COVAXIN recognition issue at WHO: Is it market dynamics at play?
As the pandemic was wreaking havoc all over the world pharmaceutical companies were racing towards the invention of coronavirus vaccine. The first vaccine that came to the market after completion of the third phase trial was Pfizer/BioNTech after which Oxford’s Astra-zeneca, Russia’s Sputnik, China’s Sinopharm and Coronovac, US’s Moderna and others were introduced for emergency usage. Most of these were approved as safe by the WHO for emergency usage worldwide. India’s Barat Biotech developed Covaxin, however, took longer to gain approval. What are the problems that have been arising for Bharat Biotech to gain recognition by WHO and how the delay is affecting India in the international market?
Bharat Biotech is no stranger to vaccine development and production. It has developed the typhoid vaccine earlier which is the only one in the world to provide long term immunity against the disease and had been approved by WHO for global use.[1] Bharat Biotech this time took the traditional approach to vaccine development that differs from the modern mRNA vaccine. Most of the vaccines that are in the market are m-RNA vaccines. Messenger RNA (mRNA) vaccines teach our cells how to make a protein that will trigger an immune response inside our bodies.[2] mRNA vaccine although never been licensed for use in humans before is now being approved in the fight against COVID-19 largely because of the speed at which these vaccines can be produced. Covaxin, however, is made by the traditional method of introducing a weak variant of the vaccine into the body for the immune system to trigger response and develop an antibody. mRNA vaccines are faster to produce and as the world economy was shut leading to huge losses in many sectors of trade, the world relied on the vaccine and quicker solutions. When questioned on why Covaxin is taking the longest to gain WHO approval its Chief scientist Dr Soumya Swaminathan cleared the air. Speaking to NDTV, Dr Swaminathan said that on average, vaccines took 50-60 days to get the Emergency Use Listing approval, but some took up to 165 days. Notably, the China-made Sinopharm and Sinovac vaccines took between 150-165 days to secure the WHO's approval, she said.[3] Covaxin took somewhat 50-100 days. The approval came seven months late compared to other vaccines like Moderna and Astra Zeneca whose approval was given in nine weeks. In an Interview with Karan Thapar from the Wire, Dr Sabhyasachi Chatterjee of All India People’s Science Network noted that WHO wants more data from India.[4] There has also been a hesitation since the first phase 3 results had not been published in a peer-reviewed journal and secondly the haste through which the Indian Council of Medical Research approved the vaccine even though there have been some unexplained deaths. WHO’s role seems to be more involved. The EUL(Emergency Use Listing) pathway involves a rigorous assessment of late phase II and phase III clinical trial data as well as substantial additional data on safety, efficacy, quality and a risk management plan.[5]
What does approval by WHO means?
Many countries rely on WHO policy directions to go ahead with their decisions. Approval from WHO will help Biotech gain approval from these countries and expedite the export.
India and China both have established the capacity and resources to manufacture vaccines rapidly. China’s Sinopharm vaccine got approval in May 202. The Sinopharm is also a product of an inactivated vaccine called SARS-CoV-2 Vaccine (Vero Cell)1. Delay in getting approval from the WHO has taken India to a slow start in the competitive market. The pandemic made China the world’s top exporter of Covid-19 vaccine, mostly to nations that haven’t been able to afford or procure more effective ones from the U.S. and Europe.[6] Covaxin is not among the vaccines made from the new technology. The market is dominated by mRNA vaccine because of their better speech and efficiency against the newer emerging coronavirus variants. Hence, most countries are looking for mRNA vaccines in which the US produced vaccines like Pfizer and Moderna are at the forefront but are expensive hence developing countries opt for cost-effective ones which are provided by Russia and China.
EU is also among the largest producer of vaccine but is exclusively producing for developed countries.[7] India’s Covaxin due to its lower cost would also help vaccinate the developing countries thereby developing links and building political influence.
Vaccine Diplomacy
India is called the pharmacy of the world. The pandemic came as a blessing in disguise. It is the largest producer of generic medicines, accounting for 20 per cent of its global production. It meets 62 percent of the global demand for vaccines.[8] It produced two vaccines one Covaxin produced by Bharat Biotech in collaboration with the Indian government and Covidshield produced by Serum Institute of India in partnership with Oxford’s Astra Zeneca. Covidshield being a variant of Astra Zeneca was approved and was exported in millions up till the second wave hit India. China, however, was able to control the pandemic at home and it became a go-to country by low-income countries for the vaccine. Secondly, the delay of approval for Covaxin restrained India’s export of vaccines. Hence, India being the pharmacy of the world was unable to utilize the opportunity and China exploited it becoming the largest exporter of vaccines. China which produced exclusively for domestic market is now the main exporter to low income companies. The numbers speak for themselves. The data analytics company, Airfinity, has tracked global production and estimates that China has exported commercially 1.1 billion doses (as of 8 October) of its vaccines to 123 countries (as either bulk substances or finished doses).[9] Vaccine diplomacy was to deepen influence in the developing world as well as develop ties which would have economic as well as political benefits. The developed countries have been hoarding vaccines with the aim of domestic interests first, which leaves China and India to fill the vacuum. Both India and China after the first wave of the pandemic had begun to deliver the vaccine to its southeast neighbourhood. India has already sent 1 million Covid-19 vaccine doses to Nepal, 2 million to Bangladesh, 150,000 to Bhutan, 100,000 to the Maldives and 1.5 million to Myanmar, per media reports. It has also sent 2 million doses to Brazil.[10] As the second wave hit India hard in March 2021, vaccine diplomacy took a break. India received a lot of criticism nationally and internationally for governance failure in managing the health crisis. Domestically the pandemic was ravaging lives and families. People were dying from the lack of oxygen in some of the biggest hospitals in the national capital of New Delhi. One Australian daily went on to say "Arrogance, hyper-nationalism and bureaucratic incompetence have combined to create a crisis of epic proportions, critics say, as India's crowd-loving PM basks while citizens literally suffocate." [11]A vaccine that was to be an effective tool of soft power for India turned out to be a failure amidst the second wave of covid-19. Internationally it brought a lot of damage to Indian foreign policy[12].
Conclusion
The good news is that Covaxin was approved by the WHO on the 3rd of November 2021.With that approval, several countries followed suit. China has been leading the race for vaccine manufacture and export. Showcasing its capabilities of manufacturing and utilizing the opportunities that the Covid crisis provided. With export restrictions now lifted and approval by WHO India is preparing to export significant quantities of Covaxin. WHO EUL will make Covaxin eligible for procurement and global distribution by UNICEF, PAHO, GAVI-COVAX and the company expects to receive orders soon.[xiii] What did delay in WHO was India’s only indigenously developed vaccine lost its market and China was able to fill that space? India even though having all the capabilities was unable to win it. The second wave of Covid 19 that hit India very harshly added fuel to that. Now that India has received the approval production as well as diplomatic efforts are set in for India to benefit from its strengths. [xiv] As majority of Indian populace is expected to get vaccinated during CY21, the opportunity for Indian pharma companies for this period is about USD 4.6 billion; however, the same is expected to increase to USD 4.9 billion during CY22 with increase in the exports.[xv] Also as many countries are thinking of a booster shot, the market is sure of increase, the competition in the small income countries will remain between India and China, to gain vaccine consignments both diplomacy and influence will play a role. Since, China already has considerable economic influence in the region.
Notes
[1] Sinha, Amitabh (2021), “Explained: Covaxin’s road to recognition”, The Indian Express, Glasgow, 9 November 2021. URL: https://indianexpress.com/article/explained/covaxin-who-recognition-covid-vaccine-7606689/
[2] Centre for Disease Control and Prevention, US department of Health and Human Services. URL:https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html
[3] Som, Vishnu (2021),” "Covaxin Didn't Take Longest": WHO Clears Air On India vs China Claim” , NDTV, India,3 November 2021. URL: https://www.ndtv.com/india-news/covaxin-didnt-take-longest-who-clears-air-on-india-vs-china-claim-2598891
[4] Thappar, Karan (2021), “'Delay in WHO Nod for Covaxin Suggests Problems Exist; This Is Serious Setback to Indian Science'” The Wire, India, 3 October 2021. URL: https://thewire.in/health/watch-who-delay-covaxin-phase-3-setback
[5] World Health Organization (2021), “WHO lists additional COVID-19 vaccine for emergency use and issues interim policy recommendations”, Geneva, 7 May 2021. URL: https://www.who.int/news/item/07-05-2021-who-lists-additional-covid-19-vaccine-for-emergency-use-and-issues-interim-policy-recommendations
[6] “China Is Leveraging Its Vaccine Diplomacy Beyond Covid Shots”, Bloomsberg Buisnessweek, 4 November 2021. URL: https://www.bloomberg.com/news/articles/2021-11-03/made-in-china-covid-vaccines-go-global-so-do-its-shots-for-pneumonia-hepatitis
[7]Jeanrenaud, Lionell Guetta et,al.,(2021), “A world divided: global vaccine trade and production”, bruegel, Europe, 20 July 2021 URL:https://www.bruegel.org/2021/07/a-world-divided-global-vaccine-trade-and-production/
[8] Pant, Harsh V. and Tirkey, Aashi (2021), “India’s Vaccine Diplomacy” , Observer Reseach Foundation, New Delhi, 23 January 2021. URL:https://www.orfonline.org/research/indias-vaccine-diplomacy/
[9] Song, Wanyuan (2021), “Covid-19 vaccines: Has China made more than other countries combined?”, BBC News, 10 October 2021. URL: https://www.bbc.com/news/58808889
[10] Choudhury, Saheli Roy (2021), “How Covid-19 vaccines can shape China and India’s global influence”, CNBC , 28 January 2021. URL:https://www.cnbc.com/2021/01/29/how-covid-19-vaccines-can-shape-china-and-indias-global-influence.html
[11] Alluri, Aparna , “India's Covid crisis delivers a blow to brand Modi”, BBC Asia, 8th May.
URL: https://www.bbc.com/news/world-asia-india-56970569
[12]Jeanrenaud, Lionell Guetta et,al.,(2021), “A world divided: global vaccine trade and production”, bruegel, Europe, 20 July 2021. URL: https://www.bruegel.org/2021/07/a-world-divided-global-vaccine-trade-and-production/
[xiii] Sridhar, Naga G. (2021), “Bharat Bio gearing up for Covaxin export”, The Hindu Business Line, Hyderabad, 6 November 2021. URL:https://www.thehindubusinessline.com/companies/bharat-bio-gearing-up-for-covaxin-export/article37346878.ece
[xiv] Sridhar, Naga G. (2021), “Bharat Bio gearing up for Covaxin export”, The Hindu Business Line, Hyderabad, 6 November 2021. URL:https://www.thehindubusinessline.com/companies/bharat-bio-gearing-up-for-covaxin-export/article37346878.ece
[xv] Care Ratings, “Covid-19 vaccine opportunities worth USD 10-11 billion for
the Indian Pharma Sector”, 16 August 2021. URL: https://www.careratings.com/uploads/newsfiles/16082021065730_Covid-19_vaccine_opportunities_worth_USD_10-11_billion_for_the_Indian_Pharma_Sector.pdf
Pic courtesy-Vietnam News Agency
(The views expressed are those of the author and do not represent views of CESCUBE.)
