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The World Health Organisation (<keyword id="19895006" type="General" weightage="20" keywordseo="WHO" source="keywords">WHO</keyword>) has announced that <keyword id="22989608" type="General" weightage="100" keywordseo="M-Pox" source="keywords">M-Pox</keyword> will continue to be classified as a <keyword id="21952478" type="General" weightage="20" keywordseo="public-health-emergency" source="keywords">public health emergency</keyword> of international concern (PHEIC), citing a resurgence in cases and the virus's ongoing geographic spread. The high-alert status initially declared in August, was reaffirmed following a meeting of the WHO Emergency Committee, The Express Tribune reported on Friday. The decision comes as M-Pox cases surge, particularly with the spread of the <keyword id="22875864" type="General" weightage="20" keywordseo="clade-Ib-variant" source="keywords">clade Ib variant</keyword> beyond its origin in the Democratic Republic of Congo to neighbouring African nations, Europe, and Asia. "Rising case numbers, the continuing geographic spread, and the need for a cohesive response have made it essential to maintain this emergency status," the WHO said in its statement. Confirmed cases of clade Ib have been detected in the United Kingdom, Germany, Sweden, and India, highlighting the global scale of the outbreak, reported The Express Tribune. M-Pox, a viral disease transmitted through close contact, presents flu-like symptoms and lesions. Although typically mild, it can be fatal, particularly in regions with inadequate healthcare. Over 46,000 suspected cases have been reported this year in Africa, with Congo accounting for the majority of the more than 1,000 suspected deaths. The new PHEIC declaration underscores the global threat posed by clade Ib and follows earlier alerts related to a separate strain during the 2022-2023 outbreak. In response to growing concerns, the WHO has expanded vaccine authorisations. Bavarian Nordic's <keyword id="24137585" type="General" weightage="20" keywordseo="M-Pox-vaccine" source="keywords">M-Pox vaccine</keyword> was approved earlier this year, with Japan's KM Biologics' vaccine added to the list of emergency-use vaccines in September. WHO officials have faced criticism for delays in <keyword id="21847727" type="General" weightage="20" keywordseo="vaccine-distribution" source="keywords">vaccine distribution</keyword> but stressed that vaccination remains a cornerstone of global response efforts, The Express Tribune reported. "The emergency status underscores the urgency to mount a unified global response," a WHO spokesperson stated. The organisation urged countries and health partners to collaborate on widespread vaccination campaigns and enhance public awareness to curb the virus's spread effectively.

M-Pox remains public health emergency: WHO

<keyword id="92247" type="COMPANY" weightage="20" keywordseo="Johnson-Johnson">Johnson &amp; Johnson</keyword>'s <keyword id="11735066" type="UNKNOWN" weightage="20" keywordseo="single-dose">single-dose</keyword> COVID-19 vaccine has been given Emergency Use approval in <keyword id="3658" type="COUNTRY" weightage="20" keywordseo="India">India</keyword>, <keyword id="700200" type="ORGANIZATION" weightage="20" keywordseo="Union-Health">Union Health</keyword> minister Mansukh Mandaviya said on Saturday. He said this will further boost the country's collective fight against the novel coronavirus infection. "India expands its vaccine basket! Johnson and Johnson's single-dose COVID-19 vaccine is given approval for Emergency Use in India. Now India has five <keyword id="2503801" type="ORGANIZATION" weightage="20" keywordseo="EUA">EUA</keyword> vaccines. This will further boost our nation's collective fight against #COVID19," the minister tweeted. The US-based pharmaceutical company had applied for <keyword id="9408526" type="UNKNOWN" weightage="20" keywordseo="emergency-use-authorisation">Emergency Use Authorisation</keyword> for its jab on Friday and was granted the approval the same day by the Drugs Controller General of India (DCGI). The five vaccines granted Emergency Use Authorisation in India are Serum Institute's Covishield, Bharat Biotech's Covaxin, Russia's Sputnik V, Moderna and now Johnson &amp; Johnson. SEE ALSO <a href="https://www.businessinsider.in/tech/news/google-is-now-using-chrome-as-another-security-layer-for-account-sign-ins/articleshow/84975356.cms">Google is now using Chrome as an added security layer for account sign-ins</a> <a href="https://www.businessinsider.in/stock-market/news/how-to-check-allotment-status-of-glenmark-life-sciences-ipo/articleshow/84978486.cms">Glenmark Life Sciences IPO: How to check allotment status, listing date and more</a>

India now has a fifth vaccine. Johnson & Johnson's single-dose COVID-19 shot gets government nod.

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

<keyword id="146915" type="COMPANY" weightage="20" keywordseo="Pfizer-India">Pfizer India</keyword> has become the <keyword id="10389973" type="UNKNOWN" weightage="20" keywordseo="first-pharmaceutical-firm">first pharmaceutical firm</keyword> to seek from the Drugs Controller General of India (DCGI) an emergency use authorisation for its COVID-19 vaccine in the country, after its parent company secured such clearance in the UK and Bahrain. The firm, in its application submitted to the drug regulator, has sought permission to import the vaccine for sale and distribution in the country, besides waiver of clinical trials on Indian population in accordance with the special provisions under <keyword id="10188407" type="COMPANY" weightage="20" keywordseo="the-new-drugs-and-clinical-trials-rules">the New Drugs and Clinical Trials Rules</keyword>, 2019, <keyword id="233909" type="POSITION" weightage="20" keywordseo="official-sources">official sources</keyword> said. "Pfizer India has submitted an application on December 4 to the DCGI seeking emergency use authorization (EUA) for its COVID-19 vaccine in India," a source said. "The firm has submitted the EUA application in Form CT-18 for grant of permission to import and market Pfizer-BioNTech's COVID-19 mRNA vaccine BNT162b2 in the country," the source said, citing the application. The UK on Wednesday became the first country to approve the Pfizer/BioNTech vaccine against COVID-19, with the UK regulator Medicines and Healthcare products Regulatory Agency (MHRA) granting a temporary authorisation for its emergency use. The British regulator said the jab, which claims to offer up to 95 per cent protection against COVID-19, is safe for roll-out. Bahrain on Friday also announced that it has granted an EUA for the two-dose vaccine made by Pfizer and its German partner BioNTech. The pharma company has already applied to the US FDA seeking EUA for the vaccine. The extreme low temperature of minus 70 degrees Celsius required for storing the vaccine poses a big challenge for its delivery in a country like India, especially in its smaller towns and rural areas where maintaining such cold chain facilities would be very difficult, top government officials have said. When contacted, Pfizer said it remains committed to engaging with the Government of India and explore opportunities to make this vaccine available for use in the country. "During this pandemic phase, Pfizer will supply this vaccine only through government contracts based on agreements with respective government authorities and following regulatory authorisation or approval," the global pharma major said in a statement. Five vaccines are in advanced phases of clinical trials in India with the Serum Institute of India conducting phase-3 trial of the Oxford-Astrazeneca COVID-19 vaccine, while the indigenously developed vaccine by Bharat Biotech in collaboration with ICMR has already started the phase-3 clinical trial. Drug firm <keyword id="72130" type="COMPANY" weightage="20" keywordseo="Zydus-Cadila">Zydus Cadila</keyword> has received the approval from the DCGI to start the phase-3 clinical trials of the indigenously-developed anti-coronavirus vaccine. Dr Reddy's Laboratories and <keyword id="9667533" type="COMPANY" weightage="20" keywordseo="the-russian-direct-investment-fund">the Russian Direct Investment Fund</keyword> (RDIF) have announced that they commenced adaptive phase 2 and 3 clinical trials for COVID-19 vaccine Sputnik V in India, Also, Biological E. Ltd has started early phase 1 and 2 human trials of its COVID-19 vaccine candidate. SEE ALSO: <a href="https://www.businessinsider.in/science/health/news/oxford-covid-19-vaccine-serum-institute-seeks-emergency-use-nod-for-covishield-vaccine-in-india/articleshow/79600349.cms" data-type="tilCustomLink">Oxford COVID-19 vaccine: Serum Institute seeks emergency use nod for Covishield vaccine in India</a> <a href="https://www.businessinsider.in/india/news/section-144-extended-across-noida-and-greater-noida-till-january-2/articleshow/79600323.cms" data-type="tilCustomLink">Section 144 extended across Noida and Greater Noida till January 2</a>

Pfizer seeks emergency use authorisation for its COVID-19 vaccine in India

<keyword id="3658" type="LOCATION" weightage="20" keywordseo="India">India</keyword>'s drug regulator may soon grant restricted emergency use authorisation for <keyword id="4912868" type="PERSON" weightage="20" keywordseo="moderna">Moderna</keyword>'s <keyword id="8904563" type="UNKNOWN" weightage="20" keywordseo="covid-19-vaccine">COVID-19 vaccine</keyword>, official sources said on Tuesday. In a separate communication, Moderna has informed that the US has agreed to donate a certain number of doses of its COVID-19 vaccine through COVAX to the Government of India for use here and has sought approval from the Central Drugs Standard Control Organisation (CDSCO), while <keyword id="6357157" type="COMPANY" weightage="20" keywordseo="cipla">Cipla</keyword>, on behalf of the US pharma major, has requested for import and marketing authorization of these jabs. According to the sources, an approval is likely anytime as the CDSCO is in favour of granting permission to Cipla for import of Moderna's COVID-19 vaccine for restricted emergency use in India considering the pandemic situation in the country and in public interest. Cipla filed an application on Monday seeking permission for import of Moderna's COVID-19 vaccine referring to DCGI notices dated April 15 and June 1 as per which if the vaccine is approved by the <keyword id="44669" type="COMPANY" weightage="20" keywordseo="USFDA">USFDA</keyword> for EUA, the vaccine can be granted marketing authorisation without bridging trial and assessment of safety data of first 100 beneficiaries of vaccines shall be submitted before rolling out in immunization programme. Also, the requirement of testing of every batch by the Central Drugs Laboratory (CDL), Kasauli can be exempted if the batch/lot is released by the CDL of country of origin. However, summary lot protocol review and scrutiny of documents shall be undertaken by the laboratory for batch release as per standard procedures, Cipla said referring to the DCGI's new revised rules. Moderna through a separate communication has informed that the <keyword id="48028" type="COMPANY" weightage="20" keywordseo="US-government">US Government</keyword> has agreed to donate a certain number of doses of the <keyword id="9708420" type="UNKNOWN" weightage="20" keywordseo="moderna-covid-19-vaccine">Moderna COVID-19 Vaccine</keyword>, mRNA-1273, through COVAX to the Government of India for use in India and has submitted the dossiers through e-mail. "This correspondence is to request the CDSCO to open a file for approval of these urgently needed vaccines," Moderna said. In a bid to expedite the roll out of vaccines, the DCGI on June 1 decided to waive off testing of batches at CDL for foreign-manufactured vaccines that have been approved by international drug regulators such as the US FDA, the UK's MHRA or the WHO. The Centre had in April issued detailed guidelines and proactively eased entry of foreign made COVID-19 vaccines approved by the US FDA, EMA, UK's MHRA and Japan's PMDA, and WHO's Emergency Use Listing into India. According to the guidelines, these vaccines will not need to undergo prior bridging trials. The provision was further amended to waive off the trial requirement altogether for the well-established vaccines manufactured in other countries.

COVID-19: India's drug regulator may soon give restricted emergency use authorisation to American vaccine Moderna

<ul><li>The COVID-19 vaccine being developed by Oxford University and AstraZeneca has shown 70% efficacy in its latest results. </li><li>While a success, the effectiveness of the <keyword id="9584306" type="UNKNOWN" weightage="20" keywordseo="oxford-covid-19-vaccine">Oxford COVID-19 vaccine</keyword> lags behind its competitors Moderna and Pfizer. </li><li>The Oxford COVID-19’s edge in India is that it can survive in warmer temperatures, reducing the stress on India’s cold storage infrastructure. </li></ul>The COVID-19 vaccine being developed by Oxford and AstraZeneca has successfully battled the infection in <a href="https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/azd1222hlr.html">70.4% of its candidates</a>, according to the study’s latest results. While still above the efficacy target laid out by White House coronavirus advisor <a href="https://www.businessinsider.in/science/news/dr-anthony-fauci-and-bill-gates-some-coronavirus-vaccines-may-work-better-in-certain-populations-than-others/articleshow/79253406.cms">Anthony Fauci</a> and the World Health Organisation (WHO) of 50%, the Oxford COVID-19 vaccine lags behind its competitors, Moderna and Pfizer. In its latest results, the COVID-19 vaccine being developed by Pfizer and BioNTech had an efficacy of 95%. Moderna, in its results so far, has claimed a 94.5% efficacy rate. However, the results of the Oxford COVID-19 vaccine leave the door open for it to become more effective. According to the study, perfecting the dose could increase protection up to 90%. “Excitingly, we’ve found that one of our dosing regimens may be around 90% effective and if this dosing regime is used, more people could be vaccinated with planned vaccine supply,” said Chief Investigator of the <keyword id="8973295" type="COMPANY" weightage="20" keywordseo="oxford-vaccine">Oxford Vaccine</keyword> Andrew Pollard. Oxford COVID-19 vaccine in India VK Paul, the chair of the National Expert Group on Vaccine Administration for COVID-19, <a href="https://www.businesstoday.in/current/corporate/oxford-covid-19-vaccine-india-may-grant-sii-emergency-authorisation-if-astrazeneca-gets-uk-govt-nod/story/422621.html">stated</a> that India may approve the emergency use of the vaccine once it gets a nod from the UK. The Company has plans to manufacture 3 billion doses of the vaccine in 2021 on a rolling basis, pending regulatory approval. And, when it comes to India, the edge that the Oxford COVID-19 vaccine has over others is that it can survive in warmer temperatures. And, it's estimated to be much cheaper as well. According to the Director of the All India Institute of Medical Sciences (AIIMS) <a href="https://www.businessinsider.in/science/health/news/indian-covid-vaccines-can-survive-in-warmer-temperatures-pfizers-says-aiims-director/articleshow/79172255.cms">Randeep Guleria</a>, the <keyword id="9655003" type="UNKNOWN" weightage="20" keywordseo="pfizer-vaccine">Pfizer vaccine</keyword>’s requirement of a lower storage temperature is something that India’s cold storage infrastructure may not be able to support for the population of 1.3 billion. In comparison to Pfizer, which needs temperatures of minus 70 degrees Celsius to survive, the Oxford COVID-19 vaccine will remain stable at normal refrigerated temperatures of between two to eight degrees Celsius, which makes both storage and transportation much easier. Oxford COVID-19 vaccine’s room for improving effectiveness Code-named AZD1222, the clinical trials of patients in the UK and Brazil were taken into account for these results. There were a total of 131 COVID-19 cases in the interim analysis. What the researchers observed was that the stronger dosage regime — of a half dose first and a full dose one month later — showed vaccine efficacy of 90%. The weaker dosing regime, given the same time apart, only gave 62% efficacy. This will get refined further as clinical trials continue to be conducted, not only in India, but also in the US, Japan, Russia, South Africa, Kenya and Latin America. In total, the Company expects to enrol up to 60,000 participants globally. SEE ALSO: <a href="https://www.businessinsider.in/tech/apps/news/how-to-earn-money-at-home-from-googles-task-mate/articleshow/79362215.cms">Google is testing ‘Task Mate’ in India, which lets users earn money for doing tasks on their smartphones</a> <a href="https://www.businessinsider.in/tech/apps/news/hdfc-banks-net-banking-upi-services-and-atms-down-due-to-data-centre-outage/articleshow/79344484.cms">HDFC Bank’s net banking, UPI service and ATMs were down due to a 'data centre outage' but RBI demands more detailed information</a> <a href="https://www.businessinsider.in/science/environment/news/mount-everest-home-to-microplastics-and-melting-glaciers/articleshow/79324609.cms">Microplastics found at the highest point on Earth as the glaciers around Mount Everest’s death zone melt</a>

Oxford and AstraZeneca COVID-19 vaccine is 70% effective — India may authorise emergency use after UK nod

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

Toronto, Feb 25 (AP) Canada has become the first country to authorize use of a plant-based COVID-19 vaccine. Canadian regulators said Thursday Medicago's two-dose vaccine can be given to adults ages 18 to 64, but said there's too little data on the shots in people 65 and older. The decision was based on a study of 24,000 adults that found the vaccine was 71% effective at preventing COVID-19 - although that was before the omicron variant emerged. Side effects were mild, including fever and fatigue. Medicago uses plants as living factories to grow virus-like particles, which mimic the spike protein that coats the coronavirus. The particles are removed from the plants' leaves and purified. Another ingredient, an immune-boosting chemical called an adjuvant that is made by British partner GlaxoSmithKline, is added to the shots. While numerous COVID-19 vaccines have been rolled out around the world, global health authorities are looking to additional candidates in hopes of increasing the worldwide supply. Quebec City-based Medicago is developing plant-based vaccines against multiple other diseases, and the COVID-19 vaccine may help spur more interest in this new method of medical manufacturing. (AP) AMS AMS

Canada authorises first plant-based COVID-19 vaccine

With the <keyword id="6356311" type="General" weightage="50" keywordseo="world-health-organisation" source="Orion">World Health Organisation</keyword> (WHO) declaring that Covid-19 is no longer a global emergency, medical device companies are likely to see a decrease in sales, according to a report on Tuesday. In the last three years of the pandemic, many medical device companies made billions through tests and pharmaceuticals. The report by data and analytics company <keyword id="1670029" type="General" weightage="80" keywordseo="globaldata" source="Orion">GlobalData</keyword> predicts that in the coming years, fewer new Covid-19 tests will be hitting the market; instead, existing tests will be improved. This could mean improving tests' specificity and sensitivity and creating multiparameter tests with existing technology. "Companies have reported decreasing sales of Covid-19 related products for the past two quarters. Therefore, having the Covid-19 pandemic declared over and instead an endemic virus, and with the emergency use authorisations on Covid-19 tests lifted, in vitro diagnostics (<keyword id="3175247" type="General" weightage="80" keywordseo="ivd" source="Orion">IVD</keyword>) companies are scrambling to minimise their losses," said <keyword id="17367396" type="General" weightage="50" keywordseo="selena-yu" source="Orion">Selena Yu</keyword>, <keyword id="17367395" type="General" weightage="50" keywordseo="medical-analyst" source="Orion">Medical Analyst</keyword> at GlobalData, in a statement. In vitro diagnostics (IVD) are tests done on samples such as blood or tissue that have been taken from the human body. Currently, there are 132 active clinical trials, out of 310 trials on infectious disease IVD devices, developing Covid-19 tests. In January 2023, many companies involved in Covid-19 tests, like <keyword id="229225" type="General" weightage="50" keywordseo="danaher" source="Orion">Danaher</keyword>, <keyword id="48168" type="General" weightage="20" keywordseo="abbott" source="Orion">Abbott</keyword>, <keyword id="248095" type="General" weightage="50" keywordseo="labcorp" source="Orion">Labcorp</keyword>, and Becton, <keyword id="292392" type="General" weightage="20" keywordseo="dickinson" source="Orion">Dickinson</keyword> and Company, also known as BD, made statements on their significant drops in Covid-19 tests. "Now that the pandemic has been announced to no longer be an emergency, the drops will become more significant in the coming months. There could be peak sales in the fall and winter seasons as the respiratory disease season starts up again," Yu said. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/tech/apps/news/jamtara-global-indian-whatsapp-users-flooded-with-spam-calls/articleshow/100103446.cms">'Jamtara Global': Indian WhatsApp users flooded with spam calls</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/stock-market/news/condom-maker-mankind-pharma-lists-at-20-premium-beats-grey-market-expectations/articleshow/100090002.cms">Mankind Pharma stock runs up in trade after listing at 20% premium</a>

End of Covid emergency to affect sales of diagnostics cos: GlobalData report

<ul><li>The final results of Pfizer and BioNTech’s COVID-19 vaccine show that it's 95% effective. </li><li>The only significant side effect, with a frequency of over 2%, was fatigue. </li><li>The company plans to file for Emergency Use Authorisation (EUA) with the US’ Food and Drug Administration (FDA) within the next few days. </li></ul>The COVID-19 vaccine being developed by Pfizer and BioNtech is 95% effective according to its <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine">final analysis</a>. Even in adults over the age of 65 years, the efficacy was observed at 94%. “No serious safety concerns were observed in the COVID-19 vaccine trial,” said the <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine">press note</a> issued by both companies. The phase 3 study only showed mild to moderate side effects that cleared up quickly. “The only significant side effect than that 2% in frequency was fatigue at 3.7%,” the study highlighted. How does the vaccine work? With a 95% efficacy rate, those who get the vaccine will be protected within 28 days of the first dose — and there is only a two-dose schedule. This is far more effective than the threshold laid out by the White House coronavirus advisor Anthony Fauci, who has previously stated that a vaccine that is 50% to 60% effective would be acceptable. When will the vaccine be able for the public? Now that the vaccine is ready for market as soon as it gets the required permissions, Pfizer and BioNTech plan to make up to 50 million doses before the end of the year and another 1.3 billion in 2021. According to the company, the vaccine’s efficacy is consistent across different ages, races and ethnicities. In light of the success, Pfizer plans to file for Emergency Use Authorisation (EUA) for the vaccine with the US Food and Drug Administration (FDA) within the next few days. It claims it has met all the safety data milestones required by the authorities. Why India shouldn’t rejoice just yet A year since the first COVID-19 case was detected, the success of a possible vaccine provides a ray of hope after the last seven grueling months of the pandemic. However, the Pfizer vaccine may not be suited for use in India since it requires storage at minus 70 degrees Celsius. According to the Director of the All India Institute of Medical Sciences (AIIMS) <a href="https://www.businessinsider.in/science/health/news/indian-covid-vaccines-can-survive-in-warmer-temperatures-pfizers-says-aiims-director/articleshow/79172255.cms">Randeep Guleria</a>, the Pfizer vaccine’s requirement of a lower storage temperature is something that India’s cold storage infrastructure may not be able to support for the population of 1.3 billion. However, Pfizer believes its expertise and existing cold-chain infrastructure will be enough to distribute the vaccine around the world in specially designed and temperature controlled thermal shippers that use dry ice. SEE ALSO: <a href="https://www.businessinsider.in/finance/banks/news/lakshmi-vilas-bank-customers-have-withdrawn-10000-crore-since-rbis-moratorium-was-announced-last-night/articleshow/79281857.cms">Lakshmi Vilas Bank customers have withdrawn ₹10,000 crore since RBI's moratorium was announced last night</a> <a href="https://www.businessinsider.in/careers/news/capgemini-hr-head-explains-why-the-french-it-major-is-going-crazy-hiring-in-india-and-around-the-world/articleshow/79277396.cms">EXCLUSIVE: Capgemini HR head explains why the French IT major is going crazy hiring in India and around the world</a> <a href="https://www.businessinsider.in/business/news/indiamart-and-justdial-in-legal-battle-over-copyright-violations/articleshow/79275178.cms">IndiaMart and JD Mart gear up for a legal battle over copyright infringement — even as Justdial calls IndiaMart’s allegations ‘baseless’</a>

Pfizer's new COVID-19 vaccine is 95% effective and the only severe side-effect to worry about is fatigue, according to the final results

<keyword id="242973" type="General" weightage="20" keywordseo="serum-institute" source="Orion">Serum Institute</keyword> of India (<keyword id="52604" type="General" weightage="20" keywordseo="sii" source="Orion">SII</keyword>) CEO <keyword id="201929" type="General" weightage="20" keywordseo="adar-poonawala" source="Orion">Adar Poonawala</keyword> on Friday said it has applied to Indian authorities for full market authorisation of <keyword id="9617748" type="General" weightage="100" keywordseo="covishield" source="Orion">Covishield</keyword>, stating supplies of the COVID-19 vaccine have exceeded 125 crore doses. SII had partnered with the developer of Covishield, AstraZeneca, for the supply of the vaccine to the Indian government, which had in January this year granted emergency use authorisation in the country. "Supplies of the COVISHIELD vaccine in India, have exceeded 1.25 billion doses. The government of India now has enough data for full market authorisation, and therefore @SerumInstIndia has applied to the @CDSCO_INDIA_INF (<keyword id="172241" type="General" weightage="20" keywordseo="dcgi" source="Orion">DCGI</keyword>) and @MoHFW_INDIA for this permission," Poonawala said in a tweet tagging the Central Drugs Standard Control Organisation (CDSCO) and <keyword id="191419" type="General" weightage="20" keywordseo="ministry-of-health-and-family-welfare" source="Orion">Ministry of Health and Family Welfare</keyword>. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/business/auto/news/tech-mahindra-buys-us-based-allyis-india-green-investments-for-125-million/articleshow/88611295.cms">Tech Mahindra buys US-based Allyis India, Green Investments for $125 million</a>

Serum Institute applies to Indian authorities for full market authorisation of Covishield

Sun Pharmaceutical Industries on Tuesday announced that one of its wholly owned subsidiaries has received emergency use authorisation (EUA) from the Drugs Controller General of India (DCGI) to manufacture and market a generic version of <keyword id="66878" type="General" weightage="20" keywordseo="merck" source="Orion">Merck</keyword>'s <keyword id="12826599" type="General" weightage="20" keywordseo="anti-Covid-pill-Molnupiravir" source="Orion">anti-Covid pill Molnupiravir</keyword> in India. <keyword id="44642" type="General" weightage="20" keywordseo="sun-pharma" source="Orion">Sun Pharma</keyword> will launch <keyword id="10880838" type="General" weightage="20" keywordseo="Molnupiravir" source="Orion">Molnupiravir</keyword> under the brand name Molxvir in India, within a week, the company said in a statement. Amid the ongoing resurgence of new Covid-19 cases in India, an expert panel of the Central Drugs Standard Control Organisation on Tuesday approved Merck's anti-viral drug molnupiravir for restricted use in emergency situations. Earlier this year, the Sun Pharma had signed a non-exclusive voluntary licensing agreement with US-based Merck to manufacture and supply a generic version of molnupiravir in over 100 low and middle-income countries (LMICs) including India. The DCGI, based on the review of clinical data of molnupiravir has approved molnupiravir for treatment of adult patients with Covid-19, with oxygen saturation less than 93 per cent and who have high risk of progression of the disease, including hospitalisation or death. "Molnupiravir is an important addition to the portfolio of oral therapies available for treating Covid-19 patients. In line with our consistent efforts to accelerate access to new drugs for Covid-19 treatment, we will make Molxvir available to patients at an affordable price," said Kirti Ganorkar, CEO of India Business, Sun Pharma, in a statement. Ganorkar added that the company is in the process of launching a toll-free helpline to ensure the availability of Molxvir to doctors and patients across India. "Our endeavour is to make the product available in a week's time," she said. The recommended dose of the drug is 800 mg twice a day for five days. The duration of treatment of molnupiravir is much shorter compared to other therapies which is a significant advantage as it reduces the pill burden and enhances compliance. Molnupiravir is an oral anti-viral that inhibits the replication of multiple RNA viruses including SARS-CoV-2. The drug is used for the treatment of non-hospitalised patients with Covid-19 globally. Molnupiravir has been developed by Merck and Ridgeback Biotherapeutics. The US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) have granted the pill EUA. SEE ALSO: <a href="https://www.businessinsider.in/science/health/news/biological-e-to-produce-100-million-doses-of-corbevax-covid-vaccine-from-february-2022/articleshow/88543250.cms">Biological E to produce 100 million doses of Corbevax Covid vaccine from February 2022</a> <a href="https://www.businessinsider.in/india/news/govt-panel-allows-emergency-use-of-mercks-new-drug-molnupiravir-for-treatment-of-mild-to-moderate-covid-19-cases/articleshow/88536179.cms">India allows emergency use of Merck's new drug Molnupiravir for treatment of mild-to-moderate COVID-19 cases</a>

Sun Pharma gets emergency use authorization to manufacture Merck's anti-Covid pill Molnupiravir

In a major shift of narrative, the government has now not disapproved the <keyword id="962031" type="PERSON" weightage="20" keywordseo="authorisation">authorisation</keyword> of <keyword id="149108" type="PERSON" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword>'s Covid vaccine to people below 18 years of age whereas earlier, it was approved for children above the age of 12 years by the Drugs Controller General of India (DCGI). A letter from the office of additional secretary at the <keyword id="83655" type="COMPANY" weightage="20" keywordseo="Union-health-ministry">union health ministry</keyword> carrying a comparative factsheet for the two Covid vaccines approved for emergency authorisation revealed that the government has "not recommended" their authorisation to people below 18 years of age. The DCGI, after approving Bharat Biotech's <keyword id="9485939" type="LOCATION" weightage="20" keywordseo="covaxin">Covaxin</keyword> for EUA, had allowed its authorization to children above 12 years of age. The document of permission to the Hyderabad-based pharmaceutical firm signed by the DCGI clearly states that "active immunization against Corona Virus Disease (Covid-19) for age above 12 years when administered in two doses interval of day 0 and day 28". At the same time, another Corona vaccine, Covishield by <keyword id="95879" type="COMPANY" weightage="20" keywordseo="Serum-Institute-of-India">Serum Institute of India</keyword> (SII), was permitted to people above 18 years of age, permission letter to the SII showed. However, when IANS approached CDSCO with the query upon this, the officials said that the provision was soon withdrawn and revised by the drug licensing authority. The sources privy to the development told IANS that this certain condition approved for Covaxin was flagged to the drug regulatory authority and soon it was rebuked. "We were flagged about the provision and soon it was revised with a condition that the vaccines would only be administered to beneficiaries above 18 years of age," a senior official said. Covaxin has been in the spotlight of controversy since it was recommended for restricted emergency use by the subject expert committee of CDSCO. It's approval for Covid immunization programme has drawn flak from public health advocacy groups, researchers, scientists and activists in the <keyword id="54611" type="PERSON" weightage="20" keywordseo="domain">domain</keyword>. The concern with the Coxaxin largely remains on its approval without the data from phase III clinical trials which determine efficacy of the drug. So far, any data proving the vaccine's efficacy has not been published in the public domain, including any results of an interim analysis. Meanwhile, a series of allegations involving violation of various protocols of human clinical trials have been put forth by trial volunteers of Covaxin in Bhopal's People's Medical College and Hospital, one of the 26 clinical trial sites of the Bharat Biotech's vaccine's phase III trials. Trial participants in Bhopal, who, incidentally, are also victims of the 1984 gas tragedy, have alleged "severe violations" of the model code of conduct pertaining to trials including absence of consent and no follow-up on their health after developing adverse reactions post the first dose by a particular clinical trial site. Notably, a 45-year-old trial participant in Bhopal also died nine days after he got the first jab at the People's Hospital, on December 21. However, Bharat Biotech, in a statement, said that the death had been "thoroughly investigated" and was found "not related to vaccine or placebo". The Madhya Pradesh government panel, too, ruled out any "lapses" from the hospital in the death case. --IANS str/rt

You Searched For "emergency use authorisation" and got 13 results

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End of Covid emergency to affect sales of diagnostics cos: GlobalData report

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Pfizer's new COVID-19 vaccine is 95% effective and the only severe side-effect to worry about is fatigue, according to the final results

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Serum Institute applies to Indian authorities for full market authorisation of Covishield

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Covaxin: Government disapproves authorisation of Bharat Biotech's Covid vaccine to those below 18 years

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