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Remdesivir should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Pixabay

The US Food and Drug Administration has 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. The FDA granted approval and reissued the revised EUA to Gilead Sciences Inc.

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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 the 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.


This approval does not include the entire population that had been authorized to use Remdesivir under an Emergency Use Authorization (EUA). Pixabay

“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 Coronovarus Treatment Acceleration Programme, the agency will 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 the 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.

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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.

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The trial looked at 1,062 hospitalized subjects with mild, moderate, and severe COVID-19 who received Veklury or placebo, 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.


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. Pixabay

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 of hospitalized adult subjects with moderate COVID-19 compared treatment with Veklury for five days and treatment with Veklury for 10 days with the standard of care.

Want to read more in Hindi? Checkout: भारत के गलत मानचित्र को लेकर सरकार ने ट्विटर को दी चेतावनी.

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 on 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 and treatment with Veklury for 10 days.

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.

Also Read: Immediate Biomedical Waste Management Halts COVID Spread: UNIDO

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. (IANS)


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Killer Smog in Delhi.

Developed by the Indian Institute of Tropical Meteorology (IITM), Pune, a Decision Support System (DSS) that extends the ability of the existing air quality early warning system (AQEWS) to have decision-making capability for air quality management in Delhi-NCR was launched on Tuesday.

The website for the DSS (https://ews.tropmet.res.in/dss/) is designed to help the Commission for Air Quality Management for NCR and Adjoining Areas (CAQM) by delivering quantitative information about the contribution of emissions from Delhi and its 19 surrounding districts; the contribution of emissions from eight different sectors in Delhi; and the contribution from biomass-burning activities in the neighbouring states.

These information would assist in managing the air quality in a timely manner, a release from the Ministry of Earth Sciences said.

The need was stated by the CAQM, which was formed by the Ministry of Environment, Forest and Climate Change, during a meeting held in January 2021.

Recently, the Commission reviewed the progress made by IITM and had in principle approved the current version of DSS for air quality management in the Delhi-NCR. The IITM has also developed a new website for DSS with the entire system made operational, the release said.

Union Minister of State for Earth Sciences, Jitendra Singh, while launching the website for AQEWS on the occasion of 'Azadi Ka Amrit Mahotsav' week organised by the Ministry of Earth Sciences, said, "DSS is a significant contribution to 'Azadi Ka Amrit Mahotsav' on behalf of MoES and IITM and suggestions are invited on this issue."

The website also has a feature whereby the users can create their own emission reduction scenarios (from 20 different districts, including Delhi) so as to examine the possible projected improvement in air quality in Delhi for the next five days.

"This information would explicitly highlight the most important emission sources responsible for the degradation of air quality in Delhi and suggest possible solutions to ameliorate the same. With a plethora of quantitative data, the AQEWS integrated with DSS could become a user-friendly tool for air-quality management in and around Delhi," the release said. (IANS/JB)

Keywords: Delhi, India, Pollution, IITM, Ministry of Earth Sciences