SII, Bharat Biotech Seek Emergency Approval: What Are the Rules?

Based on the phase 3 trials, various companies have been seeking such approvals in countries around the world.

What is the procedure for granting emergency use authorisation to a COVID-19 vaccine in India?

(Photo : iStock)

The Serum Institute of India (SII) on Sunday, 6 December, became the first Indian company to seek emergency use authorisation for the Oxford COVID-19 vaccine from Drugs Controller General of India (DCGI).

The phase-three clinical trial of the Oxford COVID-19 vaccine, Covishield, is being conducted by the SII in India on around 1,600 participants.

Soon after, on Monday, PTI reported quoting sources that Bharat Biotech, the Hyderabad-based pharmaceutical firm, has sought approval from Drugs Controller General of India (DCGI) for emergency use of its indigenously developed COVID-19 vaccine candidate – Covaxin.

Based on the phase 3 trials being conducted globally, various companies have been seeking such approvals in countries around the world.

Just like the SII and Bharat Biotech, the US drugmaker Pfizer has also applied for emergency authorisation of its vaccine candidate in India before the DCGI. It has already been approved in the United Kingdom and Bahrain.

What does emergency use authorisation (EUA) mean?

Vaccines, drugs, and diagnostic tests need to be approved by the concerned regulatory authorities - in our case the Central Drugs Standard Control Organisation (CDSCO) - before they can be put to use in a country. Such an approval is granted based on safety and efficacy assessment from clinical trials, reports The Indian Express. Normally, the whole procedure is long - taking years for a vaccine to finally roll out.

The mumps vaccine, for instance, which was the fastest ever approved, also took four years to get authorised.

However, in emergency circumstances, such as the one posed by the COVID-19 pandemic, faster mechanisms have been put in place for approvals based on sufficient evidence for safety and efficacy. This is an interim approval. The final one follows the completion of trials and the complete availability of data, while the emergency authorisation makes it possible for the vaccine to be used for the time-being.

When can a vaccine get emergency use authorisation (EUA)?

According to the standards set by the US Food and Drug Administration (FDA), an EUA can be granted when the known and potential benefits outweigh the known and potential risks of the drug being considered, and once sufficient efficacy and safety data from phase 3 trials is available.

Notably, this cannot be done based on merely phase 1 and phase 2 trial results.

The minimum efficacy bar set by the FDA for a COVID-19 vaccine is 50% - and this must be attained after the vaccine has been studied in over 3,000 participants - who are all to be tracked and monitored for any adverse event for at least one month post the administration.

How does a vaccine get EUA in India?

Much like the United States has the Food and Drug Administration, or Europe has the European Medicine Agency, CDSCO is a branch of the Ministry of Health and Family Welfare and aims to monitor the safety, effectiveness and quality of medicines, cosmetics and medical devices and to protect and promote public health. The Drugs Controller General of India (DCGI) is an official body of the CDSCO and is the final regulatory authority for the approval of clinical trials in the country.

The procedure for getting an EUA is not clearly definited by India’s drug regulators. Nevertheless, CDSCO has been granting these approvals for drugs like remdesivir, favipiravir and Itolizumab for COVID-19 treatment.

Murali Neelakantan, lawyer and former global general counsel for Cipla and Glenmark Pharmaceuticals, told The Indian Express, “We still don’t know the story behind these approvals — we haven’t seen the clinical trial data published anywhere and we haven’t seen the protocols that were followed for each drug.”

India’s provisions for EUA for a COVID-19 vaccine are yet to be made clear. According to a government official quoted in the report, it is mandatory for companies to have held local trials for the vaccine among the Indian population.

Pfizer has sought permission to import the vaccine for sale and distribution in the country, and a waiver for clinical trials on Indian population. This is in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019. “During this pandemic phase, Pfizer will supply this vaccine only through government contracts based on agreements with respective government authorities and following regulatory authorisation or approval,” a spokesperson said.

Ram Vishwakarma of the Council of Scientific and Industrial Research - Indian Institute of Integrative Medicine, told The Hindu that the procedure for EUA in India is similar to those in the UK and the US. “So a drug or a vaccine approved by the US FDA is approved here (India) with some bridging studies (limited trials on local population to establish equivalence and effect. Were Pfizer were to apply in India to the regulators here, it could in theory be approved within days or weeks here, depending on whether the Drug Controller is satisfied with the data. If the situation so demands, the regulator has the power to waive or recommend more tests, and doesn’t necessarily require Indian data.”

What is the procedure for an EUA in India?

CEO of SII Adar Poonawalla said in a press conference that after its EUA application, the Indian regulators will undertake a detailed review of the data submitted by the company.

According to The Indian Express, the SII has stated that data from four clinical studies shows that Covishield is highly effective against COVID-19 infections.

When talking about other countries and their procedures, let’s take a look at the UK. The decision by the UK regulatory authority to approve the Pfizer-BioNtech vaccine was made with advice from the Commission on Human Medicines (CHM), the government’s independent expert scientific advisory body. A team of MHRA scientists and clinicians carried out a scientific review of all the available data, starting in October 2020.

According to a press release by Pfizer concerning approval in the United States, the FDA scientists will review the data collected till date, which will be followed by an assessment by an external panel of independent experts, known as Vaccines and Related Biological Products Advisory Committee (VRBPAC).

In India, if Covishield gets an EUA, further decisions will have to be made regarding distribution, prioritizing and other plans for the vaccine administration.

Prime Minister Narendra Modi on Monday announced that there would not be much delay in the availability of Covid-19 vaccine in India. “Awaiting Corona’s vaccine. As per my recent discussion with scientists, I hope there will be no more delay now. But there should be no carelessness in following Covid prevention measures,” the prime minister said.

(With inputs from The Indian Express)

(This story was first published on FIT.)