New Delhi: Covid-19 vaccines developed outside India may have to undergo additional clinical trials to confirm their safety and effectiveness on the local population, according to a set of draft regulatory guidelines released by the Central Drugs Standard Control Organisation (CDSCO).
The guidelines, which were released Monday, said the extent of local clinical trials will be decided on a case by case basis.
The CDSCO, which regulates the quality of drugs and vaccines in India, said clinical data generated outside India will also be evaluated.
“In case a vaccine has been developed and has undergone clinical trial development outside India and marketing authorization applications for the same have been submitted to CDSCO, the clinical data generated will be considered for evaluation of overall safety and effectiveness of the vaccine,” read the 40-page draft.
The guidelines further noted that firms applying for approval of their Covid-19 vaccines will have to show the required response in at least 50 per cent of those vaccinated during human testing.
“To ensure that a widely deployed Covid-19 vaccine is effective, the primary efficacy endpoint estimate for a placebo-controlled efficacy trial should be at least 50 per cent.”
Non-clinical safety studies mandatory for vaccine candidates
A Covid-19 vaccine candidate for which no prior data is available, “nonclinical safety studies will be required prior to proceeding with the first-in-human (FIH) clinical trial”, the guidelines said.
Nonclinical trials refer to studies not related to, involving, or concerned with the direct observation and treatment of living patients.
The draft also said, “However, in some cases, it may not be necessary to perform nonclinical safety studies prior to FIH clinical trials because adequate information to characterise product safety may be available from other sources.”
For example, if a Covid-19 vaccine candidate is made using the same technology that was used to manufacture an approved or a previously-studied vaccine, it may be possible to use toxicology and other clinical data from these studies to support human clinical trials of the Covid vaccine candidate.
Separate studies for pregnant & women of childbearing age
The guidelines also emphasised that use of Covid-19 vaccine candidates on pregnant and women of childbearing age will be an important consideration for future vaccination programmes.
“…prior to enrolling pregnant women and women of childbearing potential who are not actively avoiding pregnancy in clinical trials, an applicant is required to conduct developmental and reproductive toxicity (DART) studies with their respective Covid-19 vaccine candidate,” noted the guidelines.
Alternatively, applicants can also submit DART data of a similar product that was made using comparable technology, like in the case of FIH clinical trials.
First clinical trial should be done on healthy adults
The CDSCO has also decided that people who are infected with the novel coronavirus should be included in the clinical trials, if they don’t have acute Covid-19 or any other illness.
However, it also said that in most cases, the first clinical trial should be conducted on healthy adults. Phase 2 trials, it added, should be conducted on subjects who are representative of the “intended target population for the vaccine at the time of approval”.