time. It cannot be completed in a rushed manner. We are hoping that the trial will be completed around November or December,” said Dr Prabhakar Reddy of Nizam’s Institute of Medical Sciences.
Phase 1 of the trial is set up to test the safety of a vaccine. If successful, then the vaccine is tested on a larger group in phase 2 and this is expanded by phase 3, at which point the vaccine’s efficacy is being determined.