BS RAWAT
The Drugs Controller General of India (DCGI) has issued a new set of draft guidelines, focusing on safety, immunogenicity and efficacy parameters for pharma giants who are developing Covid-19 vaccines.

The guidelines note that development of vaccines is a complex activity which involves multidisciplinary research and generation of adequate laboratory, nonclinical and clinical data to ensure their safety, efficacy and quality.

The pharma companies developing the vaccines must provide adequate data informing the potential risk of vaccine-associated Enhanced Respiratory Disease (ERD), the guidelines say.

“This should also include any planned interim analyses, which should be adequately addressed in terms of purpose, timing, and any statistical adjustments required,” the guideline said.

The guideline has highlighted that the use of Covid-19 preventive vaccines in pregnancy and in women of childbearing potential is an important consideration for vaccination programs.

DCGI has also asked the pharma companies to keep pregnant women and women of childbearing potential in mind as they are developing the vaccines.

Safety assessments throughout clinical development and all pregnancies in study participants for which the date of conception is prior to vaccination or within 30 days after vaccination should be followed for pregnancy outcomes, including pregnancy loss, stillbirth, and congenital anomalies, it said.

In the guideline, the DCGI, Dr VG Somani, has warned that if a trial fails to meet the predefined criteria for superiority and/or non-inferiority with respect to any of the antigenic components, the possible reasons for the result and the clinical implications of it should be carefully considered before proceeding with clinical development or licensure.