How one Indian company could be world's door to a COVID-19 vaccine

PUNE (Reuters) – If the world is to gain access to a vaccine for COVID-19, there’s a good chance it will pass through the doors of Serum Institute of India.

Serum Institute, the world’s largest manufacturer of vaccines by volume, is working on several candidates for the novel coronavirus – including potentially mass-producing the AstraZeneca/Oxford university one that has garnered global headlines – as well as developing its own.

The efforts are partly being shepherded by Umesh Shaligram, the head of research and development. His employer is a private company but every day, shortly before midnight, he receives a WhatsApp message from the government asking for updates, and about any new hurdles he faces.

The message is usually from K. VijayRaghavan, Prime Minister Narendra Modi’s top scientific adviser – an indication of the critical, and even strategically important, nature of the race to develop the vaccines the whole world is waiting for.

Shaligram promptly responds with a progress report and details any bottlenecks.

“Any delays, you just tell them,” said Shaligram, adding the government has been doing everything it can to fast-track clearances, and resolve import delays and other issues.

“We have begun to see approvals come through in days, even on a Sunday night, for trials and things like that,” he said, noting some of these processes typically took 4 to 6 months.

While most of the attention regarding vaccines typically goes to the pharmaceutical developer, India quietly plays a key role in manufacturing 60%-70% of all vaccines sold globally with the Serum Institute playing a lead role, said the company’s Chief Executive Adar Poonawalla.

At the company’s sprawling, 150-acre campus in the western Indian city of Pune, Shaligram and his team are working flat-out. Dozens of buses ferry in hundreds of workers each day to the grounds, which are buzzing with activity even as the city around it remains largely under lockdown.

The push comes as the number of cases of COVID-19, both globally and domestically, continue to surge and world leaders look to vaccines as the only real way to restart their stalled economies, even though none have yet been proven to be effective against the coronavirus.

Poonawalla, whose family owns he vaccine maker, said scientists, drugmakers and manufacturers were collaborating at an unparalleled scale to spur development and availability.

“We are all in a race to battle the disease, there is no one-upmanship here,” he told Reuters, sitting in his office beside his family’s 74-year-old stud farm.

VACCINE CANDIDATES

Serum, founded in 1966 by Adar’s father Cyrus Poonawalla, has partnered with U.S. biotech firm Codagenix, its U.S. rival Novavax (NVAX.O) and Austria’s Themis to potentially manufacture three COVID-19 vaccine candidates that are still in development.

Another candidate in the works is the experimental vaccine developed by a team at the University of Oxford and now licensed to drugmaker AstraZeneca (AZN.L), with whom Serum are in talks to mass produce the vaccine, which is now in the clinical trial stage.

The United States has secured almost a third of the first 1 billion doses planned for the potential vaccine, initially known as ChAdOx1 and now as AZD1222, by pledging up to $1.2 billion.

Poonawalla aims to initially produce 4-5 million doses a month, beginning from June, and then gradually ramp up to 350-400 million doses a year.

“Hopefully we will build a stock of a few million doses to give to our country and other high-risk areas across the globe come October-November when the trials ought to be concluded,” the 39-year-old said, while giving Reuters rare access to tour his facilities.

He added he had been given to understand by the development team that the trials had an 80% chance of success, given that the vaccine is based on a tried-and-tested platform.

Based on the information currently available, Poonawalla also said he anticipated AZD1222 would be a single-dose vaccine and not require a booster dose.

He sees AZD1222 potentially priced at about 1,000 rupees ($13) per dose in India, but expects it will be procured and distributed by governments without charge.

Serum is also working on developing its own in-house vaccine options to tackle the disease, Poonawalla said.

VIALS, TUBES, CHEMICALS

Even if a vaccine does succeed, a treatment to fight COVID-19 would still be required, said Poonawalla, noting some people do not get the desired immune response, even if vaccinated.

“You may get mild symptoms, you may get severe symptoms. It depends on your system, but there is a chance,” he added. “Not all vaccines are fully effective.”

The Serum Institute produces more than 1.5 billion doses of vaccines every year, for everything from polio to measles.

Poonawalla says that gave the company an edge in securing supplies of vials and high-quality chemicals required to make a vaccine in bulk once all approvals are in place.

“We have partnered with many of our suppliers to have one to two-year inventories of glass vials and tubing glass stocked in advance, so luckily for us that won’t be an issue.”

Any successful vaccine is however bound to be in short supply at first, he stressed.

India recorded more than 6,000 new cases of the coronavirus on Friday, bringing its total to over 118,000 cases with more than 3,500 deaths, even as it gradually begins to ease its nearly two-month long nationwide lockdown.

There have been more than 5 million infections and over 330,000 deaths reported worldwide.

The Indian government stands ready to cover the costs of trials of any vaccine in the country, said Poonawalla, adding that the government had also expressed interest in placing advance orders for a potential vaccine.

“We’ve reached out and they have been very positive,” he added. “But we’ve said hold on … as we don’t want to take government money until we are very confident we can deliver.”

UNLOCKING VALUE IN THE ‘HYPE’

Serum, one of the few companies ramping up hiring during the health crisis, is also designing a separate facility to make vaccines for pandemic-level diseases that could handle 90% of the current vaccine candidates being developed, beyond just the COVID-19 ones.

That facility, which will be ready in the next two to three years, would be able to potentially churn out 700-800 million doses a year, according to Poonawalla.

The CEO said he considered taking the company public some years ago to fund some large acquisitions, but changed course when the deals fell through.

Now he’s considering a different approach. He is exploring creating a holding entity that will host the company’s pandemic-level technologies, including manufacturing rights, intellectual property and the sale of all of Serum’s COVID-19-related candidates, and selling a minority stake in the venture.

“That will unlock value in the main hype,” he said.

Poonawalla said he had engaged bankers to test the waters on this, but stressed he would only consider selling a stake to ethical, long-term funds or sovereign funds that do not expect huge returns and want to “make a difference to the world”.

“After getting them onboard, I don’t want to be in a situation where I have to charge high prices to give them returns.”

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Italy government wins Senate confidence vote on decree to help virus-hit economy

ROME (Reuters) – The Italian government on Thursday won a confidence vote in the Senate on an emergency decree that lays out measures worth 25 billion euros ($28 billion) to support the economy battered by a severe COVID-19 outbreak.

The package, dubbed the “Heal Italy” decree and presented by Prime Minister Giuseppe Conte on March 16, suspends loan and mortgage repayments for hard-hit companies and families via state guarantees for banks.

Among other measures, it also increases funds to help firms pay workers temporarily laid off as a result of a lockdown imposed by the government to try to curb the spread of the coronavirus disease.

The ruling coalition dominated by the anti-establishment 5-Star Movement and the centre-left Democratic Party won the Senate motion by 142 votes to 99.

The decree was contested by the opposition, spearheaded by Matteo Salvini’s right-wing League party, which said the package was insufficient and bedevilled by bureaucracy which made it hard for people to access the funds available.

Since the March 16 initiative, the government has presented two more decrees aimed at helping the most needy with basic provisions, and offering guarantees to banks to try to ensure that credit and liquidity to companies does not dry up.

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Flatter or fight? Governors seeking help amid coronavirus pandemic must navigate Trump. – The Denver Post

SACRAMENTO, Calif. — At first, Illinois Gov. J.B. Pritzker tried to play nice. He limited criticisms of the federal government’s handling of the coronavirus pandemic and asked for medical supplies through official channels.

But nothing came, so he went on television. The first-term Democrat blasted the Trump administration on Sunday on CNN for failing to help states obtain masks, gloves and other protective gear.

It got President Donald Trump’s attention. After a Twitter feud and some mudslinging (Pritzker compared Trump to a “carnival barker”), the two got on the phone Monday, and Trump promised Illinois 250,000 masks and 300 ventilators.

Facing an unprecedented public health crisis, governors are trying to get what they need from Washington, and fast. But often that means navigating the disorienting politics of dealing with Trump, an unpredictable president with a love for cable news and a penchant for retribution.

Republicans and Democrats alike are testing whether to fight or flatter, whether to back channel requests or go public, all in an attempt to get Trump’s attention and his assurances.

At stake may be access to masks, ventilators and other personal protective gear critically needed by health care workers, as well as field hospitals and federal cash. As Gov. Gretchen Whitmer, D-Mich., put it: “I can’t afford to have a fight with the White House.”

Underlying this political dance is Trump’s tendency to talk about the government as though it’s his own private business. The former real estate mogul often discusses government business like a transaction dependent on relationships or personal advantage, rather than a national obligation.

“We are doing very well with, I think, almost all of the governors, for the most part,” he said during a town hall on Fox News on Tuesday. “But you know, it’s a two-way street. They have to treat us well.”

Such statements have some governors treading lightly. In a twist, some of the more flattering governors are Democrats.

Perhaps no governor’s approach is more uncharacteristic than that of California’s Gavin Newsom, a Democrat whose state calls itself the “resistance” to Trump. Newsom, usually a fierce Trump critic, has gone out of way not to lay the federal government’s failings during the coronavirus outbreak at Trump’s feet.

Newsom complimented Trump for “his focus on treatments” for the virus and thanked him for sending masks and gloves to California. He said the president was “on top of it” when it came to improving testing and said Trump was aware “even before I offered my own insight” of the state’s need for more testing swabs.

It’s an approach informed by Newsom’s past dealing with Trump during devastating wildfires. While Trump always has approved California’s requests for disaster declaration following fires, just days into Newsom’s tenure last year Trump threatened the state’s access to disaster relief money. Newsom also knows Trump is a careful watcher of his words and actions.

Trump has kept a close eye on the coronavirus media coverage and noted which local officials were praising or criticizing him, according to three aides who spoke on condition on anonymity because they were not authorized to publicly discuss the president’s private deliberations. In conversations, Trump has blasted Whitmer and praised Newsom, they said.

There’s no evidence that Trump has held up a governor’s request for assistance for personal or political reasons. Still aides say it’s understood that governors who say nice things about the federal response are more likely to be spared public criticism from the White House or threats of withheld assistance.

Trump approved California’s request for a statewide disaster declaration within hours of Newsom asking on Sunday. Trump also has sent a Naval medical ship as well as eight field hospitals. New Jersey will be getting four field hospitals after a phone call between the president and Democratic Gov. Phil Murphy, who has not criticized the president during the crisis.

Republican governors are navigating particularly difficult waters, knowing that any comments viewed as critical of the president could anger Trump’s loyal fans in their state. Some Republicans spoke out against Trump’s talk of reopening the U.S. economy by Easter in mid-April. Gov. Larry Hogan of Maryland, head of the nonpartisan National Governors Association, called the White House messaging “confusing.”

Others tried to avoid directly contradicting Trump, even as they contradicted Trump.

“The best thing we can do to get the economy going is to get COVID-19 behind us,” Gov. Greg Abbott, R-Texas, said as he urged Texans to follow restrictions on travel, public life and commerce.

GOP Gov. Mike DeWine of Ohio, who lead on the early action, described himself as “aligned” with Trump, but then also noted the state’s model did not show cases peaking until May 1. DeWine appealed to Ohioans to continue to stay home to limit the spread of the virus.

Those close to DeWine say he understands the importance of picking his battles.

“I think he recognizes this unprecedented once-in-a-century situation is bigger than politics,” said Ryan Stubenrauch, a former DeWine policy and campaign staffer.

It’s unusual to see a president and governors publicly feuding and name-calling while their country teeters on the brink of disaster. In past recent crises, presidents and state leaders have gone out of their way to show that politics plays no role in disaster response, and to project the appearance of cooperation. In 2005, as Republican President George W. Bush’s administration received criticism for its handling of Hurricane Katrina in New Orleans, there was never a sense he was withholding help for personal reasons, said former Sen. Mary Landrieu, D-La.

“I never had to worry that President Bush would be angry with me, personally, so he wouldn’t help the people of my state,” she said. “I knew he wasn’t a petty leader.”

In 2012, weeks before the general election, Gov. Chris Christie, R-N.J., and President Barack Obama, a Democrat, memorably made a show of their close personal relationship as they dealt with the devastation from Superstorm Sandy.

In this moment, some governors have tried both compliments and confrontation, knowing the president responds to both. When Gov. Andrew Cuomo, D-N.Y., was frustrated last week that Trump had not stepped up the federal response to hard-hit regions, he tried a counterintuitive approach.

In a series of cable TV interviews, Cuomo praised Trump for changing his tone about the severity of the virus and starting for focus on resources. In a call to the White House, Cuomo delivered the same grateful message privately, according to two officials with knowledge of the conversation who spoke on condition of anonymity because they were not authorized to publicly talk about the private discussions.

Trump later expressed happiness to aides and advisers that Cuomo had said such nice things about him, according to two White House officials and Republicans close to the West Wing.

A week later, when Cuomo delivered an urgent, frustrated plea for ventilators Tuesday, he notably didn’t mention Trump by name. Shortly after, a White House official said 4,000 more ventilators would be shipped to New York.

But later that day, Trump vented to aides about Cuomo’s cry for help, complaining that the governor made it seem like Washington had abandoned him, according to those White House officials and Republicans.

His anger broke through during the town hall. When Dr. Deborah Birx, the coordinator for the coronavirus response, was describing testing problems and mentioned New York’s high transmission rate, Trump interjected, trying to push Birx to criticize Cuomo: “Do you blame the governor for that?”

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Lemire reported from New York. Associated Press writers Julie Carr Smyth in Columbus, Ohio, and Paul J. Weber in Austin, Texas, contributed to this report.

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