After Pfizer, SII, Bharat Biotech seeks emergency use nod for Covid vaccine Covaxin in India

After Pfizer and Serum Institute, Hyderabad-based pharmaceutical firm Bharat Biotech on Monday applied to the central drug regulator seeking emergency use authorisation for its COVID-19 vaccine Covaxin.

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Covaxin is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).

Hyderabad-based Bharat Biotech has sought emergency use approval from the Drug Controller General of India (DGCI) for its indigenously made Covid vaccine Covaxin.

After Pfizer and the Serum Institute of India, Bharat Biotech has become the third pharmaceutical in India to seek emergency use authorisation for its Covid vaccine in India.

Covaxin is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).

Both the Serum Institute of India and Bharat Biotech are currently conducting Phase 3 trials of their respective vaccine candidates in India.

The phase-three randomised double-blind placebo-controlled multi-centre trial of Covaxin cover around 28,500 subjects aged 18 years and above and are being conducted in around 25 sites across 10 states. The trial has already started at a few sites.

Earlier, in an exclusive interview with India Today TV, Sai D Prasad, President, Quality Operations at Bharat Biotech, said while the company is aiming for at least 60 per cent effectiveness of the coronavirus vaccine candidate 'Covaxin', it could also be more.

This vaccine is being developed from an inactive strain of the SARS-CoV-2, the coronavirus that causes Covid-19. The strain was isolated from an asymptomatic person at a containment facility in Hyderabad in May this year.

Covaxin is different from other potential vaccine candidates for India for being a direct strain isolated from the disease-causing coronavirus.

COVAXIN IN ROW AFTER HARYANA MINISTER TESTS COVID POSITIVE POST DOSE

The Bharat Biotech vaccine ran into controversy this week after Haryana Health Minister Anil Vij, a Covaxin trial volunteer, was found to be Covid-19 positive.

The pharmaceutical later clarified that Covaxin is a two-dose anti-coronavirus vaccine and Anil Vij was given only the first dose.

"The antibodies against the infection build up in a human being only after a specific number of days pass after the second dose of the vaccine is taken. This is a two-dose vaccine. The minister in question has taken only one dose of the vaccine," the Union Health Ministry said on the matter.

The Haryana health minister too said antibodies start to develop after administration of the second dose, which is given 28 days after the first shot, and there is no protection during this period. The 67-year-old minister was given the first shot on November 20.

THREE VACCINES SEEK EMERGENCY USE NOD IN INDIA

On December 4, Prime Minister Narendra Modi at an all-party meeting had expressed hope that a Covid-19 vaccine may be ready in a few weeks. PM Modi had also visited the Bharat Biotech lab in Hyderabad on November 28 to oversee the progress of Covaxin development.

That same evening, the Indian arm of US pharmaceutical giant Pfizer sought emergency use approval for its vaccine from the central drug regulator, after the firm secured such clearance in the UK and Bahrain.

The Serum Institute sought such nod for the Oxford COVID-19 vaccine, Covishield, on December 6.

The applications of Bharat Biotech, Serum Institute of India and Pfizer will be reviewed by the subject expert committee (SEC) on COVID-19 at the Central Drugs Standard Control Organisation (CDSCO) in the coming days.

"However, none of the applications has so far been forwarded to the committee and no date has been fixed as on when the SEC will meet for assessing and evaluating the applications," the official source said.

WHAT IS THE CURRENT STATUS OF THESE VACCINES?

Pfizer :

Efficacy rate: 95%

In an official statement, Pfizer and BioNtech concluded the phase 3 trial of the covid19 vaccine candidate on November 18. 2020. Analysis of the data indicates a vaccine efficacy rate of 95% (p

The phase 3 trials of the Pfizer/BioNTech vaccine involved 42,000 people, about half of whom got the experimental vaccine and the rest a placebo. In total, 170 people fell ill with covid-19. Only eight of them were in the vaccine group; 162 had received the placebo. Pfizer is yet to publish its data in a peer-review medical journal.

Serum Institute of India: COVISHIELD

Efficacy rate: 60-70%

“Even though the lowest efficacy results are at 60-70%, it is a viable vaccine against the virus. That said, varied age groups with different dosage forms will result in slight variations and efficacy. We must be patient and not panic,” SII said in a statement.

The efficacy results of AstraZeneca were based on trials being conducted in the United Kingdom and Brazil. It does not include the trials of the same vaccine being conducted by the Serum Institute in India. The results of the Indian trials are expected to come out in December, none of their data has been put in public domain yet.

Human clinical trials of the SII led vaccine was being done in 17 sites across India on 1600 participants.

Bharat Biotech: COVAXIN

Efficacy rate: 60%

The phase 3 clinical trials for the vaccine candidate, called Covaxin, began only earlier this month, with 26,000 participants enrolled at 25 hospitals around the country, the trials are being conducted in partnership with the ICMR. The trial is double-blinded which means that the investigators, the participants and the company will not be aware of who is assigned to which group. Earlier, Covaxin was evaluated in 1,000 subjects during phase 1 and 2 clinical trials.

The trials are yet to conclude. The company has not shared any results from the vaccine candidate’s phase 1 and 2 trials, nor the pre-clinical trials, nor has it divulged the phase 3 trial’s design.

Bharat Biotech said that phase 3 efficacy data will be available approximately at the end of Q1 in 2021.

COULD EUA BE GRANTED FOR VACCINES IN INDIA?

In India, the regulatory authority for providing emergency use authorisations is the Central Drugs Standard Control Organisation (CDSCO).

In reality, India’s drug regulations do not have provisions for an EUA, the processes are not clearly defined. The US, the Food and Drug Administration (FDA) specified that it would consider an application for EUA only if phase 3 data showed it was at least 50% effective in preventing the disease. This data needed to be generated from “well over” 3,000 trial participants, “representing a high proportion of participants” enrolled.

However, during the COVID19 pandemic in India, the drug controller general India had granted emergency or restricted emergency use approvals to drugs for corona virus such as Remdesivir, Favipiravir in June and Itolizumab in July 2020.

The fastest approval for any vaccine until now — the mumps vaccine in the 1960s — took about four-and-a-half years after it was developed. Till now, health experts have said ideally, EUA could be granted to vaccine makers if their efficacy and safety data is submitted to the Subject Expert Committee (SEC) which would recommend to the CDSCO for the grant and approval of EUA.

HOW MUCH TIME COULD IT TAKE FOR APPROVAL?

That remains to be seen. An ICMR expert had earlier told India Today, that any company wanting to bring an internationally- manufactured and approved vaccine to India would have to conduct local trials here, or a shorter way to do it is to conduct a bridging study in order to prove it is safe and effective on the Indian population.

But experts are wary. “Only giving an EUA to Pfizer on the basis of just a bridging study could give rise to questions and concerns but they have only been granted an EUA in United Kingdom, which is not a final license. Besides, even the Oxford-Serum Institute vaccine has not been granted approval in any country yet. The regulator must have a very strong rationale and be transparent about the basis on which they may be provided an EUA,’ said Anant Bhan, ethical expert, researcher, Bioethics.

Dr Rajeev Jayadevan, Indian Medical Association Kochi chapter cautioned that more bridging studies and local trials would amount to crucial time being wasted. “It is known that if a sufficiently large population has been studied in other countries under controlled conditions accurately, then one need not repeat studies in the countries where the vaccine is intended to be used. To do a study now and to create a result will take time and we will lose the opportunity to vaccinate people. Secondly and importantly, it is going to be impossible to do a placebo controlled trial from now on as convincing people to take a placebo when vaccine has already been authorised in the coming weeks will be difficult. Convincing volunteer to take a dummy shot will be difficult.”

“We also need to wait till the studies are published in peer reviewed medical journals. This is an ethical question to ask a volunteer to take a placebo and not tell the volunteer what he/she will be administered,” he said.