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<keyword id="15862275" type="General" weightage="20" keywordseo="Bharat-Biotechs-intranasal-Covid-vaccine" source="Orion">Bharat Biotech's intranasal Covid vaccine</keyword> has been approved by the Union Health Ministry for inclusion in the vaccination programme as a booster dose for those above 18 years of age, official sources said on Thursday. The needle-free vaccine will be available at private centres. It will be introduced on the Co-WIN platform on Friday evening, they said. The <keyword id="383216" type="General" weightage="20" keywordseo="nasal-vaccine" source="Orion">nasal vaccine</keyword> -- BBV154 -- received approval of the Drugs Controller General of India in November for restricted use in an emergency situation for those above 18 as a heterologous booster dose. The approval for the vaccine comes amid a spurt in <keyword id="8764262" type="General" weightage="100" keywordseo="covid" source="Orion">Covid</keyword> cases in China and some other countries. Prime Minister Narendra Modi had on Thursday cautioned people against complacency and urged them to wear masks in crowded places, while also directing officials to strengthen surveillance measures, especially at international airports. SEE ALSO: <a href="https://www.businessinsider.in/international/news/police-officers-were-seen-guarding-a-crematorium-in-beijing-amid-reports-of-overflowing-funeral-homes-due-to-a-resurgence-in-covid-infections-bloomberg/articleshow/96369408.cms">Police officers were seen guarding a crematorium in Beijing amid reports of overflowing funeral homes due to a resurgence in COVID infections: Bloomberg</a> <a href="https://www.businessinsider.in/india/news/pm-modi-to-review-covid-19-situation-at-high-level-meeting-today/articleshow/96417240.cms">PM Modi to review Covid-19 situation at high-level meeting today</a> <a href="https://www.businessinsider.in/science/health/3-cases-of-omicron-subvariant-bf-7-driving-chinas-covid-surge-detected-in-india/articleshow/96397261.cms">3 cases of Omicron subvariant BF.7, driving China's Covid surge, detected in India</a>

Bharat Biotech's intranasal Covid vaccine approved by govt, to be available on CO-WIN

New Delhi, A meeting of the Subject Expert Committee (SEC) of the <keyword id="170943" type="COMPANY" weightage="20" keywordseo="Central-Drugs-Standard-Control-Organisation">Central Drugs Standard Control Organisation</keyword> (CDSCO) is currently underway to discuss the permission sought by vaccine developer <keyword id="149108" type="PERSON" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword> to conduct <keyword id="83911" type="ORGANIZATION" weightage="20" keywordseo="Clinical-trials">clinical trials</keyword> of its <keyword id="9985444" type="UNKNOWN" weightage="20" keywordseo="intranasal-vaccine">intranasal vaccine</keyword> for the <keyword id="1754604" type="PERSON" weightage="20" keywordseo="coronavirus">coronavirus</keyword>. Days after getting the Drugs Controller General of India's nod for restricted emergency use of India's first indigenously-made <keyword id="8624004" type="UNKNOWN" weightage="20" keywordseo="coronavirus-vaccine">coronavirus vaccine</keyword>, Bharat Biotech had applied to the drug regulator for permission to start Phase 1 and 2 trials of their nasal coronavirus vaccine. The nasal vaccine is different from the intramuscular vaccine which recently got approval, as it is non-invasive, needle-free, doesn't require trained healthcare workers, eliminates needle-associated risks, suits children and adults and has scalable manufacturing. Clinical trials of Bharat Biotech's 'BBV154' - a novel adenovirus vectored intranasal vaccine for coronavirus -- will be conducted at various locations, a top source privy to the development told IANS. The vaccine will be single-dosed. According to the firm, an intranasal vaccine stimulates a broad immune response at the site of infection, in the nasal mucosa, which is essential for blocking both infection and transmission of Covid-19. The vaccine has demonstrated protective efficacy in mice and hamsters. Mice and hamsters immunised with its single-dose were conferred superior protection against SARS-CoV-2 challenge, "more so than one or two intramuscular immunisations of the same vaccine and dose". "Thus, intranasal immunisation of ChAd-SARS-CoV-2-S can create an immune response in the nose, which is the point of entry for the virus, thereby protecting against disease, infection and transmission," Bharat Biotech said in a statement. On January 3, two intramuscular vaccines - Bharat Biotech's Covaxin and Oxford-AstraZeneca's Covishield manufactured by Serum Institute of India - were approved for restricted emergency use and have been administered to over three lakh people till now. Both are two-dose vaccines. While the full efficacy of Covaxin is yet to be determined, it was given go-ahead by the DCGI citing 'public interest'. Covaxin is an indigenously developed vaccine by Bharat Biotech, in collaboration with the Indian Council of Medical Research (ICMR). Public health experts believe that intranasal vaccines for coronavirus, administered through the nose rather than muscles, can be a potential gamechanger in India's fight against the coronavirus pandemic. Last month, Pune-based Serum Insititute of India and Codagenix Inc had announced that they have received regulatory approval in the UK to begin an early-stage trial of their single-dose, intranasal coronavirus vaccine. SEE ALSO: <a href="https://www.businessinsider.in/budget/news/indian-government-budget-dilemma-curb-the-sale-of-cigarettes-or-let-the-over-12-billion-tobacco-industry-provide-the-much-needed-cash/articleshow/80340422.cms">Indian government’s budget dilemma – curb the sale of cigarettes or let the over $12 billion tobacco industry provide the much needed cas</a> <a href="https://www.businessinsider.in/business/startups/news/zoom-dropbox-backer-salesforce-ventures-makes-its-first-investment-in-india-in-hr-tech-startup-darwinbox-which-claims-to-have-grown-by-200-during-lockdown/articleshow/80341562.cms">Zoom, Dropbox backer Salesforce Ventures makes its first investment in India in HR tech startup Darwinbox, which claims to have grown by 200% during lockdown</a> <a href="https://www.businessinsider.in/stock-market/news/home-first-finance-company-hffc-is-set-to-launch-its-1153-crore-ipo-on-january-21/articleshow/80341439.cms?upcache=2">Warburg Pincus-backed Home First Finance Company to launch ₹1,153 crore IPO on January 21</a>

Expert panel of India's drug regulator mulling Bharat Biotech's nasal vaccine trial proposal

Leading vaccine maker <keyword id="149108" type="COMPANY" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword> on Wednesday announced a licensing agreement with Washington University School of Medicine in St. Louis for a novel chimp-adenovirus, single dose intranasal vaccine for Covid-19. The Hyderabad-based company owns the rights to distribute the vaccine in all markets except USA, Japan and Europe. While the Phase I trials will take place in Saint Louis University's Vaccine &amp; Treatment Evaluation Unit, Bharat Biotech, upon obtaining the required regulatory approval, will pursue further stages of clinical trials in India and undertake large scale manufacture of the vaccine at its GMP facility located in Genome Valley, Hyderabad. According to Bharat Biotech, this intranasal vaccine candidate has shown unprecedented levels of protection in mice studies; the technology and data having been recently published in the prestigious scientific journal ‘Cell' and in an editorial in ‘Nature'. "We are proud to collaborate on this innovative vaccine. We envision that we will scale this vaccine to 1 billion doses, translating to 1 billion individuals vaccinated receiving a single-dose regimen. An intranasal vaccine will not only be simple to administer but reduce the use of medical consumables such as needles, syringes, etc., significantly impacting the overall cost of a vaccination drive," said Krishna Ella, Chairman and Managing Director of Bharat Biotech. "Our experience in viral vaccines, manufacturing capabilities, and distribution continue to be our strong suit in ensuring safe, efficacious, and affordable vaccines. It is prudent for Bharat to be involved in diverse but tenable projects to provide a much-needed vaccine against Covid-19 reaches all citizens of the world," he added. David T. Curiel, Director of Biologic Therapeutics Center and Professor of Radiation Oncology at Washington University School of Medicine in St. Louis and Precision Virologics Interim CEO said that the ability to accomplish effective immunization with a single nasal dose is a major advantage, offering broader reach and easier administration. "An effective nasal dose not only protects against Covid-19, but it also prevents the spread of the disease by offering another kind of immunity that occurs primarily in the cells that line the nose and throat. Most other vaccine candidates currently under development can't do that," he said. This vaccine expands Bharat's portfolio of vaccines that are currently being developed and are in various stages of clinical development including Covaxin which is currently in Phase II human clinical trials in India, the company said. <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/stock-market/news/reliance-jio-share-price-is-twice-as-valued-as-bharti-airtel-stock-while-vodafone-idea-vi-ranks-third/articleshow/78269261.cms">Reliance Jio is now twice as valued as Airtel that is down 25% from its peak in May</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/defense/news/china-has-hardened-its-stance-experts-decode-the-india-china-joint-statement-on-border-tensions/articleshow/78270081.cms">China has hardened its stance — experts decode the India-China joint statement on border tensions</a>

Bharat Biotech partners with Washington varsity for intranasal COVID-19 vaccine

The Centre on Thursday announced the "Cervavac", <keyword id="3658" type="General" weightage="80" keywordseo="india" source="Orion">India</keyword>'s first indigenously-developed <keyword id="24209" type="General" weightage="100" keywordseo="vaccine" source="Orion">vaccine</keyword> for prevention of cervical cancer, will be launched in the next few months and will be available in the price range of Rs 200-Rs 400. Cervical cancer ranks as the 2nd most prevalent cancers in India and accounts for nearly one-fourth of the world's cervical cancer deaths despite being largely preventable. As per current estimates, every year, approximately 1.25 lakh women are diagnosed with cervical cancer, and over 75,000 die from the disease in India, and 83 per cent of invasive cervical cancers are attributed to HPVs 16 or 18 in India, and 70 per cent of cases worldwide. Announcing the scientific completion of the quadrivalent Human Papilloma Virus (qHPV) vaccine in presence of Adar C. Poonawalla, CEO, <keyword id="95879" type="General" weightage="50" keywordseo="serum-institute-of-india" source="Orion">Serum Institute of India</keyword> and other prominent scientists and dignitaries, Union Science &amp; Technology Minister Jitendra Singh said that this affordable and cost-effective vaccine marks an important day for the DBT and the BIRAC as it takes India a step closer to PM Narendra Modi's vision of Atmanirbhar Bharat. He noted that the most promising intervention for preventing cervical cancer is vaccination against human papillomavirus (<keyword id="102327" type="General" weightage="50" keywordseo="hpv" source="Orion">HPV</keyword>). It is estimated that HPV types 16 and 18 (HPV-16 and HPV-18) together contribute to approximately 70 per cent of all invasive cervical cancer cases worldwide. The first indigenously developed Quadrivalent Human Papillomavirus vaccine (qHPV) vaccine will be launched in few months, Poonawalla said, adding that the vaccine will be available to the people in an affordable price range of Rs 200-400. Poonawalla, in his brief address, said that the wellbeing and protection of mother and child is the core philosophy of <keyword id="242973" type="General" weightage="50" keywordseo="serum-institute" source="Orion">Serum Institute</keyword> as only a healthy India can be a productive India. Jitendra Singh pointed out that within a year of implementation, the Mission Covid Suraksha demonstrated major achievements such as development of the world's first DNA vaccine for Covid-19 by Cadila Healthcare which received Emergency Use Authorisation on August 20, 2021, and supporting the development of the nation's first mRNA Vaccine and intranasal vaccine candidate against Covid-19. He said that "Cervavac" is an outcome of a partnership of the DBT and the BIRAC with the Bill and Melinda Gates Foundation, supported by Serum Institute of India for the indigenous development of quadrivalent vaccine through its partnership programme 'Grand Challenges India'

India to launch its first indigenously developed cervical cancer vaccine in the next few months

Hello,Today in <keyword id="6354525" type="UNKNOWN" weightage="100" keywordseo="healthcare">healthcare</keyword> news: <a href="https://www.businessinsider.com/digital-health-startups-like-ro-are-distributing-covid-19-vaccines-2021-3">Startups want in on vaccination efforts</a>, <a href="https://www.businessinsider.com/intranasal-covid-19-vaccine-spray-could-stem-spread-2021-3">the potential of an intranasal vaccine</a>, and <a href="https://www.businessinsider.com/whats-in-the-biden-covid-stimulus-checks-tax-credits-unemployment-3">what's in the stimulus bill the Senate passed this weekend</a>. <a href="https://www.businessinsider.com/digital-health-startups-like-ro-are-distributing-covid-19-vaccines-2021-3"></a><h3><a href="https://www.businessinsider.com/digital-health-startups-like-ro-are-distributing-covid-19-vaccines-2021-3">Digital health startups like Ro and Zocdoc want in on the US vaccination effort. They're wading into a complex vaccine distribution puzzle.</a></h3><ul><li>Digital health startup <keyword id="179072" type="ORGANIZATION" weightage="60" keywordseo="RO">Ro</keyword> said Wednesday that it was offering in-home COVID-19 vaccinations to currently eligible residents of Yonkers, New York.</li><li>The effort is fully funded by donations and corporate sponsorships.</li><li><a href="https://www.businessinsider.com/digital-health-startups-like-ro-are-distributing-covid-19-vaccines-2021-3">Other startups like Zocdoc have similarly expressed interest in helping local governments roll out vaccination efforts to patients that are otherwise hard to reach.</a></li></ul><a href="https://www.businessinsider.com/digital-health-startups-like-ro-are-distributing-covid-19-vaccines-2021-3">Read the full story from Megan Hernbroth here&gt;&gt;</a><h3><a href="https://www.businessinsider.com/intranasal-covid-19-vaccine-spray-could-stem-spread-2021-3"><div type="image" title="flumist intranasal flu vaccine" height="2657" width="3554" msid="81395982" hostid="261"></div></a></h3><h3><a href="https://www.businessinsider.com/intranasal-covid-19-vaccine-spray-could-stem-spread-2021-3">A future COVID-19 vaccine could be squirted up the nose. The nasal spray could stop transmission, especially in kids.</a></h3><ul><li>A US company called Altimmune is developing a COVID-19 <keyword id="24209" type="PERSON" weightage="60" keywordseo="vaccine">vaccine</keyword> that gets sprayed up the nose.</li><li>Such intranasal vaccines may reduce <keyword id="1754604" type="PERSON" weightage="60" keywordseo="coronavirus">coronavirus</keyword> transmission better than shots do.</li><li><a href="https://www.businessinsider.com/intranasal-covid-19-vaccine-spray-could-stem-spread-2021-3">Boosters designed to protect against variants could also be delivered intranasally, experts say.</a></li></ul><a href="https://www.businessinsider.com/intranasal-covid-19-vaccine-spray-could-stem-spread-2021-3">Read the full story from Aylin Woodward and Allison DeAngelis here&gt;&gt;</a><h3><a href="https://www.businessinsider.com/whats-in-the-biden-covid-stimulus-checks-tax-credits-unemployment-3"><div type="image" title="Senate Majority Leader Chuck Schumer" height="1334" width="1778" msid="81395983" hostid="261"></div></a></h3><h3><a href="https://www.businessinsider.com/whats-in-the-biden-covid-stimulus-checks-tax-credits-unemployment-3">11 things you need to know about the revised COVID stimulus bill Senate Democrats just passed</a></h3><ul><li>The Senate passed Biden's $1.9 trillion stimulus package.</li><li>They've made several changes since the House passed the bill last week.</li><li><a href="https://www.businessinsider.com/whats-in-the-biden-covid-stimulus-checks-tax-credits-unemployment-3">Biden's proposal to raise the hourly minimum wage to $15 didn't make the cut. </a></li></ul><a href="https://www.businessinsider.com/whats-in-the-biden-covid-stimulus-checks-tax-credits-unemployment-3">Read the full story from Kimberly Leonard here&gt;&gt;</a>More stories we're reading:<ul><li><a href="https://www.businessinsider.com/detroit-mayor-coronavirus-vaccine-johnson-and-johnson-moderna-pfizer-2021-3">Detroit's mayor reportedly said J&amp;J's vaccines aren't as good, so he said declined the city's first shipment</a> (Insider)</li><li><a href="https://www.bloomberg.com/news/articles/2021-03-05/unitedhealth-s-deal-machine-scoops-up-covid-hit-doctor-groups">UnitedHealth is scooping up doctors that have been hit hard by the pandemic</a> (Bloomberg)</li><li><a href="https://www.insider.com/covid-19-vaccines-black-market-may-be-real-report-says-2021-3">Real COVID-19 vaccine shots are being sold on the black market for up to $1,200 a dose, a study finds</a> (Insider)</li><li><a href="https://www.seattletimes.com/business/amazon/amazons-telehealth-arm-quietly-expands-to-21-more-states/">Amazon's medical provider has filed paperwork in 21 states now</a> (Seattle Times)</li></ul>- Lydia

Startups want to help vaccinate

<ul class="summary-list"><li>A COVID-19 vaccine mist has been approved for use as a booster dose in China.</li><li>The vaccine maker CanSino repackaged its shot as a mist meant to be inhaled.</li></ul>Just one breath of a vaccine mist can provide strong immune protection against COVID-19, vaccine maker CanSino said in a <a href="https://www.cansinotech.com/html/1///179/180/1100.html">news release</a> Sunday.Regulators in China approved a COVID-19 vaccine mist for use as a booster dose, making it the first alternative to injectable vaccines used during the pandemic.The inhaled vaccine contains the same ingredients as the jabs used in China, but a nebulizer machine turns it from liquid into an aerosol spray.Similar to the COVID-19 vaccines used in the US, CanSino's formulation contains pieces of genetic material so the body can recognize the virus. While the Moderna and Pfizer vaccines introduce that material directly, the CanSino vaccine uses a <a href="https://cen.acs.org/pharmaceuticals/vaccines/Adenoviral-vectors-new-COVID-19/98/i19">harmless version of the common cold virus</a> to carry information about the coronavirus. The single-dose CanSino shot is about 92% effective at preventing severe disease due to COVID-19, and about 58% effective at preventing illness entirely, according to data reported by the <a href="https://www.who.int/news-room/feature-stories/detail/the--cansino-biologics-ad5-ncov-s--recombinant---covid-19-vaccine--what-you-need-to-know">World Health Organization</a>. Clinical trials of the mist as a booster (following a single injected dose of the vaccine) showed it was about as effective as the <a href="https://www.who.int/news-room/feature-stories/detail/the-sinovac-covid-19-vaccine-what-you-need-to-know">two-dose vaccine</a> that's widely used in Asia and abroad.The nasal mist may bolster protection in the lining of the nose and upper airways, where the virus typically enters the body, according to the press release.Other vaccines have been repackaged as mists before, such as the <a href="https://www.flumistquadrivalent.com/">FluMist</a> intranasal vaccine seen in pediatricians' offices every flu season. Inhaled vaccines provide a needle-free alternative for kids and adults alike, but <a href="https://www.ncbi.nlm.nih.gov/search/research-news/8905">evidence from past flu seasons</a> has shown that the mist doesn't always achieve the same level of efficacy as a shot.Only time will tell if the mistable COVID vaccine provides enough booster protection to be approved and widely distributed in other countries.

China approved a COVID-19 vaccine mist that can be inhaled: the first needle-free booster option

Hyderabad, Amid the gloom caused by COVID-19, one sector which provided a ray of hope was life sciences and turning the challenge into an opportunity, Hyderabad fortified its position as a global force in the world of pharmaceuticals. This southern city, already recognised as a global information technology destination, proved its prowess in the field of pharmaceuticals and biotechnology and emerged as the vaccine capital of the world. Already known as the bulk drug capital of India, Hyderabad witnessed manufacturing of lifesaving COVID-19 drugs like Remdesivir, Hydroxychloroquine and Favipiravir by some of the top pharma companies based here. This was followed by hectic efforts in the city to develop COVID-19 vaccine. In fact, Hyderabad has emerged as the nerve centre of all research and development activities in the country for COVID-19 vaccines and has even attracted international attention. Today, almost all the vaccines being developed in the country for the pandemic have a Hyderabad connect. Four of the six companies developing COVID vaccines in India are based in Hyderabad. <keyword id="149108" type="COMPANY" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword> is currently conducting Phase III clinical trials of India's first indigenous COVID-19 vaccine Covaxin. Covaxin is being developed in collaboration with <keyword id="1256547" type="COMPANY" weightage="20" keywordseo="The-Indian-Council-of-Medical-Research">the Indian Council of Medical Research</keyword> (ICMR) - National Institute of Virology (NIV). This indigenous, inactivated vaccine is being developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) bio-containment facility at Genome Valley here. According to Bharat Biotech, Covaxin has been evaluated in approximately 1,000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity results. The Phase III human clinical trials of the vaccine began in November, involving 26,000 volunteers across India. This is India's first and only Phase III efficacy study for a COVID-19 vaccine, and the largest phase III efficacy trial ever conducted for any vaccine in India. "Covaxin has garnered interest from several countries worldwide for supplies and introduction," said Suchitra Ella, Joint Managing Director of Bharat Biotech. In April, Bharat Biotech announced development of CoroFlu, an intranasal vaccine for <keyword id="8698690" type="COMPANY" weightage="20" keywordseo="coronavirus-">Coronavirus.</keyword> University of Wisconsin–Madison and vaccine company FluGen along with Bharat Biotech began the development and testing of CoroFlu. The Hyderabad based company will produce almost 300 million doses of vaccine for global distribution. In May, Bharat Biotech and Thomas Jefferson University of Philadelphia signed an exclusive deal to develop a new vaccine candidate for COVID-19 invented at Jefferson. The novel vaccine was developed using an existing deactivated rabies vaccine as a vehicle for coronavirus proteins. Bharat Biotech claimed to have excellent track record of innovation with more than 140 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 116 countries and WHO Pre-qualifications. The company has so far developed vaccines for H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika and the world's first conjugated vaccine for Typhoid. It has delivered more than four billion doses of vaccines worldwide. It is also the largest Rabies vaccine manufacturer in the world. Another city-based firm Biological E last month initiated clinical trial of its COVID-19 subunit vaccine candidate in India following approval from the Drugs Controller General of India (DCGI). BE is making the vaccine in collaboration with <keyword id="5289395" type="COMPANY" weightage="20" keywordseo="dynavax-technologies-corporation">Dynavax Technologies Corporation</keyword> (Dynavax), a US-based vaccine focused biopharmaceutical company, and <keyword id="503459" type="COMPANY" weightage="20" keywordseo="Baylor-College-of-Medicine">Baylor College of Medicine</keyword>, a health sciences university in Houston. Biological E has also signed an agreement with Johnson &amp; Johnson to produce the latter's vaccine at its vaccine production facilities and sell them both in India and export across various global markets. Indian Immunologicals, a human and animal vaccines maker, too is developing a vaccine for COVID. Hyderabad-based pahrma major Dr Reddy's Laboratories is conducting clinical trials of Russian COVID-19 vaccine, Sputnik V. Russian Direct Investment Fund (RDIF), Russia's sovereign wealth fund, has collaborated with Dr Reddy's to conduct clinical trials and distribute the vaccine in India. Hyderabad was under spotlight with the recent visits by Prime Minister Narendra Modi and ambassadors of more than 60 countries to the facilities of Bharat Biotech and Biological E in Genome Valley Telangana's industry minister K. T. Rama Rao believes that Hyderabad has cemented its position as the vaccine capital of the world. He pointed out that Hyderabad is already manufacturing more than two billion doses of vaccines every year, which is one-third of the global vaccine output. The city, with its strong ecosystem, has played a critical role in making India not only self-sufficient in the medicine manufacture but also turned it into the pharmacy capital of the world. It accounts for 40 per cent of the total Indian bulk drugs and 50 per cent of the bulk drug exports. Industry leaders believe that Hyderabad will be an integral part of the global efforts to vaccinate the world against COVID. Even if no vaccine is developed in the city, the city will still have a big role to play in global vaccination efforts with the sheer vaccine manufacturing capacity it houses. Hyderabad has the largest US FDA approved vaccine facilities. They have the capacity to manufacture millions of doses with world-class standards. "India's vaccine sector will play a critical role in developing and producing vaccine at scale for distribution across the world. Hyderabad's importance in the global vaccine landscape is only growing," K.T. Rama Rao said. Telangana government has assured the companies that it will play the enabling role in global vaccination efforts against COVID-19. The Hyderabad airport announced few days ago that has developed necessary infrastructure to handle the exports. As per the industry insights, most of India's vaccine export will be to Africa, Latin America and Asian destinations. Hyderabad is already home to more than 800 life sciences companies and the sector employs over 1,20,000 pharmaceutical professionals. It is said to be the only city in the country to house more than 20 incubation centres focused only on life sciences and health-tech. More than 200 start-ups are also working on innovative solutions in healthcare. Genome Valley is India's first organised cluster for life sciences R&amp;D activities spread across 600 square kilometers. Set up in 1999, it has world-class infrastructure facilities in the form of <keyword id="10464926" type="COMPANY" weightage="20" keywordseo="industrial-/-knowledge">Industrial / Knowledge</keyword> parks, Special Economic Zones (SEZs), Multi-tenanted dry and wet laboratories and incubation facilities. It is home to more than 200 companies including presence of the marquee global names like Novartis, GlaxoSmithKline, Ferring Pharma, Chemo, DuPont, Ashland, United States Pharmacopeia and Lonza. With <keyword id="4920024" type="LOCATION" weightage="20" keywordseo="Hyderabad-Pharma-City">Hyderabad Pharma City</keyword> also likely to be operational soon, the city is looking to ramp-up production of Active Pharmaceutical Ingredients (APIs) and thus develop a cluster to help the country compete with China. The new project is expected to create 1,70,000 direct jobs and 5,60,000 indirect jobs. SEE ALSO: <a href="https://www.businessinsider.in/tech/enterprise/news/wistron-apple-iphone-manufacturer-could-face-these-penalties-if-found-guilty/articleshow/79790319.cms">If investigators find Wistron management guilty, here's what is at stake for the company</a> <a href="https://www.businessinsider.in/stock-market/news/heres-what-analysts-say-if-you-should-subscribe-or-not-to-the-300-crore-ipo-of-antony-waste-handling-cell/articleshow/79790998.cms">Antony Waste Handling Cell ₹300-crore IPO will open on Monday— these are the risks and opportunities</a> <a href="https://www.businessinsider.in/business/news/ikea-india-cfo-says-she-still-has-3500-crore-to-be-spent-in-india-the-pandemic-has-changed-targets-but-not-the-investment-plan/articleshow/79790938.cms">INTERVIEW: Ikea CFO says she still has ₹3,500 crore to be spent in India⁠— the pandemic has changed targets but not the investment plan</a>

Hyderabad : Vaccine capital of the world

<ul class="summary-list"><li><keyword id="16815" type="COUNTRY" weightage="60" keywordseo="Cuba">Cuba</keyword> is developing a <keyword id="24209" type="PERSON" weightage="60" keywordseo="vaccine">vaccine</keyword>, Soberana 02, which could be used to vaccinate its population.</li><li>Three others are also in the works. Cuba has a history of effective campaigns without Western help.</li><li>Several anti-capitalist countries have expressed interest in receiving the vaccine.</li></ul>A vaccine developed by the Cuban government is touted to enter Phase 3 trials in March, raising the prospect of the small, communist nation overseeing a homegrown vaccine drive.The vaccine, Soberana 2, has yet to be formally approved. But Cuba is betting big on its success, which builds on a history of medical programs where the nation has acted alone.The country aims to be one of the first in the world to vaccinate its entire population of 11 million by the end of 2021, though it will start significantly behind others countries which are already giving out jabs.100 million doses of Soberana 02 could be produced by the country for domestic use and export by the end of the year, officials there say.The country is developing four vaccines in parallel. The <a href="https://www.finlay.edu.cu/en/">Finlay Institute of Vaccines</a> is leading on Soberano 02, and also Soberano 01, which is not as far through the process.Two more, Abdala and Mambisa, are being developed by the Centro de Ingeniería Genética y Biotecnología.Mambisa, which is still very early in the phases of testing, is an intranasal treatment, which means it would be delivered through the nose rather than by a needle.Both the institutes are funded and operated by the Cuban government.<h2>A promising program - but little public data</h2>"The Finlay Institute is a leading biopharma institution in Cuba", Professor Beate Kampmann, director of the Vaccine Centre at the London School of Hygiene and Tropical Medicine, told Insider in an interview."This is a solid enterprise that is [already] making the vaccines for a lot of Latin America, including tetanus and other conjugated vaccines."If Soberana 02 is proven to be effective in Phase 3 clinical trials, it will be the first vaccine against COVID-19 to be developed in Latin America.Phase 3 is the final stage before a vaccine is generally approved by national regulators.A Phase 1 trial of a vaccine is limited to a dozen or so people, to show it is safe. Phase 2 often involves more than 100 people, and measures side-effects and how the broad immune system reacts.The Phase 3 is typically the real test of whether the vaccine works, and involves several hundred volunteers. Its goal is to measure how effective the vaccine is compared to a control group.The Pfizer, Moderna, and AstraZeneca vaccines all passed Phase 3 before widespread use. For the WHO to approve the vaccines for emergency use, Cuba will need to <a href="https://www.who.int/medicines/regulation/prequalification/prequal-vaccines/WHO_Evaluation_Covid_Vaccine.pdf?ua=1">show they has at least 50% efficacy</a>. Safety and immunogenicity data from the Phase 1 and 2 trial results have not been published yet, which makes it difficult for external experts to judge whether they work. Past performance is helpful indicator, but no guarantee of success.Experimental COVID-19 vaccines can fall at the first hurdle. Pharma giants <a href="https://www.businessinsider.com/merck-covid-vaccines-drop-out-disappointing-trial-results-2021-1">Merck</a> and <a href="https://www.businessinsider.com/gsk-sanofi-vaccine-delay-covid-19-coronavirus-elderly-warp-speed-2020-12">Sanofi</a> gave up on <keyword id="9265502" type="UNKNOWN" weightage="60" keywordseo="vaccine-candidates">vaccine candidates</keyword> after early trials didn't pan out.Cuban scientists told <a href="https://www.youtube.com/watch?v=bUjspm-REYI&amp;feature=emb_logologo">Mesa Redonda</a>, a popular Cuban television program, that the vaccines are "working well".<div type="image" title="Eduardo Martínez Díaz, president de BioCubaFarma, speaks to Mesa Redonda about the Cuban lead vaccine candidate Soberana 02 vaccine." height="936" width="1248" msid="80926820" hostid="261"></div>The scientists said they were using tried and tested vaccine platforms, developed by Cuba's biotech industry.Soberana 02 is a conjugate vaccine, a type of vaccine which carries the portion of the spike protein which binds to human cells. On its own, this bit of protein will not trigger a strong immune response, so the vaccine is tied to ("conjugated with") another substance to boost its effectiveness.In animals, <a href="https://www.biorxiv.org/content/10.1101/2021.02.08.430146v1">the vaccine triggered a strong neutralising response</a>, according to data which has not yet been reviewed by other scientists. Kampmann said that, according to available data, the vaccine's Phase 1 trials, which began in October, have just finished recruiting. The Phase 2 was initiated on December 21, 2020, and is scheduled to recruit 910 participants over the course of a year. In a tweet on January 5, however, the Finlay vaccine institute said that 700 participants had already received the first dose of the Phase 2 trial of Soberana 02 and that it expects a Phase 3 trial in March.When the trial starts, the vaccine is due to be given to 42,000 Cubans, with the aim of being extended to the rest of the population at a later date, the tweet said. On the design of the vaccine, Kampmann said that this type of vaccine has been used by this team many times before, and is likely to be pretty safe. But, she said, until the relevant data from the trials is public, it's impossible to know how good the vaccine is.<h2>Big pharma, communist-style</h2>Over the past decades, Cuba has <a href="https://medium.com/@eharris1510/cubas-booming-biotech-industry-e8c5bf97e320">plowed cash into its state-owned biotech industry</a>. After the revolution of 1959, foreign and domestically-owned pharma companies were nationalized, and the Cuban government has run a centralized biotech industry ever since.Professor Helen Yaffe, a Cuba expert, told Insider: "In the advanced capitalist countries in Europe and the US, we don't know much about Cuba's prowess in medical <keyword id="41551" type="ENTERTAINMENT" weightage="60" keywordseo="science">science</keyword> and global health"Yaffe is a lecturer of economics and social history at Glasgow University and author of "We Are Cuba!: How a Revolutionary People Have Survived in a Post-Soviet World". "But in the global South," she continued, "they do. Why? Because for over 60 years Cuba has had 400,000 healthcare professionals working around the world."The small island nation is accustomed to exporting medical professionals to crisis-hit areas of the world in a program called the Henry Reeve Brigade. <div type="image" title="Cuba doctors coronavirus covid-19 Italy" height="699" width="1400" msid="80926822" hostid="261"></div>The scheme made headlines early in the pandemic, when Cuban medics came to help the <a href="https://www.insider.com/cuban-docs-fighting-coronavirus-around-world-defying-us-2020-4">overwhelmed Lombardy region of Italy</a>.The work <a href="https://www.cubanobel.org/">prompted a campaign to nominate the Cuban doctors for the 2021 Nobel Peace Prize</a>, which has been endorsed by US celebrities Tom Morello and Danny Glover.Yaffe highlighted that the Cuban biotechnology sector is distinctive. Because it is owned by the state and not supported by speculative financing, she said its priority is not to make money, but prioritize health outcomes.This approach is seen by some as medical humanitarianism, by others as <a href="https://www.ft.com/content/debaad0c-5d6e-11df-8373-00144feab49a">medical diplomacy</a>.<h2>Friends in the Global South</h2>Cuba is "a global leader in South-South transfer of technology" <a href="https://www.who.int/phi/publications/Cuba_case_study121115.pdf">the WHO said in a report published in 2015</a>.It has struck past deals with Algeria, India, Brazil, China, South Africa, Mexico, Argentina, Vietnam and Malaysia. Several countries have publicly expressed interest in purchasing the Soberana 02 vaccine once the Phase 3 trial is complete, including Jamaica, Venezuela, Vietnam, Pakistan, and India.The African Union, which represents all 55 nations in Africa, <a href="https://www.voanews.com/covid-19-pandemic/africa-working-private-sector-china-cuba-and-russia-secure-vaccines">has also shown interest</a>. Latin American countries are also likely to request the vaccine if it proves to be efficacious, according to Kampmann, the academic in London.Cuba makes the yellow fever and the tetanus vaccine for the childhood immunization programme in the area, and Kampmann said that there is "trust in their ability to deliver vaccines""Price-wise they are also going to be attractive", Kampmann said. Cuban vaccines would likely cost less than <a href="https://www.businessinsider.com/cost-pfizer-astrazeneca-moderna-vaccine-eu-revealed-belgian-mp-2020-12">other licensed vaccines</a>, which are just too expensive for low and middle income countries, she said.On Sunday, Mexico's foreign minister said it was considering approving a phase 3 trial of a Cuban vaccine there, local media said.<keyword id="41896" type="COUNTRY" weightage="60" keywordseo="Iran">Iran</keyword> is due to be the first foreign country to receive the vaccine, in a Phase 3 trial of Soberana 02 <a href="https://www.who.int/publications/m/item/weekly-epidemiological-update---9-february-2021">run in collaboration with the Pasteur Institute in Iran.</a> Up to 150,000 Cuban and Iranian volunteers are due to receive the vaccine during this trial.Both countries have long been subject to sanctions led by the US. Iran has had a tumultuous relationship with Western vaccines, and has accused the sanctions imposed by former President Donald Trump of <a href="https://www.al-monitor.com/pulse/originals/2021/01/iran-sanctions-biden-coronavirus-vaccine-trump-nuclear-covax.html">hindering its access to vaccines</a>.In July 2020, UN special rapporteurs <a href="https://news.un.org/en/story/2020/04/1062982">called on the US to lift its embargo on Cuba</a>, which they said impeded the delivery of "medicine, medical equipment, food and other goods essential to surviving the pandemic."Iran has the highest number of COVID-19 cases of its near neighbors.On January 8, <a href="https://www.theguardian.com/world/2021/jan/08/untrustworthy-covid-vaccines-from-us-and-uk-banned-by-iran">Iran banned the imports of COVID-19 jabs from the US and UK</a>, after Ayatollah Ali Khamenei called the jabs "untrustworthy".<div type="image" title="Iranian Supreme Leader Ali Khamenei" height="638" width="851" msid="80926823" hostid="261"></div>By contrast, the country has <a href="https://www.aljazeera.com/news/2021/2/9/iran-starts-covid-vaccinations-with-sputnik-v">started rolling out the Russian Sputnik V vaccine</a> to health-care workers, with Iranian president Hassan Rouhani saying he is willing to take the shot to prove it that it's safe.Read more: <a href="https://www.businessinsider.com/guantanamo-bay-prison-abolish-biden-bush-administration-war-terror-2021-2">We can't just close Guantanamo Bay prison, we also have to abolish the injustice that allowed it to exist</a>Yaffe, the Cuba expert, said that many of the countries that have publicly expressed interest in Soberana 02 already have close collaborations or joint ventures with Cuba, which would make it easier to roll out a vaccine.It is possible, she said, that other countries have contacted Cuba about using the vaccine but did so privately for fear of vexing the US. Although President Barack Obama took steps to relax the measures against Cuba, <a href="https://www.cfr.org/backgrounder/us-cuba-relations">they were mostly walked back under the Trump administration</a>.The White House said on January 28 that it would review Cuba policy, but has yet to make any moves. For the meantime, Cuba's plan is to press on alone.

Cuba is working on a homegrown COVID-19 vaccine program. It has a history of fighting disease without help from the West

<ul class="summary-list"><li>COVID-19 vaccines are great at preventing severe illnesses and death.</li><li>But they don't always stop transmission or mild cases.</li></ul>If we could vaccinate your nose, there's a good chance we'd be able to end this pandemic right now.But the COVID-19 shots available in the US can't control everything that happens in your nostrils. If they did, they might be able to stop all transmission of the virus that happens through our talking, singing, laughing, breathing, and sneezing around each other. If successful, a new kind of vaccine - a nasal mist that requires no needle - promises to do all that by providing the special kind of <keyword id="11893194" type="UNKNOWN" weightage="60" keywordseo="coronavirus" source="Orion">coronavirus</keyword> immunity people need to stop shuttling this virus around. "An intranasal vaccine could help bring an end to the pandemic and help give us true control over SARS-CoV-2 by limiting infection and transmission," said Marty Moore, the CEO of Meissa Vaccines. "We shouldn't settle for a new normal. We can get back to the old normal."For now, that idea remains one that needs much more robust clinical data behind it to become a reality that we could all sniff up. But the prospect is still quite exciting to many immunologists around the world.<h2>Shots in the arm aren't always great at preventing the sniffles </h2>One big reason vaccine breakthrough infections happen is because the injectable COVID-19 vaccines have been designed to give a person's body good systemic immunity against the virus, protecting internal organs such as the lungs and the heart from severe infection. But a shot in the arm can't do as much for your nose in the long run. If a vaccinated person is exposed to COVID-19, they may still get a case of the sniffles, or a flu-like COVID-19 illness. This is because they haven't developed great <a href="https://medlineplus.gov/ency/article/002264.htm">mucosal</a> immunity against the coronavirus. In other words: They're still susceptible to infection via the vulnerable <a href="https://www.ncbi.nlm.nih.gov/books/NBK27169/">moist tissues</a> that interact with the outside world, such as those in the nose, eyes, and mouth."Very early on during that honeymoon initially after vaccination when your neutralizing antibodies are at their highest, you get a bit of a spillover effect into the upper airway," <a href="https://twitter.com/celinegounder?ref_src=twsrc%5Egoogle%7Ctwcamp%5Eserp%7Ctwgr%5Eauthor">Dr. Céline Gounder</a>, an infectious-disease specialist at Bellevue hospital in New York, said at the recent IDWeek <a href="https://idweek.org/">infectious-disease conference</a>, explaining the issue of lacking durable mucosal immunity after vaccination. Meissa is one of a few smaller companies pursuing COVID-19 nasal vaccines in early-stage human trials. Codagenix, another US company, has also announced some promising (but extremely small) <a href="https://www.prnewswire.com/news-releases/codagenix-announces-safety-and-immunogenicity-data-from-phase-1-covid-19-intranasal-vaccine-trial-and-intent-to-progress-to-phase-23-studies-301382120.html?tc=eml_cleartime">early trial results</a>. Other nasal vaccines are being developed around the world, with ongoing trials in Israel, Russia, Cuba, India, Hong Kong, and Iran."Our aim is to be the transmission-blocking COVID vaccine," Moore said. <h2>Immunologists are excited about the prospect of nasal vaccines - both for unvaccinated people and as boosters</h2>Meissa's early clinical data (which the company said it would share in more detail at an upcoming immunotherapy conference in late November and early December) indicated that unvaccinated patients who are given a couple drops of Meissa's vaccine in each nostril have average mucosal antibody levels slightly higher than those measured in people with natural immunity to the virus.This suggested that Meissa's vaccine could potentially work well at preventing peskier sniffly infections, not just the COVID cases that land people in the hospital."It suggests that we can deliver immunity that's like natural infection, but we can do it safely," Moore said.This prospect has many immunologists quite excited, not only because nasal vaccines could be offered to vaccine-hesitant people who don't like shots but also because they might, perhaps, be used as boosters to top up the already very good systemic immunity people have gotten from injectable vaccines. Meissa's initial human trial is still ongoing, with 70 participants in it so far. It's only in phase 1, meaning any approval or even emergency authorization for this type of vaccine is many months and likely several thousand more volunteer participants away, at best.But so far, the results look good. Meissa, which is conducting much of its research in Kansas, said there were many reasons people have chosen to join their early-stage trial. "Sometimes it's people who are Ph.D.s or highly educated, who see the benefit of an intranasal to prevent infection itself," Moore said. "And oftentimes, it's people who just don't want a shot. They don't want something injected into them."Common side-effect complaints after Meissa's nasal vaccine so far have included runny noses, coughs, sore throats, and headaches. But the company said that no worrisome safety signals had surfaced with the vaccine, which uses a <a href="https://www.meissavaccines.com/technology">live-attenuated RSV platform to deliver</a> the coronavirus' characteristic spike protein to vaccines without risking the coronavirus itself spreading from them."There are quite a few people who would rather have drops in the nose than the needle," Moore said. "So I think an intranasal vaccine could reach not all, but many vaccine-hesitant people."

A nasal COVID-19 vaccine could be the solution to ending the pandemic, experts say, and early trial data looks promising

<ul class="summary-list"><li>A US company called Altimmune is developing a <keyword id="8904563" type="UNKNOWN" weightage="60" keywordseo="covid-19-vaccine">COVID-19 vaccine</keyword> that gets sprayed up the <keyword id="6374458" type="UNKNOWN" weightage="60" keywordseo="Nose">nose</keyword>.</li><li>Such intranasal vaccines may <a href="https://www.businessinsider.com/vaccines-reduce-coronavirus-transmission-early-research-2021-2">reduce coronavirus transmission</a> better than shots do.</li><li>Boosters designed to protect against variants could also be delivered intranasally, experts say.</li></ul>It's an intuitive idea: Wouldn't it be best to administer a <keyword id="8763838" type="UNKNOWN" weightage="60" keywordseo="covid-19">COVID-19</keyword> vaccine in the place it first invades the body?Altimmune, a biotech startup based in Maryland, is trying to develop a COVID-19 vaccine that gets squirted into your nose, not jabbed in your arm."Delivering vaccines to the sight of first exposure is an advantage," Dr. Buddy Creech, who directs the Vanderbilt University vaccine-research program and has <a href="https://jamanetwork.com/journals/jama/fullarticle/2777059">worked with Altimmune</a>, told Insider. "Typically, you don't get COVID-19 in the deltoid muscle of your arm - you get it in your nose, eyes, and throat. So it makes sense we'd want to at least consider a vaccine that can generate some immunity in mucosal orifices."The three COVID-19 vaccines authorized in the US are, of course, all shots. Though they appear to curb transmission, it's unlikely that they <a href="https://www.businessinsider.com/vaccines-reduce-coronavirus-transmission-early-research-2021-2">stop it</a>. An intranasal vaccine could create an extra line of defense, since it would prompt the immune system to produce antibodies that block infection locally in the mucous membranes of your nose and throat. That would prevent transmission by stopping viral shedding from those orifices.Altimmune last month launched <a href="https://clinicaltrials.gov/ct2/show/NCT04679909?intr=adcovid&amp;spons=altimmune&amp;draw=2&amp;rank=12&amp;rank=1">a 180-person trial</a> of its intranasal vaccine, called AdCOVID, to test how safe the vaccine is, what side effects it prompts, and what levels of antibodies and T-cells it produces. Participants range in age from 18 to 55. The company expects to have data in the second quarter of this year.<div type="image" title="intranasal COVID 19 vaccine candidate AdCOVID" height="2480" width="3306" msid="81355356" hostid="261"></div>Scot Roberts, the chief scientific officer at Altimmune, told Insider that the best-case scenario would be a rollout to adults at the end of this year or in early 2022.Other intranasal vaccine candidates are being tested in <a href="https://www.europeanpharmaceuticalreview.com/news/129563/phase-i-trial-of-intranasal-covid-19-vaccine-spray-approved-in-china/">China</a>, <a href="https://health.economictimes.indiatimes.com/news/pharma/bharat-biotech-to-start-phase-1-trials-of-covid-19-intranasal-vaccine-in-feb-march/80166695">India</a>, and the <a href="https://www.biopharma-reporter.com/Article/2021/01/11/Needle-free-COVID-19-vaccine-COVI-VAC-enters-Phase-1-trials">UK</a>.<h2>A nasal spray could prevent viral shedding from noses and throats</h2><h2><div type="image" title="Altimmune" height="2989" width="3986" msid="81355358" hostid="261"></div></h2>AdCOVID wouldn't be the first vaccine that doesn't require a needle. The polio vaccine was first swallowed as pill, and the Centers for Disease Control and Prevention has approved multiple nasal-spray flu vaccines.Vaccines injected into the arm muscle, however, are most common. These prompt your immune system to start producing T-cells that remember the pathogen, should it ever return, and antibodies that fight off the virus across your body - what's known as systemic immunity.But those antibodies don't always flood into the mucus-covered surfaces of the nose and throat (where a respiratory virus likes to hang out) in large enough numbers to stop the virus from replicating there.A nasal spray can prompt your immune system to create antibodies known as immunoglobulin A locally in your mucosal orifices, said Dr. Paul Goepfert, the director of the Alabama Vaccine Research Clinic."It's possible that this would be a much more efficient vaccine to reduce <keyword id="1754604" type="PERSON" weightage="60" keywordseo="coronavirus">coronavirus</keyword> spread," Goepfert told Insider.Altimmune found in a <a href="http://www.biorxiv.org/content/10.1101/2020.10.10.331348v1">recent animal study</a> that its intranasal COVID-19 vaccine prompted both systemic immunity and mucosal immunity. <a href="https://www.cell.com/cell/fulltext/S0092-8674(20)31068-0#%20">Two</a> <a href="https://science.sciencemag.org/content/early/2021/02/16/science.abf4896">other</a> animal studies found that an intranasal spray prevented infections while almost completely blocking coronavirus transmission.<h2>Nasal sprays could serve as boosters to target coronavirus variants</h2><div type="image" title="vaccine shot" height="1335" width="2000" msid="81355359" hostid="261"></div>A proliferation of coronavirus variants has raised concerns that existing vaccines will need to be reinforced via booster shots. Pfizer and Moderna are <a href="https://www.businessinsider.com/moderna-nih-test-booster-shots-covid-19-variants-2021-2">testing new versions of their shots</a> to combat such variants, but distributing them could be another enormous undertaking.A key advantage of Altimmune's spray is that it doesn't require refrigeration and can be kept at room temperature for months."If we do need revaccinations or to top up immunity in the presence of a variant, this approach makes perfect sense," Roberts said.Daniel Oran and Eric Topol, two COVID-19 researchers at the Scripps Research Translational Institute in California, have said intranasal vaccines could help, since people might be able to administer the vaccines themselves."Simply mailing someone a nasal spray is far more convenient than arranging for an in-person injection," they <a href="https://www.scientificamerican.com/article/to-beat-covid-we-may-need-a-good-shot-in-the-nose/">wrote in Scientific American</a> on Monday. They also pointed out that swapping a needle for a spray could encourage more people to get vaccinated in the first place.<h2>Altimmune hopes to test its spray in children this year</h2><div type="image" title="intranasal vaccine h1n1 flu" height="2000" width="3000" msid="81355364" hostid="261"></div>Altimmune plans to test its intranasal vaccine in children and is talking to the Food and Drug Administration about how to formulate those pediatric trials. The company hopes to launch a trial among children while the drug is still being tested in adults.None of the COVID-19 vaccines authorized in the US can be administered to children younger than 16, since the companies didn't include kids in their early trials."Kids don't get so sick, but they sure can spread the virus. So this idea of mucosal immunity that blocks transmission is really a perfect fit for the pediatric population," Roberts said. "Clearly the FDA recognizes the need. We can't leave 70 million Americans on the side, unvaccinated."Goepfert said that developing a nasal-spray vaccine for children would be a win-win: It would stymie their capacity for transmission and make it easier to vaccinate them."Not having to stick somebody is particularly appealing for pediatricians," he said.

A future COVID-19 vaccine could be squirted up the nose. The nasal spray could stop transmission, especially in kids.

<ul class="summary-list"><li>Both <keyword id="44612" type="CITY" weightage="60" keywordseo="Pfizer">Pfizer</keyword> and <keyword id="4912868" type="PERSON" weightage="60" keywordseo="moderna">Moderna</keyword>'s <keyword id="79555" type="TECHNOLOGY" weightage="60" keywordseo="Vaccines">vaccines</keyword> have been vetted by the FDA, and so far they look very safe and effective at preventing COVID-19 infections, based on trials in tens of thousands of volunteers around the world.</li><li>Common side effects after vaccination have included arm pain, fatigue, and headaches, which last a few days, but no major safety concerns have been raised yet. </li><li>Still, some concern has been voiced about a potential connection between the vaccines and <keyword id="1348631" type="PERSON" weightage="60" keywordseo="Bells-Palsy">Bell's palsy</keyword>, a temporary facial paralysis, after 7 cases of the condition were reported among vaccine recipients. </li><li>"At this point, there's no evidence to support that these vaccines trigger an increased risk of Bell's palsy, it's really important for the public to understand that," one otolaryngologist said. </li></ul>By now, <a href="https://www.businessinsider.com/pfizer-vaccine-allergy-concerns-reactions-rare-not-life-threatening-2020-12">hundreds of thousands of people around the world</a> have gotten injections of Pfizer's new <keyword id="8904563" type="UNKNOWN" weightage="60" keywordseo="covid-19-vaccine">COVID-19 vaccine</keyword>, which was <a href="https://www.businessinsider.com/pfizer-moderna-covid-19-vaccines-comparison-how-the-shots-compare-2020-12">deemed both safe and effective</a> enough for a Food and Drug Administration <a href="https://www.businessinsider.com/fda-authorizes-pfizer-biontech-coronavirus-vaccine-for-us-emergency-use-2020-12">emergency use authorization </a>during the pandemic.Before the shot was released to the public, more than 20,000 volunteers around the world tried it out over a period of several months, with no major safety concerns reported among trial volunteers from the US to Argentina, South Africa, Germany, Brazil, and Turkey. Common - <a href="https://www.businessinsider.com/pfizer-coronavirus-vaccine-side-effects-and-safety-for-covid-19-2020-12">but temporary - side effects reported</a> in the trials included pain at the injection site (in the arm), fatigue, and headaches, generally lasting about a day or two post-jab.The same was generally true of Moderna's new <keyword id="1754604" type="PERSON" weightage="60" keywordseo="coronavirus">coronavirus</keyword> vaccine, which was also tested out in more than 15,000 volunteers across the US. Both shots were deemed more than 94% effective at preventing symptomatic coronavirus infections, making them critical disease-fighting tools at this stage in the pandemic. The coronavirus is now among the leading causes of death in the US, killing more than 3,000 people across the country every day. However, some concerns have been raised about seven people who received the vaccine in trials from Pfizer and Moderna, who developed a temporary form of facial paralysis called Bell's palsy.<h2>What is Bell's palsy, and is it a concern?</h2>The condition involves a sudden weakness of the face, usually on one side. Why this happens isn't well understood, although the paralysis is linked to inflammation of facial nerves.People with <a href="https://www.britannica.com/science/Bell-palsy#ref1142512">Bell's palsy may have trouble</a> closing one eye, wrinkling their forehead, or pulling up the corner of their mouth to swallow food. Most people make a full recovery in six months or less. The FDA has said that it can't rule out with absolute certainty that Pfizer and Moderna's vaccine did not have an impact on these seven cases, and the agency will continue to investigate the issue. But based on the evidence we have, there's no reason to think the vaccine caused the facial paralysis, according to Dr. Nate Jowett, director of the surgical photonics &amp; engineering laboratory at Mass Eye &amp; Ear, and an associate professor of otolaryngology at Harvard Medical School. "At this point, there's no evidence to support that these vaccines trigger an increased risk of Bell's palsy, it's really important for the public to understand that," Jowett told Insider. <h2>The number of cases is small enough to be explained by coincidence</h2><div type="image" title="pfizer covid 19 vaccine distribution" height="1467" width="2200" msid="79806205" hostid="261"></div>Four people in Pfizer's trial, and three in Moderna's, developed the condition, out of a total of more than 37,000 people in both studies. (At least one unvaccinated person in Moderna's trial also developed Bell's palsy.)In other words, 99.98% of people who got two doses of a coronavirus vaccine did not develop Bell's palsy, and just 0.02% did. That rate is no higher than would be expected among the general population, <a href="https://www.fda.gov/media/144434/download">according to the FDA.</a> The number of cases is small enough that they may not be related to the vaccine at all, according to Jowett, given how commonly the condition occurs in the population. "The number of Bell's palsy cases that occurred in those massive cohorts is completely within the number you'd expect to happen by chance alone in a regular population without a vaccine or pandemic happening," he said. In a typical year, data suggests that for every 100,000 people in the population, 15 to 30 people will develop Bell's palsy. In contrast, out of more than <a href="https://www.businessinsider.com/live-updates-fda-advisory-committee-moderna-coronavirus-vaccine-2020-12#245-pm-one-panelist-inquires-about-above-average-bells-palsy-rates-but-the-numbers-are-too-small-to-draw-conclusions-from-2">37,000 vaccine recipients</a>, seven developed Bell's palsy. While Jowett said it's "somewhat unusual" that most of the cases occured in people who received the vaccine, compared to one case in the placebo group, it's not significant enough to suggest a causal link. "Those numbers are well within what you'd expect statistically to note by pure random association. You'd expect 5-10 people would develop Bell's palsy by chance during that follow up," Jowett said. The FDA has acknowledged that more people who received the coronavirus vaccines developed Bell's palsy than those who got a placebo, and the agency will continue monitoring for more cases, as the vaccine is rolled out to states.Vaccine expert Paul Offit, who is a member of the FDA's independent advisory board on vaccines, <a href="https://www.businessinsider.com/live-updates-fda-advisory-committee-moderna-coronavirus-vaccine-2020-12#245-pm-one-panelist-inquires-about-above-average-bells-palsy-rates-but-the-numbers-are-too-small-to-draw-conclusions-from-2">said during a committee meeting on Thursday that</a> he was pleased the agency is going to continue to closely monitor these vaccines going forward, given that there were more paralysis cases in the vaccinated groups than among controls.Still, he stressed that it is important to not fall victim to "the tyranny of small numbers" and conclude any vaccine-Bell's relationship just yet. <h2>Bell's palsy is linked to latent viruses like chickenpox</h2><div type="image" title="pfizer vaccine us" height="1467" width="2200" msid="79806207" hostid="261"></div>Facial paralysis is linked to viruses generally, but not specifically to the novel coronavirus that causes COVID-19. Instead, research suggests that Bell's palsy can be triggered by certain viruses that are already in our bodies, lying dormant. "Our best evidence suggests it is the result of the reactivation of a virus [such as chickenpox or other herpes viruses]," Jowett said. "These are benign viruses most of us pick up as children and we carry them for the rest of our lives."When we recover from such viral illnesses, they remain in a usually-harmless or latent form in our bodies (including in our nerves). In rare cases, these viruses can reactivate, causing conditions such as shingles. <keyword id="41551" type="ENTERTAINMENT" weightage="100" keywordseo="science">Science</keyword> doesn't completely understand why this happens, but it may be triggered by stress or immune disruption. Bell's palsy can occur when viral reactivation causes inflammation in the nerves of the face, triggering muscle weakness and paralysis. It's also been associated with other underlying <keyword id="6354750" type="UNKNOWN" weightage="60" keywordseo="health">health</keyword> conditions, such as diabetes, high blood pressure, and upper respiratory infections, according to the <a href="https://www.ninds.nih.gov/disorders/patient-caregiver-education/fact-sheets/bells-palsy-fact-sheet">National Institute of Neurological Disorders and Stroke</a>. Several COVID-19 vaccine recipients who developed Bell's palsy also reported these associated illnesses, <a href="https://www.fda.gov/media/144434/download">including a</a> 67-year-old woman with diabetes, and a 30-year-old woman who had a respiratory infection a month prior to getting the vaccine. Bell's palsy is the most common diagnosis for facial paralysis, but other conditions can have the same symptoms, including Lyme disease and strokes, according to Jowett.<h2>Most patients make a full recovery</h2><h2><div type="image" title="covid 19 infections soar" height="1356" width="1808" msid="79806210" hostid="261"></div></h2>Bell's palsy is rarely considered to be a serious illness as patients nearly always recover on their own, without needing treatment. In the vaccine studies, two of the Bell's cases were reported as completely resolved, and many of the other five were resolving, as <a href="https://www.fda.gov/media/144245/download">Pfizer</a> and <a href="https://www.fda.gov/media/144434/download">Moderna</a> submitted their safety data to the FDA. "The vast majority of cases are not serious in that they will completely, spontaneously resolve within a few days to a few weeks, with complete return of normal facial function," Jowett said. If necessary, steroids and anti-viral medications can be used in severe cases to help improve the odds that patients will return to normal more quickly. Infrequently, Bell's palsy can cause longer lasting symptoms. "In severe cases, nerve fibers can be damaged and regenerate, but connected to the wrong muscle," Jowett said. "For instance, when a patient starts to smile, their eye may involuntarily close."These ongoing issues can be treated with physical therapy, medical Botox, and surgery if necessary, he said. <h2>Experts have debunked the idea that vaccines cause Bell's palsy before</h2><div type="image" title="pfizer vaccine covid 19 nursing homes" height="1558" width="2200" msid="79806211" hostid="261"></div>According to Jowett, the theory that vaccines are linked to Bell's palsy is primarily based on <a href="https://pubmed.ncbi.nlm.nih.gov/14985487/">one 2004 study</a> of a new flu vaccine. That vaccine was distributed in Switzerland during the 2000-2001 flu season and was linked to a significant increase in cases of Bell's palsy (at least 13 extra cases for every 10,000 vaccine recipients). No extra cases were reported in the US though, because the Swiss-made vaccine was pulled from the market before it got to the states.However, later evidence found that it was likely the way the vaccine was administered that was the real culprit. The 2000 vaccine was the world's first licensed intranasal flu mist, administered through the nose instead of with a needle in the arm.In a <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5414992/">follow-up study</a>, researchers administered similar strains of the same flu vaccine as a shot into muscle fibers, and found it was not linked to any more cases of facial paralysis. "It's possible that proximity to facial nerve fibers somehow induced inflammation in the nerve, which is what triggers Bell's palsy," Jowett said. Both Pfizer and Moderna's new <a href="https://www.businessinsider.com/mrna-vaccine-pfizer-moderna-coronavirus-2020-12">mRNA</a> vaccines are injected into people's arm muscles, not administered through the nose.Read more:<a href="https://www.businessinsider.com/pfizer-moderna-covid-19-vaccines-comparison-how-the-shots-compare-2020-12">Coronavirus vaccines compared: What to know about shots from Moderna and Pfizer, from safety to side effects</a><a href="https://www.businessinsider.com/when-can-i-get-a-coronavirus-vaccine-timeline-2020-11">When can I get a coronavirus vaccine?</a><a href="https://www.businessinsider.com/why-experts-voted-no-to-pfizers-covid-19-vaccine-2020-12">The reasons 4 experts voted 'no' on authorizing the Pfizer COVID-19 vaccine for Americans over 16 years old</a>

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