Modi's Vaccine Nationalism: India's Hasty Approval of Homegrown COVID19 Vaccine

[Riaz Haq]

Indian drug regulator has approved COVAXIN, a Covid19 vaccine developed by Bharat Biotech.  The approval has been granted without completing large-scale phase 3 trials in India, according to media reports. It is India's first indigenous vaccine co-developed with Pennsylvania-based startup Ocugen. Ocugen, led by Indian-American scientists, does not currently sell any products.  India is the world's second worst-hit country by the global coronavirus pandemic.  Critics say the hasty approval of the homegrown Indian vaccine is motivated by "chest thumping nationalism". 

US-Based Ocugen: 

How COVAXIN Works. Source: NY Times

Ocugen is a US-based biotech company. It has no track record. It has not developed any drugs and doesn't have any products to sell yet. This lack of experience makes Ocugen a strange choice for an international commercialization partner, according to an investment analysis published in the United States. The Food and Drug Administration has made it clear that it won't authorize a coronavirus vaccine without data from a phase 3 trial conducted in the United States. NASDAQ-listed Ocugen stock has soared since the approval of COVAXIN for use in India. 

Bharat Biotech:

Bharat Biotech is an Indian biotechnology company based in the South Indian city of Hyderabad. 

Dr. Krishna Ella, the Chairman of the Bharat Biotech, has claimed that they are "no way" inferior to Pfizer in terms of coronavirus vaccine. He also said that Bharat Biotech is the only firm to have published five articles on the Covid-19 vaccine process, according to media reports. 

COVAXIN Vaccine: 

Some critics have dismissed COVAXIN approval as a manifestation of "chest thumping nationalism". Bloomberg's Andy Mukherjee has a story entitled "COVAXIN: Science, not pride will help India build trust in this vaccine". 

Indian government's decision to authorize COVAXIN has been sharply criticized by public interest groups in India. “The decision to approve an incompletely studied vaccine, even under accelerated process, raises more questions than answers and likely will not reinforce faith in our scientific decision-making bodies,” Malini Aisola, of the All India Drug Action Network (AIDAN), an independent collective of healthcare non-profits, said in a statement.

COVID19 Pandemic:

India has been hit hard by the coronavirus pandemic with over 10 million infections, second only to the United States. Indian economy has shrunk by double digits. Tens of millions of daily wage earners who make up the bulk of India's workforce have lost their livelihoods. Prime Minister Narendra's Modi's decision to impose a sudden nationwide lockdown is blamed for it. 

Summary:

COVAXIN is India's first indigenously developed vaccine that has just been approved for emergency use in the country. It has been co-developed with US-based Ocugen. COVAXIN's hasty approval without any phase 3 efficacy data has come under  sharp criticism. Some critics have dismissed COVAXIN approval as a manifestation of "chest thumping nationalism". Bloomberg's Andy Mukherjee has a story entitled "COVAXIN: Science, not pride will help India build trust in this vaccine". 

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[Riaz Haq]

#India confirms #Asia's first #monkeypox death. The 22-year-old #Indian man died on Saturday in #Kerala. It's only the fourth known fatality in the world from the disease in the current outbreak. #Modi #Disease #BJP #Hindutva #Health https://www.reuters.com/world/india/india-confirms-its-first-monkey...


India confirmed its first monkeypox death on Monday, a young man in the southern state of Kerala, in what is only the fourth known fatality from the disease in the current outbreak.

Last week, Spain reported two monkeypox-related deaths and Brazil its first. The death in India is also the first in Asia. The World Health Organization declared the outbreak a global health emergency on July 23.

The 22-year-old Indian man died on Saturday, Kerala's revenue minister told reporters, adding that the government had isolated 21 people who had come in contact with him.

"The person reached Kerala on July 21 but visited a hospital only on July 26 when he displayed fatigue and fever," Minister K. Rajan said, adding that there was no reason to panic as none of the primary contacts were showing symptoms.

Kerala's health minister, Veena George, told reporters on Sunday that the man's family told authorities the previous day that he had tested positive in the United Arab Emirates before returning to India.

India's federal health ministry had no comment on the death, except for saying that the government had formed a task force of senior officials to monitor monkeypox cases in the country, where local media have reported at least five infections.

The WHO said late last month 78 countries had reported more than 18,000 cases of monkeypox, the majority in Europe.

It says the monkeypox virus causes a disease with less severe symptoms than smallpox and occurs mainly in central and west Africa. The disease is transmitted from animals to humans.

Human-to-human transmission happens through contact with bodily fluids, lesions on the skin or on internal mucosal surfaces, such as in the mouth or throat, respiratory droplets and contaminated objects.

[Riaz Haq]

India-made cough syrups may be tied to 66 deaths in Gambia: WHO | Business and Economy News | Al Jazeera


https://www.aljazeera.com/economy/2022/10/5/india-made-cough-syrups...

The WHO also issued a medical product alert asking regulators to remove Maiden Pharma goods from the market.


The deaths of dozens of children in The Gambia from kidney injuries may be linked to contaminated cough and cold syrups made by an Indian drug manufacturer, the World Health Organization said on Wednesday.

WHO Director-General Tedros Adhanom Ghebreyesus told reporters that the UN agency was conducting an investigation along with Indian regulators and the drugmaker, New Delhi-based Maiden Pharmaceuticals Ltd.

Maiden Pharma declined to comment on the alert, while calls and Reuters messages to the Drugs Controller General of India went unanswered. The Gambia and India’s health ministry also did not immediately respond to a request for comment.

The WHO also issued a medical product alert asking regulators to remove Maiden Pharma goods from the market.

The products may have been distributed elsewhere through informal markets, but had so far only been identified in The Gambia, the WHO said in its alert.

The alert covers four products – Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.


Lab analysis confirmed “unacceptable” amounts of diethylene glycol and ethylene glycol, which can be toxic when consumed, the WHO said. The Gambia’s government said last month it has also been investigating the deaths, as a spike in cases of acute kidney injury among children under the age of five was detected in late July.

Medical officers in The Gambia raised the alarm in July, after several children began falling ill with kidney problems three to five days after taking a locally sold paracetamol syrup. By August, 28 had died, but health authorities said the toll would likely rise. Now 66 are dead, WHO said on Wednesday.

The deaths have shaken the tiny West African nation, which is already dealing with multiple health emergencies including measles and malaria.

Maiden Pharmaceuticals manufactures medicines at its facilities in India, which it then sells domestically, as well as exporting it to countries in Asia, Africa and Latin America, according to its website.