On November 28, Serum Institute of India (SII) said it will seek emergency use authorisation for the AstraZeneca’s COVID-19 vaccine candidate in about two weeks.
Adar Poonawalla, founder and CEO of SII, said the institute is in the process of submitting the data for the clinical trials to the Drug Controller General of India (DCGI) to seek the authorisation. He said there will be no delay in the rollout of the AstraZeneca vaccine as the trials are more than enough for establishing efficacy and it will not affect emergency use authorisation in Europe and certainly not in India. There was a recent error in dosage during trials that AstraZeneca is trying to correct, as per reports.
He said the implementation plan for the AstraZeneca and Oxford vaccine, Covishield, will be clear only after emergency use authorisation is received. There are plans to roll out hundreds of millions of doses in the second quarter but only after all regulatory approvals are received.
The Indian scenario
In emergency situations such as COVID-19, regulatory authorities around the world have developed mechanisms to grant interim approvals to medicines, vaccines and other medical products if there is sufficient evidence to suggest that these are safe and effective and would help in dealing with the emergency.
In India, medical devices and in vitro diagnostics (IVDs) are regulated by the Drug Controller General of India (DCGI) within the Central Drugs Standard Control Organization (CDSCO). The regulatory framework for medical devices and IVDs is based on drug regulations under the Drugs and Cosmetics Act, 1940, and Drugs and Cosmetics Rules, 1945 (D&C Rules), as well as the Medical Device Rules, 2017 (MDR-17).
“What we might have to do is trials for under-18 candidates. That is the way all vaccines go. You first have to establish safety for adults and then go for studies on the impact on children,” Poonawalla said.
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In the country, therapeutic use of unapproved drugs/interventions for the treatment of serious life-threatening conditions/infections in situation of unavailability of any authorised drug is called as compassionate use. It has been proposed to be defined as “compassionate use for treatment of patients suffering from life threatening disease or disease causing serious permanent disability or disease requiring therapy for unmet medical need, which has not been permitted in the country but is under Phase III clinical trial in the country or in any other country.”
The Ministry of Health and Family Welfare in India notified the draft for amendment to the New Drugs and Clinical Trial Rules, 2019, inviting public comments and introduced the regulatory framework for import or manufacture of unapproved new drugs for compassionate use. This is a much needed step in the COVID-19 crisis to have access to experimental drugs as no approved therapies are available for the management of this pandemic.
In October, Union health minister Harsh Vardhan had said the government has not yet taken a view on granting emergency authorisation to COVID-19 vaccines in India, as and when they become available.
In a huge country like India, it is critical to prioritise vaccine delivery based on various factors such as risk of exposure, comorbidity among various population groups, the mortality rate among COVID-19 cases, and several others, the minister said. He also added that India is looking at the availability of several different types of vaccines, of which some may be suitable for a particular age group while others may not be.
The US Food & Drug Administration (FDA) issued the guidelines for emergency use authorization for vaccines to prevent COVID-19 through a notice on March 25, 2020, announcing procedures for making available its guidance related to the pandemic. These procedures, which operate within FDA’s established good guidance practices regulations, are intended to allow FDA to rapidly disseminate agency recommendations and policies related to COVID-19 to industry, FDA staff, and other stakeholders.
The March 25 notice stated that due to the need to act quickly and efficiently to respond to the COVID-19, FDA believes that prior public participation will not be feasible or appropriate before FDA implements COVID-19-related guidance. Therefore, FDA will issue COVID-19-related guidance for immediate implementation without prior public comment.
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