Amidst the huge increase in infections and deaths, India agreed to fast-track emergency approval for COVID-19 vaccines, which have been authorized by Western countries and Japan and listed by the World Health Organization (WHO).
Vaccines authorised by the World Health Organization or authorities in the United States, Europe, the United Kingdom and Japan “may be granted emergency use approval in India, mandating the requirement of post-approval parallel bridging clinical trial,” a Union health ministry statement said on Tuesday.
The ministry said the decision is aimed to potentially pave the way for possible imports of Pfizer-BioNTech, Johnson & Johnson, Novavax and Moderna shots.
The move comes at a time when India is facing great shortage of vaccines as the Serum Institute of India and the Bharat Biotech International struggle to boost production of Covishield and Covaxin, respectively in order to meet domestic demand.
On Monday, India added more than 160,000 new cases, pushing total active cases to 1.25 million. This is in sharp contrast to the situation in February when daily case addition was below 10,000 per day.
Meanwhile on Wednesday, thousands of Hindu devotees are set to bathe in the Ganges river, the third major day of the religious festival. Surge in the daily COVID-19 infections has called for the government’s critics to cancel the huge events.
RULES ON REGULATORY APPROVALS FOR FOREIGN VACCINES
The New Drugs and Clinical Trial norms, 2019 state that whenever a foreign manufacturer applies for emergency use authorisation(EUA) of vaccines, it is required to submit the results of local clinical tests. These tests are called ‘bridging trials’, in which manufacturers perform phase 2/3 to collect data for safety and immunogenicity. Since efficacy data is already made at a foreign site, limited participants are enrolled (approximately 1,000) and a clinical test is performed to find out if the jab is safe in the Indian population.
The regulations also empower the regulator to relax the rules if the jab has been approved by another country’s national regulator. These relaxations are beseeched if “no major unexpected serious adverse event has been recorded” in the shot. Also, if the vaccine is indicated in life-threatening or critical illness or of particular relevance to the Indian health condition; and for “an unmet need in India”.
These norms have now been implemented; India has technically waived the prerequisite for conducting Phase 2-3 trials at Indian sites.
“Vaccines made outside of India, if approved by authorities in the US, UK, European Union, Japan, or under the WHO’s emergency use listing, are approved for use in India. The condition of clinical trials won’t apply, they can continue trials after approval,” said VK Paul, member (Health) Niti Aayog.
According to the new rules, instead of conducting a local clinical test before seeking EUA, vaccine manufacturers can perform a bridging trial parallel to the rollout post-authorization, the government said.
“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,” the health ministry statement said.
At the ministry briefing, union health secretary Rajesh Bhushan 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 in the day, the Union health ministry said the step was recommended by the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC) ahead of a meeting on April 11.
The accelerated approval will apply to vaccines 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 World Health Organization.
VACCINES APPROVED BY REGULATORS
Currently, there are vaccines by three companies that are approved by government-identified regulators and have not yet been authorized in India: Pfizer-BioNTech, Modern and J&J. A fourth vaccine, made by Novavax, has progressed in clinical trials and has sought approval from many of these regulators.
Among these, Novavax and J&J have already tied up with Indian companies for production. Novavax has licensed Serum Institute of India (SII) to obtain a billion doses and the Pune-based company is also carrying out bridging trials in the country.
However, the J&J vaccine faced a setback on Tuesday after US regulators stopped immunizations with the shot, pending a review of rare blood clots. Last year, the Pfizer-BioNTech and Moderna vaccines were among the first to be approved anywhere in the world. Both have an efficacy rate of over 95% and use mRNA technology, which has emerged as a breakthrough platform for COVID-19 jabs. A single shot of J&J’s vaccine has an efficacy of 66%.
“We have noted the recent announcement with regard to the regulatory pathway for global vaccines. We remain committed to continuing our engagement with the government towards making the Pfizer and BioNTech vaccine available for use in the government’s immunization programme in the country,” a spokesperson for Pfizer said in a statement.
A spokesman for J&J did not immediately respond to a question on whether the company would apply for restricted emergency use under the new rules.
COST OF THE VACCINES
Health Ministry officials said it would be speculative to discuss costs yet, in the absence of any vaccines having been approved by this route. So far, Covaxin and Covishield are being given for Rs 250 per dose in private hospitals. In January, the ministry cited the price of one dose of Pfizer vaccine at Rs 1,431 (not including overhead costs and taxes). The cost of a single dose was Rs 2,348-2,715 for Moderna’s vaccine and Rs 734 for Sputnik V. The price of the single-dose vaccine developed by J&J was cited as Rs 734.
WHEN WILL VACCINES BE AVAILABLE IN THE MARKET?
Presently, the decision is only in relation to the approvals for foreign vaccine producers. No decision has been taken by the Center as to when, or if, the vaccines will be made available to the private market. The outcome of that decision will largely rely on how many foreign manufacturers are willing to seek approval to market their products in India.
VK Paul told Hindustan Times that under the emergency-use licensing norms, the process of distribution and procurement will remain under the control of the government just like now. “It is not a regular marketing licensure, it is EUA and all vaccines are governed by EUA laws where the government controls procurement and distribution to ensure those who need the vaccine get it on priority. All countries are procuring and distributing Covid-19 vaccines under EUA currently,” he said, adding that since it will be under EUA, the government will monitor side-effects.
Private hospitals and clinics are allowed to give shots but the process is monitored by the government, which uses the platform of CO-WIN to track the factory-to-injection process.
VACCINES AUTHORISED IN INDIA
India, the world’s largest manufacturer of vaccines, has so far administered more than 108 million doses of Covishield and Covaxin – the first two shots to be approved in the country. On Tuesday, the Ministry of Health said that the third vaccine – Russia’s Sputnik V – was also given a nod for emergency use.
Russian Direct Investment Fund (RDIF) said the drug controller-general of India had approved the use of Sputnik V, developed by Moscow’s Gamaleya Institute.
Doses are expected to be imported at first before a group of five Indian companies that have contracts to begin churning out doses. Limited number of doses are going to be made available by the end of April, RDIF chief executive Kirill Dmitriev told India’s broadcaster, NDTV. Dr Reddy’s has the rights for distribution of the first 100 million doses in India, which will be a combination of Indian and Russian made vaccines, the RDIF said on Tuesday.
“India is the most populated country to register the Russian vaccine. Total population of 60 countries where Sputnik V is approved for use is 3 billion people or about 40 per cent of the global population,” a statement from RDIF said.