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Inside the company at the forefront of China's push to develop a coronavirus vaccine – CNN

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In some areas, the interior fit-out is still underway. Outside, construction vehicles are digging up dirt.
The 215,000 square feet (20,000 square meter) production plant was built in recent months specifically for producing a Covid-19 vaccine developed by Chinese pharmaceutical company Sinovac Biotech.
CoronaVac, the vaccine candidate from Sinovac, is part of China’s push to be at the forefront of rolling out immunizations against the deadly novel coronavirus — and to demonstrate its scientific prowess.
Scientists globally are racing to find a way to stop to the virus that has infected more than 23 million people and claimed over 800,000 lives. Six vaccine candidates have started Phase 3 clinical trials — the last step of testing to prove efficacy and safety before seeking approval from regulators — and three are Chinese.
CoronaVac’s last-stage trials are being rolled out in Brazil and Indonesia with about 11,000 volunteers.
“If everything goes well, we hope that we can have some results around the end of the year,” said Helen Yang, director of investor relations at Sinovac, from the CaronaVac production plant in the Chinese capital’s Daxing district.
The Nasdaq-listed biotech company began developing its vaccine in late January, less than a week after Wuhan — the original epicenter of China’s coronavirus outbreak — went into a strict lockdown. Construction of the plant started in March, and Yang said the facility will eventually produce 300 million doses of the vaccine a year, if it is approved by China’s National Medical Products Administration.
CaronaVac uses an old-fashioned approach — employing an inactivated whole virus to prompt the body to develop immunity. The virus is grown under controlled conditions and killed chemically, so it cannot replicate to cause disease when injected into the body. This method has long been proven effective with other viruses, and is still used in polio and flu shots, as well as the rabies vaccine.
A Sinovac spokesperson said the company chose an inactivated vaccine because it was most familiar with this approach.
The US is pushing ahead with a newer type of vaccine made using genetic material from the virus. This type of vaccine is faster to produce, because whole samples of a virus do not have to be cultured, but there is less known about which genetic material to choose from the virus to replicate to induce an strong immune response.
To fast-track the preclinical process — where researchers develop the vaccine candidate and test it on animals — Yang said the company had conducted several studies in parallel so it could select the best results.
Sinovac has also been working closely with China’s equivalent of the Food and Drug Administration to speed up the approval process. “Once we complete a certain study, we submit the data … immediately so they can start to review,” Yang added.
In May, Sinovac published in the journal Science the results of animal trials, which found that its vaccine induced effective antibodies in mice and rats, as well as primates such as the rhesus macaques. A month later, the company said its Phase 2 trial of 600 volunteers found the vaccine caused the human body to produce antibodies 14 days after vaccination.
But the Phrase 3 trial requires large-scale testing of thousands of participants.
By June, China had largely contained the coronavirus, contending with only small, sporadic outbreaks. China had reported 84,996 Covid-19 cases by Wednesday, with fewer than 2,000 new infections since the start of June — and more than a third of those were imported, according to the country’s National Health Commission (NHC).
Yang said the small number of newly reported Covid-19 cases in China didn’t meet the necessary conditions for a Phase 3 trial, so Sinovac reached an agreement with Brazil — which ranks second in the world for infections, with more than 3.6 million reported cases.
In collaboration with the Butantan Institute in São Paulo, a Phase 3 study was launched in late July involving 9,000 volunteers, all health professionals who have worked with Covid-19 patients but haven’t been infected with the virus, according to São Paulo officials.
In exchange, Brazil was promised 120 million doses of the vaccine, if the tests found it to be effective.
The tests are ongoing, but Dimas Covas, president of the Butantan Institute, said Wednesday preliminary data shows CoronaVac induced immunity in 97% of the people vaccinated after two doses — a level he said was “fundamental to break the chain of transmission of the coronavirus.”
Covas said earlier this month that data on the efficacy of the vaccine could be available by October — potentially starting the formal approval process in a matter of months. He expects the vaccine to be available to the Brazilian public by January.
“I am very optimistic. I think it would be a reasonable time frame given the performance so far,” he said at a public hearing at the Brazilian Chamber of Deputies.
This month, Sinovac also rolled out another Phase 3 trial in Indonesia with 1,620 volunteers. Indonesia’s state-owned Bio Farma said in a statement Friday that it signed a preliminary agreement with Sinovac for the bulk purchase of 50 million vaccines from November to March 2021, with guaranteed priority access until the end of next year.

A race for vaccine

With the global race for vaccines heating up, Yang down played competition between biotech companies — saying demand was too huge for a single company to meet.
The real competition, she said, is with the virus.
“Our speed should be faster than the transmission of the virus instead of competing with others. We like everyone to be successful then there will be enough supply to protect people,” Yang said.
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The two other Chinese vaccines to have started Phase 3 trials are being developed by the state-owned Sinopharm, while a vaccine from the United Kingdom, produced by the University of Oxford and AstraZeneca has reached this stage, along with two from the United States, one by pharmaceutical giant Pfizer in collaboration with German company BioNTech, and the other by Moderna.
As it stands, 13 companies in China are working on coronavirus vaccines. Of those, nine vaccine candidates are in human trials — more than in any other country.
Ivan Hung, an infectious diseases specialist at the Hong Kong University School of Medicine, said vaccination is key for countries like China where strict measures have helped keep the percentage of infected people in the population low.
“The overall immunity is very low. And so in these places, definitely the way forward is vaccinations,” he said.

Geopolitical implications

Senior US national security officials have warned of alleged Chinese government attempts to steal coronavirus research from American institutions for months. In July, US prosecutors charged two Chinese nationals accused of trying to steal Covid-19 vaccine research on behalf of the government.
China’s leader Xi Jinping has repeatedly urged Chinese scientists to accelerate the research and development of coronavirus vaccines. Xiao Yaqing, the country’s former top market regulator, told pharmaceutical companies last month to treat coronavirus vaccine development as an “important political task.”
Xiao has since been appointed the minister of industry and information technology.
Not only would a safe and effective coronavirus vaccine save lives, deliver scientific prestige and represent a tantalizing opportunity for economic recovery, it could also have significant geopolitical implications.
The Chinese government has faced sharp criticism — most notably from the US — for its initial handling of the coronavirus outbreak. Its subsequent “mask diplomacy” — an effort to ship medical supplies to countries grappling with Covid-19 — has fueled suspicion that it is trying to change the coronavirus narrative.
Winning the vaccine race would present China with an opportunity to shore up its global standing by positioning itself as a leader in fighting the pandemic.
Last month, Philippine President Rodrigo Duterte said he had asked Xi to help the Southeast Asian nation get priority access to a Chinese vaccine.
The number of countries granted such access is growing fast. Besides Brazil and Indonesia, which have been approved for early access from Sinovac, Pakistan — one of China’s closest allies — will receive early vaccine doses from Sinopharm, if its Phase 3 trials are successful.
In a video summit with African leaders in June, Xi pledged that “once the development and deployment of Covid-19 vaccine is completed in China, African countries will be among the first to benefit.”
This month, China’s ambassador in Afghanistan, Wang Yu, told the Afghanistan Times that “once China’s vaccine is successfully developed and produced, it will be our priority to consider providing the vaccine to Afghan people.”
And on Monday, Chinese Premier Li Keqiang said Beijing would also give priority access to Cambodia, Myanmar, Laos, Thailand and Vietnam.

“Emergency use”

Within China, authorities have rolled out coronavirus vaccines for “emergency use” before the last-stage trials are finished.
Last weekend, a senior official from the NHC revealed that China has been using an experimental vaccine on people who work in high-risk professions since July, including front line medical professionals and border inspectors.
The vaccine, developed by Sinopharm, is still in Phrase 3 trials in the United Arab Emirates, Peru, Morocco and Argentina.
Zheng Zhongwei, director of the Science and Technology Development Center of the NHC, told China’s state broadcaster that the “emergency use” of a vaccine during a “major public health incident” was in accordance with the country’s vaccine law.
It comes after the Chinese government approved the use of a different vaccine candidate for the country’s military in June.
However, on Monday, Dr. Anthony Fauci — the top US infectious disease expert — warned against early emergency use authorization, explaining that such a step could damage efforts to develop other vaccines.
“One of the potential dangers if you prematurely let a vaccine out is that it would make it difficult, if not impossible, for the other vaccines to enroll people in their trial,” he said.

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Health Canada approves updated Moderna COVID-19 vaccine

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TORONTO – Health Canada has authorized Moderna’s updated COVID-19 vaccine that protects against currently circulating variants of the virus.

The mRNA vaccine, called Spikevax, has been reformulated to target the KP.2 subvariant of Omicron.

It will replace the previous version of the vaccine that was released a year ago, which targeted the XBB.1.5 subvariant of Omicron.

Health Canada recently asked provinces and territories to get rid of their older COVID-19 vaccines to ensure the most current vaccine will be used during this fall’s respiratory virus season.

Health Canada is also reviewing two other updated COVID-19 vaccines but has not yet authorized them.

They are Pfizer’s Comirnaty, which is also an mRNA vaccine, as well as Novavax’s protein-based vaccine.

This report by The Canadian Press was first published Sept. 17, 2024.

Canadian Press health coverage receives support through a partnership with the Canadian Medical Association. CP is solely responsible for this content.

The Canadian Press. All rights reserved.

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These people say they got listeria after drinking recalled plant-based milks

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TORONTO – Sanniah Jabeen holds a sonogram of the unborn baby she lost after contracting listeria last December. Beneath, it says “love at first sight.”

Jabeen says she believes she and her baby were poisoned by a listeria outbreak linked to some plant-based milks and wants answers. An investigation continues into the recall declared July 8 of several Silk and Great Value plant-based beverages.

“I don’t even have the words. I’m still processing that,” Jabeen says of her loss. She was 18 weeks pregnant when she went into preterm labour.

The first infection linked to the recall was traced back to August 2023. One year later on Aug. 12, 2024, the Public Health Agency of Canada said three people had died and 20 were infected.

The number of cases is likely much higher, says Lawrence Goodridge, Canada Research Chair in foodborne pathogen dynamics at the University of Guelph: “For every person known, generally speaking, there’s typically 20 to 25 or maybe 30 people that are unknown.”

The case count has remained unchanged over the last month, but the Public Health Agency of Canada says it won’t declare the outbreak over until early October because of listeria’s 70-day incubation period and the reporting delays that accompany it.

Danone Canada’s head of communications said in an email Wednesday that the company is still investigating the “root cause” of the outbreak, which has been linked to a production line at a Pickering, Ont., packaging facility.

Pregnant people, adults over 60, and those with weakened immune systems are most at risk of becoming sick with severe listeriosis. If the infection spreads to an unborn baby, Health Canada says it can cause miscarriage, stillbirth, premature birth or life-threatening illness in a newborn.

The Canadian Press spoke to 10 people, from the parents of a toddler to an 89-year-old senior, who say they became sick with listeria after drinking from cartons of plant-based milk stamped with the recalled product code. Here’s a look at some of their experiences.

Sanniah Jabeen, 32, Toronto

Jabeen says she regularly drank Silk oat and almond milk in smoothies while pregnant, and began vomiting seven times a day and shivering at night in December 2023. She had “the worst headache of (her) life” when she went to the emergency room on Dec. 15.

“I just wasn’t functioning like a normal human being,” Jabeen says.

Told she was dehydrated, Jabeen was given fluids and a blood test and sent home. Four days later, she returned to hospital.

“They told me that since you’re 18 weeks, there’s nothing you can do to save your baby,” says Jabeen, who moved to Toronto from Pakistan five years ago.

Jabeen later learned she had listeriosis and an autopsy revealed her baby was infected, too.

“It broke my heart to read that report because I was just imagining my baby drinking poisoned amniotic fluid inside of me. The womb is a place where your baby is supposed to be the safest,” Jabeen said.

Jabeen’s case is likely not included in PHAC’s count. Jabeen says she was called by Health Canada and asked what dairy and fresh produce she ate – foods more commonly associated with listeria – but not asked about plant-based beverages.

She’s pregnant again, and is due in several months. At first, she was scared to eat, not knowing what caused the infection during her last pregnancy.

“Ever since I learned about the almond, oat milk situation, I’ve been feeling a bit better knowing that it wasn’t something that I did. It was something else that caused it. It wasn’t my fault,” Jabeen said.

She’s since joined a proposed class action lawsuit launched by LPC Avocates against the manufacturers and sellers of Silk and Great Value plant-based beverages. The lawsuit has not yet been certified by a judge.

Natalie Grant and her seven year-old daughter, Bowmanville, Ont.

Natalie Grant says she was in a hospital waiting room when she saw a television news report about the recall. She wondered if the dark chocolate almond milk her daughter drank daily was contaminated.

She had brought the girl to hospital because she was vomiting every half hour, constantly on the toilet with diarrhea, and had severe pain in her abdomen.

“I’m definitely thinking that this is a pretty solid chance that she’s got listeria at this point because I knew she had all the symptoms,” Grant says of seeing the news report.

Once her daughter could hold fluids, they went home and Grant cross-checked the recalled product code – 7825 – with the one on her carton. They matched.

“I called the emerg and I said I’m pretty confident she’s been exposed,” Grant said. She was told to return to the hospital if her daughter’s symptoms worsened. An hour and a half later, her fever spiked, the vomiting returned, her face flushed and her energy plummeted.

Grant says they were sent to a hospital in Ajax, Ont. and stayed two weeks while her daughter received antibiotics four times a day until she was discharged July 23.

“Knowing that my little one was just so affected and how it affected us as a family alone, there’s a bitterness left behind,” Grant said. She’s also joined the proposed class action.

Thelma Feldman, 89, Toronto

Thelma Feldman says she regularly taught yoga to friends in her condo building before getting sickened by listeria on July 2. Now, she has a walker and her body aches. She has headaches and digestive problems.

“I’m kind of depressed,” she says.

“It’s caused me a lot of physical and emotional pain.”

Much of the early days of her illness are a blur. She knows she boarded an ambulance with profuse diarrhea on July 2 and spent five days at North York General Hospital. Afterwards, she remembers Health Canada officials entering her apartment and removing Silk almond milk from her fridge, and volunteers from a community organization giving her sponge baths.

“At my age, 89, I’m not a kid anymore and healing takes longer,” Feldman says.

“I don’t even feel like being with people. I just sit at home.”

Jasmine Jiles and three-year-old Max, Kahnawake Mohawk Territory, Que.

Jasmine Jiles says her three-year-old son Max came down with flu-like symptoms and cradled his ears in what she interpreted as a sign of pain, like the one pounding in her own head, around early July.

When Jiles heard about the recall soon after, she called Danone Canada, the plant-based milk manufacturer, to find out if their Silk coconut milk was in the contaminated batch. It was, she says.

“My son is very small, he’s very young, so I asked what we do in terms of overall monitoring and she said someone from the company would get in touch within 24 to 48 hours,” Jiles says from a First Nations reserve near Montreal.

“I never got a call back. I never got an email”

At home, her son’s fever broke after three days, but gas pains stuck with him, she says. It took a couple weeks for him to get back to normal.

“In hindsight, I should have taken him (to the hospital) but we just tried to see if we could nurse him at home because wait times are pretty extreme,” Jiles says, “and I don’t have child care at the moment.”

Joseph Desmond, 50, Sydney, N.S.

Joseph Desmond says he suffered a seizure and fell off his sofa on July 9. He went to the emergency room, where they ran an electroencephalogram (EEG) test, and then returned home. Within hours, he had a second seizure and went back to hospital.

His third seizure happened the next morning while walking to the nurse’s station.

In severe cases of listeriosis, bacteria can spread to the central nervous system and cause seizures, according to Health Canada.

“The last two months have really been a nightmare,” says Desmond, who has joined the proposed lawsuit.

When he returned home from the hospital, his daughter took a carton of Silk dark chocolate almond milk out of the fridge and asked if he had heard about the recall. By that point, Desmond says he was on his second two-litre carton after finishing the first in June.

“It was pretty scary. Terrifying. I honestly thought I was going to die.”

Cheryl McCombe, 63, Haliburton, Ont.

The morning after suffering a second episode of vomiting, feverish sweats and diarrhea in the middle of the night in early July, Cheryl McCombe scrolled through the news on her phone and came across the recall.

A few years earlier, McCombe says she started drinking plant-based milks because it seemed like a healthier choice to splash in her morning coffee. On June 30, she bought two cartons of Silk cashew almond milk.

“It was on the (recall) list. I thought, ‘Oh my God, I got listeria,’” McCombe says. She called her doctor’s office and visited an urgent care clinic hoping to get tested and confirm her suspicion, but she says, “I was basically shut down at the door.”

Public Health Ontario does not recommend listeria testing for infected individuals with mild symptoms unless they are at risk of developing severe illness, such as people who are immunocompromised, elderly, pregnant or newborn.

“No wonder they couldn’t connect the dots,” she adds, referencing that it took close to a year for public health officials to find the source of the outbreak.

“I am a woman in my 60s and sometimes these signs are of, you know, when you’re vomiting and things like that, it can be a sign in women of a bigger issue,” McCombe says. She was seeking confirmation that wasn’t the case.

Disappointed, with her stomach still feeling off, she says she decided to boost her gut health with probiotics. After a couple weeks she started to feel like herself.

But since then, McCombe says, “I’m back on Kawartha Dairy cream in my coffee.”

This report by The Canadian Press was first published Sept. 16, 2024.

Canadian Press health coverage receives support through a partnership with the Canadian Medical Association. CP is solely responsible for this content.

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B.C. mayors seek ‘immediate action’ from federal government on mental health crisis

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VANCOUVER – Mayors and other leaders from several British Columbia communities say the provincial and federal governments need to take “immediate action” to tackle mental health and public safety issues that have reached crisis levels.

Vancouver Mayor Ken Sim says it’s become “abundantly clear” that mental health and addiction issues and public safety have caused crises that are “gripping” Vancouver, and he and other politicians, First Nations leaders and law enforcement officials are pleading for federal and provincial help.

In a letter to Prime Minister Justin Trudeau and Premier David Eby, mayors say there are “three critical fronts” that require action including “mandatory care” for people with severe mental health and addiction issues.

The letter says senior governments also need to bring in “meaningful bail reform” for repeat offenders, and the federal government must improve policing at Metro Vancouver ports to stop illicit drugs from coming in and stolen vehicles from being exported.

Sim says the “current system” has failed British Columbians, and the number of people dealing with severe mental health and addiction issues due to lack of proper care has “reached a critical point.”

Vancouver Police Chief Adam Palmer says repeat violent offenders are too often released on bail due to a “revolving door of justice,” and a new approach is needed to deal with mentally ill people who “pose a serious and immediate danger to themselves and others.”

This report by The Canadian Press was first published Sept. 16, 2024

The Canadian Press. All rights reserved.

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