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<keyword id="18568" type="COMPANY" weightage="20" keywordseo="kathmandu">Kathmandu</keyword>, Ahead of signing a major Covid <keyword id="24209" type="PERSON" weightage="20" keywordseo="vaccine">vaccine</keyword> deal with <keyword id="3658" type="LOCATION" weightage="20" keywordseo="India">India</keyword>, probably on Friday, Nepal's Department of Drug Administration (DDA) has given permission for the <keyword id="9156702" type="UNKNOWN" weightage="20" keywordseo="emergency-use">emergency use</keyword> of India-made coronavirus vaccine Covishield in the country. Nepal's Foreign Minister Pradeep Gyawali is currently in New Delhi to take part in the sixth meeting of Nepal-India Joint Commission. One of the major agreements that both sides are likely to ink is on cooperation in Covid vaccine manufactured in India. The vaccine, developed by the <keyword id="30725" type="COMPANY" weightage="20" keywordseo="Oxford-university">Oxford University</keyword> and Astra-Zeneca and produced by the <keyword id="95879" type="COMPANY" weightage="20" keywordseo="Serum-Institute-of-India">Serum Institute of India</keyword>, has been given conditional permission for emergency use, the department said. The DDA had two days ago called for the registration of vaccines to be used for emergency use. This is the first time that any Covid-19 vaccine has been approved for use in Nepal. Other manufacturing countries like China and Russia were also interested in providing vaccines to Nepal but due to climatic conditions, pricing, logistic facility and ease of import, Nepal preferred the Indian Covid vaccine. India has already permitted the use of Covishield as well as Covaxin of <keyword id="149108" type="PERSON" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword>. SEE ALSO: <a href="https://www.businessinsider.in/defense/news/these-amazing-facts-about-the-indian-army-will-make-you-beam-with-pride/slidelist/80270052.cms">Army Day 2021: These amazing facts about the Indian Army will make you beam with pride</a> <a href="https://www.businessinsider.in/business/corporates/news/hcl-tech-clocks-in-nearly-27-jump-in-profit-crosses-the-10-billion-revenue-in-third-quarter-of-year-2020-21/articleshow/80278852.cms">HCL Tech clocks in nearly 27% jump in profit, crosses the $10 billion revenue milestone with one more quarter left</a> <a href="https://www.businessinsider.in/india/news/india-will-begin-its-covid-19-vaccination-drive-tomorrow-heres-everything-you-need-to-know/articleshow/80281740.cms">India will begin its COVID-19 vaccination drive tomorrow — here’s a look at how the world’s largest vaccine rollout is set to take place</a>

Nepal approves Covishield vaccine for emergency use

In a setback to <keyword id="149108" type="PERSON" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword>'s COVID-19 vaccine <keyword id="9485939" type="PERSON" weightage="20" keywordseo="covaxin">Covaxin</keyword>, the <keyword id="6356255" type="COMPANY" weightage="20" keywordseo="us-food-and-drug-administration">US Food and Drug Administration</keyword> has "recommended" Ocugen Inc, the US partner of the Indian vaccine maker, to go for Biologics Licence Application (BLA) route with additional data, nixinghopes of <keyword id="9408526" type="COMPANY" weightage="20" keywordseo="emergency-use-authorisation">Emergency Use Authorisation</keyword>. Ocugen in a statement on Thursday announced that as recommended by theFDA,it will pursue submission of a biologics licence application (BLA) for Covaxin. BLA,is a "full approval" mechanism by the <keyword id="6354656" type="COMPANY" weightage="20" keywordseo="fda">FDA</keyword> for drugs and vaccines. "The company will no longer pursue an Emergency Use Authorization (EUA) for Covaxin. The FDA provided feedback to Ocugen regarding the Master File. The company had previously submitted and recommended that Ocugen pursue a BLA submission instead of an EUA application for its vaccine candidate and requested additional information and data," Ocugen said. The development may delay the Covaxin launch in the US, Ocugen said. Ocugen is in discussions with the FDA to understand the additional information required to support a BLA submission. The company anticipates that data from an additional clinical trial will be required to support the submission. "Although we were close to finalising our EUA application for submission, we received a recommendation from the FDA to pursue a BLA path. While this will extend our timelines, we are committed to bringing Covaxin to the US," Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer and co-founder of Ocugen said. "This differentiated vaccine is a critical tool to include in our national arsenal given its potential to address the SARS-CoV-2 variants, including the delta variant, and given the unknowns about what will be needed to protect US population in the long term," he added. Ocugen recently announced that it secured exclusive rights to commercialise Covaxin in Canada and has initiated discussions with Health Canada for regulatory approval. The company will pursue expedited authorisation for the vaccine under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 in Canada. SEE ALSO: <a href="https://www.businessinsider.in/tech/gadgets/news/realme-is-expected-to-launch-the-realme-book-and-realme-pad-on-june-15/articleshow/83398969.cms">Realme Book leaked ahead of launch, expected to debut with Realme Pad on June 15</a> <a href="https://www.businessinsider.in/cryptocurrency/news/iran-is-planning-to-introduce-a-legal-framework-for-crypto-even-as-bitcoin-mining-activity-remains-restricted/articleshow/83396588.cms">Iran is planning to introduce a legal framework for crypto even as bitcoin mining activity remains restricted</a>

US drug regulator rejects emergency use authorisation for India's Covaxin

Washington, May 2 (AP) US regulators on Friday allowed emergency use of an experimental drug that appears to help some coronavirus patients recover faster.It is the first drug shown to help fight COVID-19, which has killed more than 230,000 people worldwide.The Food and Drug Administration acted after preliminary results from a government-sponsored study showed that Gilead Sciences's remdesivir shortened the time to recovery by 31 per cent, or about four days on average, for hospitalized COVID-19 patients.The study of 1,063 patients is the largest and most strict test of the drug and included a comparison group that received just usual care so remdesivir's effects could be rigorously evaluated.President Donald Trump announced the FDA's action at the White House.Those given the drug were able to leave the hospital in 11 days on average versus 15 days for the comparison group.The drug also might be reducing deaths, although that's not certain from the partial results revealed so far.The National Institutes of Health's Anthony Fauci said the drug would become a new standard of care for severely ill COVID-19 patients like those in this study.The drug has not been tested on people with milder illness, and currently is given through an IV in a hospital.Gilead has said it would donate its currently available stock of the drug and is ramping up production to make more.No drugs are approved now for treating the coronavirus, and remdesivir will still need formal approval.The FDA previously gave emergency use authorization to a malaria drug, hydroxychloroquine, after President Donald Trump repeatedly promoted it as a possible treatment for COVID-19.No large high-quality studies have shown the drug to work for that, however, and it has significant safety concerns. (AP) AD

FDA allows emergency use of drug for coronavirus

Pharmaceutical companies <keyword id="44612" type="DOMAIN" weightage="20" keywordseo="Pfizer">Pfizer</keyword> and <keyword id="3124139" type="COMPANY" weightage="20" keywordseo="BioNTech">BioNTech</keyword> on Wednesday announced that their Covid-19 <keyword id="24209" type="PERSON" weightage="20" keywordseo="vaccine">vaccine</keyword> -- BNT162b2 -- demonstrated 100 per cent efficacy and robust antibody responses in a Phase 3 trial in <keyword id="6381562" type="UNKNOWN" weightage="20" keywordseo="Adolescents">adolescents</keyword> between 12 to 15 years old. The Phase 3 <keyword id="122283" type="PERSON" weightage="20" keywordseo="Clinical-trial">clinical trial</keyword> enrolled 2,260 adolescents aged between 12 to 15 years old in the US. "We share the urgency to expand the authorisation of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15," Albert Bourla, Chairman and Chief Executive Officer, Pfizer, said in a statement. In the trial, 18 cases of Covid-19 were observed in the placebo group (n=1,129) versus none in the vaccinated group (n=1,131). Vaccination with BNT162b2 elicited SARS-CoV-2-neutralising antibody geometric mean titres (GMTs) of 1,239.5, demonstrating strong immunogenicity in a subset of adolescents one month after the second dose. This compared well (was non-inferior) to GMTs elicited by participants aged 16 to 25 years old (705.1 GMTs) in an earlier analysis. Further, BNT162b2 administration was well tolerated, with side effects generally consistent with those observed in participants 16 to 25 years of age. The BNT162b2 has not been approved or licensed by the <keyword id="6356255" type="COMPANY" weightage="20" keywordseo="us-food-and-drug-administration">US Food and Drug Administration</keyword> (FDA), but has been authorised for <keyword id="9156702" type="UNKNOWN" weightage="20" keywordseo="emergency-use">emergency use</keyword> by FDA under an Emergency Use Authorization (EUA) to prevent Covid-19 for use in individuals 16 years of age and older. "We plan to submit these data to FDA as a proposed amendment to our Emergency Use Authorisation in the coming weeks and to other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year," Bourla added. SEE ALSO: <a href="https://www.businessinsider.in/tech/mobile/news/samsung-galaxy-a72-mobile-phone-review/slidelist/81774857.cms">Samsung Galaxy A72 review – a premium mid-range phone in a crowded market</a> <a href="https://www.businessinsider.in/science/environment/news/earth-lost-more-arctic-sea-ice-than-the-area-of-rajasthan-and-madhya-pradesh-combined-in-2021/articleshow/81775537.cms">The planet lost more Arctic sea ice than the area of Rajasthan and Madhya Pradesh combined in 2021</a> <a href="https://www.businessinsider.in/tech/news/from-smartphones-to-cars-india-needs-so-many-semiconductor-chips-that-modi-may-offer-billion-dollar-cash-reward/articleshow/81777612.cms">Howzzat! A $1 billion cash reward for making semiconductor chips in India⁠ is under consideration</a> <a href="https://www.businessinsider.in/finance/banks/news/sbi-icici-hdfc-and-other-bank-customers-could-face-otp-issues-from-april-1/articleshow/81777962.cms">Bank OTP issue – SBI, ICICI, HDFC and other bank customers could face OTP issues from April 1</a>

Pfizer-BioNTech COVID-19 vaccine shows 100% efficacy in 12-15 yrs old

<ul class="summary-list"><li><keyword id="3001" type="COUNTRY" weightage="60" keywordseo="Pakistan">Pakistan</keyword>'s regulators approved <keyword id="6409874" type="COMPANY" weightage="60" keywordseo="astrazeneca">AstraZeneca</keyword> and <keyword id="30725" type="ORGANIZATION" weightage="60" keywordseo="Oxford-university">Oxford University</keyword>'s <keyword id="8763838" type="UNKNOWN" weightage="60" keywordseo="covid-19">COVID-19</keyword> shot for emergency use. </li><li>The shot will first be given to over-65s and <keyword id="6354525" type="UNKNOWN" weightage="100" keywordseo="healthcare">healthcare</keyword> workers, per <a href="https://apnews.com/article/pakistan-immunizations-india-coronavirus-pandemic-coronavirus-vaccine-d4393d78c1ff3d5a23cf1751d577f8d2">The Associated Press</a>. </li><li>Local governments and private firms were free to import the shot, reported Dawn, a local newspaper. </li></ul>Pakistan on Saturday approved the <keyword id="1754604" type="PERSON" weightage="60" keywordseo="coronavirus">coronavirus</keyword> <keyword id="24209" type="PERSON" weightage="60" keywordseo="vaccine">vaccine</keyword> developed by AstraZeneca and Oxford University for emergency use, according to multiple reports. Asad Umar, a government official working on the vaccine rollout, said the vaccine will first be given to people older than 65 and healthcare workers, according to <a href="https://apnews.com/article/pakistan-immunizations-india-coronavirus-pandemic-coronavirus-vaccine-d4393d78c1ff3d5a23cf1751d577f8d2">The Associated Press</a>. Speaking on Saturday, Umar said provinces and the private sector were free to import the drug, subject to the approval of the Drug Regulatory Authority of Pakistan (DRAP), according to <a href="https://www.dawn.com/news/1602026/provinces-private-sector-free-to-import-covid-19-vaccines-after-drap-approval-asad-umar">Dawn</a>, a local newspaper. Read more: <a href="https://www.businessinsider.com/coronavirus-vaccine-tracker-top-covid-shots-to-watch-in-2021?r=ks-sub">What's coming next for COVID-19 vaccines? Here's the latest on 11 leading programs.</a> "From day 1, the [National Command and Operation Centre] has adopted the policy that the federal government shall not have the monopoly to import anti-coronavirus vaccines," said Umar, according to Dawn.<div type="image" title="AstraZeneca Vaccine Bottles COVID 19 coronavirus.JPG" height="3294" width="4958" msid="80314714" hostid="261"></div>Pakistan late last year signed an agreement with China's National Pharmaceutical Group, known as Sinopharm, for more than a million doses of its vaccine, according to <a href="https://tribune.com.pk/story/2280204/astrazeneca-covid-19-vaccine-approved-for-emergency-use-in-pakistan">The Express Tribune</a>. Sinopharm's drug has not yet been approved by DRAP. The country may also import "tens of millions" of doses of a vaccine made by China's CanSinoBio, Faisal Sultan, special assistant to the prime minister on national health services, told <a href="https://tribune.com.pk/story/2280204/astrazeneca-covid-19-vaccine-approved-for-emergency-use-in-pakistan">the newspaper</a>. Pakistan has had 519,291 confirmed COVID-19 cases, with 10,951 deaths, according <a href="https://coronavirus.jhu.edu/region/pakistan">to data compiled</a> by Johns Hopkins University.In the last week, about 307 people died following COVID-19 infections, down from the country's record high of 861 weekly deaths in mid-June, according to Johns Hopkins. A second wave of coronavirus cases hit Pakistan in November and December, according to data shared on Twitter by Umar earlier this month. Umar urged people in Pakistan to follow safety regulations in an effort to flatten the curve. Last week, he said: "Data clearly shows that covid health consequences are strongly correlated with our decisions &amp; personal choices. Hence it's important that we all take responsibility &amp; take precautions. If we do the right things we shall inshallah continue to safeguard lives &amp; livelihoods." Neighboring India began the <a href="https://www.businessinsider.com/india-begins-drive-to-vaccinate-millions-against-covid-19-2021-1">world's largest vaccination drive</a> on Saturday, with the goal of inoculating 300,000 people in one day. India <a href="https://www.businessinsider.com/astrazeneca-covid-19-vaccine-approved-for-emergency-use-in-india-2021-1">approved</a> AstraZeneca's vaccine, which goes under the name Covishield in the country, for emergency use in early January.

Pakistan approves AstraZeneca's COVID-19 vaccine for emergency use

<ul class="summary-list"><li><keyword id="1754604" type="PERSON" weightage="60" keywordseo="coronavirus" source="Orion">Coronavirus</keyword> vaccines won't be available for children under 12 until fall at the earliest.</li><li><keyword id="44612" type="CITY" weightage="60" keywordseo="Pfizer" source="Orion">Pfizer</keyword> expects to know how its vaccine performs among kids ages 5 to 11 by the end of September.</li><li><keyword id="4912868" type="PERSON" weightage="60" keywordseo="moderna" source="Orion">Moderna</keyword> could produce data for that same age group in late fall or early winter.</li></ul>It's one of the US's biggest hurdles to getting the population vaccinated: Children under 12 - nearly 15% of the country, or around 48 million Americans - aren't yet eligible to receive coronavirus shots. Both Pfizer and Moderna entered young kids into their clinical trials in March, but the results of those studies haven't been published.Pfizer expects to have data about its vaccine's efficacy among kids ages 5 to 11 by the end of September. It usually takes the Food and Drug Administration a few weeks to review such data, so that would put the US on track to start administering shots to young kids in October at the earliest, assuming the trial results are good.Data for the other age group Pfizer is studying, children ages 6 months to 5 years, could be available shortly thereafter, Pfizer said in July. The company previously estimated that results for its youngest age group could be available by October or November.Moderna, meanwhile, expects to have data about its vaccine's efficacy among young kids in late fall or early winter.<h2>Federal health authorities and Wall Street analysts have offered slightly different timelines</h2><div type="image" title="Fauci" height="2624" width="3936" msid="85818723" hostid="261"></div>Former <keyword id="6354656" type="ORGANIZATION" weightage="60" keywordseo="fda" source="Orion">FDA</keyword> Commissioner Scott Gottlieb, who sits on Pfizer's board, <a href="https://www.cnbc.com/2021/08/30/pfizer-director-dr-scott-gottlieb-on-covid-vaccine-for-kids-5-to-11.html">told CNBC on Monday</a> that the FDA could greenlight Pfizer's shot for kids under 12 in late fall or early winter. But he added that Pfizer's emergency-use application "probably isn't going to be submitted until some point in October." From there, he estimated, the FDA might take four to six weeks to review the data.White House Chief Medical Advisor Anthony Fauci <a href="https://www.today.com/health/fauci-when-kids-will-be-able-get-covid-19-vaccine-t228946">told NBC's "TODAY"</a> last week that "there's a reasonable chance" that younger kids could be vaccinated by the winter holidays.But Wall Street analysts have a slightly more optimistic timeline.In a Tuesday report, Morgan Stanley analysts said they expected Pfizer to submit an emergency authorization for kids ages 5 to 11 in September, putting the US on track to vaccinate this age group in the fall. The analysts estimated that Pfizer would produce data for kids ages 6 months and up in November, meaning the youngest kids could get vaccinated in late 2021 or early 2022.Moderna, they said, could produce data for kids ages 6 to 12 in the fall, around one to two months after Pfizer. Data for kids 6 months and up would then be available in late 2021 or early 2022, they added, meaning Pfizer could file for emergency authorization for its youngest age group next year.<h2>The FDA hasn't yet authorized Moderna's and J&amp;J's shots for older kids</h2><div type="image" title="kid pfizer vaccine" height="2793" width="4200" msid="84992749" hostid="261"></div>The FDA asked both Pfizer and Moderna to expand their under-12 trials in July, citing concerns that the studies weren't large enough to detect rare side effects such as heart inflammation.Until then, Pfizer had been studying its vaccine in up to 4,500 young children, divided among two age groups: 5 years to 11 years and 6 months to 5 years. Moderna's trial, meanwhile, included three age groups - 6 years to 11 years, 2 years to 5 years, and 6 months to less than 2 years - each with 2,265 participants. The FDA asked both companies to include at least 3,000 children in the 5-to-11 age group, <a href="https://www.nytimes.com/2021/07/26/us/politics/covid-vaccine-trials-children.html">The New York Times</a> reported.The FDA authorized Pfizer's shot for children ages 12 to 15 in May. But Moderna is still waiting on the agency to authorize its shot for kids from 12 to 17, after seeking emergency authorization in June. The FDA could greenlight that shot for this age group any day now.<keyword id="92247" type="COMPANY" weightage="60" keywordseo="Johnson-Johnson" source="Orion">Johnson &amp; Johnson</keyword> is on a slower timeline. The company won't start studying its vaccine among children ages 12 to 17 until this fall. If the shot is shown to be safe and effective among older kids, J&amp;J could then start enrolling 2- to 11-year-olds, followed by children younger than 2. That means a single-dose shot likely won't be available to kids until sometime in 2022. <h2>Young children may receive a lower dose </h2><div type="image" title="israel kid vaccine" height="3648" width="5472" msid="84992750" hostid="261"></div>Pfizer's phase-one trial indicated that a lower dose of its vaccine - 10 micrograms, as opposed to the 30 given to adults - is safe among children ages 5 to 11. The trial administered an even smaller dosage, 3 micrograms, to children ages 6 months to 5 years, who seemed to tolerate it well.Moderna is similarly comparing its standard dose (100 micrograms) with lower doses for all age groups. Children ages 2 to 12 in the trial are receiving either 50 or 100 micrograms, and kids between 6 months and 2 years are receiving either 25, 50, or 100.A lower dose could help avoid unnecessary side effects. Adolescents in Pfizer's trials seemed to develop side effects <a href="https://www.businessinsider.com/most-common-vaccine-side-effects-teens-young-adults-chart-2021-5">more frequently than adults</a>, likely because kids' immune systems rev up quickly. But even the most common side effects, such as fatigue and headaches, were relatively minor.Since the FDA has fully approved Pfizer's vaccine for people 16 and older, pediatricians can legally prescribe the shot for "off-label" use in young kids. But health officials have warned them not to do so yet."Keep in mind kids are not just scaled down adults," Francis Collins, director of the National Institutes of Health, <a href="https://www.goodmorningamerica.com/News/video/nih-director-talks-full-fda-approval-pfizer-vaccine-79615351" target="_blank" rel="noopener">said on "Good Morning America"</a> last week. "They have different immune systems and metabolism. You really have to do the careful trials to make sure you got the dose right and there aren't any surprises."

Vaccines could get authorized for young kids this fall. Here are the drug companies' most likely timelines.

<ul><li>The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the experimental anti-viral drug <keyword id="8775508" type="UNKNOWN" weightage="20" keywordseo="remdesivir">remdesivir</keyword> to treat COVID-19.</li><li>Remdesivir is an investigational antiviral medicine to treat certain people in the hospital with COVID-19, said the FDA.</li><li>Remdesivir was shown in a clinical trial to shorten the time to recovery in some people.</li></ul> The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the experimental anti-viral drug remdesivir to treat COVID-19. In an FDA fact sheet for patients and their families and caregivers, the agency on Friday noted that remdesivir has not undergone the same type of review as an FDA-approved or cleared product, reports Xinhua news agency. Remdesivir is an investigational antiviral medicine to treat certain people in the hospital with COVID-19, said the FDA, adding the drug was still being studied. "There is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with COVID-19," said the FDA. Remdesivir was shown in a clinical trial to shorten the time to recovery in some people. There are no medicines approved by the FDA as safe and effective to treat people in the hospital who have COVID-19. Therefore, the FDA has authorized the emergency use of remdesivir for the treatment of COVID-19 under an EUA, said the agency. Remdesivir is given to patients through a vein one time each day for up to 10 days depending on recommendations of healthcare providers, according to the FDA. The drug may help decrease the amount of the coronavirus in bodies and help patients get better faster, said the agency. Possible side effects of remdesivir include infusion-related reactions and increases in levels of liver enzymes, according to the FDA. "These are not all the possible side effects of remdesivir. Remdesivir is still being studied so it is possible that all of the risks are not known at this time," said the FDA. See Also: <a href="https://www.businessinsider.in/science/health/news/remdesivir-the-coronavirus-miracle-drug-may-be-overhyped-suggests-lancet-study/articleshow/75470476.cms">The curious case of Remdesivir — the coronavirus ‘miracle drug’ may be overhyped, suggests Lancet study</a>

US FDA approves emergency use of Remdesivir for COVID-19 patients

<ul class="summary-list"><li>The US Food and Drug Administration <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-emergency-use-authorization-potential-covid-19-treatment">will allow emergency use</a> of <keyword id="195727" type="COMPANY" weightage="60" keywordseo="Gilead">Gilead</keyword>'s <keyword id="1754604" type="PERSON" weightage="60" keywordseo="coronavirus">coronavirus</keyword> treatment remdesivir.</li><li>Remdesivir helped coronavirus patients recover 31% faster than those taking a placebo, the US National Institutes of <keyword id="6354750" type="UNKNOWN" weightage="60" keywordseo="health">Health</keyword> said Wednesday.</li><li>The move allows for broader use of remdesivir. However an emergency use authorization is not regulatory approval. The FDA can apply a lower standard of evidence to allow emergency use.</li><li>FDA is only allowing the use of remdesivir in relatively sick coronavirus patients who are hospitalized.</li></ul>The US Food and Drug Administration is <a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-emergency-use-authorization-potential-covid-19-treatment">allowing emergency use</a> of Gilead Sciences' new coronavirus treatment.The regulatory action quickly follows<a href="https://www.businessinsider.com/coronavirus-treatment-gilead-says-positive-data-remdesivir-from-niaid-study-2020-4">positive trial results</a> showing the drug, called <a href="https://www.businessinsider.com/coronavirus-treatment-gileads-remdesivir-clinical-testing-timeline-2020-3">remdesivir</a>, helped coronavirus patients recover 31% faster than a group that got a placebo. Remdesivir has only been studied in hospitalized patients and is given as an IV infusion, so it's unlikely to become a broadly used treatment.An emergency use authorization is not the same as a typical approval. Emergency use is only allowed during public health emergencies, and treatments face a lower bar of evidence than used for FDA approval. There are no drugs that are specifically approved to treat COVID-19, the disease caused by the coronavirus."It is reasonable to believe that remdesivir may be effective in treating COVID-19," FDA said in a <a href="https://www.fda.gov/media/137564/download">letter</a> authorizing the drug's emergency use. "When used under the conditions described in this authorization, the known and potential benefits of remdesivir when used to treat COVID-19 outweigh the known and potential risks of such products."The agency previously allowed the emergency use of chloroquine and hydroxychloroquine, the anti-malaria pills. It also stipulated these drugs were only to be used when a patient was hospitalized and could not enroll in a suitable clinical trial.Read more: <a href="https://www.businessinsider.com/wuhan-coronavirus-treatments-vaccine-jj-regeneron-gilead-2020-2">Here's how 13 top drugmakers are sprinting to develop a coronavirus vaccine or treatment that can halt this pandemic</a>FDA is only allowing for the use of remdesivir in relatively sick coronavirus patients who are hospitalized. To be eligible for the drug, patients need to have severe symptoms of the disease, such as a need for oxygen or other help breathing. The US government will handle distribution of the drug.Read the original article on <a href="https://www.businessinsider.com/gilead-remdesivir-emergency-fda-authorization-coronavirus-2020-5">Business Insider</a>

You Searched For "emergency use" and got 8 results

Nepal approves Covishield vaccine for emergency use

IANS

US drug regulator rejects emergency use authorisation for India's Covaxin

PTI

FDA allows emergency use of drug for coronavirus

PTI

Pfizer-BioNTech COVID-19 vaccine shows 100% efficacy in 12-15 yrs old

IANS

Pakistan approves AstraZeneca's COVID-19 vaccine for emergency use

Kevin Shalvey

Vaccines could get authorized for young kids this fall. Here are the drug companies' most likely timelines.

Aria Bendix

US FDA approves emergency use of Remdesivir for COVID-19 patients

IANS

US health authorities will allow emergency use of Gilead's coronavirus treatment

Zachary Tracer,Andrew Dunn

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