'Prime Minister Narendra Modi could have prevented India's devastating Covid-19 crisis, critics say. He didn't

MODI MASS MURDERER 

SACRIFICING TO  KALI 

By Julia Hollingsworth, CNN

Sat May 1, 2021

(CNN) On April 17, ahead of a state election, a maskless Prime Minister Narendra Modi boasted to a sea of cheering supporters: "I've never ever seen such huge crowds at a rally."
His country was on the brink of a humanitarian crisis. That day, India recorded more than 261,000 new coronavirus cases -- more than many countries have seen during the entire pandemic.
And it was only going to get worse. Each day since April 22, the country has reported more than 300,000 new cases -- at times, up to half of the daily cases reported globally. The capital New Delhi is now running out of wood for cremations. Hospitals are full and lacking oxygen. Only 2% of the population has been fully vaccinated. Foreign leaders are now rushing to India's aid.

While Modi's Hindu nationalist Bharatiya Janata Party (BJP) spokesman Narendra Taneja told CNN this week that responsibility for India's second wave belonged "first and foremost" to the government, he maintained the crisis could not have been foreseen -- despite countless countries being battered by second waves as new variants emerged globally.

Others in Modi's orbit have argued state governments are to blame for not imposing regional lockdowns and mismanaging their health care systems. Last weekend, Health Minister Harsh Vardhan said oxygen shortages at hospitals were a problem not of supply but distribution, which he claimed was the responsibility of state governments.
But many in India believe responsibility lies with Modi and his Hindu nationalist government, which not only didn't prepare for a second wave but also encouraged mass gatherings at Hindu festivals and political rallies, including in a closely contested battleground state.
"The government has failed us all," Priyanka Gandhi Vadra, the general secretary of opposition party Indian National Congress, said in a statement this week. "Even those of us who oppose and fight them could not have foreseen a complete abdication of leadership and governance at a time as devastating as this."


Photos: India's Covid-19 crisis
People line up for vaccines at an indoor stadium in Guwahati on April 22.
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A relative of a Covid-19 victim breaks down during a cremation in New Delhi on April 20.
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Police officers patrol a deserted street in New Delhi on April 20. The capital city has been on lockdown because of Covid-19.
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Signs inform people that a vaccination center in Mumbai was out of vaccines on April 20.
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Migrant workers crowd the Kaushambi bus station on April 19. They were trying to return home after a lockdown order was announced in the capital.
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A woman waits to receive a Covid-19 vaccine in Mumbai on April 18.
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Relatives of a Covid-19 victim mourn for their loved one outside a government hospital in Ahmedabad on April 17.
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Migrant workers line up at a railway station to leave Mumbai ahead of a lockdown on April 14.
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People gather at a Srinagar mosque on the first day of Ramadan on April 14.
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A Hindu priest puts a face mask on an idol of the Goddess Ashapura during Navaratri celebrations in Beawar on April 13.
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Photos: India's Covid-19 crisis
Hindu holy men wade into the Ganges River during the Kumbh Mela religious festival on April 12. People also packed the streets of Haridwar for what is the largest religious pilgrimage on Earth, and the massive crowds created concern.
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Photos: India's Covid-19 crisis
Protesters wearing protective suits lie on a street near the Election Commission office in Kolkata on April 7. They were calling for a stop to the ongoing state legislative election and its associated campaign rallies.
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Children wear face shields at a martial-arts class in Kolkata on April 5.
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Supporters of the Bharatiya Janata Party wear masks of Prime Minister Narendra Modi during an election rally in Sonarpur on April 3.
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Social distancing was not easy to achieve as people walked through a busy market in Old Delhi on March 27.
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People wear protective suits while watching a relative's cremation in New Delhi on April 28. Their loved one died from Covid-19.
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A man performs the last rites of a deceased relative on April 30.
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A health worker collects a nasal swab sample to test for Covid-19 in Siliguri on April 30.
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Police personnel hold placards on their motorbikes during a Covid-19 awareness rally in Chennai on April 29.
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Workers prepare beds for a Covid-19 isolation center that was set up inside a stadium in Srinagar on April 27.
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Multiple funeral pyres burn in New Delhi on April 27.
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A health worker administers a Covid-19 test at a hospital in Noida on April 26.
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Umar Farooq mourns at the grave of his mother, a Covid-19 victim, in Srinagar.
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Health workers turn away an ambulance at the main entrance of the Lok Nayayak Jaiprakash Hospital in New Delhi on April 25.
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A worker digs a grave for a Covid-19 victim in Guwahati on April 25.
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A relative of a Covid-19 victim is consoled by another during a cremation in Jammu on April 25.
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People wait to refill their oxygen cylinders at a refilling station in Allahabad on April 24.
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A man inspects an intensive-care ward after a fire broke out at a Covid-19 hospital in Virar on April 23. At least 13 Covid-19 patients were killed in the fire.
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This aerial photo, taken with a drone, shows a mass cremation in New Delhi on April 22.
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Ambulances carrying Covid-19 patients line up outside a government hospital in Ahmedabad on April 22.
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Photos: India's Covid-19 crisis
People line up for vaccines at an indoor stadium in Guwahati on April 22.
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Photos: India's Covid-19 crisis
A relative of a Covid-19 victim breaks down during a cremation in New Delhi on April 20.
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Photos: India's Covid-19 crisis
Police officers patrol a deserted street in New Delhi on April 20. The capital city has been on lockdown because of Covid-19.
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Photos: India's Covid-19 crisis
Signs inform people that a vaccination center in Mumbai was out of vaccines on April 20.
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Photos: India's Covid-19 crisis
Migrant workers crowd the Kaushambi bus station on April 19. They were trying to return home after a lockdown order was announced in the capital.
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Photos: India's Covid-19 crisis
A woman waits to receive a Covid-19 vaccine in Mumbai on April 18.
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Photos: India's Covid-19 crisis
Relatives of a Covid-19 victim mourn for their loved one outside a government hospital in Ahmedabad on April 17.
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Photos: India's Covid-19 crisis
Migrant workers line up at a railway station to leave Mumbai ahead of a lockdown on April 14.
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Photos: India's Covid-19 crisis
People gather at a Srinagar mosque on the first day of Ramadan on April 14.
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Photos: India's Covid-19 crisis
A Hindu priest puts a face mask on an idol of the Goddess Ashapura during Navaratri celebrations in Beawar on April 13.
Hide Caption
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Photos: India's Covid-19 crisis
Hindu holy men wade into the Ganges River during the Kumbh Mela religious festival on April 12. People also packed the streets of Haridwar for what is the largest religious pilgrimage on Earth, and the massive crowds created concern.
Hide Caption
26 of 30


Photos: India's Covid-19 crisis
Protesters wearing protective suits lie on a street near the Election Commission office in Kolkata on April 7. They were calling for a stop to the ongoing state legislative election and its associated campaign rallies.
Hide Caption
27 of 30


Photos: India's Covid-19 crisis
Children wear face shields at a martial-arts class in Kolkata on April 5.
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Photos: India's Covid-19 crisis
Supporters of the Bharatiya Janata Party wear masks of Prime Minister Narendra Modi during an election rally in Sonarpur on April 3.
Hide Caption
29 of 30


Photos: India's Covid-19 crisis
Social distancing was not easy to achieve as people walked through a busy market in Old Delhi on March 27.
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Photos: India's Covid-19 crisis
People wear protective suits while watching a relative's cremation in New Delhi on April 28. Their loved one died from Covid-19.
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Photos: India's Covid-19 crisis
A man performs the last rites of a deceased relative on April 30.
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Photos: India's Covid-19 crisis
A health worker collects a nasal swab sample to test for Covid-19 in Siliguri on April 30.
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Photos: India's Covid-19 crisis
Police personnel hold placards on their motorbikes during a Covid-19 awareness rally in Chennai on April 29.
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Photos: India's Covid-19 crisis
Workers prepare beds for a Covid-19 isolation center that was set up inside a stadium in Srinagar on April 27.
Hide Caption
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Photos: India's Covid-19 crisis
Multiple funeral pyres burn in New Delhi on April 27.
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Photos: India's Covid-19 crisis
A health worker administers a Covid-19 test at a hospital in Noida on April 26.
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Umar Farooq mourns at the grave of his mother, a Covid-19 victim, in Srinagar.
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Photos: India's Covid-19 crisis
Health workers turn away an ambulance at the main entrance of the Lok Nayayak Jaiprakash Hospital in New Delhi on April 25.
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Photos: India's Covid-19 crisis
A worker digs a grave for a Covid-19 victim in Guwahati on April 25.
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Photos: India's Covid-19 crisis
A relative of a Covid-19 victim is consoled by another during a cremation in Jammu on April 25.
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Photos: India's Covid-19 crisis
People wait to refill their oxygen cylinders at a refilling station in Allahabad on April 24.
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Photos: India's Covid-19 crisis
A man inspects an intensive-care ward after a fire broke out at a Covid-19 hospital in Virar on April 23. At least 13 Covid-19 patients were killed in the fire.
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Photos: India's Covid-19 crisis
This aerial photo, taken with a drone, shows a mass cremation in New Delhi on April 22.
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Ambulances carrying Covid-19 patients line up outside a government hospital in Ahmedabad on April 22.
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Modi's pandemic PR moves

Modi has been keen to tie himself to positive aspects of India's pandemic responses.
Vaccinated Indians receive a certificate with his face on it. The Covid relief fund, a charitable trust which gathers voluntary contributions to help support those affected, is named PM Cares -- an acronym for Prime Minister's Citizen Assistance and Relief in Emergency Situations Fund. It also bears Modi's face on its official website.

With his name tied to these positive initiatives, a first wave that avoided the catastrophic caseload some experts feared, and a roaring pharmaceutical industry that had produced a homegrown vaccine, India's pandemic response was on track to be a PR win for Modi. The country was positioning itself to help other countries, having exported more than 66 million doses of vaccines, rather than be the one in need of aid.

"(India) has saved the world, entire humanity, from a major tragedy by effectively controlling coronavirus," Modi boasted at the World Economic Forum on January 28.
With many in India feeling the pandemic was over, there was a slower take-up of vaccines there than expected. About 300 million of India's 1.3 billion population are illiterate, meaning they may have had less ability to investigate what was going on for themselves.

"You can't blame people for thinking 'maybe the government knows best, maybe things are back to normal, maybe we should go out and live our normal lives,'" said Pradeep Taneja, an expert on Asian politics at the University of Melbourne and a fellow of the Australia India Institute.

But the pandemic was far from over. By February, cases were beginning to tick up. The BJP, however, still claimed India had "defeated Covid under the able, sensitive, committed and visionary leadership" of Modi.

On March 7, when the country reported about 18,000 new daily cases, the Health Minister Vardhan said India was in the "end game of the Covid-19 pandemic." And on March 30, a day before authorities reported more  than 81,000 cases in a single day, Vardhan said: "The situation is under control."

Yet mutations had been circulating overseas for months, and epidemiologists in India believed another wave was coming. While the second wave was inevitable, its size took everyone by surprise, said Ramanan Laxminarayan, an economist and epidemiologist at Princeton University who is in New Delhi.

"I think there was a premature sense of optimism among many that was probably unwarranted and in hindsight has ended up being quite deadly," he said.
Asia politics expert Taneja said: "Modi was complacent, even arrogant in thinking that India had succeeded when more developed countries, countries with much stronger health systems ... were struggling."

Fury over the second wave

As it became clear India's cases were spiraling, Modi stayed largely silent -- and a second nationwide lockdown that some expected never came. In a national address last month, he actively advocated against a nationwide lockdown.

Modi's apparent inaction prompted a wave of anger, spurring hundreds to share hashtags on Twitter such as #ModiMustResign and #ModiMadeDisaster. This week, the national vice president of the Indian Medical Association, Navjot Dahiya, called Modi a "super spreader" for holding political rallies and allowing millions of pilgrims to descend on Haridwar in northern India, to celebrate the Hindu festival Kumbh Mela, local media reported.

"People expect their governments to assure them that they are in charge and taking care of things ... but the government is almost missing in action," Pradeep Taneja said. "Now that India is facing the worse crisis, in my lifetime, certainly, where is the Prime Minister?"

Members of Prime Minister Narendra Modi's Bharatiya Janata Party continue to hold rallies despite a devastating second wave of coronavirus gripping the country.


Naked Hindu holy men take dips in the Ganges River during Kumbh Mela, one of the most sacred pilgrimages in Hinduism, in Haridwar, northern state of Uttarakhand, India, on April 12, 2021.

This sort of criticism of Modi is remarkable in a country where he is seen by many as a "saintly" figure who always acts in the national interest, according to Asim Ali, a researcher at the Delhi-based Centre for Policy Research think tank. Modi's landslide 2019 re-election for a second five-year term gave him a sweeping mandate to push his Hindu nationalist agenda, in a country where 80% of the population is Hindu.
Despite this, experts believe Modi was too concerned about losing support to impose another nationwide lockdown.

When on March 24, 2020, Modi announced an unprecedented nationwide lockdown, India had only reported 519 cases. Buses and trains were brought to a halt, cross-state travel was banned, and most people weren't allowed out of their house unless they were buying groceries. Some called it the world's strictest lockdown.

That lockdown lasted months in some parts of the country. Although cases eventually fell after peaking in September, the elongated lockdown hurt India's millions of daily wage workers. The country's economy shrank by a record 24% in the second quarter, and GDP contracted by 6.9% overall last year.

This time, Modi has instead advocated for "micro containment zones," where restrictions are focused on areas of concern. It's been up to states to decide when and how to implement them. So far, at least eight of India's states and territories have some form of lockdown, ranging from a curfew in Karnataka and Gujurat states to a full lockdown in New Delhi.

The crowd during the first T20 international match between India and England at Sardar Patel Stadium on March 12, 2021 in Ahmedabad, India.

Rajeev Sadanandan, a former bureaucrat in the health ministry of the state of Kerala and CEO of non-profit Health Systems Transformation Platform, said the reason for that was simple: "Last time, the lockdown was widely criticized as a failure" because it came at a huge economic cost and suffering to the poor.
The legislative elections held over the past month in Assam, West Bengal, Kerala and Tamil Nadu states, and Puducherry union territory, may have also been a factor. Two of those are BJP-run, while one -- West Bengal -- was a closely contested state. When asked why BJP had continued to hold rallies, the party's spokesman Taneja said the "autonomous" Election Commission of India allowed election events to proceed.
Michael Head, a senior research fellow in global health at the University of Southampton's Clinical Informatics Research Unit, said aside from restricting gatherings and having clearer messaging, the government could have curtailed cross-country travel -- as it did during the first lockdown.

Lack of preparedness

As India enjoyed a relative period of calm at the beginning of this year, Modi could have been preparing his country for another battle with Covid-19, patching up health care gaps in preparation for a possible future outbreak.

Pradeep Taneja said there was "criminal negligence on the part of the government" to not prepare for another wave despite knowing other countries with better health care systems had experienced multiple waves.

Both the US and the UK were hit harder by their second waves than their first, despite warnings from experts. In the US, White House trade adviser Peter Navarro said last June the US was preparing for a second wave by "filling the stockpile."

Despite local media in India reporting officials had warned of looming oxygen shortages in April last year, and then again in November, the government didn't appear to take action. Pradeep Taneja said it was "arrogant" for Modi to hold campaign rallies, rather than safeguarding the country's oxygen supplies.

The criticisms of the lack of preparedness in India's government, however, go beyond Modi.

In April, local media outlet The Caravan reported the country's national scientific taskforce -- a group intended to advise the central government on how to respond to the pandemic -- did not meet during February and March, as daily cases increased more than sixfold. CNN has contacted the chairman of the taskforce, V. K. Paul, for comment.
And India's health system has been underfunded for years. In 2018, India spent 3.5% of its GDP on health care, according to World Bank figures -- well below the world average of 10%, or the 17% spent in the US, which also battled to contain its Covid-19 outbreak. India has 0.9 physicians per 1,000 people, well under the world average of 1.6, or the US's 2.6, according to the World Bank.

As human rights activist Harsh Mander puts it, India had "starved" its public health systems for decades -- long before Modi's time in office.

An employee fills oxygen cylinders inside an oxygen filling centre on April 28, 2021 in Bengaluru, India.

Even before hospitals were overwhelmed, this impacted India's ability to monitor the virus. According to a paper published in February, India had only sequenced 0.06% of its reported cases. Its rate is lower than neighbors Sri Lanka and Bangladesh.

Sadanandan, the former Kerela health official, said most parts of India did not have an adequate surveillance system to keep track of the outbreak. But to him, that was a state-level failing -- not a central government one -- as health is a state issue. "I'm not surprised by what has happened because we've seen this happen for many epidemics," he noted.

Was it all Modi's fault?

To critics, while state leaders have some blame to bear, ultimately if Modi is going to take credit for India's pandemic wins, he also needs to take responsibility for its pandemic failings.

His extraordinary popularity means his actions have power -- so underplaying the risk of the pandemic could have influenced how millions of his followers across the country acted. By the start of this year, many people in India stopped wearing masks and many social distancing measures had fallen by the wayside.

It's too early to know if the grim scenes India is witnessing will tarnish Modi's reputation. There are still three years before the next general election, and Modi has no clear challenger.

Supporters of Bharatiya Janata Party (BJP) wave towards a helicopter carrying Indian Prime Minister Narendra Modi upon his arrival at a public rally at Kawakhali on the outskirts of Siliguri on April 10, 2021.

But Taneja expects to see a "significant reevaluation of the Modi government by the Indian public."
"No single person can be blamed for the catastrophe that India finds itself in. But if you are the Prime Minister, clearly the primary responsibility falls on you," he said.
Barkha Dutt, a Washington Post columnist whose father died from Covid a few days ago, said her father's last words were: "I'm choking. Please give me treatment." She felt angry and betrayed that as people across India battled the virus, politicians were still holding rallies. Dutt described Modi's government as "callousness," "tone deaf" and in "complete denial."

She said the health care system had clearly collapsed -- but that wasn't the fault of doctors, hospitals or frontline workers.

"We've been failed by the government that did not think to put in place a contingency plan for the second wave," she said. "Is anyone going to take accountability for the thousands that are dying?"

Esha Mitra and Manveena Suri contributed reporting from New Delhi. Akanksha Sharma contributed reporting from Hong Kong.

India Covid crisis: government ignored warnings on variant, scientists say

Country’s government failed to impose extra restrictions despite warnings of a new, more dangerous strain in early March, experts claim

A relative of a person who died of Covid-19 breaks down during cremation in Jammu, India, Photograph: Channi Anand/AP

Reuters
Sat 1 May 2021 

A panel of Indian scientists warned officials in early March of a new and more contagious variant of the coronavirus taking hold in the country, it has emerged.

Despite the warning, four of the scientists said the federal government did not seek to impose major restrictions to stop the spread of the virus, Reuters reported on Saturday. Millions of largely unmasked people attended religious festivals and political rallies that were held by prime minister Narendra Modi, leaders of the ruling Bharatiya Janata party and opposition politicians.

Tens of thousands of farmers, meanwhile, continued to camp on the edge of New Delhi protesting Modi’s agricultural policy changes.


‘We are witnessing a crime against humanity’: Arundhati Roy on India’s Covid catastrophe

The world’s second-most populous country is now struggling to contain a second wave of infections much more severe than its first last year, which some scientists say is being accelerated by the new variant and another variant first detected in Britain.

05:03The Hindu priest struggling to cremate India’s Covid dead – video

India reported another world record 401,993 new coronavirus cases on Saturday, while deaths from Covid-19 jumped by 3,523 over the past 24 hours. Experts believe the real figures are far higher.]

Compounding the misery, a fire broke out in a Covid-19 hospital ward in western India early Saturday, killing 18 patients. The fire, which broke out at the Welfare Hospital in Bharuch, a town in Gujarat state, was extinguished within an hour, police said. The cause was being investigated.

The spike in infections is India’s biggest crisis since Modi took office in 2014. It remains to be seen how his handling of it might affect Modi or his party politically.

The warning about the new variant in early March was issued by the Indian Sars-CoV-2 genetics consortium, or Insacog. It was conveyed to a top official who reports directly to the prime minister, according to one of the scientists, the director of a research centre in northern India who spoke on condition of anonymity.

Reuters could not determine whether the Insacog findings were passed on to Modi himself. Modi’s office did not respond to a request for comment from Reuters.

Insacog was set up as a forum of scientific advisers by the government in late December specifically to detect genomic variants of the coronavirus that might threaten public health. Insacog brings together 10 national laboratories capable of studying virus variants.

Indian Prime Minister Narendra Modi and his BJP party continued to hold election rallies despite fears of a surge in Covid infections Photograph: Diptendu Dutta/AFP/Getty Images

Insacog researchers first detected B.1.617, which is now known as the Indian variant of the virus, as early as February, Ajay Parida, director of the state-run Institute of Life Sciences and a member of Insacog, told Reuters.

Insacog shared its findings with the health ministry’s National Centre for Disease Control (NCDC) before 10 March, warning that infections could quickly increase in parts of the country, the director of the northern India research centre told Reuters.

The findings were then passed on to the Indian health ministry, this person said. The health ministry did not respond to requests for comment.

Around that date, Insacog began to prepare a draft media statement for the health ministry. A version of that draft, seen by Reuters, set out the forum’s findings: the new Indian variant had two significant mutations to the portion of the virus that attaches to human cells, and it had been traced in 15% to 20% of samples from Maharashtra, India’s worst-affected state.


‘We are not special’: how triumphalism led India to Covid-19 disaster

The draft statement said that the mutations, called E484Q and L452R, were of “high concern.” It said that mutated versions of the virus could more easily enter a human cell and counter a person’s immune response to it.

The ministry made the findings public about two weeks later, on 24 March, when it issued a statement to the media that did not include the words “high concern”. The statement said only that more problematic variants required following measures already under way – increased testing and quarantine.

Hindus take dips in the Ganges River during Kumbh Mela, or pitcher festival, one of the most sacred pilgrimages in Hinduism, in Haridwar, India Photograph: Karma Sonam/AP

Asked why the government did not respond more forcefully to the findings, for example by restricting large gatherings, Shahid Jameel, chair of the scientific advisory group of Insacog, said he was concerned that authorities were not paying enough attention to the evidence as they set policy.

“Policy has to be based on evidence and not the other way around,” he said. “I am worried that science was not taken into account to drive policy. But I know where my jurisdiction stops. As scientists we provide the evidence, policymaking is the job of the government.”

The northern India research centre director told Reuters the draft media release was sent to the most senior bureaucrat in the country, cabinet secretary Rajiv Gauba, who reports directly to the prime minister. Gauba did not respond to a request for comment.

The government took no steps to prevent gatherings that might hasten the spread of the new variant, as new infections quadrupled by 1 April from a month earlier.

Modi, some of his top lieutenants, and dozens of other politicians, including opposition figures, held rallies across the country for local elections throughout March and into April.

The government also allowed the weeks-long Kumbh Mela religious festival, attended by millions of Hindus, to proceed from mid-March. Meanwhile, tens of thousands of farmers were allowed to remain camped on the outskirts of the capital New Delhi to protest against new agriculture laws.

“We are in a very grave situation,” said Shanta Dutta, a medical research scientist at the state-run National Institute of Cholera and Enteric Diseases. “People listen to politicians more than scientists.”

The Indian variant has now reached at least 17 countries including Britain, Switzerland and Iran, leading several governments to close their borders to people travelling from India.

Is Russia’s COVID-19 vaccine safe? Brazil’s veto of Sputnik V sparks lawsuit threat and confusion

These Russian-made doses of the Sputnik V COVID-19 vaccine can’t be imported yet into Brazil because a regulatory agency there believes they contain infectious common cold viruses. ANDREY RUDAKOV/BLOOMBERG VIA GETTY IMAGES

By Sofia Moutinho, Meredith Wadman

Apr. 30, 2021 , 
Science’s COVID-19 reporting is supported by the Heising-Simons Foundation.


A confusing and unusually nasty fight broke out this week over the safety of a Russian COVID-19 vaccine known as Sputnik V after a Brazilian health agency declined on Monday to authorize its import because of quality and safety concerns. The stakes escalated yesterday when the Twitter account officially associated with the vaccine said “Sputnik V is undertaking a legal defamation proceeding” against Brazil’s regulators.

In an online press conference several hours later, the Brazilian Health Regulatory Agency (Anvisa) defended its decision, maintaining that documentation from some of the Russian facilities making Sputnik V shows that one of its two doses contains adenoviruses capable of replication, a potential danger to vaccine recipients. The vaccine uses two different adenoviruses, which cause the common cold, to deliver the gene for the spike protein of SARS-CoV-2, the virus that causes COVD-19. Both are supposed to be stripped of a key gene that allows them to replicate.

The Monday announcement left many scientists and media outlets believing Anvisa had directly tested Sputnik V for replicating adenoviruses, which would be unusual for a regulatory agency. But Anvisa has since clarified—it had not and was relying on information provided by the Gamaleya National Center of Epidemiology and Microbiology, the Moscow-based developer of the vaccine.

“The data we evaluated shows the presence of replicating virus,” Gustavo Mendes, general manager of medicines and biological products at Anvisa, said at the press conference. Anvisa would not accept the vaccine, he said, without further studies to indicate it is safe.

Gamaleya said in a statement on its website that Anvisa’s allegations “have no scientific grounds and cannot be treated seriously.” The research institute added that “no replication-competent adenoviruses (RCA) were ever found in any of the Sputnik V vaccine batches” and said a four-stage purification process prevents contamination.

The furor comes as Brazil, which has one of the highest burdens of COVID-19 in the world, is desperately trying to expand its vaccination campaign. The country has vaccinated just 14% of its people with a first dose and governors from some states hoped to bolster that effort by grouping together to buy 30 million doses of Sputnik V.

The spat has bewildered and divided outsider observers, in Brazil and elsewhere. Some scientists have used social media to decry the apparent contamination and some have denounced the aggressive response by Sputnik V’s backers, who were already under fire for releasing little data on the vaccine’s safety record. On Wednesday, an agency of the European Union also issued a report criticizing Russia’s promotional effort for Sputnik V for providing disinformation.

Other scientists, however, have questioned whether Anvisa appropriately interpreted the information provided by Sputnik V’s makers, and whether the media has too readily accepted the agency’s claim that the vaccine is contaminated. The stakes are high because Sputnik V has been authorized for use in more than 60 countries, although neither the World Health Organization nor the European Medicines Agency has yet authorized it. “We need this vaccine. It’s cheap. It’s effective. It’s easy to store and transport,” says Hildegund Ertl, an adenovirus vaccine scientist at the Wistar Institute. “If the press could just take a deep breath before they rush to conclusions it would really help us all.”

One of the scientists who criticized Sputnik V this week on Twitter said she is keeping an open mind. “I will be glad to correct myself in public should the data be shared,” says

Angela Rasmussen, a virologist at the Vaccine and Infectious Disease Organization at the University of Saskatchewan. (Her Twitter thread about Anvisa’s decision got a response from Sputnik V’s account that read “please do not spread fake news.”)
Viruses reborn?

The Anvisa review of Sputnik V was triggered because the Brazilian governors needed the agency’s sign-off to import the vaccine. Although complaints about Russia’s lack of transparency with Sputnik V data have simmered for months, many public health officials and scientists worldwide had been reassured when The Lancet recently published results from nearly 20,000 people in a clinical trial. The study showed the vaccine was safe and had an efficacy of 91.6% at preventing symptomatic COVID-19.

Both of the adenoviruses that make up Sputnik V, known as Ad5 and Ad26, are churned out by cultured human cells called HEK293 cells. The adenoviruses ferry the coronavirus spike gene to the vaccine recipient’s cells, which then make spike, prompting an immune response. In order to stop the adenoviruses from replicating once inside their human host, the vaccinemaker removed a gene they need for reproduction, called E1. The viruses can copy themselves in HEK293 cells, which are engineered to have a stand-in E1 gene, but they are not supposed to be able to replicate once they are separated from the human cells and packaged in the final vaccine product.

It’s long been known that Ad5 can on rare occasions acquire the E1 gene from the HEK293 cells, converting what is supposed to be a crippled virus into an RCA. Although adenoviruses typically cause mild colds, they can rarely kill people, and immunocompromised people who receive a vaccine that inadvertently contains RCAs could be at particular risk.

Vaccinemakers and others have developed tests to check for replicating adenoviruses in their products. Anvisa said that although the standard worldwide has been zero tolerance for the presence of replicating adenovirus in the vaccine, Gamaleya established an acceptable limit of 5000 replication-capable virus particles per vaccine dose. The Russian quality control documents displayed by Anvisa during the press conference state the batches tested had “less than 100” replication-capable particles per dose.

During yesterday’s press conference, Mendes also showed video of parts of an online meeting in March between officials from Anvisa and the vaccine’s developer. In one of the clips, Anvisa officials ask Gamaleya representatives why they had not changed their production methods once they “had detected the RCA occurrence in your production” The Gamaleya representatives responded that they were aware of the risk, but that changing the process “would take too much time.”

Mendes noted that Anvisa has analyzed the quality control documentation on other adenovirus-based COVID-19 vaccines, such as those made by AstraZeneca and Johnson & Johnson, and found no evidence of replication-competent viruses in those companies’ final products.

Immunologist Jorge Kalil, a vaccine expert at the Federal University of São Paulo, São Paulo, and member of the Data and Safety Monitoring Board at the U.S. National Institutes of Health, disagrees with Anvisa’s interpretation. He believes Russian quality-control documents are actually referring to the sensitivity of the testing. “When the Russians say ‘less than 100 parts per dose’ they are not saying if there are replicant viruses [in the dose] or not,” he contends. “What they are saying is that if there are viruses, they are [there] in less than 100 parts per dose.”

Mendes told Science this is not the case and that if it were, Gamaleya would have reported “no detection.” One way or the other, Anvisa won’t tolerate replicating virus in the vaccine and needs more assurance there is none. “The limit for us is zero,” agency President, Antonio Barras said during the press conference.
Other quality concerns

Anvisa also reported a long list of other issues with the vaccine that it wants the Russians to address. Those include the lack of detailed information on the 63 cases of adverse events and four deaths reported during the clinical trial. (The Lancet paper on Sputnik V’s efficacy trial reported no serious adverse events or deaths were deemed to be related to vaccination.)

The Brazilian agency also complains that during an inspection trip to Russia in April its technicians were only allowed to visit three of seven manufacturing sites—and were not allowed to visit Gamaleya’s quality-control center. As a result, “It is not possible to verify the existence of standards within the … facilities,” according to an Anvisa report published Monday with the veto announcement.

“So, the word that sums up the visit to Russia is frustration,” Anvisa Director Alex Machado Campos said during the Monday discussion on the import vote, according to a video of the event.

Mendes yesterday said these issues alone, even without the possible presence of the replicating adenovirus, “would be enough to reject” the import request. It was the totality of the deficiencies that led to Anvisa’s decision, he says.
Unnecessary turmoil

The outcome has dismayed many in Brazil, who were hoping Sputnik V would help them blunt the nation’s out-of-control epidemic. Brazil’s former science minister, Sergio Rezende, who is part of the scientific board supporting the state governors who requested the vaccine, says he was surprised by how Anvisa presented information on Monday. He was among those who believed Anvisa said it had directly tested Sputnik V for replicating adenoviruses. “Most people don’t know that Anvisa does not have a laboratory, so this is very serious because Anvisa is an agency that has credibility,” Rezende says.

He still doubts the agency's decision, even after the press conference. “Anvisa did not clarify anything,” he says, noting that the governors have sent new technical documentation from Gamaleya to Anvisa and that they may appeal Anvisa’s decision to Brazil’s Supreme Court.

Immunologist Ricardo Gazzinelli, president of the Brazilian Immunology Society, calls the political fight around Anvisa’s decision “an unnecessary turmoil.” He believes all the vaccine concerns listed by the regulatory agency are basic and easily addressed. “Sputnik should have responded to [Anvisa’s considerations] instead of starting a fight.”

Anvisa officials say Sputnik V’s makers have not sought a meeting to address the agency’s concerns and that if Gamaleya clarifies the issues raised by the regulatory agency, the import ban can still be reversed. “We have made demands and we are waiting for the response,” Mendes says. “Sputnik V is not out of the question” for use in Brazil, he says.

SPACE RACE 2.5;

BILLIONAIRE VS BILLIONAIRE

NASA suspends SpaceX’s $2.9 billion moon lander contract after rivals protest

SpaceX won’t receive NASA funding until the GAO resolves two formal protests

By Joey Roulette Apr 30, 2021,

A digital illustration of SpaceX’s Starship lunar lander sitting on the Moon’s surface, as proposed to NASA under its Artemis program. Image: SpaceX

NASA has suspended work on SpaceX’s new $2.9 billion lunar lander contract while a federal watchdog agency adjudicates two protests over the award, the agency said Friday.

Putting the Human Landing System (or HLS) work on hold until the GAO makes a decision on the two protests means SpaceX won’t immediately receive its first chunk of the $2.9 billion award, nor will it commence the initial talks with NASA that would normally take place at the onset of a major contract.

Elon Musk’s SpaceX was picked by NASA on April 16th to build the agency’s first human lunar lander since the Apollo program, as the agency opted to rely on just one company for a high-profile contract that many in the space industry expected to go to two companies.

As a result, two companies that were in the running for the contract, Blue Origin and Dynetics, protested NASA’s decision to the Government Accountability Office, which adjudicates bidding disputes. Blue Origin alleges the agency unfairly “moved the goalposts at the last minute” and endangered NASA’s speedy 2024 timeline by only picking SpaceX.

“Pursuant to the GAO protests, NASA instructed SpaceX that progress on the HLS contract has been suspended until GAO resolves all outstanding litigation related to this procurement,” NASA spokeswoman Monica Witt said in a statement.

Starship, SpaceX’s fully reusable rocket system under development to eventually ferry humans and cargo to the Moon and Mars, won NASA’s award mainly for its massive cargo capability and its proposed bid of $2.9 billion — far cheaper than Blue Origin’s and Dynetics’, according to a NASA source selection document.

Starship’s development to this point has been driven primarily by Musk, SpaceX’s billionaire founder and chief executive. The company has launched several Starship prototypes in short- and high-altitude test flights at its Boca Chica, Texas, launch facilities. Landing the prototypes after soaring over six miles in the air has proved to be a formidable challenge — all of SpaceX’s high-altitude prototype rockets have been destroyed in landing-phase explosions.

SpaceX’s private Starship development will likely continue. The company’s most recent test of a Starship prototype, SN15, is slated to launch within the next few days after clinching license approval from the Federal Aviation Administration this week.

NASA has said picking one company was the best decision it could make at the time with the funds made available from Congress. Last year, Congress gave the agency $850 million of the $3.3 billion it requested to procure two lunar landers.

SpaceX’s award was a key “first step” in a broader program to secure transportation to the Moon, NASA’s human spaceflight chief Kathy Lueders said at the time, promising that new contract opportunities will open up in the near future.