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Thursday 29 October 2020

M’sian in the running for global prize

Malaysian among top 10 finalists for Global Teacher Prize 2020

  • 29 Oct 2020
  • The Star Malaysia
  • By SANDHYA MENON sandhyamenon@thestar.com.my



PETALING JAYA: Malaysian Samuel Isaiah’s dedication to nurturing Orang Asli children has put him among 10 finalists for the prestigious Varkey Foundation Global Teacher Prize 2020.


The teacher from SK Runchang, Pahang, made the top 10 list from a selection of over 12,000 nominations and applications from more than 140 countries, the London-based Varkey Foundation said yesterday.


Isaiah, 33, who teaches English, said the honour represents Malaysian teachers’ capabilities and struggles, and highlights the Orang Asli community.

“It’s high time we spoke about indigenous people’s potential.


“With the right policies, resources, intervention, pedagogy and environment, they can achieve amazing things.


“Putting my children in the international spotlight is one of the best things this award can do for me,” he said in an interview with The Star.


If he wins the US$ 1mil (RM4.3mil) prize given by the foundation in partnership with Unesco, Isaiah wants to build an educational hub that caters to Orang Asli education, social welfare and well-being.


The challenges the community faces in accessing education, he said, are interconnected.


“Matters such as malnutrition and poverty affect their performance in school as well.


“The hub will work with one Orang Asli community at a time and they will be central in the decision-making process. We need to listen to their voices.


“It will also require collaboration with non-governmental organisations, the Education Ministry and people from various expertise.”


The Covid-19 pandemic has made things worse for indigenous communities, said Isaiah, adding that digital literacy and online education does not work well for Orang Asli schoolchildren due to poverty and the lack of infrastructure.


“Efforts by schools have been commendable but there is a limit to what they can do.


“The hub will address all these problems,” he added.


Every year, the Global Teacher Prize recognises an exceptional teacher who has made an outstanding contribution to the profession and underlines the important role teachers play in society.


In a video message announcing Isaiah’s nomination, British actor and comedian Stephen Fry said the teacher provided laptops and tablets for his students through a national crowdfunding campaign.


“You dedicate yourself to inspiring your pupils to dream big and to connect to the outside world.


“This has resulted in your school’s average pass rate in English increasing from 30% to between 80% and 85%.


“Congratulations, Samuel, and thank you for everything you do,” Fry said.

Unesco (education) assistant director- general Stefania Giannini hopes Isaiah’s story will inspire aspiring teachers and highlight the work of Malaysian teachers and educators throughout the world.


“The Global Teacher Prize helps put the teacher’s voice at the heart of our mission to champion inclusive learning opportunities for children and young people all over the world, especially the most marginalised and disadvantaged, during this sudden and unprecedented disruption to global education,” Giannini said.


Varkey Foundation and the Global Teacher Prize founder Sunny Varkey said this year has seen teachers go above and beyond to keep young people learning, adding that teachers should be applauded for their creativity, compassion and resolve to fulfil every child’s right to a good education.


The award ceremony will be held virtually on Dec 3 and hosted by Fry from the Natural History Museum in London.


Samuel is a Fulbright scholar pursuing a Master’s degree in Educational Policy and Leadership in State University of New York.


Last year, he was recognised as one of the 10 winners of the Star Golden Hearts Award 2019 – an annual award that celebrates everyday Malaysian unsung heroes – for his work with the Orang Asli children.

Another Malaysian teacher, Norhailmi Abdul Mutalib, was also among the 50 educators shortlisted for the 2020 prize.

http://mystar.newspaperdirect.com/epaper/viewer.aspx

https://www.thestar.com.my/news/nation/2020/10/28/malaysian-among-top-10-finalists-for-global-teacher-prize-2020



Malaysian teacher humbled, surprised to be among
Top 10 finalists for Global Teacher Prize 2020
Samuel shot to fame when tweets on how 100 Orang Asli students travelled 200km to attend his wedding in 2017 made the news. — Picture via the Varkey Foundation
Samuel shot to fame when tweets on how 100 Orang Asli students travelled 200km to attend his wedding in 2017 made the news. — Picture via the Varkey Foundation

KUALA LUMPUR, Oct 28 — Teacher Samuel Isaiah was surprised to be the eighth educator to join Top 10 finalists of the Global Teacher Prize 2020 as he was initially reluctant to join the competition.

It was only after two of his mentors persuaded and encouraged him to do so that he decided to take on the challenging task of convincing the panel that not only was he worthy, but also to provide exposure for the work he was doing.

“Dr Mariah Ibrahim, my former lecturer from University Utara Malaysia and Datin Rosliza Rosli, who worked in the Ministry of Education inspired and encouraged me to apply for this award,” Samuel said when contacted by Malay Mail.

“Initially I didn’t want to apply as I did not want to be glorified as a teacher and I want the focus to be on the kids but after some convincing I decided to do so and to be honest I am very surprised and humbled by it.

“Both of them said don’t do it for myself, do it for the kids. Bring some exposure and let the world know about these kids and the Orang Asli’s plight,” he recalled.

Thus began the arduous task of writing 10 essays — 700 words each — in two days, knowing full well the other applicants would be sending in videos.

“It was not an easy process as I applied at the last minute and had to write those essays but at that point I was determined to do it.”

Samuel shot to fame when tweets on how 100 Orang Asli students travelled 200km to attend his wedding in 2017 made the news.

Samuel has regularly gone to great lengths to educate the Orang Asli children, many of whom live in remote areas.

Samuel, who taught at Sekolah Kebangsaan Runchang school, Muadzam Shah, Pahang, incorporated the use of technology, started a successful national crowdfunding campaign to renovate the physical condition of his school classroom and implemented an e-mail exchange project called ‘Asli E-Pal’, where they communicate in English with adult volunteers all over Malaysia and overseas.

He also used music as an education piece.

Samuel is back in Pahang now with the school and his beloved kids. He returned to Malaysia in July from New York where he was pursuing his Master of Science in Educational Policy & Leadership at the State University of New York at Albany, New York due to the Covid-19 pandemic.

He said his students were thrilled to see him and they have been enjoying each other's company while he is back here, which could be till January 2021.

“There was some separation anxiety in the beginning. I’d get calls from the students all the time and we would send videos to each other just to see how we we’re doing,” said Samuel who at the time of calling said the kids have not found out about his nomination.

The winner of the Global Teacher Prize will get US$1 million (RM4.16 million) over a span of 10 years.

Samuel said he plans to use the money to form a foundation to help the Orang Asli as well as highlight their plight so they can be given the help they need.

He wants to convince the public that they are not incapable like most people think and want to dissociate the narrative that Orang Asli are just poor, illiterate and not capable of being productive members of society.

“I’d like to start with my community first and eradicate poverty, build better infrastructure, help with social and health problems and overall, give them a better quality of life.

“To do that I need the help of the education ministry and the local NGOs,” he added.

Teachers from Malaysia have excelled at the Global Teacher Prize since it was first awarded in 2015.

Dr Muhamad Khairul Anuar bin Hussin, a special needs teacher at Taman Universiti 2 Secondary School, Johor Bahru, reached the top 50 shortlist for this year’s prize.

KA Razhiyah, a special needs education teacher at Smk Panji School, Kota Bharu, was shortlisted for the 2018 prize, having been selected from over 30,000 nominations and applications from 173 countries around the world.

Mohd Sirhajwan Idek, a teacher at Keningau Vocational College, reached the top 50 shortlist for the 2017 prize.

The Global Teacher Prize virtual ceremony is expected to take place on December 3 where the overall winner will be announced.

It will be hosted by English comedian, actor, writer and presenter Stephen Fry from the Natural History Museum in London.

https://www.malaymail.com/news/malaysia/2020/10/28/malaysian-teacher-humbled-surprised-to-be-among-top-10-finalists-for-global/1917077

Sunday 25 October 2020

South Korea finds no link between flu shot, boy's death as toll ...

 South Korea presses on with flu vaccination programme amid concerns about deaths

SEOUL (Reuters) - The Korea Disease Control and Prevention Agency (KDCA) said on Friday it would press on with a wide flu vaccination programme aimed at heading off complications from the coronavirus, after reviewing more than two dozen cases of deaths that have raised public concern.

A man gets an influenza vaccine at a branch of the Korea Association of Health Promotion in Seoul, South Korea, October 23, 2020. REUTERS/Kim Hong-Ji

A review had shown no direct link between the vaccination and 26 deaths that were investigated, the KDCA said in a statement, adding it planned to meet on Saturday to review additional analysis.

The toll of deaths among people who have been vaccinated reached 36 on Friday, sparking calls from doctors and politicians for a halt to the programme, which aims to vaccinate about 30 million of the country’s 52 million population.

Some 20 initial autopsy results from the police and the National Forensic Service showed that 13 died of cardiovascular, cerebrovascular and other disorders not caused by the vaccination, while seven are undergoing additional examinations, KDCA said.

Both the forensic agency and police were not immediately reachable for comment.

Prime Minister Chung Sye-kyun expressed condolences to the families of those who died, calling for a thorough investigation to verify the exact cause of deaths.

“So far experts said there was low possibility that the shots and deaths were related but many citizens remain anxious,” he told a meeting.

The rising death toll has fuelled debate about whether the programme, which is free for some citizens, should be suspended. The country’s largest grouping of doctors called for a halt until the safety of the vaccines is confirmed, while a major vaccine society said inoculation should continue as no relation to the deaths have been found.

ADVISED AGAINST SHOTS

Some local governments and district offices around the country have voluntarily advised residents against taking a flu shot or are considering suspending the programme.

The vaccine providers include domestic firms such as GC Pharma, SK Bioscience, Korea Vaccine and Boryung Biopharma Co Ltd, a unit of Boryung Pharm Co Ltd 003850.KS, along with France's Sanofi SASY.PA. They supply both the free programme and paid services.

Slideshow ( 4 images )

Of those who have died, 10 people received products from SK Bioscience, five each from Boryung and GC Pharma, four from Sanofi and one from Korea Vaccine. There were no details about the latest 11 case

KDCA director Jeong Eun-kyeong said on Thursday that vaccines would continue to be supplied but the government might consider suspending some products that have identification numbers matching batches manufactured at the same plant on the same day if more people die using them. One batch consists of around 150,000 doses.

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.

All four domestic firms declined to comment.

Sanofi referred to the KDCA findings but said in a statement to Reuters that scientific assessments and monitoring were under way and that it would closely work with local health authorities.

South Korea ordered 20% more flu vaccines this year to ward off what it calls a “twindemic” of concurrent major flu and COVID-19 outbreaks in winter.

So far 9.4 million people had been inoculated since the programme began in September, with about 789 cases of adverse reactions reported, the KDCA said.

The KDCA reported 155 new coronavirus cases as of Thursday midnight, bringing total infections to 25,698, with 455 deaths.

https://www.reuters.com/article/us-health-coronavirus-southkorea-flushot/south-koreas-forensic-team-found-no-links-between-flu-shot-boys-death-media


Friday 23 October 2020

FDA approves remdesivir despite doubts about effectiveness

US: FDA approves coronavirus drug remdesivir despite doubts about effectiveness

Though remdesivir can reduce the mortality rate and the duration of the illness COVID-19, it's not considered entirely effective. Nevertheless, US authorities have now approved the drug for use against the disease.

23 October 2020


The US Food and Drug Administration (FDA) has approved the drug remdesivir for the treatment of COVID-19, issuing a statement on Friday, October 23. The drug had previously been approved in the US only under an Emergency Use Approval (EUA). In Europe, the product had also received an EUA in July for the treatment of certain COVID-19 patients. 

Remdesivir came into focus as a potential cure immediately after the first infections of the novel coronavirus were reported in China. Remdesivir was originally developed to treat Ebola infections, but it also showed effectiveness  against SARS and MERS coronaviruses in laboratory tests. The new SARS-CoV-2 is considered a variant of the 2002 SARS pathogen.

The drug was developed by the US pharmaceutical company Gilead Sciences as GS-5734. At the outset of the pandemic, it was not approved by any country.

It has since been used in the context of emergency use, as well as in the context of scientific studies in numerous countries. Gilead Sciences gave the drug the brand name Veklury in Autumn 2020. 

After an initial clinical trial in the US showed positive results in May 2020, the FDA granted the EUA. Since then, remdesivir was able to be used in hospitals for the treatment of individual patients with the lung disease COVID-19 outside clinical trials. 

Read more: Is compulsory licensing of remdesivir a feasible option?

The World Health Organization (WHO)  published a non-peer-reviewed preprint study on MedRxiv  on October 15 showing that remdesivir barely reduces the mortality rate of COVID-19 patients. The study is a result of the so-called 'SOLIDARITY Trial' in which the data of 11,266 patients was evaluated. 

Gilead Sciences in a statement  argued that by having the study published as a preprint, "the data from this open-label global trial have not undergone the rigorous review required to allow for constructive scientific discussion."

In the same statement, the companyreferenced another study  with 1062 volunteers, that was recently published in the New England Journal of Medicine (NEJM),  which showed that remdesivir could reduce the average healing time from 15 to 10 days. 

Gilead Sciences filed an application for regular approval of the drug with the FDA on August 7, 2020. 

Read moreDoes nicotine help against the new coronavirus?

How does remdesivir work? 

The antiviral effect of remdesivir derives from its function as a so-called nucleotide analogue. The active substance inhibits the RNA polymerase (RdRp) of viruses such as Ebola and MERS because its structure is similar to RNA building blocks. During virus replication, these are erroneously incorporated into the genetic strands of the new virus copies. Truly functional new viruses cannot be created in this way.

Although remdesivir did not prove to be really effective in fighting Ebola, cell culture experiments and initial experiments on macaques showed that it had a promising effect against the coronaviruses SARS and MERS-CoV, which are closely related to SARS-CoV-2.

Early clinical trials with remdesivir carried out in the US and China were intended to show if the drug also helps against COVID-19.

Read moreCoronavirus: EU approves COVID-19 drug remdesivir

White House celebrates positive effects

Initial positive results of an early randomized clinical trial in the US were announced on April 29, 2020 directly from the White House in Washington. Speaking about remdesivir at a press conference with US President Donald Trump at the White House, the director of the National Institute for Allergy and Infectious Diseases (NIAID), Anthony Fauci, then stated: "This will be the standard of care."

A total of 1,063 patients with varying degrees of severity of the disease had taken part in the NIAID-funded study, the 'Adaptive COVID-19 Treatment Trial', and were treated with remdesivir or a placebo for 10 days.

In such a randomized double-blind study, neither the treating physicians nor the patients know who is injected daily with the active substance and who receives a placebo. This is to prevent any expectations of the drug from possibly distorting the actual results. 

Read more: Coronavirus crisis: Children suffer most from being locked down

The results were similar, albeit not quite as clear as those from the new NEJM study. According to NIAID, preliminary results suggested that COVID-19 patients receiving remdesivir had, on average, a 31% faster recovery time than patients given the placebo. Patients that received remdesivir had an average recovery time of 11 days and patients receiving the placebo had an average recovery time of 15 days.

The mortality rate in the remdesivir-treated group was 8% compared to 11.6% in the placebo group. Those responsible for the trials then considered them sufficient. The National Institutes of Health in the US said that the results were meaningful enough. 

In parallel with the successful reports from Washington, there were additional reports from China, where remdesivir was first tested for its efficacy in randomized clinical trials in Wuhan on patients in intensive care units suffering from severe cases of COVID-19.

There are now too few patients at the source of the coronavirus pandemic in Wuhan

Eventually, however, Wuhan lacked the necessary patients because of a sharp decline in new infections, and that study was also terminated prematurely, according to a report in The Lancet. 

What do the results mean?

Both the early two studies, as well as the more recent published and leaked studies, seem to point to the same conclusion: The active substance remdesivir has clearly proven to be moderately effective. It reduces the death rate slightly but not significantly and it reduces the duration of the disease by a few days.

Although this is encouraging, it is far from being the resounding success that many had hoped for from what was described as the most promising drug candidate to date.

German infectious disease expert, Gerd Fätkenheuer, professor of medicine at the University Hospital Cologne, had expected a quick approval for remdesivir after the publication of the NIAID study in May. He was leading a clinical trial of remdesivir with patients in Germany.

"For patients with a severe form of this disease, this study gives hope that they will be able to recover from the infection more quickly and safely," he said. "The yardstick for the effectiveness of potential other drugs will, in the future, be remdesivir." 

"The results of the large-scale SOLIDARITY study from the WHO with 11,266 patients included worldwide are not entirely unexpected, but no less disappointing" Clemens Wendtner, chief physician for infectiology and tropical medicine at the Munich Municipal Hospital said.

"Despite the limitation that no detailed data are available on the preprint server to date and a peer review process is still pending, it can be stated that the study has failed to meet its primary endpoint: None of the four drugs tested — remdesivir, hydroxychloroquine, Lopinar/Ritonavir, and IFN-ß1a - are capable of reducing COVID-19 mortality in symptomatic patients requiring hospital treatment," said Wendtler about the most recent study.

This article was originally published on April 30, 2020 — before remdesivir was approved. It has since been updated to include the latest information from recent scientific studies and the latest FDA approval.  

This article was translated from German.


https://www.dw.com/en/us-fda-approves-coronavirus-drug-remdesivir-despite-doubts-about-effectiveness/a-53326847


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Can Ivermectin Help Prevent COVID-19 Deaths? - MUST READ

US gives full approval to antiviral remdesivir to treat Covid-19 (now updated with add'l info)

The FDA has granted full approval to the antiviral drug remdesivir as a treatment for patients hospitalised with Covid-19 (see update below)


 By AFP - October 23, 2020 @ 11:18am

(FILES) In this file photo taken on April 8, 2020 one vial of the drug Remdesivir is seen during a press conference about the start of a study with the Ebola drug Remdesivir in particularly severely ill patients at the University Hospital Eppendorf (UKE) in Hamburg, northern Germany, amidst the new coronavirus COVID-19 pandemic. - The US Food and Drug Administration on October 22, 2020 granted full approval to the antiviral drug Remdesivir as a treatment for patients hospitalized with Covid-19, its manufacturer Gilead said, following conditional authorization granted in May. (Photo by Ulrich Perrey / POOL / AFP)

(FILES) In this file photo taken on April 8, 2020 one vial of the drug Remdesivir is seen during a press conference about the start of a study with the Ebola drug Remdesivir in particularly severely ill patients at the University Hospital Eppendorf (UKE) in Hamburg, northern Germany, amidst the new coronavirus COVID-19 pandemic. - The US Food and Drug Administration on October 22, 2020 granted full approval to the antiviral drug Remdesivir as a treatment for patients hospitalized with Covid-19, its manufacturer Gilead said, following conditional authorization granted in May. (Photo by Ulrich Perrey / POOL / AFP)


WASHINGTON: The US Food and Drug Administration on Thursday granted full approval to the antiviral drug remdesivir as a treatment for patients hospitalised with Covid-19, after conditional authorisation was given in May.

See also updates to this article:


Gilead said the drug, sold under the brand name Veklury, was the only specific treatment for Covid-19 approved so far under a more rigorous process.

However, other treatments have received authorisation for emergency use, though that approval can be revoked once the public health emergency sparked by the coronavirus pandemic is over.

Other medications, like the steroid dexamethasone, are also being used in the fight against Covid-19.

Gilead's shares on the New York Stock Exchange jumped four percent soon after the announcement.

"The FDA is committed to expediting the development and availability of Covid-19 treatments during this unprecedented public health emergency," said FDA Commissioner Stephen Hahn.

"Today's approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the Covid-19 pandemic."

Europe and other countries such as Canada also have granted temporary approval for the use of remdesivir.

Remdesivir, which is administered by an injection, was one of the first drugs to show relative promise in shortening the time to recovery in some coronavirus patients.

But its efficacy in reducing the mortality rate is unproven.

It can be administered to adults and children over the age of 12 who weigh more than 40 kilos (88 pounds) who require hospitalization for the treatment of Covid-19, the illness caused by the novel coronavirus.

The drug can only be given to patients in a hospital or equivalent setting.

Emergency approval has been granted for its use on pediatric patients under the age of 12 weighing at least 3.5 kilos.

President Donald Trump, who tested positive for the coronavirus early in October, was treated with remdesivir at a military hospital outside Washington, among other drugs.

The drug was first developed to treat Ebola, a viral hemorrhagic fever.

In February, the US National Institute of Allergy and Infectious Diseases (NIAID) announced it was dusting off remdesivir to investigate against SARS-CoV-2, the pathogen that causes Covid-19, because it had shown promise in animal testing against fellow coronaviruses SARS and MERS.

Its study involving more than 1,000 people, the results of which were released in April, found that patients on the drug had a 31 percent faster time to recovery than those on a placebo.

Since the medicine is complex to manufacture and is administered via injection, rather than a pill, there have been questions about whether supply could initially be limited.

The United States bet early on remdesivir's success, rushing to preorder nearly all of Gilead's summer production.

Gilead has set the price at $390 per vial in developed countries, or $2,340 for six vials used over the normal five-day course, though US private insurers will pay $520 per vial. -- AFP

https://www.nst.com.my/world/world/2020/10/634594/us-gives-full-approval-antiviral-remdesivir-treat-covid-19


See also updates to this article:


SEE ALSO:

Thursday 22 October 2020

FDA Approves First Treatment for COVID-19 (Now with add'l info)

 October 22, 2020

(See also updates to this article:


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 less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg. Clinical trials assessing the safety and efficacy of Veklury in this pediatric patient population are ongoing.

“The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic. As part of the FDA’s Coronavirus Treatment Acceleration Program, the agency will to continue to help move new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks.”

Under the Federal Food, Drug, and Cosmetic Act, approval of a new drug product requires substantial evidence of effectiveness and a demonstration of safety for the drug’s intended use(s). In considering approval of a drug, the FDA conducts a benefit-risk assessment based on rigorous scientific standards to ensure that the product’s benefits outweigh its risks for the intended population. This is different from the standard used in the issuance of an EUA

The approval of Veklury was supported by the agency’s analysis of data from three randomized, controlled clinical trials that included patients hospitalized with mild-to-severe COVID-19.

One randomized, double-blind, placebo-controlled clinical trial (ACTT-1), conducted by the National Institute of Allergy and Infectious Diseases, evaluated how long it took for subjects to recover from COVID-19 within 29 days of being treated. The trial looked at 1,062 hospitalized subjects with mild, moderate and severe COVID-19 who received Veklury (n=541) or placebo (n=521), plus standard of care. Recovery was defined as either being discharged from the hospital or being hospitalized but not requiring supplemental oxygen and no longer requiring ongoing medical care. The median time to recovery from COVID-19 was 10 days for the Veklury group compared to 15 days for the placebo group, a statistically significant difference. Overall, the odds of clinical improvement at Day 15 were also statistically significantly higher in the Veklury group when compared to the placebo group.

A second randomized, open-label multi-center clinical trial of hospitalized adult subjects with moderate COVID-19 compared treatment with Veklury for five days (n=191) and treatment with Veklury for 10 days (n=193) with standard of care (n=200). Researchers evaluated the clinical status of subjects on Day 11. Overall, the odds of a subject’s COVID-19 symptoms improving were statistically significantly higher in the five-day Veklury group at Day 11 when compared to those receiving only standard of care. The odds of improvement with the 10-day treatment group when compared to those receiving only standard of care were numerically favorable, but not statistically significantly different.

A third separate, randomized, open-label multi-center clinical trial of hospitalized adult subjects with severe COVID-19 compared treatment with Veklury for five days (n= 200) and treatment with Veklury for 10 days (n= 197). Researchers evaluated the clinical status of subjects on Day 14. Overall, the odds of a subject’s COVID-19 symptoms improving were similar for those in the five-day Veklury group as those in the 10-day Veklury group, and there were no statistically significant differences in recovery rates or mortality rates between the two groups.

Important information about using Veklury to treat COVID-19 for its approved use is available in the prescribing information which includes dosing instructions, potential side effects and drug interactions. Possible side effects include: increased levels of liver enzymes, which may be a sign of liver injury; and allergic reactions, which may include changes in blood pressure and heart rate, low blood oxygen level, fever, shortness of breath, wheezing, swelling (e.g., lips, around eyes, under the skin), rash, nausea, sweating or shivering. Similar safety information about using Veklury to treat COVID-19 in certain hospitalized pediatric patients under the EUA is available in the fact sheets for health care providers and patients/caregivers.

The FDA granted this application Fast Track and Priority Review designations. The Agency also granted this application a Material Threat Medical Countermeasure Priority Review Voucher, which provides additional incentives for certain medical products intended to treat or prevent harm from specific chemical, biological, radiological and nuclear threats. 

The FDA granted approval and reissued the revised EUA to Gilead Sciences Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Related Information

https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19


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