How prepared is the existing global cold chain, and especially refrigerated transport, to cope with the full temperature ranges required for the multiple COVID-19 vaccine candidates? A cold chain expert responds. “Overall, securing an end-to-end unbroken cold chain – from vaccine manufacturer to the site of injection, is an extremely hard thing to do. It requires constant monitoring and remedial action. “Why? The constituent parts of the cold chain are vastly distinct. They are separately operated but uniformly coordinated systems within an overall vaccine supply chain,” said Raja Rao, director, cold chain strategy and markets, B Medical Systems. Storage Vaccine distribution is complexity at its finest, he said. “It is almost always the case that the cold chain is relatively strongest between the site of manufacture and arrival at the port of entry, from Belgium to Nairobi, for example. This is because vaccines are air-shipped in modern, cold storage containers, ...
A man works in a laboratory of Sinovac Biotech in Beijing on Sept. 24. The Chinese company is developing an experimental coronavirus vaccine. (Thomas Peter/Reuters) By Eva Dou November 18, 2020 at 5:09 p.m. GMT+8 Sinovac Biotech, one of China’s coronavirus vaccine front-runners, published mixed findings from its two first clinical trials Tuesday, raising the stakes in Indonesia, which has already declared plans to roll out Sinovac’s vaccine. While the vaccine appeared to be safe in these early clinical trials, the company reported that it generated lower levels of protective antibodies in the bloodstream compared with those arising in recovered coronavirus patients. In comparison, Moderna and Pfizer, which have separate experimental vaccines, had reported antibody levels on par with or higher than those produced in recovered coronavirus patients. These early results put Sinovac on the back foot to prove its vaccine is effective in ongoing Phase 3 trials. “That is a concern,” ...
With the COVID-19 pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infecting over 50 million people worldwide with hundreds of thousands experiencing severe respiratory illness, researchers have been trying to find the factors associated with severe disease. From the start of the pandemic in March this year, several studies have indicated heart disease, high blood pressure, diabetes, obesity, etc. could be linked to severe disease. Now German researchers have published a study on the association between severe respiratory infection caused by SARS CoV-2 and factors such as age, body mass index (BMI) and ABO blood group. Their study titled, “Severity of Respiratory Infections due to SARS-CoV-2 in Working Population: Age and Body Mass Index Outweigh ABO Blood Group,” was released prior to peer review on the preprint site medRxiv*. Background There is a rise in cases of COVID-19, and there is a lack of consensus regarding the high-risk ...
President Fernández reveals in interview with Russian news agency that government will receive initial 10 million doses of Sputnik V vaccine by as early as December, should it clear clinical trials. resident Alberto Fernández said Monday that Argentina has accepted a proposal from Russia to buy an initial 10 million doses of its experimental Covid-19 vaccine, with delivery expected before the end of the year. The vaccine, which is given in two parts, could even arrive as early as next month provided clinical trials are successful, the president said in an interview with a Russian news agency. If successful, another 15 million doses could arrive in January, he added. The news comes just days after Perfil journalist Rosario Ayerdi revealed that Health Access Secretary Carla Vizzotti had travelled to Russia on October 17 on a fact-finding mission to learn more about the Russian vaccine, known as Sputnik V. Fernández confirmed Vizzotti’s ...
by University of South Florida Children with multiple islet autoantibodies—biological markers of autoimmunity—are more likely to progress to symptomatic type 1 diabetes (T1D) than those who remain positive for a single autoantibody. Now, new findings from The Environmental Determinants of Diabetes in the Young (TEDDY) study in the U.S. and Europe show that detailed information about the order, timing and type of autoantibodies appearing after the first autoantibody can significantly improve prediction of which children are most likely to progress to type 1 diabetes more rapidly. The TEDDY analysis was published in the September 2020 issue of Diabetes Care. “A better understanding of distinct autoantibody spreading is important, because it will allow us to identify at-risk children earlier in the disease process,” said the study’s lead author Kendra Vehik, Ph.D., a professor of epidemiology at the University of South Florida Health (USF Health) Morsani College of Medicine’s Health Informatics ...
For Immediate Release: October 22, 2020 Today, the U.S. Food and Drug Administration approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Veklury is the first treatment for COVID-19 to receive FDA approval. This approval does not include the entire population that had been authorized to use Veklury under an Emergency Use Authorization (EUA) originally issued on May 1, 2020. In order to ensure continued access to the pediatric population previously covered under the EUA, the FDA revised the EUA for Veklury to authorize the drug’s use for treatment of suspected or laboratory confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to ...
By Mick Krever and Phil Black, CNN Updated 4:26 AM ET, Tue October 20, 2020 Why she is volunteering to get infected with Covid-19 03:26 London (CNN) The UK government has signed a contract for the first human challenge studies for the novel coronavirus, in which healthy volunteers are deliberately infected with the virus in a controlled setting, and some receive an experimental vaccine. Up to 19 volunteers at a time will take part in the tests, to be held at the Royal Free Hospital in London, which houses a Biosafety Level 3 ward. They will be run by hVIVO, a medical research company that specializes in running challenge trials, in partnership with Imperial College London. These clinical trials will be a little different from most. For the current Covid-19 vaccine candidates that are in Phase 3 — the final stage of testing — tens of thousands of volunteers are given an experimental ...
A hospital in the US is among the first to offer rapid genome sequencing of critically ill newborns to help identify the cause of their illnesses, which could save their lives. This technology could be used on healthy babies too. But some experts raise concerns about sequencing every baby at birth.
In different parts of the world, scientists are racing to develop a vaccine for coronavirus (COVID-19). A lot is at stake as governments worldwide are in a frenzy to prevent the spread of the virus in key hotspots.
Another busy year for clinical research has come and gone. What are the most important findings from 2019? Here is our overview of some of the most noteworthy studies of the year.What happened in medical research in 2019? In this special feature, we summarize this year’s top findings. “Medicine is of all the Arts the most noble,” wrote the Ancient Greek physician Hippocrates — whom historians call the “father of medicine” — over 2,000 years ago. Advances in therapeutic practices have been helping people cure and manage illness since before the time of Hippocrates, and, today, researchers continue to look for ways of eradicating diseases and improving our well-being and quality of life.Each year, specialists in all areas of medical research conduct new studies and clinical trials that bring us a better understanding of what keeps us happy and in good health, and what factors have the opposite effect. And, ...
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