Govt fast-tracks foreign Covid vaccine approvals
Exempts bridge studies, says India wants Pfizer, Moderna and J&J to seek licence soon
Coronavirus vaccines cleared for use in western countries and Japan will get fast-track approval in India, the Union government announced on Tuesday, throwing open the market for possible imports of Pfizer, Moderna and Johnson & Johnson’s (J&J) doses.
Coming at a time when India records the world’s biggest surge in infections, the decision removes a significant barrier to more doses being made available, although questions remain on how soon any of these companies can bring their products, whether they have the additional capacity to, or if they will tie up with Indian companies for production.
“Vaccines made outside of India, if approved by authorities in the US, UK, European Union, Japan, or under the World Health Organization’s emergency use listing, are approved for use in India. The condition of clinical trials will no longer apply, they can continue trials after approval. This is only for Covid- 19 vaccines under the exceptional circumstances we are in now,” said VK Paul, member ( Health) Niti Aayog.
“We hope, and we invite vaccines makers such as Pfizer, Moderna and J&J or any other vaccines that get approvals from these authorities to bring their products to India,” he added while speaking at the government’s weekly briefing on the Covid- 19 situation on Tuesday.
Union health secretary Rajesh Bhushan, also at the briefing, described the step as a “significant streamlining and fast-tracking of the regulatory system” which now “opens doors for import of bulk or finished vaccines or import leading to fill and finish”.
In a statement issued earlier, the Union health ministry said the step was recommended by the National Expert Group on Vaccine Administration for Covid- 19 ( NEGVAC) after a meeting on April 11.
The accelerated approval will apply to doses authorised by US’s food and drug administration (FDA), UK’s Medicines and Healthcare products Regulatory Agency (MHRA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA) Japan or by the WHO.
Instead of requiring them to conduct a “bridging trial” prior to seeking approval, the government will allow them to roll these coronavirus vaccines and conduct “parallel bridging clinical trial” after the get the authorisation.
“Further, the first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further immunisation programme within the country,” the statement said. At present, there are vacci
nes by three companies that are approved by regulators identified by the government and are yet to be authorised in India: Pfizer-BioNTech, Moderna and J&J. A fourth vaccine, made by Novavax, has made progress in clinical trials and sought approval from several of these regulators.
Among these, two companies already have tied up with Indian companies for production -- Novavax and J& J. Novavax has licensed Serum Institute of India (SII) to produce a billion doses and the Pune-based company is also carrying out bridging trials in the country. Similarly, Hyderabad’s Biological E has a deal to produce 600 million doses of the J& J vaccine and was recently poised to begin bridging studies.
India, the world’s biggest maker of vaccines, has so far administered a little over 108 million doses of Covishield and Covaxin – the first two shots to be approved in the country. A third, Sputnik V made by Russia’s Gamaleya Institute, was approved formally on Tuesday and doses are expected to be imported at first before a group of five Indian companies that have contracts begin churning out doses.
But concerns have been mounting about whether there are adequate supplies. According to production capacities declared by SII (which makes Covishield – the Indian version of the Oxford- AstraZeneca dose) and Bharat Biotech, the average production capacity at present comes to about 2.5 million doses a day.
Over the past week, India has administered 4.1 million doses a day.
“The EC has already increased the silence period from 48 hours to 72 hours for the fifth phase [ of polling in West Bengal on Saturday]. All political campaigns for the fifth phase would have to be stopped on April 14 [Wednesday], instead of April 15 [Thursday]. So, there is no time to lose,” said a second TMC leader.
Banerjee called the ban “undemocratic” and said she will protest against it. The ban came amid tensions in the state after the death of four people during voting on Saturday last in Coochbehar. The central forces and EC said the forces fired in self-defence after being surrounded by an armed crowd. But TMC and the villagers accuse the security personnel of opening fire without provocation.
Last week, the EC sent two separate notices to Banerjee over her comments on April 7 and April 8.
In her response to the first notice, she said that she did not appeal for votes on communal lines and instead promoted peace and harmony. To the second notice, Banerjee said that she only advocated for peaceful and democratic forms of protest.
Criticising Banerjee over her decision to hold a protest in the city, state Bharatiya Janata Party (BJP) chief Dilip Ghosh said the TMC supremo has “no regard for the poll panel”. “There have been instances when the EC banned our leaders from campaigning. We have always respected the EC’s decision. What she (Banerjee) did is unacceptable,” he said.