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’s Vaccine Nationalism Is a Global Risk
By Andy Mukherjee | Bloomberg
Jan. 4, 2021 at 5:58 p.m. PST

https://www.washingtonpost.com/business/indias-vaccine-nationalism-...

The hasty nod for Bharat Biotech International Ltd.’s Covaxin, developed in collaboration with the Indian Council of Medical Research and National Institute of Virology, has raised eyebrows in the scientific and healthcare communities about a “public rollout of an untested product,” according to a national network of nongovernment organizations.

This is unfortunate. With more than 10 million coronavirus infections, India is the world’s second-worst-affected nation after the U.S. New Delhi’s strategy for vaccinating 1.3 billion people will matter greatly for bringing the global pandemic to a decisive end. The country’s virus-battered economy and its overstretched health systems are also yearning for a reprieve. It will be dangerous to allow political calculations to enter the equation and shake people’s confidence in what’s being offered to them — and on what basis.

That’s just what seems to be happening with the unusual approval for Covaxin, which comes with the odd caveat that its use will be restricted to “public interest as an abundant precaution, in clinical trial mode, especially in the context of mutant strains.” Nobody seems to know what this will mean on the ground. Who’ll get Covishield, and who’ll be given Covaxin? More importantly, who’ll decide? In a country beset by massive inequalities in income, wealth and social status, these aren’t trivial questions.

When opposition leaders raised doubts about the vaccine selection process, a minister in Prime Minister Narendra Modi’s cabinet likened their objections to questioning “the valor of our soldiers.”

To be sure, India is not even in the front row of vaccine nationalism. China and Russia are more desperate to beat the West in saving the world. But as my colleague Clara Ferreira Marques has noted, both countries’ vaccine candidates face a transparency deficit, which could limit their global acceptance.

That’s a risk that India, which manufactures more than 60% of the world’s vaccines, should avoid at all cost. According to media reports, Hyderabad, India-based Bharat Biotech has enlisted 23,000 volunteers for phase three clinical trials. That’s encouraging because another report, published last month, had cited a major New Delhi-based research hospital as saying that it couldn’t find enough subjects for the study. If the drug proves to be effective, introducing it even at a later date should pose no problems. Naming Covaxin as an alternative even in the absence of phase three data could be a commercial tactic to squeeze “better discounts” on bulky Covishield purchase contracts, brokerage Jefferies says. Still, cutting corners with science isn’t exactly the best strategy to negotiate drug prices.

The Kremlin-backed Sputnik V is also undergoing trials in India, in partnership with local manufacturer Dr. Reddy’s Laboratories Ltd. The Ahmedabad-based Cadila Healthcare Ltd. is also in the race to develop an indigenous Covid-19 vaccine. Ultimately, it doesn’t matter whether India’s homegrown shots make the final cut. Serum Institute, the world’s largest producer, has already stockpiled 70 million doses of Covishield. Big parts of the developing world will rely on Indian manufacturers to supply easy-to-administer, affordably priced vaccines in large quantities.

[Riaz Haq]

Up to 1m #Hindus gather in #India as festival goes ahead amid #COVID19 fears. Millions more are expected to descend on Haridwar in the coming weeks for #KumbhMela2021, one of the world’s biggest religious gatherings. #Muslim #Hajj was canceled in 2020. https://www.theguardian.com/world/2021/jan/14/hindus-gather-india-k...

Many religious gatherings across the world have been cancelled or scaled back because of Covid. Only a few thousand Muslims took part in last year’s hajj, the annual pilgrimage to Mecca, compared with more than 2 million in normal years.

The pope celebrated midnight mass on Christmas Eve with fewer than 100 participants instead of the usual 10,000. In nearly all countries, Christians, Muslims, Jews and those of other faiths have curtailed or cancelled events marking religious festivals in the past 10 months.

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Most of those walking into the freezing river on Thursday morning were not wearing masks and social distancing was hard to maintain. Senthil Avoodai K Raj, a senior police official, said thousands of security forces were present and fines could be imposed for breaching Covid regulations.


India has recorded more than 10m Covid cases – the second highest number in the world after the US – and has recorded more than 150,000 deaths.

On Saturday, the government will launch a vaccination drive, aiming to inoculate 300 million people by early August. Healthcare and frontline workers will be vaccinated first, followed by people over 50 and those with underlying health conditions.

Some pilgrims in Haridwar dismissed the threat from the virus. “India is not like Europe … when it comes to immunity we are better,” said 50-year-old Sanjay Sharma. “It’s really sad to see people not gathering at Kumbh in the same numbers as they would earlier … The greatest truth on Earth is death. What’s the point of living with fear?”

[Riaz Haq]

#Chinese Foreign Minister Wang Yi Speaks with #Pakistani Foreign Minister Shah Mahmood Qureshi on the Phone. #Beijing has decided to assist Pakistan with #Covid19 #vaccine and coordinating with Chinese enterprises to accelerate its export to Pakistan

https://www.fmprc.gov.cn/mfa_eng/zxxx_662805/t1847949.shtml

Wang Yi said that fighting the pandemic is a top priority for the international community. President Xi Jinping has repeatedly said that the Chinese COVID-19 vaccines, once developed and put into use, will be global public goods. China has not only made promises, but also taken concrete actions to fulfill them by vigorously promoting vaccine cooperation with other countries, in particular, offering assistance and support to developing countries. Pakistan is China's all-weather strategic cooperative partner, and the two sides enjoy a fine tradition of supporting and helping each other. When one side is in trouble, the other side will always lend a helping hand without hesitation. The Chinese government has decided to assist the Pakistani side on vaccine and actively coordinated with Chinese enterprises to accelerate the export of vaccines to Pakistan. Our phone conversation today and the vaccine cooperation between China and Pakistan will unveil the beginning of the celebration of the 70th anniversary of China-Pakistan diplomatic ties.

On behalf of the Pakistani government and people, Shah Mahmood Qureshi expressed gratitude to the Chinese government for its decision to provide vaccine aid and procurement facilitation to Pakistan. He said Pakistan has approved a vaccine by China's Sinopharm for emergency use and will actively consider granting market access to other China-developed vaccines. He also suggested the two sides strengthen communication to ensure successful celebrations of the 70th anniversary of the bilateral ties and hold the 10th CPEC Joint Cooperation Committee meeting at an early date, so as to push for greater progress in bilateral relations.

[Riaz Haq]

Tears and safety fears as #India huge #coronavirus #vaccine campaign falters. Motivated by vaccine nationalism, #Indian made #Covaxin vaccine was hastily approved by #Modi government without completing phase 3 trials - World - DAWN.COM

https://www.dawn.com/news/1603362

India's huge coronavirus vaccination drive is behind schedule, with a third of recipients not showing up for appointments because of safety fears, technical glitches and a belief that the pandemic is ending.

After one week, India has vaccinated 1.4 million people, or 200,000 people per day. It had initially hoped to process 300,000 per day before ramping up the rollout and inoculating 300m by July.

At the Sharda Hospital in Greater Noida near New Delhi, pharma student Khushi Dhingra, 17, hugged a friend and wept as she waited to get her shot.

“I am very afraid. I hate needles and I am worried about side effects,” she told AFP.


“My papa is very worried too. He is calling me again and again to make sure I am okay.”

“There are about 80 students in my batch but only two have opted to get the shot,” said nursing student Sakshi Sharma, 21, in Greater Noida.

“My friends are saying there will be side effects, that you can even get paralysis.”

India is using two shots for its drive.

One is Covishield, a locally produced version of the Oxford-AstraZeneca vaccine, which has been approved and safely used in a number of other countries after completing Phase 3 human trials.

The other — Covaxin — was developed locally by Bharat Biotech and has not yet completed Phase 3 trials, though the government has insisted it is “110 per cent safe”.

WhatsApp worries
Side effects are a common fear, with a few cases of severe reactions — and even deaths — reported widely in the media and circulating wildly on Facebook and WhatsApp.

In the eastern state of West Bengal, health chief Ajoy Chakraborty said that turnout was just under 70pc, calling it “not encouraging”.

“We could have achieved our target if some hadn't backed out after seeing television reports of adverse effects following immunisation,” Chakraborty said.

But Alisha Khan, 20, a nursing student in Greater Noida, said people were also hesitant because of the “rushed” approval of Covaxin.

“Why are they trying to experiment on us? First, they should have completed trials in a proper way,” Khan told AFP. “I am shivering already out of fear.”

Coronavirus complacency
Dhingra, in the end, did not get a shot after staff realised she was under 18. She had, however, received a text telling her to come for the vaccination from the IT system managing the mammoth process.

The government says that this and other glitches are being ironed out.

One was that if a person did not show up for vaccination, someone else could not simply take their place.

This led to unfinished vaccine vials — which contain a certain number of doses and have to be used that day — being thrown away.

Also hurting the effort is complacency with the number of coronavirus infections and deaths in India falling sharply in recent months.

“In the beginning when there was lockdown, [villagers] were very scared of the coronavirus,” said Asha Chauhan, 30, who is part of vaccination efforts in rural areas.

“Now that fear has gone because cases have come down. They feel corona has gone from our country now,” she said. “They fear they will die if they take the vaccine.”

Selfie zones
Many of the 30m people due for jabs in the first phase are health workers who have seen the deadly pandemic close up — yet many of them are hesitant.

This needs to addressed before the vaccine is rolled out to the wider Indian population, experts say, where vaccine scepticism is already rife.

“They must launch awareness campaigns in every nook and corner of the country,” Anita Yadav, 25, an auxiliary nurse and midwife, told AFP.

The government has attempted to boost participation, even adapting a classic Bollywood song with lyrics telling people not to believe false rumours.

[Riaz Haq]

If Poor Countries Go Unvaccinated, a Study Says, Rich Countries & Global #Economy Will Be Hurt. Sharing #Covid_19 #vaccine with poor nations is not an act of charity. Study says it is in rich countries' self-interest to do so. #Covid_19 #CovidVaccine https://www.nytimes.com/2021/01/23/business/coronavirus-vaccines-gl...

A failure to distribute the Covid-19 vaccine in poor nations will worsen economic damage, with half the costs borne by wealthy countries, new research shows.

This is the crucial takeaway from an academic study to be released on Monday. In the most extreme scenario — with wealthy nations fully vaccinated by the middle of this year, and poor countries largely shut out — the study concludes that the global economy would suffer losses exceeding $9 trillion, a sum greater than the annual output of Japan and Germany combined.

Nearly half of those costs would be absorbed by wealthy countries like the United States, Canada and Britain.

In the scenario that researchers term most likely, in which developing countries vaccinate half their populations by the end of the year, the world economy would still absorb a blow of between $1.8 trillion and $3.8 trillion. More than half of the pain would be concentrated in wealthy countries.

[Riaz Haq]

While Pakistan has yet to start a Covid vaccination drive, signs are emerging that it’s going to happen pretty soon. After China’s announcement of ‘gifting’ 500,000 doses of a vaccine to Pakistan by the end of January, another good news on free-of-cost availability of a vaccine has come from the World Health Organization. In a statement last Sunday, the world body has announced signing of an agreement for Pfizer-BioNTech vaccine and another arrangement for AstraZeneca/Oxford University vaccine for procurement of two billion doses by the end of the current year. And 150 million of these doses will be made available in the first quarter of the ongoing month.


https://tribune.com.pk/story/2281328/covid-19-vaccination


The agreements have come under the WHO-led Covax programme — a global initiative to ensure rapid and equitable access to Covid-19 vaccines for all countries regardless of income level. Covax is an alliance that had been set up in April last year by the Global Alliance for Vaccines and Immunisation, Coalition for Epidemic Preparedness Innovations and WHO. It has pledged free vaccine for 20% of Pakistan’s population.
Of the two billion doses to be procured under the Covax programme, 1.3 billion will be provided to 92 lower-income economies, including Pakistan, says the UN’s health agency. Therefore, chances of Pakistan getting the free doses in the first quarter of the current year seem to have brightened. And this is why the Ministry of National Health Services has termed it a positive development and expressed the hope that vaccination against the coronavirus will start soon.
A cash-strapped Pakistani government has earmarked a meager amount of $150 million for Covid vaccination campaign, with the amount just enough for 0.2% population. The country is thus heavily relying on free procurement of a vaccine in pursuit of vaccinating at least 70 million people to achieve ‘herd immunity’. The government has also rightly allowed import of vaccine by the private sector so as to cut the burden of the affording class. A mix of this all could take us to the pre-Covid normal.

[Riaz Haq]

#Israel said to be paying average of $47 per person for #Pfizer, #Moderna #vaccines to get large quantities delivered rapidly.  It’s much higher than $19.50 for #US and $14.76 for #EU. #covid19 | The Times of Israel 

https://www.timesofisrael.com/israel-said-to-be-paying-average-of-4...

The price tag per person for coronavirus vaccines that Israel has purchased from the Pfizer-BioNtech and Moderna pharmaceutical companies is $47, the Kan public broadcaster reported on Monday evening.

In total the country will pay out NIS 1 billion ($315 million) to the two manufacturers for their two-shot vaccination products, the station reported, without citing sources.

The government has set a goal to inoculate five million of Israel’s 9.9 million citizens by the end of March.

Pfizer, which is providing the vaccines that Israel is already using for its mass vaccination program, will receive NIS 775 million ($245 million). The bulk of vaccines used for the campaign are expected to come from Pfizer.

Moderna, which began supplying its vaccines to the country last week, will receive NIS 320 million ($101 million).

The sum means the average price for each dose of vaccine from both companies is about $23.50, slightly higher than the amount that Pfizer had initially said the shots would cost, according to the report. The higher price is because Israel has pushed to buy large numbers of the vaccines and to have them delivered quickly to keep the vaccination drive in high gear.

Vaccine prices reported by the Washington Post and the BBC in December indicate Israel is paying significantly more for the Pfizer vaccine than either the US or the European Union.

The Washington Post reported at the time that the US was paying Pfizer/BioNTech $19.50 per dose while the EU 27-country bloc was paying $14.76. It cited Moderna vaccine prices as $15 per dose for the US and $18 per dose for the EU.

The figures were based on EU prices that were tweeted — and then deleted — by a Belgian government official as well as calculations from Bernstein Research, an analysis and investment firm.

The BBC reported a day earlier that Pfizer was marketing its vaccines to countries at a price range of $10.65 to $21 per dose, while Moderna’s range was $25 to $37 per dose.

Israel was late joining the line for the Pfizer vaccine behind the US, Canada and Japan.

Kan reported that the total price tag of NIS 1 billion is about the same as the cost to the economy for every two days of Israel’s ongoing lockdown, currently scheduled to end next week. The lockdown, the third the government has ordered since the virus outbreak began early last year, started two weeks ago and then was further tightened at the end of last week.

As the vaccination drive presses on, Prime Minister Benjamin Netanyahu held a meeting Monday with health officials to discuss exactly what rights will be granted in the so-called green passports to be issued to those who have been fully vaccinated, Kan reported. The documents, which will begin to be printed next week, will grant holders access to large gatherings and cultural venues.

Health Ministry sources told the broadcaster that the green passport system will have a significant influence on the lockdown exit strategy, with more benefits being granted as the number of vaccinated citizens increases.

The Foreign Ministry has recently been in contact with several countries to explore the possibility that that Israelis carrying a green passport will be exempt from quarantine when visiting those destinations, the station said

So far Israel has give at least a first dose of the Pfizer vaccine to 1,854,055 million citizens, the Health Ministry said Tuesday — by far the highest vaccination rate in the world, according to the Our World In Data website.

Netanyahu vowed Sunday that Israel would ramp up its vaccine drive further, to a target of administering 170,000 shots a day, as a new batch of hundreds of thousands of doses of Pfizer’s vaccine touched down at Ben Gurion Airport.

Moderna informed an Israeli shipping firm that it can expect a shipment of up to 480,000 doses of its own COVID-19 vaccine on Wednesday or Thursday, Channel 12 reported. A first Moderna shipment of more than 100,000 doses arrived last week.

There are 74,639 active virus patients in the country, according to Health Ministry figures published Tuesday.

Since the start of the virus outbreak 504,269 people have been diagnosed with the virus in the country and there have been 3,704 deaths.

[Riaz Haq]

#Pakistan to start #COVID19 #vaccination drive next week. “God willing, the vaccination of front-line health workers will start next week,” Asad Umar, who oversees Pakistan’s efforts to stem the coronavirus pandemic, said in a tweet. https://reut.rs/2M0TJX7

China has pledged to donate 500,000 doses of coronavirus vaccine made by the Chinese firm SinoPharm.

Two government sources said the first batch would be flown in on Saturday.]

Pakistan has so far approved two vaccines for emergency use, one made by China National Pharmaceutical Group (SinoPharm) and the other by AstraZeneca.

Russia’s Sputnik V vaccine is also likely to get similar approval, officials say, adding that the authorisations will be reviewed quarterly with regard to safety, efficacy and quality.

Health Minister Faisal Sultan has said Pakistan could get “in the range of tens of millions” of vaccine doses under an agreement with China’s Cansino Biologics Inc.

Cansino’s Ad5-nCoV vaccine candidate is nearing completion of Phase III clinical trials in Pakistan, and preliminary results may be available by mid-February, Sultan said.

The South Asian nation of 220 million people also expects China to donate a further million vaccine doses.

Dr Ghazna Khalid, a member of the government task force on COVID-19, said Pakistan would procure vaccines from various markets.

“There’s going to be an accumulation of vaccines, a consortium available, there’s going to be Chinese vaccines, there’s going to be AstraZeneca,” she said.

“We are the fifth biggest country in the world, and it’s going to be very difficult to immunise.”

Pakistan reported 1,563 new coronavirus infections and 74 deaths in the latest 24-hour period, taking the total number of cases to more than 537,477, with 11,450 deaths.

[Riaz Haq]

The project approved by the Executive Committee of the National Economic Council (ECNEC) includes Rs45 billion for new healthcare facilities, Rs7 billion for national health surveillance, Rs13 billion water sanitation, hygiene as well as interventions in less developed areas, said Minister for Planning, Development and Special Initiatives, Asad Umar.

https://gulfnews.com/world/asia/pakistan/pakistan-federal-government-approves-largest-healthcare-project-worth-rs70-billion-1.76673020



Besides the healthcare project, the economic body also approved several projects regarding infrastructural and human development, education and water resources worth around Rs209 billion.

Focus on heath amid pandemic
Pakistan is investing in stronger health systems after the coronavirus pandemic unveiled the shortcomings of the country’s health system. The government’s focus is on strengthening the health system and engaging communities to protect people from future health threats. Pakistan government has also allocated $250 million initial funds for the purchase of the COVID-19 vaccine and has announced to provide coronavirus vaccines free of charge to its citizens.

Universal health coverage
Prime Minister Imran Khan has vowed to improve healthcare spending and also announced universal health coverage for all citizens for the first time in Pakistan. The programme, first initiated in Khyber Pakhtunkhwa province in 2020, would soon be extended to other provinces. Under the universal health insurance programme, each family would be entitled to medical treatment of up to Rs1 million ($6,000) a year at over 250 government and private hospitals across Pakistan.

“The development of the Universal Health Coverage benefit Package of Pakistan and its implementation will become the cornerstone of health reforms across Pakistan” believes PM’s Special Assistant on Health Dr. Faisal Sultan.

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The government plans to establish 48 nutrition centres under its Ehsaas programme to overcome common health problems like stunting, underweight and overweight in children under five years of age, especially in under-developed and poor areas of the country.

https://www.dawn.com/news/1601030/48-nutrition-centres-to-be-set-up...

Under this programme, nutrition/health services and conditional cash transfers will be made available to mothers and children. In the beginning, these centres will be set up in 13 districts.

This was decided at a meeting of the Ehsaas Na­­shonuma (nutrition) Steer­ing Committee presided over by Special Assistant to the Prime Minister on So­­cial Protection and Poverty Alleviation Dr Sania Nishtar here on Monday.

The meeting was informed that the programme was being implemented in partnership with the World Food Programme and provincial governments. The participants of the meeting discussed issues related to coordination between the parties which will implement the programme and how to effectively address the issue of undergrowth and malnutrition in the country.


The meeting was infor­med that it is a three-year programme which delivers conditional cash transfers to vulnerable pregnant women, mothers and children under five and provide them specialised nutritious food, immunisations and health-awareness sessions.

Representatives from the federal and provincial ministries, Foreign Commonwealth and Deve­lopment Office, Wor­­­­­ld Bank, World Food Pro­gramme, Wor­ld Health Orga­nisation, Asian Develo­p­ment Bank and Unicef atten­ded the meeting. Nutri­tion under the Ehsaas progra­mme aims to support multi-sectoral stra­tegies through poor-friendly programmes by targeting mothers and children.

[Riaz Haq]

The special assistant (Dr. Faisal Sultan) said that China had donated 500,000 doses of the vaccine to Pakistan, while as many as 400,000 healthcare workers had already registered to get inoculated.

https://www.thenews.com.pk/print/781289-vaccination-to-begin-next-w...

It is pertinent to mention here that Pakistan may be receiving the Pfizer-BioNTech vaccine in the first quarter of the year under the World Health Organisation’s COVAX programme.

The global initiative signed an advance purchase agreement with the American pharmaceutical for up to 40 million doses of the Pfizer-BioNTech coronavirus vaccine candidate — which has already been approved for emergency use by the global health body.

Two days ago, the National Command and Operations Centre (NCOC) said that provinces have almost completed the training for the medical staff for the coronavirus immunisation drive which will be held in the country.

“[The] provinces have almost completed the training of the staff of teaching hospitals, Tehsil and District Head Quarters Hospitals regarding Covid-19 vaccination for swift inoculation of the vaccine,” read the press release from NCOC.

Government officials, in a meeting at the NCOC, discussed details of the complete procedure of vaccination, its time of availability, distribution process, and most demanding areas where it can be used at the earliest. The NCOC stressed the purchase of the quality of vaccination to ensure a successful treatment of COVID-19 patients.