Soumya Swaminathan
Days after the Indian Council of Medical Research issued a letter calling for fast-tracking the trial process of Bharat Biotech’s COVID-19 vaccine, Chief Scientist at the World Health Organisation Soumya 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),” Dr. Swaminathan told The Hindu, responding to questions via email.
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 sizeable 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 “speed 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.
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