In a major shift, India fast-tracks restricted use approval for vaccines developed in other countries

On April 13, India permitted fast-track approval of COVID-19 vaccines developed, tested and approved outside the country. The decision has been taken to “expand the basket of vaccines for domestic use and hasten the pace and coverage” of COVID-19 vaccination. But before mass roll out of the vaccines that are developed and tested abroad can happen, the vaccines will be first given to 100 beneficiaries and these individuals will be assessed for seven days for safety outcomes.

In a major shift in vaccine approval policy, the government has decided to fast track approvals for COVID-19 vaccines that have been developed outside India and have been granted the emergency use authorisation (EUA) by other drug regulatory agencies. The decision was taken based on the recommendation made by the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) in a meeting held on April 11. The decision has been taken to “expand the basket of vaccines for domestic use and hasten the pace and coverage” of COVID-19 vaccination.

The vaccines that would be eligible for the fast-track approval will include those that have been granted an EUA by the US Food and Drug Administration (FDA), European Medicines Agency (EMA), UK Medicines and Healthcare products Regulatory Agency (MHRA) and the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan, or those that have been prequalified by the WHO for emergency use. This would mean that Pfizer, Moderna and Johnson and Johnson vaccines would be eligible for fast-track approval.

Under the fast-track approval process, the bridging studies will take place in parallel to mass vaccination. So far, clinical trials conducted in India were needed before the Indian regulator could approve the vaccine. But before mass roll out of the vaccines that are developed and tested abroad can happen, the vaccines will be first given to 100 beneficiaries and these individuals will be assessed for seven days for safety outcomes.

“The decision will facilitate quicker access to such foreign vaccines by India and would encourage imports including import of bulk drug material, optimal utilisation of domestic fill and finish capacity etc., which will in turn provide a fillip to vaccine manufacturing capacity and total vaccine availability for domestic [use],” says a government release.

“This is a welcome decision by the government to expand the basket of vaccines and overcome any shortage of vaccines,” says Dr. Shahid Jameel, Director of the Trivedi School of Biosciences at Ashoka University. At least half-dozen States had reported vaccine shortage a few days ago.

Professor of Microbiology at CMC Vellore Dr. Gagandeep Kang says: “The decision finally complies with the WHO’s recommendation of regulatory reliance.”

While so far there have been no tie-ups with Pfizer and Moderna by any vaccine manufacturer in India, Hyderabad-based Biological E (Bio E) has tied up with Johnson and Johnson to test and manufacture the vaccine locally. Since the decision also allows imports of bulk drug material and fill and finish locally, it is likely that India will have access to Johnson and Johnson vaccine at the earliest.

However, on April 13, U.S. FDA said in a tweet that along with CDC it is recommending a pause in the use of Johnson and Johnson vaccine “out of an abundance of caution”. The decision to pause came after “reviewing data involving six reported cases of a rare and severe type of blood clot in individuals after receiving the vaccine. Right now, these adverse events appear to be extremely rare”. The FDA said in another tweet: “CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance,”

Pfizer had earlier filed for a restricted use approval with the Indian regulator but withdrew its application after a short while. Though the reason why Pfizer withdrew its application is not known, the policy then required Pfizer to carry out bridging studies in India before the vaccine could be taken up for approval.

It is unclear at this point if the vaccines developed, tested and approved outside India will be made available through the government at a subsidised rate or will vaccine manufacturers be able to import them and sell them in the private market. “So far, I am not aware of any vaccine being made available through private players anywhere. It is governments that are purchasing vaccines for its citizens,” says Dr. Kang.

India has already approved three vaccines — Covishield, Covaxin and Sputnik V — for restricted use. The Subject Expert Committee cleared Sputnik V vaccine on April 12 and the Indian drug regulator’s nod came on Tuesday.  

Published in The Hindu on April 13, 2021