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Expert panel suggests against granting permission to SII for Covovax’s trials on kids-asks for data

Novovax vaccine

On Wednesday, an expert panel of the India’s central drug authority recommended against granting permission to the Serum Institute of India (SII) to conduct the phase 2/3 trial of Covid-19 vaccine Covovax on children aged two to 17 years.

Serum Institute had applied to the Drugs Controller General of India (DCGI) on Monday seeking permission for conducting a trial of Covovax on 920 children, 460 each in the 12-17 and 2-11 age groups, at 10 sites.

Subject Expert Committee of the Central Drugs Standard Control Organisation denied the permission saying that Covovax has not been approved in any country. SII is currently carrying out trials on adults. The Pune-based drug-maker has been asked to submit the safety and immunogenicity data (of Covovax) from the ongoing clinical trial in adults before proceeding with the trials on children.

Also See: Are Covid vaccines magnetic? Facts you should know related to coronavirus

A source with knowledge over the issue stated, “The SEC on Covid-19 of the Central Drugs Standard Control Organisation (CDSCO), which deliberated on the application, noted that the vaccine has not been approved in any country.”

The source also added, “It also recommended that the Pune-based company should submit the safety and immunogenicity data (of Covovax) from the ongoing clinical trial in adults for considering the conduct of a clinical trial in children.”

Also See: New mutants of Coronavirus

Last month Novavax had announced that NVX-CoV2373 demonstrated 100% protection against moderate and severe disease, and 90.4% overall efficacy, in its Phase 3 trial.

Covovax would have been the third vaccine to be tested on children in the country after Bharat Biotech’s Covaxin and Zydus Cadilla’s ZyCov-D, if approved.

Serum Institute has tied up with US biotechnology company Novavax to locally manufacture NVX-CoV2373 under the brand name Covovax.

The clinical trials of Covovax began in India in March. SII-CEO Adar Poonawalla had earlier said that the vaccine could be launched in India by September for adults.

Poonawalla later said in a post on Twitter, “Excited to witness the first batch of Covovax (developed by @Novavax) being manufactured this week at our facility in Pune. The vaccine has great potential to protect our future generations below the age of 18. Trials are ongoing. Well done team @seruminstindia!”

Novovax had carried out its phase 3 trials in US and Mexico. In June, in an interim analysis from its phase 3 trial on 29,960 participants in the US and Mexico, the drug-maker reported an efficacy of 90.4%.

Also Read: Indemnity from liability to be granted to vaccine manufacturers like Pfizer and Moderna

Novovax also showed that the vaccine had an efficacy of 100% in preventing people from getting moderate and severe diseases.

Its vaccine is based on a recombinant protein technology. This approach is also being used in the candidate developed by Sanofi and GlaxoSmithKline Plc. The Pune-based drug-maker started “at-risk” production of the vaccine in small quantities last month. Because of the significant financial risk taken by the company, the production is termed as“at-risk”.

Till now, a total of four vaccines have been cleared by the Indian government. They are Bharat Biotech’s Covaxin, the SII’s Covishield, Russia’s Sputnik V and the one manufactured by Moderna (sold under the brand name ‘Spikevax’ in the US).

The Pune based drug-maker had rolled out Covishield vaccine in the country in January. It had entered into a collaboration with AstraZeneca and the University of Oxford to manufacture the vaccine.

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Would vaccination drive in Canada be a mixed story for Ocugen?

OCGN-US India Canada

Ocugen Inc is the US-based partner for Bharat Biotech’s Covid19 vaccine-Covaxin. The company with HQ at Malvern, Pennsylvania has announced the payment of $15 million upfront to the Indian drug maker for extending the vaccine rights to Canada. In a regulatory filing, Ocugen said that it has agreed to pay another $10 million to Bharat Biotech. It has been agreed that the payment would be made a month from the commercial launch of Covaxin in the North American country.

On June 3, Bharat Biotech said that it has agreed to expand the agreement with Ocugen Inc to commercialise the jab in Canada also. Ocugen Inc and the Indian biotech company have entered into a definitive agreement to co-develop, supply, and commercialise Covaxin for the US market.

Also See: New mutants of Coronavirus

On Monday, June 7, 2021Ocugen said, “The company further agreed to pay to Bharat a milestone payment of $10 million within 30 days of the first commercial sale of Covaxin in Canada.”

Shankar Musunuri is a co-founder of Ocugen. The company is working towards the submission of the emergency use application in the U.S. As per Musunuri, the company will simultaneously seek authorisation under interim order for emergency use in Canada. On profit sharing agreement between the two companies, Bharat Biotech had said that similar to the U.S. arrangement, Ocugen will retain 45 percent of the profit from sales of Covaxin in Canada.

Suchitra Ella is the Joint MD of Bharat Biotech. She said that regulatory approvals for Covaxin is in over 60 countries including the US, Brazil and Hungary while Emergency Use Authorisation has been obtained in 13 nations. In a statement on twitter, she said, “Application for EUL has been submitted to WHO-Geneva & regulatory approvals are expected by July-Sept 2021.”

Also Read: Indemnity from liability to be granted to vaccine manufacturers like Pfizer and Moderna

Rise and fall of Ocugen share-price

Meanwhile, Ocugen’s work towards commercialisation of the Bharat Biotech’s near-to-market coronavirus vaccine in US & Canada has seen mixed outcomes. At first the shares have surged as much as 700% from the start of the year to a peak in February. But, as per S&P Global Market Intelligence data, the shares have recently dropped by 31.1% in May. It has been interpreted that the investors were concerned because of the downward trend in Covid-19 cases in the United States. Another factor can be that Canada is slated to receive a substantial number of Pfizer and Moderna shots from US, which may be problematic for Covaxin-plan of Ocugen.

Also Read: US President Joe Biden announced vaccine distribution plans; Kamala Harris dialed New Delhi

That could hurt the chances for the company’s vaccine, which it is developing with India’s Bharat Bioscience.

A master file has been submitted by Ocugen to the U.S.FDA. The company will request Emergency Use Authorization this month and said that it will “simultaneously” request emergency authorization in Canada.

Vaccination scenario in Canada

Vaccination rollout in Canada has not been particularly smooth. The country does not produce its own vaccines, and has therefore relied on importing doses. There it has faced a lack of supply. US-based Moderna has filed for Health Canada authorization, for its Covid-19 vaccine to be used in adolescents. In a statement on Monday, the pharna-giant has said that results from a clinical trial in the U.S. last month showed their two-shot vaccine was effective in adolescents between the ages of 12 and 17.

As more Canadians get their first and second jabs, Canada is scheduled to receive 2.4 million doses of the Pfizer-BioNTech Covid-19 vaccine, this week. Those shots of Pfizer are the only expected shipments in what should be a comparatively quiet week of vaccine deliveries to Canada.

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Phase-III trials begin for Bharat Biotech’s COVID-19 Vaccine-Covaxin while Biological E Ltd began adaptive Phase I and II human trials

bbio tech

Bharat Biotech has declared the beginning of Phase-III trials of COVAXIN.  This trial will cover 26,000 volunteers across India and will be carried out in partnership with ICMR. It is the largest clinical trial performed for a COVID-19 vaccine in India.

This is India’s first Phase-III efficacy study for a Covid-19 vaccine. The trial volunteers will get two intramuscular injections almost 28 days apart. Participants will be randomly selected to take Covaxin or placebo. The trial would be double-blinded where the investigators, participants, and the company will not be informed of who has been assigned to which group.

In Phase I and Phase II Clinical trials, COVAXIN has been assessed in approximately 1,000 subjects, giving promising safety and immunogenicity data. The volunteers who want to participate in the Phase-III trial should be over 18 years of age. Joint Managing Director of Bharat Biotech, Suchitra Ella, told that the development and clinical evaluation of COVAXIN have garnered interest from several countries worldwide for supplies and introduction.

Russia’s sovereign wealth fund, also known as Russian Direct Investment Fund, has published the results of a survey of 12,000 respondents in 11 countries regarding Covid-19 vaccination and preferences in vaccine selection. As per the results, 73 percent of respondents were willing to be vaccinated. Among those aware of Russia’s Sputnik V vaccine, the number was higher at 4 out of every 5 respondents.

A UK research data and analytics group, YouGov conducted the survey from October 9-19. The survey was conducted before the announcement that the Sputnik V is 92 percent effective at protecting people from Covid-19, as per interim trial results. The survey found that a majority of participants in India are positive about vaccination at about 80%. Among those aware of Sputnik V, the percentage of those willing to be vaccinated is over 85 percent of those surveyed.

In a parallel development, Biological E Ltd, a Hyderabad-based firm has started an adaptive Phase I and II human trial for its COVID-19 vaccine candidate. The firm has already sought approvals from Drugs Controller General of India (DCGI) and expects to get the results back by February, next year.

It is being developed along with Baylor College of Medicine (BCM ventures) in Houston, Texas, and Dynavax Technologies Corp. According to the press release by Biological E Ltd, the trial will test two doses of the vaccine in around 360 volunteers who are aged between 18 to 65 years. It will be administered via intramuscular injection 28 days apart. Intramuscular injection is a technique used to deliver the vaccine deep into the muscles, allowing it to be absorbed into the bloodstream quickly.

The author is a student member of Amity center of Happiness