Image credit: Suneesh K
Central government on Tuesday said it is going to fast track Emergency Approvals for foreign produced COVID-19 vaccines that have been granted Emergency Use Authorisation (EUA) in other countries.
The government said the decision to fast track EUA is to expand the basket of vaccines for domestic use and hasten the pace and coverage of vaccination.
The government arrived at this decision based on the recommendation of the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC). The expert group chaired by Dr. V K Paul, Member (Health), Niti Aayog met on April 11 2021, held comprehensive deliberations, on augmenting the basket of vaccines available for fighting the pandemic as well as to accelerate the pace and coverage of domestic vaccination programme.
India is seeing a second wave of COVID-19 cases, with last seven day average clocking over 1.3 lakh cases on daily basis. India has so far approved three vaccines for emergency use.
So. how does this decision change will impact the approval process and availability of vaccines.
No need of bridge trial
The government decision means that the local clinical trials or bridging studies that involves testing the vaccine in Indian participants to assess the safety and immunogencity in the local population will now be waived-off. In short it will be an automatic approval.
The government now says that the first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further immunization programme within the country. This will save about 2-3 months for foreign vaccine makers to conduct a bridge trial involving 1500-1600 participants. Now it is mandatory in India to conduct local clinical trials.
Which foreign regulatory body approvals will be considered?
The NEGVAC has recommended that vaccines for COVID-19, which have been developed and are being manufactured in foreign countries and which have been granted emergency approval for restricted use by USFDA, European Medicines Agency (EMA), UK MHRA, PMDA Japan or which are listed in WHO under Emergency Use Listing may be granted emergency use approval in India, in place of local clinical trial as per the provisions prescribed under Second Schedule of the New Drugs & Clinical Trials Rules 2019.
The foreign vaccine makers will have to do a post-approval parallel bridging clinical trial.
Which foreign vaccines will be available
COVID-19 vaccines of Johnson & Johnson, Pfizer, Moderna and Novavax vaccines could become available much sooner. The drug regulator has earlier sought data from local Pfizer.
Will the waiver of local clinical trials compromises safety and immunogencity of the vaccine?
Not necessarily. Many Indians living abroad have received the shots of Pfizer and Moderna. Moreover, those vaccines are approved by regulators following global clinical trials. There is an emerging real world evidence that these vaccines are safe and effective.
How this will boost capacity?
The government believes that this decision will facilitate quicker access to such foreign vaccines by India and would encourage imports including import of bulk drug material, optimal utilization of domestic fill and finish capacity etc., which will in turn provide a fillip to vaccine manufacturing capacity and total vaccine availability for domestic users.
How this will help consumers?First this will hasten the approval process, which means that more vaccines will be available soon. Second more vaccines means more supplies and third it may open up private market possibly giving people a choice of vaccine.
