January 1, 2022 rang in some good news for Covaxin, the indigenous vaccine against COVID-19 developed by a consortia led by Bharat Biotech, Hyderabad and National Institute of Virology (NIV), Pune. The vaccine reached Afghanistan, a country caught up in troubled times.
The government of India gifted five lakh doses. The consignment was flown to Kabul by Mahan Air of Iran. It is part of the one million doses India has committed to Afghanistan and will be supplied in the coming weeks. According to reports, the vaccines will be kept at the Indira Gandhi Children’s hospital in Kabul.
Bharat Biotech, the vaccine maker was involved in a similar gesture a few years ago too. In 2018, the company initially donated about 50,000 doses of the indigenously developed Typhoid vaccine -Typbar to Pakistan.
Later, through the WHO another 200,000 doses were supplied to the hostile neighbour, which reportedly helped thousands of children. The vaccine developed over a decade of research and development and trials got WHO nod for use in infants and children below 15 years. It’s supplied to over 15 countries now, according to Dr Krishna Ella Chairman & Managing Director of Bharat Biotech International Limited.
The troubles and triumphs of Covaxin
Controversy has dogged the developments of Covaxin right from the beginning. To its credit, Bharat Biotech, with 20 years experience and 15 vaccines under its belt was quick to get into the race of developing a vaccine against the SARS -Cov2 virus. With the backing of the Indian Council of Medical Research (ICMR), it got the genome sequence from the NIV, Pune and worked fast to come up with a potential vaccine in June-July 2020.
As the virus began to spread and cases spiked in the summer of 2020 across the country, the pressure to come up with a vaccine was high. The Prime Minister, Narendra Modi wanted to make a big vaccine breakthrough on Aug 15. This promoted, the ICMR to devise steps on fast tracking trials and getting results. The move attracted sharp criticism from professional scientific bodies like the Indian National Science Academy.
In January 2021, the Indian Drug Regulator accorded Emergency Use Authorisation (pending large scale phase -3, human trials data) to Covaxin along with Covishield vaccine developed by Oxford University, Astra Zeneca of UK and produced and tested in India by the Serum Institute of India (SII), Pune.
This again, got the critics questioning the rationale behind the decision and asking for more data before it’s mass use. The company, given its limitations forged an alliance with a US based Ocugen to market in the US and later Canada. It also applied for WHO authorisation, which would give it the access to export markets.
Then came the issue of pricing of the vaccines. The Union Government initially accepted a higher price of procurement for Covaxin vis a vis Covishield. At the same time it allowed the two manufacturers fix a separate price for hospitals and private players into vaccination.
With the ‘ Second wave ‘ taking a heavy toll during April to July 2021, the State governments too were given freedom in the procurement and administration of the vaccines. However, shortages of vaccine and spiralling demand posed huge problems. Simultaneously, critics raised issues of intellectual property rights, high price and responsibilities of the governments to bear the burden and ensure vaccination at an accelerated pace. The Supreme Court too intervened directing the Modi Government to firm up a uniform policy. Finally the Union Government announced that it will procure 75 percent and supply to states and leave rest to hospitals, bringing in clarity.
Meanwhile, Bharat Biotech got an order for supply of the Covaxin to Brazil, where the President, Jair Bolsonaro took a decision on the issue. Even before any supplies were made, the issue turned into a controversy in the South American nation. With difficulty, Bharat Biotech exited from the deal.
These developments had global ramifications too as international travel began and countries imposed restrictions and conditions for entry. One of them was the mandatory rule that the vaccine taken (vaccine passport) should be WHO approved. Here, the Covaxin was found wanting. Covishield too faced some initial problems, but it’s global trial data provided by Astra Zeneca was accepted.
During the 6 months of these fast paced events putting the Covaxin in the spotlight and questions raised on its data, though it’s efficacy was scientifically proven and good, Bharat Biotech did the large scale trials and applied for the WHO nod in September. After, raising issues and as, King for clarifications, the WHO gave the Emergency Use Listing (EUL) to Covaxin in November, 2021.
Big gain for India
November 3, 2021 will be an important milestone day for India’s vaccine development efforts as, Covaxin, the ‘Made in India’, Vaccine against COVID-19, made in a record time on par with Covishield, Sputnik, Pfizer’s and Moderna’s mRNA based vaccines got global acceptance to fight the Pandemic, that began in December 2019 in China. It is also a good example of public-private partnership.
The WHO granted Emergency Use Listing (EUL) on that day. It means, Covaxin will be accepted by all nations for use. The move also ended months of suspense for all those who got the vaccination in India and were unable to travel to many developed nations or had to undergo a long quarantine etc.
The Technical Advisory Group of the WHO made up of regulatory experts from around the world has determined that Covaxin meets the WHO standards for protection against COVID 19, that the benefits of the vaccine far outweighs risks & the vaccine can be used, said the announcement.
The challenges of production
Unlike Serum Institute, which has a huge installed capacity and benefitted from contract manufacturing agreements with Astra Zeneca and NVAX during 2020 itself to manufacture the vaccine in large scale and fund support from the Bill and Melinda Gates Foundation, Bharat Biotech did not have the capacity nor funding support for a long time. As of October SII has achieved an impressive 200 million doses per month capacity.
In addition, Bharat’s indigenous effort and development from scratch with the ICMR-NIV hinging on its own funding and many challenges translated into slower upscaling. Since October it has managed to reach 50-55 million doses per month. Further, it is in the process of transferring technology to four Indian companies to scale up production. Hyderabad has production facilities, the three others- Hester Biosciences, BIBCOL and Haffkine have to set up manufacturing facilities.
The politics and prejudice
Covaxin also took political colour. If it got a big boost with Prime Minister, Narendra Modi taking the jab and give an endorsement the statements by ICMR and also some BJP leaders gave it a political bend by even claiming the role of the PM in getting the WHO nod. The Opposition parties, especially the Cong (I) leader, Rahul Gandhi has voiced strident criticism and alleging politics in vaccine pricing and distribution too.
Most recently, the Chief Justice of India, Justice N V Ramana waded into controversy by stating that major Pharma companies, including Pfizer made attempts to see to it that Bharat Biotech made Covaxin did not become popular.
Speaking at the awards function of the Ramineni Foundation on Dec 24 in Hyderabad he said, at a time when Covaxin was found to be the most effective in combating COVID and its variants. Many leaders of the Pharma industry criticised and even complained to the WHO to see that it did not get recognition.
Having gone through all these challenges, Covaxin has successfully entered the export market too. In December the company announced a donation of two lakh doses to the Republic of Vietnam. It is gearing up to substantially raise capacities. In addition, Bharat Biotech has developed a version for children and is in advanced stages of making a nasal vaccine too.
Somasekhar Mulugu, former Associate Editor & Chief of Bureau of The Hindu BusinessLine, is a well-known political, business and science writer and analyst based in Hyderabad