Days after the Indian Council of Medical Research issued a letter calling for last-tracking the trial process of Bharat Biotech's COVID-19 vaccine , Chief Scientist at the World Health Organisation Sowmya Swaminathan said a vaccine trial usually takes at least six months to complete.
"A realistic (but very optimistic) timeline from the start of Phase-1 to the completion of Phase-3 (trials) could be about six to nine months(if all goes exactly according to plan)," Ms. Swaminathan explained.
On the specific question of Whether Phase-3 trials can be skipped for making the vaccine available for public use in light of the pandemic, Dr. Swaminathan said: "Any vaccine must demonstrate efficacy and safety on a size able number of participants. The WHO has published target product profiles for a COVID vaccine (and) immunogenicity data alone would be insufficient for a vaccine use policy. It is possible to have protocols which flow seamlessly from Phase-2 to Phase-3 based on interim analysis of data.
After scientists and experts raised serious concerns over the ICMR's communication, the nodal agency issued a clarification saying the letter was meant only to "cut unnecessary red tape" and " seed up recruitment of participants", Experts globally have been saying it would take at least 12 to 18 months to launch a vaccine for COVID-19.
Bharat Biotech has got an approval to conduct only the Phase-1 and Phase-2 trials. So launching the vaccine for public use before August 15 this year would mean that the Phase-3 trial, which tests the efficacy of the vaccine on the large number of participants and takes the longest time to complete, may have to be skipped or rushed.
In the midst of the pandemic and in the absence of any safe and efficacious vaccine, attempts are being made to accelerate vaccine development.