Prince of Songkla Uni aims for Andaman medical hub status with new service centre
Prince of Songkla University Phuket Campus has opened a medical technology service centre as the first step to becoming an international medical hub in the Andaman.
Phuket Campus vice president Assoc Prof Dr Pun Thongchumnum said the centre has been set up to provide various medical services, such as laboratory tests, medical screening and advice for citizens and tourists alike.
He said the centre would be a learning facility for students as well as those who are interested.
“This move aims to enable people in Phuket and the Andaman Sea coast to seek medical services and promote medical tourism among foreign tourists,” he said, adding that the centre will help boost the economy under the Phuket Sandbox project scheduled to launch on July 1.
Prince of Songkla Uni aims for Andaman medical hub status with new service centre
He said the centre would initially focus on providing Covid-19 tests, medical screening and annual physical exams, such as tests for blood sugar and cholesterol levels.
“We hope the centre will promote Phuket as an international medical hub on the Andaman Sea coast,” he added.
Prince of Songkla Uni aims for Andaman medical hub status with new service centre
CureVac, the latest experimental coronavirus vaccine, proved just 47% effective amid spread of variants, preliminary analysis shows
A closely watched coronavirus vaccine invented by the German company CureVac was just 47% effective in a large trial at its interim analysis, a disappointing result that may highlight the challenge posed by virus variants.
The results of the 40,000-person trial, announced by news release Wednesday, mark a setback for a promising vaccine based on messenger RNA technology, the same approach at the core of the Pfizer-BioNTech and Moderna vaccines authorized late last year for use in the United States.
The trial in 10 countries in Latin America and Europe will continue, and a final result is not expected until the end of June. The CureVac vaccine is of key importance to Europe, which has preordered 225 million doses, with the option to buy 180 million more.
“While we were hoping for a stronger interim outcome, we recognize that demonstrating high efficacy in this unprecedented broad diversity of variants is challenging,” Franz-Werner Haas, Curevac’s chief executive, said in a statement.
Only minimal information was given about the trial results, with details expected in the final analysis and a company call planned Thursday. But the information known so far underscores the complexity of the changing pandemic. Thirteen variants caused cases of covid-19 in the trial, with only a single case caused by the original SARS-CoV-2 virus. More than half of the cases were infections with variants of concern.
“They’re testing their vaccine much later than all the other vaccines we have were tested, and there are a lot more variants out there that could confound the ability of a vaccine to protect,” said Deborah Fuller, a vaccine scientist at the University of Washington.
With other vaccines, it has become clear that while shots continue to protect against the worst outcomes from variants, immunity can wane against milder infections. That could be true for CureVac, but it would be necessary to see the breakdown of cases and their severity, data not yet available.
“It’s up in the air,” Fuller said. “I would not at this point say this is a failed vaccine, but people are going to make those comparisons.”
It remained unclear Wednesday whether the variants explained the results not meeting expectations. Results released earlier this week from a trial of the experimental vaccine made by Novavax found that vaccine was highly effective – even when variants were flourishing.
In the Novavax trial, tests run to determine the genetic fingerprint of infections showed most were caused by the alpha variant first identified in the United Kingdom, which spreads more readily but has not posed much of a challenge to other vaccines. A breakdown of which variants were found in the CureVac trial will not be available until the final analysis.
The CureVac vaccine uses messenger RNA technology found in other highly successful vaccines but has some key differences. The Pfizer-BioNTech and Moderna vaccines use a chemically modified version of messenger RNA, but CureVac does not. It also is stable at refrigerator temperatures and can be more easily shipped and stored.
Emerging data from real-world use of other vaccines suggests that even when they are challenged by some variants, they remain strongly protective against the most important outcomes of hospitalization or death.
Data from the use of the Pfizer-BioNTech vaccine in Qatar found that vaccine was 90% effective at preventing people from getting sick overall, but that the protection fell to about 75% against the beta variant first identified in South Africa. Protection against hospitalizations remained high, even against that variant.
A recent study by public health officials in the United Kingdom found that the Pfizer-BioNTech and AstraZeneca vaccines were both more than 90% effective in preventing hospitalization against the delta variant, which emerged in India, but were less effective at blocking any case of illness with symptoms.
One of the benefits of the messenger RNA vaccines, which are getting their first large-scale use during the pandemic, is that they can be rebooted quickly to match a new strain of the virus if needed. The emergence and increasing dominance in the last six months of variants has shown that such flexibility may be necessary to end the pandemic.
CureVac, like other vaccine makers, is already reformulating second-generation vaccines in partnership with GlaxoSmithKline, with the goal of making a vaccine that protects against multiple variants available by next year.
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If the CureVac vaccine is ultimately shown successful, it could run directly into the next challenge: manufacturing.
CureVac, a company founded more than two decades ago, has been racing to scale up production of its first medical product at a time that supply chains for workhorse laboratory ingredients, such as large plastic bags used to line bioreactors, are strained by unprecedented global demand and competition.
The German firm has partnerships with the big pharmaceutical companies Novartis and Bayer to help make its vaccine. The rapid scale up of manufacturing to meet the demands of the pandemic have been a challenge, even for veteran pharmaceutical companies.
CureVac has said it plans to manufacture 300 million doses this year, although final testing and quality checks could delay release of some of those doses until 2022, Haas, the CEO, said in an interview before the data were released. The European Commission has placed orders for 225 million doses, with an option to buy 180 million more. The company has said it plans to manufacture more than 1 billion doses next year.
Thai FDA delays Sputnik V approval after importer duplicates registration data
The Thai Food and Drug Administration (FDA) has postponed approval of the Sputnik V Covid-19 vaccine after discovering that the importer failed to supply registration details as requested.
Paisarn Dankum, secretary-general of the FDA, revealed that a second dossier of data was sent by Kingen Biotech Co on June 9, but was found to contain the same data previously submitted.
The data still lacks important information used to determine safety, quality and evidence of manufacturing standards, he said. As a result, 50 per cent of the information needed for registration, including data on active ingredients and product safety education, was still missing.
The FDA has asked Kingen Biotech Co to deliver the missing data for urgent consideration.
Meanwhile, the registration application for BioNTech-Pfizer vaccine is currently under consideration, the agency revealed last week.
So far, the FDA has approved five Covid-19 vaccine brands: AstraZeneca, Sinovac, Johnson & Johnson, Moderna and Sinopharm.
Chulalongkorn University’s Faculty of Engineering, in collaboration with PTT, has come up with a new three-layer face mask that provides protection from both fine dust particles and Covid-19.
Initial testing shows that the mask can filter up to 84 per cent of PM2.5 dust particles and trap up to 99 per cent of bacteria or viruses, said engineering lecturer Dr Pitchaya Rachadawong.
Dr Pitchaya Rachadawong
The mask’s outer layer is waterproof polyester infused with antiseptic compounds, the second layer is a filter made from fine fibres to trap dust particles, while the innermost layer is made of 100-per-cent cotton for the user’s comfort and safety.
The mask can be cleaned either by spraying it with alcohol or washed with soap and water. It can be washed up to 15 times.
The three-layer mask is suitable for airconditioned areas, as the wearer may find it too uncomfortable to wear outdoors.
The research team is working on thinner masks that offer the same or better protection.
Novavax covid shot 93% effective against variants in trial
Novavax Inc.s coronavirus vaccine candidate showed strong efficacy against the coronavirus, including mutated variants, in a large trial.
The shot was 90% effective at preventing symptomatic covid and 100% effective at preventing moderate and severe symptoms, the U.S. biotech firm said Monday. The shot was 93% effective against variants of concern, it said.
The vaccine uses a recombinant protein technology, also used in the vaccine candidate developed by Sanofi and GlaxoSmithKline Plc. At over 90%, the overall efficacy of the vaccine is close to reported rates for mRNA shots developed by Pfizer Inc. with BioNTech SE and by Moderna Inc., as well as the Sputnik V vaccine from Russia, using viral vector technology. However, immunologists tend to caution against comparing efficacy results across different trials as conditions and evaluation methods aren’t the same.
Novavax’s phase 3 trial included almost 30,000 participants in the U.S. and Mexico and studied the vaccine’s efficacy against major variants circulating in the U.S., as defined by the Centers for Disease Control and Prevention. Only one case of the highly contagious delta strain, which was first identified in India and remains rare in the U.S., was detected among trial participants, so the vaccine’s efficacy against it isn’t conclusive.
In results from a 15,000-person trial in the U.K. released in March, the shot demonstrated 90% effectiveness at preventing covid symptoms across variants and the original version of the virus.
The company previously said it wouldn’t file for vaccine authorization in the U.S. and Europe until the third quarter of the year. Novavax says it’s on track to reach manufacturing capacity of 100 million doses per month by the end of the third quarter and 150 million per month by the end of 2021.
“Novavax is one step closer to addressing the critical and persistent global public health need for additional coronavirus vaccines,” Chief Executive Officer Stanley C. Erck said in a statement. “Novavax continues to work with a sense of urgency to complete our regulatory submissions and deliver this vaccine, built on a well understood and proven platform, to a world that is still in great need of vaccines.”
Published : June 15, 2021
By : Syndication Washington Post, Bloomberg · Todd Gillespie
Human trials of the Covid-19 vaccine developed by Chulalongkorn University began on Monday, with 72 volunteers receiving shots under the supervision of doctors, nurses and researchers.
ChulaCov19 is an mRNA vaccine developed domestically in collaboration with the University of Pennsylvania’s Professor Drew Weissman, the world-renowned scientist who invented the technology, said Chula Professor Kiat Ruxrungtham.
The vaccine is made from parts of the coronavirus’s genetic material, not the whole virus.
The body uses this tiny piece of genetic material to build a spike protein, which stimulates the immune system to fight the virus in case of infection. After triggering the body to make proteins, the mRNA vaccine is destroyed and passes out of the body in a few days, Kiat said.
The second phase of human trials will involve 150-300 volunteers, who will receive the jab around August to measure their immune response to ChulaCov19.
The tests on humans come after successful trials in monkeys and rats.
Rats modified to develop Covid-19 were given two ChulaCov19 shots three weeks apart. The vaccinated rats showed strong immune responses that prevented infection and reduced virus levels in the nose and lungs by at least 10 million times. When tested for toxicity, the vaccine was found to be safe. The unvaccinated rats developed Covid-19 symptoms within 3-5 days, showing high infection in the bloodstream, nose and lungs.
Another plus point is that ChulaCov19 can be stored in refrigerators at temperatures of 2-8C for up to three months and room temperature (25C) for 2 weeks. This makes it easier to store than other mRNA vaccine brands.
TOKYO – Saturday marked two months since the start of Japans COVID-19 inoculation campaign for people aged 65 and up.
According to a Yomiuri Shimbun review of vaccination progress in the nation’s 74 major municipalities, only 19 municipalities have given over 40% of their elderly populations at least one dose as of June 11. Chuo Ward in Tokyo led the municipalities surveyed, administering at least one dose to 70.9% of its nearly 25,000 elderly residents.
The survey found that four cities — including Sakai, Osaka Prefecture — have administered a first shot to over 50% of their populations, while another 14 cities — including Yamaguchi — have cleared the 40% threshold. Rounding out the bottom of the list were 15 municipalities where fewer than 20% of elderly residents had received their first shot.
As early as February, officials in Tokyo’s Chuo Ward began enlisting the assistance of local medical associations and other groups to line up a roster of qualified vaccinators by the time the ward’s vaccination venues opened their doors on May 2.
Similar quick initial responses were observed across other municipalities that had logged high vaccination rates.
Vaccination of the nation’s over-65 demographic — all 36 million in total — began on April 12. A running tally of people who have received shots has since been kept in the government’s Vaccination Record System (VRS) database.
According to government figures, the number of elderly who had received their first dose passed the 10 million mark on Thursday, bringing the elderly national ratio to 29%.
The government has said it aims to complete vaccination of all elderly who want shots by the end of July.
Most people (90.27 per cent) had no side effects after getting their Covid-19 jab, the National Research Council of Thailand and the Higher Education, Science, Research and Innovation Ministry reported on Friday.
Among those who have received a Covid-19 jab, only 9.73 per cent reported some side effects, the most common being muscle pain, headache and pain where the jab was taken.
Even though the vaccines being administered have been approved by the Food and Drug Administration, people are still advised to observe their symptoms and seek medical help if they worsen.
Assoc Prof Dr Panpit Suwangool, an infectious diseases specialist at Bangkok Hospital, is advising people to consume a lot of water to avoid blood clots and take paracetamol for fever or headache.
“People who develop a rash, high fever, dizziness, muscle weakness or pain in the chest should see a doctor immediately,” she said.
She also urged people to continue wearing facemasks, wash hands regularly and maintain social distancing. She added that people who have visited high-risk areas or come in contact with Covid-19 patients must go into self-isolation for 14 days.
“People who have been infected with Covid-19 should receive their jab three months later because there is no information on the duration of immunity after infection,” she added.
FDA advisers debate standards for a coronavirus vaccine for young children
WASHINGTON – With coronavirus vaccines available to adolescents and adults, regulators are now turning their attention to younger children and the level of proof needed before authorizing shots for children as young as six months.
On Thursday, many members of a panel that advises the Food and Drug Administration on vaccines argued that faster authorization should be an option because of uncertainties about virus variants and a potential fall surge in cases.
The discussion was not centered on a particular vaccine, and it unfolded as Pfizer-BioNTech and Moderna conduct trials of their vaccines in children.
The Pfizer-BioNTech vaccine is already authorized for adolescents as young as 12, and Moderna announced Thursday it had submitted an application to the FDA for authorization for adolescents. Executives from Pfizer and Moderna have said that data showing whether their vaccines are effective in younger children are expected by fall.
The timeline is welcome news to many families eager to go back to normal and gain confidence about in-person school. But the expert discussion included many points of disagreement and often strayed into currently unanswerable questions about the future, reflecting how the question about vaccines for children may become emotional and tricky in the fall. Because covid-19, the disease caused by the virus, rarely results in serious illness in young children, several of the advisers argued that a longer and more conventional review of the vaccine should take place.
But A. Oveta Fuller, associate professor of microbiology and immunology at the University of Michigan Medical School, said that as the country opens up, she fears that unvaccinated children who have been largely insulated from the virus would begin to bear the burden of disease.
“We haven’t seen it for the children because they have been isolated, or there are other mitigations,” Fuller said at the meeting of vaccine advisers. As mitigation measures are relaxed, she said, the virus could take root in unvaccinated populations. “I think we are in an emergency situation, and we will be going into winter.”
Children can suffer a rare inflammatory condition after infection, and about 300 children and adolescents are among the nearly 600,000 people in the United States who have died of covid-19.
The risk to children varies with age: Data presented at the meeting showed that children under age 5 were less likely to be infected or to have illness with symptoms compared with older children. But hospitalization rates – although low compared to adults – were similar.
The role that children play in transmission is still poorly understood, but Hannah Kirking, a medical epidemiologist at the respiratory viruses branch of the Centers for Disease Control and Prevention, presented unpublished data that suggests children of all ages play a role similar to adults in transmission and infection.
“I very strongly believe that we need a vaccine for adolescents and children, but I want to be sure that the risk of the vaccine is lower than the risk of hospitalization” from covid-19, said Cody Meissner, an infectious-diseases physician at Tufts Medical Center, noting that vaccines can carry risks and young children have a very low risk of being hospitalized. “As we generate herd immunity, this disease is disappearing, between the vaccine and natural immunity.”
The meeting included a review of evolving data on rare cases of inflammation of the heart muscle – known as myocarditis – that most often occur days after the second dose of the Moderna or Pfizer-BioNTech vaccine, predominantly in younger men. Public health officials have not drawn a link to the shot, but are investigating. Israeli health officials have said there is a probable link.
Tom Shimabukuro, a CDC official, presented slides showing that half of the 528 cases reported in a safety database occurred in people 12 to 24 years old, even though they represent only 9% of vaccine recipients. He also showed that the cases in younger age groups are occurring more frequently than would normally be expected.
Some experts said that untangling whether there is a link between the vaccines and the myocarditis cases is necessary before making a vaccine more widely available to children.
Coronavirus cases have been plummeting in the United States, and the summer is expected to bring further relief, with much of the eligible population vaccinated. But the fall and winter present an unknown, and many on the panel did not share Meissner’s confidence that the virus would not be a threat in autumn.
With the virus continuing to circulate globally and children returning to in-person school, many of the FDA advisers expressed concern that the virus would take hold among people who are not vaccinated – sickening some children and resulting in transmission to other vulnerable people. Others pointed out that children are routinely vaccinated for diseases far more rare than covid-19.
“We still vaccinate children in this country for polio, even though we have not had a case since the 1970s,” said Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia. “The notion that we are not going to have to vaccinate children going forward, I think, is wrong.”
For full approval, the FDA would typically require six months of follow-up of 3,000 children ages 6 months to 12 years. But because of the health emergency, the agency has authorized coronavirus vaccines in other age groups based on two months of median follow-up of study participants. Granting emergency authorization would make it theoretically possible for children to have access to the vaccine as soon as this fall.
“I’d hate to not have the tool,” said Eric Rubin, an infectious-disease expert at the Harvard T.H. Chan School of Public Health. He said he feared what might happen when children return to school and people head back indoors, especially in swaths of the country with low rates of vaccination.
Doran Fink, an FDA vaccine expert, said increasing the size of pediatric vaccine trials would not necessarily flag rare events. Such reactions often are not detected until vaccines are used in millions of people.
Several experts recommended that infants and toddlers should be studied in slightly larger numbers given their especially low risk of covid-19 and because vaccine side effects that are manageable in adults, such as fever, could cause seizures.
Trials in children aim to figure out the protective dose – which may be lower – in progressively younger age groups. In the adult trials, researchers had to wait to see whether people who received the vaccine were less likely to fall ill than those who received a placebo. But the pediatric trials are immune bridging trials, designed to check whether children’s immune systems muster an equivalent immune response to people who were protected against illness in older age groups.
Pfizer announced this week that children between 5 and 11 years old will receive one-third the dose given to adults, with testing in that group starting this week. Children 6 months to 5 years old will receive a dose that is one-tenth of the adult dose, with studies likely to begin later in June. The Pfizer trial will include 4,500 children total in the United States, Finland, Poland and Spain. Two-thirds will receive the vaccine, and the rest will receive a placebo.
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Moderna’s 6,750-person trial began in March and follows a similar format, finding the right dose in three age clusters. The researchers start with a low dose and gradually increase it to a safe and tolerable level. Then, the researchers will test the safety and effectiveness of the vaccine in each age group.
Cancer patients should get inactivated Covid vaccine, says hospital director
A hospital director has advised cancer patients to choose inactivated Covid-19 vaccine to protect their weakened immune systems.
The only inactivated Covid-19 vaccine currently available in Thailand is the Sinovac brand.
Live attenuated vaccines elicit strong immune responses but are not suitable for people with a weakened immune system, said Dr Thanut Kuai-Charoenpanich, director of Chewamitra Hospital in Ubon Ratchathani.
Due to their lowered immunity, cancer patients, the elderly and those with congenital diseases are considered to be at high risk of developing severe symptoms when infected with Covid-19. They also take longer to rehabilitate than other Covid patients, Dr Thanut said.
These people need to get the Covid-19 vaccine to build immunity and reduce the risk of infection and severe symptoms, he added.
The American Cancer Society recommends that most patients with cancer or a history of cancer should get a Covid-19 vaccination but says factors to be considered include the type of vaccine, type of cancer, and treatment process.
Cancer patients who have completed treatment can be vaccinated immediately, Thanut said. However, cancer patients who are still being treated for the disease must consult their doctor to help determine the appropriate time for vaccination and also reduce the risk of side effects.
Prince of Songkla Uni aims for Andaman medical hub status with new service centre
Prince of Songkla Uni aims for Andaman medical hub status with new service centre
Dr Pitchaya Rachadawong
Side effects to look out for after Covid-19 jab
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