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

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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Comment by Riaz Haq on January 28, 2021 at 8:50pm

9 people have died in vaccine rollout. India must disclose status of probe into each case

The deaths were reported from Uttar Pradesh, Karnataka, Andhra Pradesh, Rajasthan, Telengana, Gurugram and Odisha. The six men and three women who died were between 27 and 56 years old. The deaths took place between 24 hours and five days of taking the vaccines and all have been ascribed to cardiovascular problems or “brain stroke”. The vaccine taken in each case was Covishield.

https://scroll.in/article/985273/nine-health-workers-have-died-in-v...

Comment by Riaz Haq on January 29, 2021 at 6:52pm

#Pakistan expects to vaccinate 32 million people against #COVID19 at govt's expanse. #Sindh Medical Stores will import #AstraZeneca #vaccine for private sale at $13 a dose. Pak to get 45 million doses of #coronavirus vaccine through COVAX, co-led by WHO. https://www.npr.org/sections/goatsandsoda/2021/01/29/961258106/paki...


Here are three key takeaways from the conversation.

Worries about vaccine 'snatching'

The government hopes to begin its COVID-19 vaccine rollout by April at the latest. It will begin with frontline health-care workers. They number about 10 million people. Next will be Pakistan's elderly citizens, a cohort that numbers some 22 million people.

But even at this phase, there's concern that Pakistan's powerful elites could muscle in to obtain the free, government-provided vaccine.

They could do this by pressuring local health officials in charge of vaccinating particular districts to allow them priority access, threatening people administering the vaccine, or pressuring health officials to ensure they are offered the vaccine ahead of others. Elite Pakistanis could offer to pay for the vaccine, which could create a black market that would siphon off doses meant for high-priority people.

And if Pakistans with health vulnerabilities are eligible, that rule could likely favor elites. They are more likely to have access to health services and medical documents to demonstrate they have a condition that puts them at the head of the vaccination line. They also have access to the ears of decision-makers, from managers of health clinics to ministers.

Poor, less literate Pakistanis, particularly women and rural residents, will have far less sway, and so they'll be less likely to be part of the second cohort, unless there's a concerted effort to include them.

The concern that elites could elbow their way to the front of the line was most recently articulated by the former adviser to the prime minister on health.

"In developing countries such as ours, the influential people get vaccines first," said Zafar Mirza at a conference on Jan. 1, as reported by local media."The government, too, should take care that [the vaccine] should be given to those in line of priority, and there should not be any snatching."

There's one idea that could help address this conundrum: letting elites buy their own vaccines. Starting in the summer, the government will allow companies that import vaccines to conduct their own rollout.

"The government will be following its own plan, where they'll be focusing on the elderly and people with co-morbidities. But since the private sector will come in, other people can also get vaccinated," says Hayat.

So far, the government has given one Pakistani company, Sindh Medical Stores permission to import the AstraZeneca vaccine for private sale. Local media describes the company as "one of the biggest importers of vaccines and other pharmaceutical products in Pakistan." The company says it is likely to charge $13 for a dose, which they expect to be made available at large non-governmental hospitals. However, the company says it still has no timeframe on when it will be able to offer the AstraZeneca vaccine for sale because of stiff global competition on orders.

The government's decision to allow private vaccine sales reflects the stages of the rollout of COVID-19 testing. Initially the government was in charge. But weeks into the pandemic, diagnostic labs were given permission by the government to conduct tests for a fee. That appears to have helped boost testing numbers and reduce pressure on the government's free testing services.

Allowing Pakistanis to purchase the vaccine could lead to a similar result – reducing pressure on the government, with its scarce supplies, to vaccinate wealthier citizens.

Comment by Riaz Haq on January 30, 2021 at 5:10pm

The concept of vaccine nationalism has become a significant global concern, highlighted by the ongoing public spat between the European Union and British-Swedish drug maker AstraZeneca, which recently informed the bloc it would not be able to supply the number of vaccines the EU had hoped for by the end of March. EU leaders are furious the company appears to be fulfilling its deliveries for the UK market and not theirs.

https://www.cnn.com/2021/01/30/asia/coronavirus-vaccine-divide-paki...

"I think we can expect that it's not going to be all smooth sailing, as the vaccine manufacturing is scaled up and distribution happens," Nguyen said. "I think it's important for everyone to be able to be accountable to the commitments that they've made."
Nguyen said it was inevitable that initial vaccine demand would outstrip supply. "This is exactly the reason why COVAX was created, to avoid a bidding war for vaccines," she added.
"Without concerted effort, lower-income countries will be left behind because of the restrictions of their financial capabilities to be able to buy vaccines."
COVAX has so far raised $6 billion from wealthier countries and other organizations, including a giant injection of $4 billion from the US, approved by Congress in December. The Biden administration also announced it would join the global initiative.
"That's been a hugely welcome move on the part of the Biden-Harris administration," Nguyen said. "I think it's a very strong endorsement of the COVAX facility, of the aim to have a global and multilateral approach to fair and equitable access for Covid-19 vaccines."
Vaccinating 20% of people in the world's poorest countries, however, won't be enough to help their populations reach herd immunity. Although COVAX plans to expand the program for as long as it is needed, analysis by the Economist Intelligence Unit suggests huge swathes of Asia and Africa will not see widespread availability of Covid-19 vaccines until 2022 or 2023.

Comment by Riaz Haq on March 17, 2021 at 8:35am

Serum Institute of India’s (SII) CEO, Adar Poonawalla, told NDTV that only three vaccines had passed all the scientific evaluations -- Pfizer-BioNTech, Modera and Oxford-AstraZeneca -- and that while the others were safe, “safe like water”, their effectiveness had not yet been evaluated.

https://www.hindustantimes.com/india-news/phase-3-covaxin-data-in-f...

Sparks fly over ‘water’: Covaxin hits out at critics, says trials 200% honest
Experts pointed out that the government may have acted in haste, and the sentiment was echoed by some Opposition politicians who suggested that the Union government ignored scientific protocols to give the nod to a fully indigenous vaccine because it tied in with the Atmanirbhar Bharat slogan.

Bharat Biotech chairman and managing director, Krishna Ella, on Monday hit out at comments suggesting that its anti-coronavirus disease (Covid-19) vaccine, Covaxin, was “safe like water”, and said that their Phase 3 efficacy data, likely to be out by February or March, will silence all critics.

Though he did not take any names, Ella’s remarks appear to have sparked a rare war of words between vaccine-makers a day after Serum Institute of India’s (SII) CEO, Adar Poonawalla, told NDTV that only three vaccines had passed all the scientific evaluations -- Pfizer-BioNTech, Modera and Oxford-AstraZeneca -- and that while the others were safe, “safe like water”, their effectiveness had not yet been evaluated.

“It is easy to target Indian scientists. I had to tell this because some other company has branded my product as ‘safe like water’. Some local company in press yesterday said that safety is like water of other companies. Only three companies have done efficacy, and other vaccine is like water. I want to deny that. It hurts us as scientists; we work 24 hours and don’t deserve this type of bashing from people,” Ella told a media briefing.

Comment by Riaz Haq on March 18, 2021 at 12:50pm

#Pakistan imports #COVID19 #vaccines for private sale, starting with 50,000 doses of #Russia’s #SputnikV. Pakistan's 220 million is favored with a very young population and doctors believe they can still give jabs to 40 to 50 million people this year. https://www.telegraph.co.uk/global-health/science-and-disease/pakis...

Pakistan has begun importing Covid-19 vaccine for private sale, starting with 50,000 Sputnik V Russian shots.

The consignment will be the first of regular deliveries, officials said, and came as the country braces for a third wave of infections.

Officials have again closed schools and begun locking down hotspot neighbourhoods as the UK variant drives a new spike in cases. Pakistan has appeared to escape the heavy death tolls of many countries, but the coronavirus has again flared up in recent weeks.

Hospital daily admissions and the number of people in critical care were rising fast, said Asad Umar, the minister overseeing the government's Covid-19 response.

He said if compliance with the rules did not improve “we will be forced to place stronger restrictions on activities”.

“Please be very very careful. The new strain spreads faster and is more deadly.”

Pakistan's vaccination programme has until now relied on donations from China and allocations from the World Health Organisation's Covax scheme, which have yet to arrive.

The government last year gave permission for businesses to import vaccines, in a country where private hospitals and clinics fill gaps left by underfunded and overstretched public provision.

“This is the first shipment of 50,000 doses which came last night only,” an official of AG Pharma which imported the vaccine told Reuters. Local media reported another 150,000 doses were on their way.

Pakistan began vaccinating health workers six weeks ago and opened up jabs to the elderly last week. Shots have so far been donations from China, with a tranche of 17m Oxford AstraZeneca shots due from Covax, but currently delayed

It remains unclear how much private clinics will be able to charge for vaccinations. Pakistan had at first agreed that private firms would be able to sell vaccine without price caps, but that decision had been reversed, said health minister Dr Faisal Sultan.

“Now, however, there is a formula, already in vogue, to determine max price,” he said. “So yes, there is a price cap that DRAP (Drug Regulatory Authority of Pakistan) will recommend and get approval for,” he said.

The decision to allow commercial imports of the vaccine with an exemption on upper price caps had sparked criticism that it will create inequality.

Pakistan has a history of vaccine hesitancy and still sees stubbornly high numbers of people refuse to give their children polio shots. Officials fear a nationwide Covid vaccine roll out will be hit by similar scepticism.

But the country of around 220 million is favoured with a very young population and doctors believe they can still give jabs to 40 to 50 million people this year.

Comment by Riaz Haq on March 21, 2021 at 8:37pm

#India Battles a Second #COVID19 Wave and #Vaccine Skepticism. Confirmed infections have risen to about 31,600 daily from a low of about 9,800 in February. In a recent two-week period, deaths shot up 82%. #Modi #vaccinenationalism https://www.nytimes.com/2021/03/21/world/asia/india-covid19-vaccine...

The outbreak is centered on the state of Maharashtra, home to Mumbai, the country’s financial hub. Entire districts of the state have gone back into lockdown. Scientists are investigating whether a new strain found there is more virulent, like variants found in Britain, South Africa and Brazil.

Officials are under pressure from Prime Minister Narendra Modi to aggressively ramp up testing and vaccination, especially in Mumbai, to avoid disruptions like last year’s dramatic nationwide lockdown and resulting economic recession.

“I am very categorical that we should stop it, contain it, just here,” said Dr. Rahul Pandit, a critical care physician at a private hospital in Mumbai and a member of the Maharashtra Covid-19 task force.

India’s vaccination campaign could have global consequences.

Last week, Prime Minister Boris Johnson said that an expected drop in Britain’s Covid-19 vaccine supplies stemmed from a nearly monthlong delay in delivery of five million doses of the Oxford-AstraZeneca vaccine being manufactured in India. The reasons for the delay are not clear, but the manufacturer, Serum Institute of India, has said shipments will depend in part on domestic Indian needs.

India is a crucial link in the vaccination supply chain. Amid hoarding by the United States and other wealthy countries, India has given away or sold tens of millions of doses to other countries, even as it struggles to vaccinate its own people. Subrahmanyam Jaishankar, the foreign minister, has said that the availability of vaccines in India will determine how many doses go overseas.

While vaccinations were initially available only in public hospitals, India is now giving jabs in private clinics and enormous makeshift vaccination centers, and it is considering making them available in pharmacies, too. Vaccination hours have been extended, and those eligible can register in person and receive a shot the same day, bypassing an online scheduling system.

The Indian government is playing catch-up. Since it launched a nationwide vaccination drive two months ago, uptake has been disappointing. Less than 3 percent of the population has received a jab, including about half of health care workers. At the current rate, it will take India about a decade to vaccinate 70 percent of its people, according to one estimate. By comparison, roughly a quarter of the population of the United States has had at least one jab.

Not everybody in India has the internet access needed to register for a shot online. But the campaign has also been plagued by public skepticism. The government approved a domestically developed vaccine, called Covaxin, before its safety and efficacy trials were even over, though preliminary findings since then have suggested it works.

Comment by Riaz Haq on March 22, 2021 at 11:25am

Rich Countries Signed Away a Chance to Vaccinate the World. #US will control the patent that is at the heart of 5 major #Covid19 vaccines. US & #EU officials didn't use leverage to guarantee access for billions of people. This will prolong the #pandemic https://www.nytimes.com/2021/03/21/world/vaccine-patents-us-eu.html...

For months, the United States and European Union have blocked a proposal at the World Trade Organization that would waive intellectual property rights for Covid-19 vaccines and treatments. The application, put forward by South Africa and India with support from most developing nations, has been bogged down in procedural hearings.

“Every minute we are deadlocked in the negotiating room, people are dying,” said Mustaqeem De Gama, a South African diplomat who is involved in the talks.

---------------

Growing numbers of health officials and advocacy groups worldwide are calling for Western governments to use aggressive powers — most of them rarely or never used before — to force companies to publish vaccine recipes, share their know-how and ramp up manufacturing. Public health advocates have pleaded for help, including asking the Biden administration to use its patent to push for broader vaccine access.

Governments have resisted. By partnering with drug companies, Western leaders bought their way to the front of the line. But they also ignored years of warnings — and explicit calls from the World Health Organization — to include contract language that would have guaranteed doses for poor countries or encouraged companies to share their knowledge and the patents they control.

“It was like a run on toilet paper. Everybody was like, ‘Get out of my way. I’m gonna get that last package of Charmin,’” said Gregg Gonsalves, a Yale epidemiologist. “We just ran for the doses.”

--------------

In the coming days, a patent will finally be issued on a five-year-old invention, a feat of molecular engineering that is at the heart of at least five major Covid-19 vaccines. And the United States government will control that patent.

The new patent presents an opportunity — and some argue the last best chance — to exact leverage over the drug companies producing the vaccines and pressure them to expand access to less affluent countries.

The question is whether the government will do anything at all.

The rapid development of Covid-19 vaccines, achieved at record speed and financed by massive public funding in the United States, the European Union and Britain, represents a great triumph of the pandemic. Governments partnered with drugmakers, pouring in billions of dollars to procure raw materials, finance clinical trials and retrofit factories. Billions more were committed to buy the finished product.

But this Western success has created stark inequity. Residents of wealthy and middle-income countries have received about 90 percent of the nearly 400 million vaccines delivered so far. Under current projections, many of the rest will have to wait years.

Comment by Riaz Haq on March 24, 2021 at 7:46am

#Coronavirus: 'Double mutant' #Covid variant found in #India. India reported 47,262 cases and 275 deaths on Wednesday - the sharpest daily rise this year. #Modi #BJP https://www.bbc.com/news/world-asia-india-56507988

A new "double mutant" variant of the coronavirus has been detected from samples collected in India.

Officials are checking if the variant, where two mutations come together in the same virus, may be more infectious or less affected by vaccines.

Some 10,787 samples from 18 Indian states also showed up 771 cases of known variants - 736 of the UK, 34 of the South African and one Brazilian.

Officials say the variants are not linked to a spike in cases in India.

India reported 47,262 cases and 275 deaths on Wednesday - the sharpest daily rise this year.

The Indian SARS-CoV-2 Consortium on Genomics (INSACOG), a group of 10 national laboratories under India's health ministry, carried out genomic sequencing on the latest samples. Genomic sequencing is a testing process to map the entire genetic code of an organism - in this case, the virus.

The genetic code of the virus works like its instruction manual. Mutations in viruses are common but most of them are insignificant and do not cause any change in its ability to transmit or cause serious infection. But some mutations, like the ones in the UK or South Africa variant lineages, can make the virus more infectious and in some cases even deadlier.

Virologist Shahid Jameel explained that a "double mutation in key areas of the virus's spike protein may increase these risks and allow the virus to escape the immune system".

The spike protein is the part of the virus that it uses to penetrate human cells.

Comment by Riaz Haq on April 8, 2021 at 10:59am

#Indian #COVID #vaccine giant Serum Institute warns of supply hit from #US raw materials #export ban on bags, filters and critical items that manufacturers need. It goes against the global goal of sharing vaccines equitably. #AstraZeneca #Novavax https://reut.rs/3ei4nV7


A temporary U.S. ban on exports of critical raw materials could limit the production of coronavirus vaccines by companies such as the Serum Institute of India (SII), its chief executive said in a World Bank panel discussion here on Thursday.

SII, the world’s biggest vaccine maker, has licensed the AstraZeneca/Oxford University product and will soon start bulk-manufacturing the Novavax shot.

“There are a lot of bags, filters and critical items that manufacturers need,” Adar Poonawalla said. “The Novavax vaccine, which we are a major manufacturer of, needs these items from the U.S.”

He said the recent invocation of the U.S. Defence Production Act to preserve vaccine raw materials for its own companies went against the global goal of sharing vaccines equitably.

The White House said this week it had used the act to help drugmaker Merck & Co produce Johnson & Johnson’s COVID-19 vaccine.

“This really needs to be looked at because if they are talking about building capacity all over the world, the sharing of these critical raw materials, which just can’t be replaced in a matter of six months or a year, is going to become a critical limiting factor,” Poonawalla said.

India’s Biological E has tied up with J&J to potentially contract manufacture up to 600 million doses of its vaccine per year. They have signed an initial deal but production volumes have not been agreed upon.

Comment by Riaz Haq on April 9, 2021 at 6:55pm

#Mumbai in #lockdown as #Indian #vaccines run short. #Covid_19 pandemic grows worse after mass religious festivals, political rallies & spectators at #cricket matches. India adds more than a million new infections since late March. #Modi #BJP https://f24.my/7YQW.T via @FRANCE24

India's most coronavirus-hit state Maharashtra went into a weekend lockdown on Saturday as the country battles exploding infection numbers and vaccine shortages.

Having let its guard down with mass religious festivals, political rallies and spectators at cricket matches, the world's second most populous nation has added more than a million new infections since late March.

After a lockdown a year ago caused widespread misery and hit the economy for six, the central government is desperate to avoid a hugely unpopular second shutdown.

But many states are tightening the screw, in particular the epicentre Maharashtra and its capital Mumbai, where restaurants are shut and public gatherings of more than five people are banned.

Every weekend from Saturday until the end of April the state's 125 million people are confined to their homes unless shopping for food, medicine or travelling.

"I'm not for the lockdown at all but I don't think the government has any other choice," media professional Neha Tyagi, 27, told AFP in Mumbai.

"This lockdown could have been totally avoided if people would take the virus seriously."

Cricket is now played behind closed doors -- including the big-bucks Indian Premier League, which began Friday -- and in many states including in the capital New Delhi a night curfew is in force.

All eight teams in the IPL, which includes the sport's top international stars, are in strict bio-bubbles and four players have so far tested positive.

Raipur district, home to the capital of Chhattisgarh state, is under a 10-day lockdown with no one allowed to enter the area unless performing essential services.

- Short on stocks -

India's drive to vaccinate its 1.3 billion people also looks to be hitting problems, with just 94 million shots provided so far and stocks running low.

In megacity Mumbai, 25 out of 71 private hospitals administering jabs ran out of supplies Thursday, city authorities said.

The situation at government-run inoculation centres was not much better, with a giant 1,000-bed field hospital turning away people arriving for their first dose on Friday morning.

City authorities tweeted that the shortage was "due to non-receipt of stocks" from the national government.

The Times of India reported Friday that states on average had just over five days of stock left, according to health ministry data, with some regions already grappling with severe shortages.

But the central government has accused some states -- run by opposition parties -- of "distract(ing) attention from their failures" and playing politics.

"It is not right to say that there is a vaccine shortage. Vaccines have been made available to all states according to their needs," Home Minister Amit Shah said on Friday.

The CEO of the Serum Institute of India, the world's biggest vaccine maker by volume, has warned that production capacity is "very stressed".

Poorer countries, as well as some rich nations, have relied heavily on Serum for supplies of the AstraZeneca vaccine, but last month New Delhi put the brakes on exports to prioritise domestic needs.

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