Tag: Bharat Biotech

Cyrus Poonawala to receive Lokmanya Tilak Award

The founder of the Serum Institute of India (SII) in Pune, businessman Cyrus Poonawalla has been named the winner of the prestigious National Lokmanya Tilak Award 2021.He will be commended for his work during the COVID-19 pandemic and how his company helped save many lives by creating the Covishield vaccine and then making provided the medicine to the citizens of the country at an affordable price.Although the awards ceremony takes place on August 1 each year on the anniversary of the Freedom Fighter’s death, this epidemic-stricken year the award has been scheduled for August 13. The prize includes a cash prize of 1,00,000 rupees and souvenirs for the winners. The award was first presented in the year 1983. Winners include former Prime Minister Indira Gandhi, Dr. Manmohan Singh and Atal Bihari Vajpayee; Infosys founder NR Narayana Murthy and former President Pranab Mukherjee.

Cyrus poonawalla

Cyrus S. Poonawalla (born in 1941) is an Indian billionaire businessman, and the chairman & managing director of the Cyrus Poonawalla Group, which includes the Serum Institute of India, an Indian biotech company which is the largest vaccine manufacturer in the world. In 2021, he was ranked number eight on Forbes’ India rich list with a net worth of $12.7 billion. Poonwalla founded the Serum Institute of India in 1966 and built it to the largest vaccine manufacturer in the world by doses. Serum produces over 1.5 billion doses annually of a range of vaccines, including for measles, polio and flu. In May 2019, it was reported that Poonawalla, in partnership with Naum Koen, had proposed supplying Ukraine with 100 thousand doses of the measles vaccine for free vaccination.

Serum institute of India [SII]

Serum Institute of India (SII) is an Indian biotechnology and biopharmaceuticals company. It is the world’s largest manufacturer of vaccines located in the city of Pune, India and was founded by Cyrus Poonawalla in 1966. The company is a subsidiary of the holding company Poonawalla Investment and Industries. he company set out to produce immunobiologicals, which were imported into India at high prices. Among the first products the Serum Institute of India manufactured in large quantities were the tetanus antitoxin, snake antivenom, DPT vaccine, and MMR vaccine. The company’s product lines was expanded to include different types of vaccines against bacterial or virus infections, combination vaccines, influenza vaccine, and meningococcal vaccine. Besides vaccine the company also manufactures antisera, blood plasma, and hormone products. As of 2014 the vaccines manufactured by the Serum Institute of India have been used in international vaccination programmes run by the World Health Organization (WHO), UNICEF, and the Pan American Health Organization (PAHO). Today the Serum Institute of India is run by the Poonawalla Group and engages in research, development, and manufacturing.

The company has partnered with the British-Swedish multinational pharmaceutical company AstraZeneca, which is developing AZD1222 (Covishield) in partnership with the University of Oxford. It is reported that Serum Institute of India would provide 100 million (10 crore) doses of the vaccine for India and other low and middle-income countries. This target was later increased to 1 billion doses by the end of 2021. It is estimated to be priced at ₹225 (around $3) per dose.In September 2020, trials were halted by DCGI after a volunteer in Oxford developed illness following vaccination, but were soon resumed after consent by the British regulators. In December 2020, the Serum Institute of India sought emergency approval for the vaccine developed with AstraZeneca which was approved a month later. In March 2021, an agreement was reached to supply some doses to the UK.

why hasn’t the world health organization(WHO) authorized Covaxin yet?

Traveling the world is valuable and who doesn’t want such worthwhile experience. Even In this trying times, everyone has an urge to travel the globe to experience the beauty of the world and have incredible experiences to add up in their brain’s memory bank.

But are you the one who is vaccinated by covaxin but can’t be treated as vaccinated and be permitted to travel across international borders?

Well, here are the reasons why covaxin is not approved by world health organization yet. 

First of all, we need to understand the process of getting a vaccine approved By WHO. It consists of four parts, Namely,

1. acceptance of the manufacturer’s expression of interest, 

2.A pre submission meeting between WHO and the manufacturer, 

3. Acceptance of the dossier for review by WHO, 

4.Decision on status of assessment and the final decision on approval.

Now If we talk about  the approval of covaxine which was manufactured by Bharat Biotech. The first step itself is not completed yet. That is the acceptance of the manufacturer’s expression of interests is not accepted by the WHO and more information is needed as reported by Who in order to clear the first stage. Bharat Biotech, located in Hyderabad, submitted 90 percent of the documents required for the WHO’s Emergency Use Listing in April month. The rest of the paperwork would be presented this month, according to the statement provided by the manufacturing company.

The second step which consists of a pre submission meeting between WHO and the bharat biotech will also be held in this month Meanwhile, the WHO authorized the Pune-based Serum Institute of India (SII), which manufactures Astrazeneca’s Covishield vaccine, on February 15 after passing the same four phases. The approval procedure is classified, and it is unclear what papers are needed at this time to approve covaxine. Therefore, the Indian people who got fully vaccinated by covaxine are sceptical of it’s authorization by WHO because recently, US food and drug administration also rejected Bharat Biotech’s proposal for an emergency use authorization (EUA) of Covaxin, delaying the company’s vaccine launch in that country. 

The government of india’s take on US FDA disapproval is that it respects the FDA’s decision not to grant Covaxin an EUL, but claims it will have no influence on India’s immunisation programme. Union minister of information and broadcasting prakash javedekar said in the press briefing that “The World Health Organization (WHO) has not made a judgement on whether or not persons who have been vaccinated with Covaxin should be prohibited from travelling. Covaxin is a vaccination that has shown to be one of the most successful to date.”

So, when can we expect the authorization of covaxin by world health organization is a question we all needs answer for. On June 9 bharat biotech said that the company will reveal all of Covaxin’s phase 3 trial results in July 2021, after which it will commence the phase 4 trial while concurrently applying for a complete license in India. The submission of trial results are important because it is a prerequisite for Obtaining the WHO Emergency Use Listing.

A good news for the people who got inoculated by covaxine is that so far, few countries like Iran, Philippines, Mauritius, Mexico, Nepal, Guyana, Paraguay and Zimbabwe have approved the Covaxin. But, The European Union and the United States are unwilling to let Indians who have been vaccinated with Covaxin to enter their countries since WHO authorisation is still pending.

Why Bharat Biotech’s Covaxin is not getting approval in highly regulated countries

India made COVID-19 vaccine, Covaxin manufactured by Bharat Biotech in collaboration with Indian Council of Medical Research  is been used extensively in most of the countries. However, the regulatory body of USA, USFDA has still not given the approval of usage of Covaxin on their citizens. It is believed that their regulatory body wants further clarification on the clinical trials conducted for Covaxin by Bharat Biotech.

What is the reason behind USFDA’s unapproval?

USFDA has asked Bharat Biotech to submit the clinical trial data of Covaxin so as to get the vaccine approval in United States. But after the submission of partial data of clinical trials of Covaxin, the regulatory body of USA rejected the approval and has asked Ocugen( Hyderabad based pharma company which is also Bharat Biotech’s US partner) to submit the additional trial data. Covaxin is therefore rejected for emergency use due to lack of scientific data according to US regulators. However,  if they get the complete trial data from Bharat Biotech they can file a Biologics License Application(BLA) seeking a full approval instead.

Recently, USFDA has revised their guidelines for emergency use authorization and stated that they won’t be entertaining further requests. After all this, Occugen remains hopeful for a good news.

Bharat Biotech’s delay to share Phase- 3 clinical trial data

Bharat Biotech has not yet shared the clinical trial data of phase 3 trials and are expected to share it on next month. Following which, the company will start applying for a full licensure of Covaxin. “Once data from the final analysis of phase III studies are available, Bharat Biotech will apply for full licensure for Covaxin,” Bharat Biotech told the news channels.

Further they added, they have already taken the data of Phase-4 clinical trials which is the post- marketing surveillance to check the safety and effectiveness of the vaccine.

Hurdles of Bharat Biotech’s Covaxin

COVID-19 vaccine, Covaxin manufactured by Bharat Biotech has been facing enormous hurdles in front of them pertaining to it’s approval. The wait of Phase 3 clinical trial data is taking long and that is the reason it is still not being validated by World Health Organization(WHO). Without which they are unable to export their vaccine and make an entry into the Covid 19  passport.   

Different countries has different regulations and also some of the them have stingent  regulations. Due to which COVID- 19 vaccine manufactured by Bharat Biotech, Covaxin remains unapproved in all those countries without their Phase 3 clinical trial data.  This is the reason why, foreign universities are also not considering students who has been vaccinated with Covaxin. They are considering them as “un-vaccinated” in this regard.

Now it remains to be seen how soon they can procure the clinical trial data of phase 3 and then they can get the approval from foreign countries for emergency use. Also, the approval from WHO is required to get into the coveted COVID-19 vaccine passport. “We are aware that Bharat Biotech has sought the WHO emergency-use listing for Covaxin. We hope that the process of getting this approval is completed at an early date,” said Ministry of External Affairs spokesperson, Arindam Bagchi on this issue.