PHARMA FIRMS START WORK ON NON-COVID VACCINES
Approach drug regulator seeking permission to conduct clinical trials
Injecting hope into the veins of pharmaceutical (pharma) companies in India, work on non-covid vaccines slowly gathers pace in the country. Several pharma firms have approached the drug regulator, seeking permission to conduct clinical trials.
As a result of the pandemic, regulatory work on non-covid vaccine proposals hit the skids last year.
In July and August, a subject expert committee on vaccines met and cleared several proposals, including marketing authorisations granted to Bharat Biotech’s influenza vaccine, Glaxosmithkline’s (GSK'S) rotavirus vaccine, among others.
The expert panel also allowed biotechnology and biopharma firms like the Serum Institute of India, Sanofi, and GSK to start Phase 3 clinical trials of their inactivated Salk polio vaccine, hexavalent vaccine (paediatric vaccine that protects against diphtheria, tetanus, pertussis, poliomyelitis, haemophilus B, and hepatitis B), quadrivalent influenza, and the herpes zoster vaccines.
Some firms like Biological E were allowed to manufacture the measles vaccine for export only. Cadila Healthcare and Biological E were allowed to start Phase 4 trials of their typhoid and influenza vaccines, respectively.
“Work on Covid vaccines was prioritised for obvious reasons. Many pharma players found it difficult to start trials on non-covid vaccines during a pandemic, especially when recruiting volunteers or their regular monitoring. Therefore, the proposals seeking approvals to conduct trials were fewer,” said a senior executive of a vaccine firm.
He added that the Central Drugs Standard Control Organisation's (CDSCO'S) review process has not yet reclaimed the pre-pandemic levels, and Covid-19 work is still prioritised. But noncovid work is picking up pace alongside, he said. The CDSCO had relaxed the stringent requirements needed to adhere to all protocols of a clinical trial last year.
In fact, in a notification in March last year, the CDSCO had said that in the current state it understood the challenges that may arise during conduct of clinical trials.
“This may lead to difficulties in complete adherence to the approved protocol, regulatory provisions, etc. Reiterating that rights, safety, and well-being of trial subjects is of paramount importance, the CDSCO, nonetheless, noted that in some cases, protocol amendment, deviation or modification may be necessary due to unavoidable circumstances,” it had noted.
However, industry sources claimed that with the focus on rolling reviews of Covid vaccine research, reviews of proposals to start clinical trials of non-covid vaccines were on the back-burner.
“Hardly any fresh approval was given to start new trials. The drug regulator's office and the experts were busy reviewing the real-time data from the Covid vaccine trials,” said another senior executive of a drug firm, which also markets vaccines.