Govt fast-tracks approval for foreign-produced COVID vaccines

With an aim to expand the basket of COVID-19 vaccines and enhance the pace of inoculation in India, the central government on Tuesday said it has decided to fast-track emergency approvals for all coronavirus jabs that have been given a similar nod by the World Health Organization or regulators in the United States, Europe, Britain or Japan.

The move is significant as it may make available several vaccines, including those made by Pfizer, Moderna and Johnson & Johnson, in India with certain conditions.

The first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before they are rolled out for further immunisation programme within the country, the Union health ministry said.

Terming it a significant development and a liberal regulatory step that will increase the access to vaccines manufactured outside,NITI Aayog member (Health) Dr V K Paul said, "We hope and we invite vaccine makers such as Pfizer, Moderna, Johnson and Johnson and others...to be ready to come to India as early as possible."

The government has decided that COVID-19 vaccines which have been developed and are being manufactured in foreign countries and which have been granted emergency approval for restricted use by authorities in the US, Europe, the UK, Japan or which are listed in the WHO Emergency Use Listing may be granted emergency use approval in India.

They will be given emergency use approval mandating the requirement of post-approval parallel bridging clinical trial in place of a local clinical trial under the provisions of the New Drugs and Clinical Trials Rules 2019, the ministry said.

“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 (use)," the ministry said.

The decision came following the recommendations of the National Expert Group on Vaccine Administration for COVID-19.

Currently, two vaccines -- Covaxin by Bharat Biotech and Covishield by Serum Institute of India -- are being used for inoculation in India.

India's drug regulator also granted permission for the restricted emergency use of the Russian COVID-19 vaccine Sputnik V with certain conditions on Monday.

At a press conference, Union Health Secretary Rajesh Bhushan said the decision has created a regulatory provision to enable those foreign made vaccines which have been approved by "credible foreign regulators" to get emergency use nod in India.

"It denotes a very significant streamlining and fast tracking of the regulatory approval system which means that the pre-condition of having a bridging clinical trial which is phase 2 and 3 trial here for a foreign vaccine, before it can be considered for emergency use authorisation, has been done away with and has been replaced with a parallel bridging trial. As the approval happens the clinical trial can proceed. So, therefore, the availability of the vaccine becomes much faster," he said.

"It also opens up, eventually, doors for import of bulk or import of finished vaccines in vials or import leading to fill and finish in the country," Bhushan stated.

The matter of augmenting the basket of vaccines available for fighting the pandemic as well as to accelerate the pace and coverage of domestic vaccination programme were discussed in the 23rd meeting of NEGVAC chaired by V K Paul on April 11.

India is following a comprehensive approach to tackle the pandemic in a proactive and pre-emptive manner, the ministry said in a statement.

In this context, as early as May 2020, India constituted a task force headed by the Principal Scientific Advisor to encourage research and development for vaccine manufacture and constituted in August 2020 an expert group headed by Member, NITI Aayog to assist in the rollout of the COVID vaccination programme.

It was because of these strategies that India became the first country to have two "Made in India" vaccines for domestic vaccination drive, it said.

Vaccination is one of the critical pillars of COVID-19 control and management strategy adopted by the Centre, it underlined.