A day after scientists and experts raised serious concerns over Indian Council of Medical Research’s (ICMR) letter to all 12 principal investigators to speed up the trial process of Bharat Biotech’s COVID-19 vaccine and enable it to be launched for “public health use latest by August 15”, the nodal agency issued a clarification saying the letter was meant only to “cut unnecessary red tape” and “speed up recruitment of participants”. Experts around the world have been saying that it would take at least 12-18 months to launch a vaccine for COVID-19.
In an email to The Hindu, Soumya Swaminathan, Chief Scientist at the World Health Organization, said: “A realistic (but very optimistic) timeline from the start of Phase-1 to the completion of Phase-3 could be about six to nine months (if all goes exactly according to plan).”
Bharat Biotech has got an approval to conduct only 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 a large number of participants and takes the longest time to complete, may have to be skipped or rushed up.
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Responding to a specific question whether Phase-3 trial 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 in a sizable 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.”
In the midst of the pandemic and in the absence of any safe and efficacious vaccine, attempts are being made to accelerate vaccine development.
On whether vaccine development can be rushed through by bypassing certain critical stages of testing, she said: “The pandemic demands unprecedented efforts to develop a vaccine. That is why the WHO and partners launched the ACT [Access to COVID-19 Tools] accelerator to accelerate the development, deployment and delivery of COVID vaccines. While clinical trials need to be performed with scientific rigour and demonstrate efficacy and safety, timelines can be shortened by investing in manufacturing upfront, preparing sites in advance, regulatory harmonisation, collaboration between the different government agencies and anticipating the next steps. Performing trials in areas and among groups with a high risk of infection will also help by accumulating the necessary endpoints in a shorter time.”
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China has recently approved the use of one of its COVID-19 vaccines, which has completed Phase-1 and Phase-2 trials, to be used exclusively by the military for one year. The vaccine is not currently being made available for public use. Reiterating the need to conduct a Phase-3 trial before launching the vaccine for public use, Dr. Swaminathan told The Hindu: “Any vaccine that is going to be used at large scale must demonstrate efficacy and safety. The WHO has offered our support to vaccine developers all over the world to enable that the best science is performed, and to facilitate multi-country clinical trials.”
‘Important to start preparing for vaccine delivery’
“The scientific establishment in India has a long history of rising to national challenges and delivering the needed products. Indian manufacturers supply over half of childhood vaccines procured by the UNICEF and the GAVI. I am optimistic that with the capacity available in the public and private sector in India, that one or more successful vaccines will emerge,” she said.
She also added that the WHO, along with the GAVI and the CEPI, is in dialogue with Secretary, DBT, and five Indian vaccine manufacturers to provide any kind of support and facilitate advancing the candidates to trials.
Dr. Swaminathan added: “It is encouraging to see that at least seven Indian companies are developing COVID-19 vaccines. All of them must be tested, through the various phases, in collaboration with the DBT and the ICMR, and till we see results from these trials, we cannot predict which of them will be successful. Having a regulatory standard and clear criteria for advancing vaccines through the various stages, will be very helpful (the FDA has recently produced such a document, and so has the WHO). At the same time, it is important to start preparing for vaccine delivery and preparing the strategy and policy for deployment among various risk groups. Community engagement and preparedness will be an important component and must be addressed.”