LONDON (Reuters) – A major non-profit health emergencies group has set up a global laboratory network to assess data from potential COVID-19 vaccines, allowing scientists and drugmakers to compare them and speed up selection of the most effective shots.
Speaking to Reuters ahead of announcing the labs involved, Melanie Saville, director of vaccine R&D at the Coalition for Epidemic Preparedness Innovations (CEPI), said the idea was to “compare apples with apples” as drugmakers race to develop an effective shot to help control the COVID-19 pandemic.
The centralised network is the first of its kind to be set up in response to a pandemic.
In a network spanning Europe, Asia and North America, the labs will centralise analysis of samples from trials of COVID-19 candidates “as though vaccines are all being tested under one roof”, Saville said, aiming to minimise the risk of variation in results.
“When you start off (with developing potential new vaccines) especially with a new disease, everyone develops their own assays, they all use different protocols and different reagents – so while you get a readout, the ability to compare between different candidates is very difficult,” she told Reuters.
“By taking the centralised lab approach … it will give us a chance to really make sure we are comparing apples with apples.”
The CEPI network will initially involve six labs, one each in Canada, Britain, Italy, the Netherlands, Bangladesh and India, Saville said.
Hundreds of potential COVID-19 vaccines are in various stages of development around the world, with shots developed in Russia and China already being deployed before full efficacy trials have been done, and front-runners from Pfizer PFE.N, Moderna MRNA.O and AstraZeneca AZN.L likely to have final-stage trial results before year-end.
Typically, the immunogenicity of potential vaccines is assessed in individual lab analyses, which aim to see whether biomarkers of immune response – such as antibodies and T-cell responses – are produced after clinical trial volunteers receive a dose, or doses, of the vaccine candidate.
But with more than 320 COVID-19 vaccine candidates in the works, Saville said, the many differences in data collection and evaluation methods are an issue.
As well as potential variations in markers of immunity, there are differences in how and where samples are collected, transported and stored – all of which can impact the quality and usefulness of the data produced, and make comparisons tricky.
And with a range of different vaccine technologies being explored – from viral vector vaccines to ones based on messenger RNA – standard evaluation of their true potential “becomes very complex”, she said.
“With hundreds of COVID-19 vaccines in development … it’s essential that we have a system that can reliably evaluate and compare the immune response of candidates currently undergoing testing,” she said.
By centralising the analysis in a lab network, much of what Saville called the “inter-laboratory variability” can be removed, allowing for head-to-head comparisons.
CEPI says all developers of potential COVID-19 vaccines can use the centralised lab network for free to assess their candidates against a common protocol. For now, the network will assess samples from early-stage vaccine candidate testing and first and second stage human trials, but CEPI said it hoped to expand its capacity to late stage (Phase III) trial data in the coming months.
Results produced by the network will be sent back to the developer, with neither CEPI nor the network owning the data.
CEPI itself is co-funding nine of the potential COVID-19 vaccines in development, including candidates from Moderna, AstraZeneca, Novavax NVAX.O and CureVac.
Reporting by Kate Kelland, editing by Mark Potter
Growing deaths in South Korea spark fears over safety of flu vaccine program – Global News
South Korean officials refused to suspend the country’s seasonal flu inoculation program on Thursday, despite growing calls to do so following the deaths of at least 13 people who were vaccinated in recent days.
Health authorities said they have found no direct links between the deaths, which include a 17-year-old boy, and the vaccines being given under a program to inoculate some 19 million teenagers and senior citizens for free.
“The number of deaths has increased, but our team sees low possibility that the deaths resulted from the shots,” Jeong Eun-kyeong, director of the Korea Disease Control and Prevention Agency (KDCA), told parliament.
South Korea ordered 20% more flu vaccines this year to ward off what it calls a “twindemic” of people with flu developing potential COVID-19 complications, and overburdening hospitals over the winter.
“I understand and regret that people are concerned about the vaccine,” Health Minister Park Neung-hoo said on Thursday, while confirming the free program would go ahead.
“We’re looking into the causes but will again thoroughly examine the entire process in which various government agencies are involved, from production to distribution,” he added.
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The country’s free vaccine program uses doses manufactured by local drug makers GC Pharma, SK Bioscience and Ilyang Pharmaceutical Co, along with France’s Sanofi and Britain’s Glaxosmithkline. The vaccines are distributed by local companies LG Chem Ltd and Boryung Biopharma Co. Ltd., a unit of Boryung Pharm Co. Ltd. .
GC Pharma, LG Chem, SK Bioscience and Boryung declined to comment. Ilyang Pharmaceutical, Sanofi and GSK did not immediately reply to requests for comment.
It was not immediately clear if any of the South Korean-manufactured vaccines were exported, or whether those supplied by Sanofi and GSK were also being used in other countries.
Kim Chong-in, leader of the main opposition People Power party, said the program should be halted until the exact causes of the deaths had been verified.
Health authorities said on Wednesday that a preliminary investigation into six deaths found no direct connection to the vaccines. No toxic substances were found in the vaccines, and at least five of the six people investigated had underlying conditions, officials said.
The free program has proved controversial from its launch last month. Its start was suspended for three weeks after it was discovered that some 5 million doses, which need to be refrigerated, had been exposed to room temperature while being transported to a medical facility.
Officials said 8.3 million people had been inoculated since the program resumed on Oct. 13, with around 350 cases of adverse reactions reported.
The government is also offering a paid vaccine program which, combined with the free program, aims to inoculate about 30 million of the country’s 52-million population. Under the paid program, the purchaser can select the vaccine provider from a larger pool that includes the free vaccine manufacturers plus others.
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The highest number of deaths in South Korea linked to seasonal flu vaccinations was six in 2005, according to the Yonhap news agency. Officials have said it is difficult to make comparisons to previous years because of the greater numbers of people taking the vaccine this year.
Kim Myung-suk, 65, who is eligible for a free vaccine, was among a growing number of people opting to exercise choice instead.
“Though just a few people died so far, the number is growing and that makes me uneasy,” she told Reuters in Seoul. “So I’m getting a shot somewhere else and will pay for it.”
(Reporting by Hyonhee Shin; Additional reporting by Sangmi Cha, Dogyun Kim and Daewoung Kim; editing by Jane Wardell)
© 2020 Reuters
At least 49 cases of COVID-19 linked to wedding in Calgary: Alberta Health – Burns Lake Lakes District News
Alberta Health says 49 active COVID-19 cases have been linked to a wedding in Calgary earlier this month.
The health agency says the wedding had a large number of Albertans from different households.
Alberta Health spokesman Tom McMillan says aggressive contact tracing is underway to identify anyone who may have been exposed to make sure they are isolating and getting tested.
He did not say how many people attended the wedding and says specifics about individual cases cannot be disclosed because of patient confidentiality.
COVID-19 restrictions implemented by the province say a maximum of 100 people can attend outdoor and indoor seated events, such as wedding ceremonies, funeral services, movie theatres, indoor arts and culture performances.
McMillan says the city of Calgary has recently seen several outbreaks linked to social gatherings.
“This is a reminder to all Albertans that this virus is still here and any social gathering carries a risk of exposure,” he said in an email Tuesday.
“It is important that nobody attend if they are feeling ill with even mild symptoms, or if they are awaiting test results.”
He says it is also important that organizers do everything possible to comply with the public health guidance in place, including having enough space for physical distancing between cohorts, following gathering size restrictions and avoiding sharing food and utensils.
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South Korea sticks to flu vaccine plan despite safety fears after 13 deaths – CBC.ca
South Korean officials refused to suspend a seasonal influenza inoculation effort on Thursday, despite growing calls for a halt, including an appeal from a key group of doctors, after the deaths of at least 13 of those vaccinated.
Health authorities said they found no direct links between the deaths and the vaccines.
At least 11 of the 13 dead, including a 17-year-old boy, were part of a campaign to inoculate 19 million teenagers and senior citizens for free, the Korea Disease Control and Prevention Agency (KDCA) said.
“The number of deaths has increased, but our team sees low possibility that the deaths resulted from the shots,” the agency’s director, Jeong Eun-kyeong, told Parliament.
South Korea ordered a fifth more flu vaccines this year to ward off what it calls a “twindemic,” or the prospect that people with flu develop coronavirus complications and overburden hospitals in winter.
“I understand and regret that people are concerned about the vaccine,” said Health Minister Park Neung-hoo said, who confirmed the free program would go ahead.
“We’re looking into the causes but will again thoroughly examine the entire process in which various government agencies are involved, from production to distribution.”
Vaccine providers include domestic firms such as GC Pharma, SK Bioscience, Korea Vaccine and Boryung Biopharma, a unit of Boryung Pharm, along with France’s Sanofi.
They supply both the free program and paid services that together aim to vaccinate about 30 million of a population of 52 million.
Of the 13 who died, five received products from SK Bioscience, three from Boryung, two each from GC Pharma and Korea Vaccine and one from Sanofi.
All four domestic firms declined to comment, while Sanofi did not immediately reply to requests for comment.
It was not immediately clear if any of the vaccines made in South Korea were exported, or if those supplied by Sanofi were also being used elsewhere.
Medical association calls for pause
The Korean Medical Association, an influential grouping of doctors, urged the government to halt all inoculation programs for now, to allay public concerns and ensure the vaccines were safe.
Kim Chong-in, leader of the main opposition People Power party, wanted the program halted until the causes of the deaths were verified.
But health authorities have said a preliminary investigation into six deaths found no direct link to the vaccines, with no toxic substances uncovered.
KDCA data on Thursday showed at least seven of the nine people it investigated had underlying conditions.
The free program has proved controversial since it began last month. The launch had been suspended for three weeks after the discovery that about five million doses were kept at room temperature rather than being refrigerated, as required.
Officials said 8.3 million people had been inoculated since the program resumed on Oct. 13, with about 350 cases of adverse reactions reported.
A separate paid program allows buyers to pick from a larger pool of firms that make free vaccines and others.
The most deaths in South Korea linked to seasonal flu vaccinations was six in 2005, the Yonhap news agency said. Officials have said comparisons to previous years are tough, since more people are taking the vaccine this year.
Kim Myung-suk, 65, is among a growing number of South Koreans who decided to pay for a vaccine of their choice, despite being eligible for a free dose.
“Though just a few people died so far, the number is growing and that makes me uneasy,” she told Reuters in the capital, Seoul. “So I’m getting a shot somewhere else and will pay for it.”
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