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The government has waived the requirement for clinical trials of certain categories of drugs in <keyword id="19895063" type="General" weightage="20" keywordseo="India" source="keywords">India</keyword> if they are approved in the <keyword id="19899478" type="General" weightage="20" keywordseo="US" source="keywords">US</keyword>, the <keyword id="19922618" type="General" weightage="20" keywordseo="UK" source="keywords">UK</keyword>, Japan, Australia, Canada and the European Union. The waiver only covers five categories -- orphan drugs for rare diseases, gene and cellular therapy products, <keyword id="22559447" type="General" weightage="20" keywordseo="new-drugs" source="keywords">new drugs</keyword> used in pandemic situations, new drugs used for special defence purposes and new drugs having significant therapeutic advances over the current standard care. This waiver would ensure expeditious availability of the latest medicines for treating diseases like cancers, rare diseases like Spinal Muscular Atrophy (SMA) and Duchenne Muscular Dystrophy (DMA), and autoimmune conditions in India. "As per Rule 101 of New Drugs and Clinical Trials Rules, 2019, the Central Licensing Authority, with the approval of the Central Government, may specify, by an order, the name of the countries, from time to time, for considering waiver of local clinical trial for approval of new drugs under Chapter X and for grant of permission for conduct of clinical trial under Chapter V of the said rules," the Drugs Controller General of India (<keyword id="20559042" type="General" weightage="20" keywordseo="DGCI" source="keywords">DGCI</keyword>) said in an order issued on August 7. "In exercise of the powers conferred under Rule 101 of the said rules with the approval of the Central Government, the countries namely USA, UK, Japan, Australia, Canada and EU are hereby specified for following categories of new drugs," it said. Presently, several medicines already approved by other regulatory authorities in the US, the UK and the EU are not immediately available for Indian patients because of certain regulatory requirements under the Drugs and Cosmetics Act and rules made thereunder. These include the requirement of conducting a local clinical trial and generating safety and efficacy data before marketing authorisation in India, an official explained. However, Rule 101 of the New Drugs and Clinical Trials, 2019, allows the DCGI to specify certain countries for considering waiver of local clinical trials for approval of new drugs. "The advantages of operationalising this rule are that the latest medicines to treat diseases like cancers, rare diseases like SMA and DMA, and autoimmune conditions will become available expeditiously in India. "Presently, the delay in launching a new or novel medicine in India is anywhere between 5-20 years when compared to western markets. With the waiver of Rule 101, the scope of parallel launches of medicines in India along with the West will be opened up," the official explained. Besides, there will be a considerable reduction in the cost of various advanced medicines. Also, there will be a substantial reduction in the public procurement costs of the central and state governments under various schemes like the Central Government Health Scheme (CGHS) and Ayushman Bharat. Another advantage is that the resources which would have gone into approving the Indian clinical trials could now be utilised productively elsewhere, the official said. The costs of conducting local clinical trials will be reduced for pharmaceutical firms, therefore passing on these savings to patients. This is especially true for cases of rare diseases where firms have logistical difficulties in finding participants. The change will promote further research in these areas as there will be access to patient data in the Indian context much earlier, ultimately promoting indigenous innovation and shift from volume to value, the government's mission for the pharmaceutical industry, the official said. SEE ALSO:<a href="https://www.businessinsider.in/business/news/ola-wants-to-re-enter-the-quick-commerce-business-to-take-on-blinkit-and-swiggy-instamart/articleshow/112364583.cms" target="_blank"></a> <a href="https://www.businessinsider.in/business/news/ola-wants-to-re-enter-the-quick-commerce-business-to-take-on-blinkit-and-swiggy-instamart/articleshow/112364583.cms" target="_blank">Ola wants to re-enter the quick commerce business to take on Blinkit and Swiggy Instamart</a><a href="https://www.businessinsider.in/finance/banks/news/rbi-mpc-meet-cheque-clearing-time-reduced-upi-limit-increased-for-tax-payment/articleshow/112366099.cms" target="_blank"></a> <a href="https://www.businessinsider.in/finance/banks/news/rbi-mpc-meet-cheque-clearing-time-reduced-upi-limit-increased-for-tax-payment/articleshow/112366099.cms" target="_blank">RBI MPC meet – Cheque clearing time reduced, UPI limit increased for tax payment</a><a href="https://www.businessinsider.in/business/auto/news/tata-curvv-ev-with-up-to-585-km-range-launched-starting-at-17-49-lakh/slidelist/112342769.cms" target="_blank"></a> <a href="https://www.businessinsider.in/business/auto/news/tata-curvv-ev-with-up-to-585-km-range-launched-starting-at-17-49-lakh/slidelist/112342769.cms" target="_blank">Tata Curvv EV with up to 585 km range launched starting at ₹17.49 lakh</a>

Govt waives clinical trial requirement for several drugs approved in select countries

<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

<ul class="summary-list"><li>The Biden administration said on Wednesday it <a href="https://www.businessinsider.com/biden-administration-supports-waiving-ip-rights-for-covid-19-vaccines-2021-5">supported IP waivers</a> for COVID-19 vaccines.</li><li>But <keyword id="4912868" type="PERSON" weightage="60" keywordseo="moderna">Moderna</keyword>'s CEO said on Thursday he doesn't believe the move would hurt the company.</li><li>Stéphane Bancel said it would take a long time for other companies to recreate Moderna's <keyword id="24209" type="PERSON" weightage="60" keywordseo="vaccine">vaccine</keyword>.</li></ul>The CEO of Moderna said he "didn't lose a minute of sleep" following the US <a href="https://www.businessinsider.com/biden-administration-supports-waiving-ip-rights-for-covid-19-vaccines-2021-5">decision to back waiving intellectual-property rights for COVID-19 vaccines</a>.Members of the World Trade Organization are currently discussing a waiver, which if approved would leave countries free to recreate several vaccines from around the world without fear of sanctions.President Joe Biden's administration said Wednesday it supported the move, meaning vaccines from US-based firms like Moderna, Pfizer, and Johnson &amp; Johnson could be replicated.Pharmaceutical companies usually guard their intellectual property closely, but Moderna CEO Stéphane Bancel said Thursday the move wouldn't affect the company's bottom line."I didn't lose a minute of sleep over the news during the night," Bancel said during <a href="https://www.businessinsider.com/waiving-vaccine-patents-unlikely-to-boost-supplies-experts-say-2021-5">Moderna's first-quarter earnings.</a>Such a move "doesn't change anything for Moderna," he said.Read more: <a href="https://www.businessinsider.com/waiving-vaccine-patents-unlikely-to-boost-supplies-experts-say-2021-5">Global leaders want to override COVID-19 vaccine patents to boost production. It probably isn't going to work.</a><div type="image" title="Moderna vaccine" height="999" width="1999" msid="82454989" hostid="261"></div>During the announcement, Bancel said that the global capacity to produce mRNA vaccines - <a href="https://www.businessinsider.com/ceo-of-moderna-on-mrna-innovation-behind-covid-vaccine-2021-3">a new type of vaccine popularized by Moderna and Pfizer in response to the COVID-19 pandemic</a> - was at its limit anyway."There is no idle mRNA manufacturing capacity in the world," Bancel said. "This is a new technology.""You cannot go hire people who know how to make mRNA. Those people don't exist," he said.Moderna has long been open to sharing its success, <a href="https://investors.modernatx.com/news-releases/news-release-details/statement-moderna-intellectual-property-matters-during-covid-19">announcing on October 8</a> that it would not enforce its patent rights "while the pandemic continues.""We are also willing to license our intellectual property for COVID-19 vaccines to others for the post-pandemic period," the company said.Bancel said after the earnings call that it would take a long time for other companies to start up production of Moderna's vaccine, <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/moderna-raises-2021-sales-forecast-covid-19-vaccine-192-bln-2021-05-06/">Reuters reported</a>."They will have to go run a clinical trial, get the data, get the product approved and scale manufacturing. This does not happen in six or 12 or 18 months," Bancel said.<a href="https://www.bloomberg.com/news/articles/2021-05-07/spain-backs-ip-waivers-for-vaccines-ahead-of-eu-leaders-summit?sref=FSjtyMb8">Spain on Friday</a> said it supported the US proposal to waive the IP rights. However, other stakeholders have objected to the idea.Germany said on Thursday <a href="https://www.businessinsider.com/germany-objects-biden-support-covid-vaccine-patent-waiver-2021-5">that it could not support a waiver</a>, with a government spokeswoman telling Reuters "the protection of intellectual property is a source of innovation and must remain so in the future."Albert Bourla, the CEO of Pfizer, also <a href="https://www.timesofisrael.com/pfizer-head-bourla-says-hes-not-at-all-in-favor-of-us-vaccine-patent-waiver/">told Agence France-Presse</a> on Thursday that he was "not at all" in favor of an IP waiver.On Wednesday, Moderna's stock dipped following the US announcement, but Matthew Harrison, an equity research analyst at Morgan Stanley, said in a note published Thursday that Moderna will face little financial impact if a waiver is passed, as <a href="https://markets.businessinsider.com/news/stocks/moderna-stocks-biden-vaccine-waiver-covid-support-pfizer-biontech-2021-5-1030398298">Insider's Carla Mozée reported</a> Thursday. Harrison also said the <keyword id="6357761" type="UNKNOWN" weightage="60" keywordseo="WTO">WTO</keyword> doesn't have a way to to force Moderna to teach others how to make its vaccine, per Markets Insider.

Moderna's CEO said he 'didn't lose a minute of sleep' over the US support for waiving patents for COVID-19 vaccines

Three COVID-19 vaccines, developed by Bharat Biotech, Serum Institute of India and Pfizer, are under active consideration of India's drug regulator and there is hope that early licensure is possible for all or any of them, the Union health ministry said on Tuesday. Over the last four days, the Indian arm of US pharmaceutical giant Pfizer, Pune-based Serum Institute of India and Hyderabad-based pharmaceutical firm Bharat Biotech have applied to the <keyword id="281019" type="POSITION" weightage="20" keywordseo="Drugs-Controller-General">Drugs Controller General</keyword> of India (DCGI) seeking emergency use authorisation for their COVID-19 vaccines. At a press briefing, NITI Aayog member (Health) V K Paul said the COVID-19 situation in India has stabilised. With active cases reducing, a "clear-cut declining trend" in the pandemic is being seen even though the situation in many other countries is becoming quite serious, he said. The concern and anxiety following an increase in daily cases of infection in Delhi also looks like to have settled, Paul added. Asked what steps would be followed by the DCGI in the absence of a water-tight emergency use authorisation law for granting licence to <keyword id="24209" type="PERSON" weightage="20" keywordseo="vaccine">vaccine</keyword> makers, Union Health Secretary Rajesh Bhushan said not all countries' regulatory framework or rules and acts mention emergency use authorisation. "So, the fact that this phrase is not used in the national regulatory framework of any country does not mean that a specific country would not have an enabling provision to accord an approval which is early and distinct from a regular market approval. "India's regulatory framework has a specific provision for grant of emergency use authorisation, although this phrase is not used," he said. The New Drugs and Clinical Trials Rules, 2019, clearly specifies that under specific special situations, relaxation, abbreviation, omission, or deferment of data including local clinical trial data may be considered for approval. "This is our law. Similarly, other countries too have their laws," Bhushan said. Giving a bird's-eye view of the Indian landscape of COVID-19 vaccines, Bhushan mentioned that eight vaccines are at different stages of development. One is Covishield, manufactured by Serum Institute of India in collaboration with <keyword id="6409874" type="COMPANY" weightage="20" keywordseo="astrazeneca">AstraZeneca</keyword>. Phase two and three clinical trials of this vaccine is underway and the firm has applied for emergency use authorisation. Another is Covaxin, which is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and is in phase three of clinical trials. It has also applied for emergency use authorisation. The third one is ZyCOV-D, being developed by Cadila Healthcare Ltd in Ahmedabad in collaboration with the Centre's Department of Biotechnology and is in phase two of the trials. The fourth vaccine candidate is Sputnik V which is being manufactured by Dr Reddy's Lab, Hyderabad, in collaboration with Russia's Gamaleya National Centre. The phase two trial in India is over and phase three will begin next week. The fifth one is NVX-CoV2373, which is being developed by Serum Institute of India in collaboration with Novavax and its phase three clinical trial is under consideration with the drug regulator. The sixth vaccine candidate is Recombinant Protein Antigen-based vaccine, to be manufactured by Biological E Ltd, Hyderabad, in collaboration with MIT, USA. Its pre-clinical animal studies have concluded and phase one and two human clinical trials have started. Another one is HGCO 19, being manufactured by Genova in Pune in collaboration with HDT, USA. Its pre-clinical animal studies are over and phase one and two clinical trials is set to start. The eighth vaccine is being developed by <keyword id="1028672" type="COMPANY" weightage="20" keywordseo="Bharat-Biotech-International">Bharat Biotech International</keyword> Ltd in collaboration with Thomas Jefferson University, USA and it is at the pre-clinical stages. "Another vaccine, which is in the initial stage, is being developed by <keyword id="171312" type="COMPANY" weightage="20" keywordseo="Aurbindo-Pharma">Aurbindo Pharma</keyword>. So, there are nine vaccines out of which six are in clinical trials and three are in pre-clinical stage," Bhushan said. "There are multiple vaccine candidates in different stages of development and some may get licensed in the next few weeks. But we cannot foretell at this moment because licensure or market authorization is the domain of the national regulator." Most of the vaccines are of two or three doses to be administered three to four weeks apart. However, even after vaccination, COVID precautions must be taken and this has been advised by WHO also, Bhushan said, adding, "Vaccination does not mean people become carefree." About cold chain infrastructure augmentation, the health secretary said presently the system consists of 85,634 equipment for storage of vaccine at about 28,947 cold chain points across the country. "Current cold chain is capable of storing additional quantity of COVID-19 vaccine required for first the three crore -- healthcare and frontline workers," he said, adding states have collected data of frontline healthcare workers who would get the shots. The data is being uploaded on Co-WIN software, Bhushan said. The ministry, in consultation with states, has assessed the additional requirement for cold chain storage and the first supply of such additional equipment would begin from December 10, the health secretary said. Bhushan said that while 2.38 lakh auxiliary nurse midwives help in vaccination under universal immunisation programme, only 1.54 lakh such health workers will be used for COVID-19 inoculation. Additional vaccinators are being arranged in collaboration with states and UTs, he added. SEE ALSO: <a href="https://www.businessinsider.in/india/news/farmers-protest-talks-between-amit-shah-and-farmer-leaders-fail-sixth-round-of-talks-uncertain/articleshow/79635770.cms" data-type="tilCustomLink">Farmers' protest: Talks between Amit Shah and farmer leaders fail — sixth round of talks uncertain</a> <a href="https://www.businessinsider.in/finance/banks/news/supreme-court-told-that-blanket-waiver-of-moratorium-loans-would-take-6-lakh-crore-and-wipe-out-the-net-worth-of-banks/articleshow/79636002.cms" data-type="tilCustomLink">Supreme Court told that blanket waiver of moratorium loans would take ₹6 lakh crore and wipe out the net worth of banks</a>

Three COVID-19 vaccines under active consideration of drug regulator: Health Ministry

Brussels, Feb 18 (AP) The first African countries selected to receive the technology necessary to produce mRNA vaccines against COVID-19 are Egypt, Kenya, Nigeria, Senegal, South Africa and Tunisia, a summit meeting of European Union and African Union nations heard on Friday. The six countries have been chosen to build vaccine production factories as part of a bid the World Health Organisation launched last year to replicate what are believed to be the most effective licensed shots against COVID-19. Africa currently produces just 1% of coronavirus vaccines. According to WHO figures, only 11% of the population in Africa is fully vaccinated, compared with the global average of about 50%. WHO Secretary-General Tedros Adhanom Ghebreyesus told the Brussels summit meeting that although more than 10 billion doses of COVID-19 vaccines have been administered globally, billions of people still remain unvaccinated. "The tragedy, of course, is that billions of people are yet to benefit from these life-saving tools," he said, calling for an urgent increase of local production of shots in poor countries. It is the first time WHO has supported efforts to reverse-engineer a commercially-sold vaccine, making an end run around the pharmaceutical industry that has largely prioritized supplying rich countries over poor in both sales and manufacturing. The U.N.-backed effort known as COVAX to distribute COVID-19 vaccines fairly to lower-income countries has missed numerous targets and only about 10% of people in poorer countries have received at least one dose. Earlier this year, the Cape Town company attempting to replicate Moderna Inc.'s COVID-19 shot said it had successfully made a candidate vaccine that will soon start laboratory testing. Both Moderna and Pfizer-BioNTech, makers of the two authorized mRNA COVID-19 vaccines, have declined to share their vaccine recipe or technological know-how with WHO and its partners. Doctors Without Borders welcomed the announcement, but cautioned that much more work was needed to recreate the mRNA vaccines and called for Moderna to help. Kate Stegeman, the medical charity's advocacy coordinator, said it would still take considerable time for African scientists to make Moderna's highly technical vaccine, including creating a heat-stable version and to perform clinical trials. "The fastest way to start vaccine production in African countries and other regions with limited vaccine production is still through full and transparent transfer of vaccine know-how of already-approved mRNA technologies to able companies," Stegeman said. She pointed to research showing that there are more than 100 manufacturers in Asia, Africa and Latin America that could make the vaccines. Earlier this week, BioNTech said that it would start sending shipping container-sized factories to African countries to help them start making their COVID-19 vaccine with European staff, in what some activists called a "neo-colonial stunt" to maintain control. Although Moderna pledged not to go after companies for infringing on its coronavirus vaccine patents, it recently filed claims for several broad patents in South Africa. The move raised fears the company will begin enforcing patents while COVID-19 is still spreading in Africa, undermining efforts to build African vaccine production. In addition to supporting the transfer of vaccine technology, the EU has been exporting millions of COVID-19 vaccine doses to Africa. The 27-nation bloc said it has supplied Africa with almost 145 million doses, with a goal of reaching at least 450 million shots by the summer. South African President Cyril Ramaphosa said Friday's announcement "means mutual respect, mutual recognition" of what African nations can contribute as well as bringing in investment to the continent. But Ramaphosa repeated his call for lifting patent protections on coronavirus vaccines that he believes would allow more manufacturers to produce the shots. The EU remains opposed to the move, favouring instead individual deals with companies for technology transfers and know-how. The decision is up to the 164-member World Trade Organization. If just one country votes against a patent protection waiver, the proposal will fail. Finland's Prime Minister Sanna Marin said talks on patents should continue because expanding vaccinations globally is key. "Otherwise we will see more variants and the next variant might be even (more) dangerous than (the ones that) we have seen," said Marin. European Commission president Ursula von der Leyen said officials from both continents will keep working at reaching a common position and will meet again later this Spring. "The goal is clear, we have to deliver," she said. "Europe wants to remain Africa's first partner, a loyal partner, and we are moving right now from words to action." (AP) VM VM

Six African countries to receive mRNA vaccine technology

<div class="KonaFilter image-container display-table"><div><div class="image on-image"></div></div></div><ul><li>A new vaccine for heroin is getting closer to human trials.</li><li>But it's still 10 to 15 years from reaching the market.</li><li>Addiction experts and treatment professionals are wary of how much it will help the current opioid crisis.</li></ul>Two scientists are locked in a race to develop a groundbreaking vaccine for heroin. But many addiction experts and health officials warn that the medicine is unlikely to be the end game for the current opioid crisis and is a decade from reaching the market, at the earliest.Dr. Kim Janda, a chemist at the Scripps Research Institute in La Jolla, California, has been developing vaccines targeting addictive substances for nearly 30 years and has pioneered much of the research in the field. He began developing the heroin vaccine about a decade ago and in recent years has begun work on a vaccine for fentanyl, <a href="http://www.businessinsider.com/fentanyl-drug-prince-overdose-deaths-2016-8">a painkiller 50 times more powerful than heroin</a> and <a href="http://www.businessinsider.com/fentanyl-legal-drug-stronger-heroin-contaminating-street-drugs-vancouver-canada-2017-5">the cause of an increasing number of overdose deaths</a>.His competitor, Dr. Gary Matyas, has been developing his vaccine since 2011 at the Walter Reed Army Institute of Research in Maryland, a facility run by the Department of Defense. Matyas' work largely builds on Janda's and grew out of a research push to develop a vaccine for HIV - his vaccine has since become a combination heroin and HIV vaccine. So far, both Janda's and Matyas' vaccines have been tested only in animals.While work on opioid vaccines stretches back decades, the research has gained added urgency in light of the opioid crisis. Last year, <a href="http://www.businessinsider.com/opioid-overdose-death-statistics-2016">more than 30,000 Americans died from overdoses</a> related to opioids, with that number rising nearly every year since 1999. President Donald Trump announced <a href="http://www.businessinsider.com/trump-opioid-crisis-national-emergency-2017-8">that he was declaring the crisis "a national emergency</a>" last month, but his administration has yet to officially do so.Still, the prospect of a heroin vaccine has stoked a lot of interest and enthusiasm in the research. But as more is learned about the vaccine, its limitations as a moonshot cure have become clearer."Vaccines are an innovative approach that may be promising, but it won't be the panacea," Dr. Ivan Montoya, a <a href="https://www.drugabuse.gov/about-nida/organization/divisions/division-pharmacotherapies-medical-consequences-drug-abuse-dpmcda/office-director-od">director at the National Institute on Drug Abuse</a>, who has approved grants for both projects, told Business Insider.<h2>Keeping heroin from entering the brain</h2>Vaccines help the body create antibodies. For example, a measles vaccine works by helping the body's immune system make antibodies that can confront the virus should you come across it. That way, you won't get sick.That's how a heroin vaccine would work, in theory, helping the body's immune system recognize the heroin molecule and knock it out of the body before it can get to the brain receptors that give you a high. If you aren't able to get high - ideally for a long period after the vaccine's given - it could make it easier to quit, or at least protect you from overdose."These drugs have to get in the brain to have their function," Matyas said.While the details are still being worked out, each vaccine works in different ways. Janda's vaccine is designed to specifically eliminate heroin, while Matyas is working to make his vaccine bind to the substances that heroin breaks down to. If successful, that would mean Matyas' vaccine could block the effects of a wider variety of opioids.That's important because one of the main concerns is that many addicts switch between substances to get their fix. A persistent opioid addiction leaves the brain perpetually lacking endorphins for long periods after use stops. Because neither vaccine fixes that, it could leave addicts trying to alleviate cravings by opioids not covered by the vaccine."If you create a vaccine for morphine, people could switch to fentanyl. We already have people using fentanyl rather than heroin to avoid triggering drug tests because fentanyl is so difficult to detect," Mark Willenbring, a leading addiction psychiatrist who runs Alltyr, a treatment clinic in Minneapolis, told Business Insider.On the other hand, creating a vaccine that targets a broad spectrum of opioids has its own problems. One of the most effective treatments for opioid use disorder are maintenance drugs like buprenorphine (commonly known as Suboxone) and methadone, which are chemically similar to opioids and work by attaching to the same brain receptors, preventing users from using other opioids to get high while reducing cravings and withdrawal symptoms.Matyas acknowledged that creating a vaccine that stops problematic opioids while avoiding treatment drugs is the goal.<h2>What it will take to get a heroin vaccine approved</h2><h2><div class="KonaFilter image-container display-table"><div><div class="image on-image"></div></div></div></h2>For now, the vaccine has been tested only in animals. Montoya at NIDA called current studies of the vaccines' use in animals "encouraging" but said it remains to be seen whether they will work in humans.The hope is to get a human clinical trial started within a couple of years, but that could take <a href="http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/how-clinical-trials-are-planned-and-organised/how-long-it-takes-for-a-new-drug-to-go-through-clinical-trials">up to 15 years</a> from the earliest of human trials to approval. First, <a href="http://www.businessinsider.com/how-fda-drug-approval-works-2017-2">researchers will have to show that the vaccine is safe to administer</a>, then you have to show it's effective at what it sets out to do. A heroin vaccine will likely take just as long, by Matyas' estimate.That process won't be cheap and will need the backing of a drug company.While Matyas has licensed his vaccine to biotech company Opiant, which <a href="http://www.businessinsider.com/price-of-naloxone-narcan-skyrocketing-2016-7">developed the NARCAN anti-overdose spray</a>, CEO Dr. Roger Crystal told Business Insider it is waiting for more pre-clinical data before deciding whether to proceed. The data should be available by the end of the year.In the event Matyas' vaccine doesn't pan out, Crystal said Opiant would look to license other potential vaccines until the company found a success. "We're here for the long run," Crystal said.Despite being the trailblazer in the field, Janda has had more difficulties attracting significant interest for his vaccine, at least until recently. He said that just a few years ago he nearly gave away the vaccine free. As the opioid crisis has intensified, so has interest. He is now working on a deal with a small biotech company - he declined to name which since the deal isn't done - to bring his vaccine through clinical trials, which he says will cost between $30 million and $40 million.Janda says his focus is on getting the vaccine to the public as soon as possible."I'm not looking to make money off this," he said. "The people out there that have these problems don't have deep pockets."<h2>Making 'a good decision once'</h2><div class="KonaFilter image-container display-table float_right"><div><div class="image on-image"></div></div></div>The heroin vaccine appears to be part of a trend in addiction research focusing on long-acting treatments that rely less on patients' decision-making.Opioids hijack the brain's rewards system, resulting in fundamental changes to addicts' brain wiring. The longer one uses, the <a href="http://www.businessinsider.com/maia-szalavitz-unbroken-brain-treating-addiction-as-a-learning-disorder-2016-4">more profound changes are to an addict's ability to make choices</a>. One recovering addict, Andi Peterson, told Business Insider that even while enrolled in a treatment program, getting high "<a href="http://www.businessinsider.com/heroin-addict-explains-why-hard-stay-sober-drug-rehab-center-2017-4">required no thought" and was "like breathing</a>."Most addicts go through years and several stints of treatment to achieve abstinence. Relapse is a common and expected part of the process.Addiction experts and treatment professionals have long worked toward solutions that acknowledge this aspect of brain <keyword id="41551" type="UNKNOWN" weightage="100" keywordseo="science">science</keyword>. The "gold standard" of opioid-use-disorder treatment, according to them, are psychological therapies in conjunction with maintenance medication like buprenorphine or methadone, which prevent users from getting high while reducing cravings.But such treatments must be taken daily, and while buprenorphine can be taken anywhere, methadone must be taken at a clinic often far from the patient's home. If a patient forgets or misses a dose, the cravings return and can trigger a relapse.Researchers such as Matyas and Janda are looking to work around that daily-choice issue. The first medication to achieve that is Vivitrol, <a href="https://www.vivitrol.com/opioid-dependence/what-is-vivitrol">a monthly injection</a> approved by the FDA in 2010 that blocks opioid receptors in the brain. But the drug has been criticized for its side effects - including a painful withdrawal process - and questionable success.Many patients that do end up trying Vivitrol, according to treatment professionals that spoke to Business Insider, tend to stop after the first monthly shot, largely because the drug, like the vaccine, has no effect on cravings."Some places have good luck with patients returning for their monthly shot, but we haven't had much success," Sandi Kuehn, the CEO of the Center for Addiction Treatment in Cincinnati, told Business Insider. Most patients aren't interested in the treatment, she said.&#xa0;Crystal, Opiant's CEO, thinks the vaccine will be more effective than Vivitrol precisely because it works for longer than Vivitrol's one-month timeline, and requires patients to only "make a good decision once."While it is unclear how long a vaccine will remain effective, Janda said it would likely require three injections over three months, with the possibility of a booster shot at a later date. A study <a href="http://pubs.acs.org/doi/ipdf/10.1021/jacs.7b03334">presented in August at an industry conference</a> found that the vaccine lasted as long as eight months in monkeys.NIDA is also funding research into long-acting versions of buprenorphine, particularly Probuphine, an <a href="https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm503719.htm">implant that doles out the medicine</a> for six months. Approved last year, Probuphine <a href="https://www.drugabuse.gov/about-nida/noras-blog/2016/05/probuphine-game-changer-in-fighting-opioid-dependence">has been called a "game changer</a>" by Dr. Nora Volkow, the director of NIDA, largely because it solves the daily-decision issue while alleviating cravings, unlike the vaccine or Vivitrol."The more often you have to administer the medication, you lower the adherence to treatment," said Montoya of NIDA, adding that the agency thinks long-acting treatments will improve adherence.<h2>Another Vivitrol</h2><div class="KonaFilter image-container display-table float_right"><div><div class="image on-image"></div></div></div>Vivitrol has drawn headlines over the past year after investigations by <a href="https://www.propublica.org/article/vivitrol-opiate-crisis-and-criminal-justice">ProPublica,</a> <a href="https://www.nytimes.com/2017/06/11/health/vivitrol-drug-opioid-addiction.html?mcubz=1&amp;_r=0">The New York Times</a>, and the <a href="https://www.statnews.com/2016/11/14/opioids-prisons-vivitrol/">Associated Press</a> reported how Alkermes, which developed the drug, grew its business from $30 million in 2015 to $209 million a year later, primarily by <a href="https://www.propublica.org/article/vivitrol-opiate-crisis-and-criminal-justice">marketing its product directly to drug courts, prisons,</a> and other parts of the criminal-justice system.In many cases, the company targeted judges in areas hard hit by the opioid crisis wary of maintenance treatment and with a bias toward viewing addiction as a moral weakness. Vivitrol was pitched as a way to avoid treatment that "substitutes one opioid for another," a still common misconception of buprenorphine <a href="http://www.businessinsider.com/hhs-secretary-tom-price-medication-assisted-treatment-suboxone-news-opioid-crisis-2017-5">repeated in May by Health and Human Services Secretary Tom Price</a>.Daniel Wolfe, a director at progressive organization Open Society Foundations, slammed Vivitrol in STAT News as a treatment that "<a href="https://www.statnews.com/2017/06/29/vivitrol-methadone-opioids/">prioritizes the fantasy of being drug-free</a> over the real interests of people in need of help."Addiction experts and treatment professionals worry that the heroin vaccine, if marketed improperly, could go down the same path - providing governments another reason to avoid maintenance therapies, which they see as more effective.<div class="KonaFilter image-container display-table"><div><div class="image on-image"></div></div></div>"When the courts start practicing medicine from the bench, there is a real fear that they may latch onto vaccines and mandate them without involving clinicians," Dr. Devang Gandhi, the head of the University of Maryland's addiction residency program, told Business Insider. "That is often the case now, where decisions are made by judges who don't really understand what these medications are."That fear may not be entirely unfounded. When asked what Opiant saw as a potential market for the vaccine, Crystal said it would be "ideal" to administer to those with a history of abuse, "particularly in the prison setting."<h2>'You can't find a magic bullet for this'</h2><div class="KonaFilter image-container display-table float_right"><div><div class="image on-image"></div></div></div>While addiction experts and treatment professionals expressed excitement at the prospect of Janda's and Matyas' research, many wondered how "practically useful" such a vaccine would be for those on the front lines of the crisis.Willenbring, the addiction psychiatrist, said that solving the opioid crisis is not a matter of developing new treatments but expanding access of current treatments to those that need it."The problem right now is not that we don't have effective treatments, it's that we don't have enough of it," said Willenbring, who was the director of treatment research at the National Institute of Alcohol Abuse and Alcoholism from 2004 to 2009.The treatment paradigm - psychological therapies in conjunction with buprenorphine or methadone - represents&#xa0;"some of the most effective treatments not just in addiction but all of medicine," Gandhi said.While the Obama administration <a href="http://www.businessinsider.com/obama-buprenorphine-suboxone-policy-2016-7">made administrative changes to increase the number of prescribers </a>administering buprenorphine last year, a study <a href="http://www.healthline.com/health-news/anti-opioid-drug-is-underused#2">conducted by the Johns Hopkins School of Medicine earlier this year</a> found that only 44% of physicians who had obtained a waiver to prescribe buprenorphine were doing so at full capacity. The White House opioid commission <a href="http://www.businessinsider.com/trump-opioid-commission-republican-healthcare-obamacare-repeal-2017-8">recommended expanding access to buprenorphine and other</a> medication-assisted treatments in its July report.<div class="KonaFilter image-container display-table"><div><div class="image on-image"></div></div></div>Willenbring put it bluntly: "It's hard for me to talk about highly theoretical treatments that may not work when we already have highly effective treatments that people can't access," he said. "If we're serious about ending this crisis, we'd make sure anybody who wants medicated-assisted treatment can have immediate access at an affordable price, if not free."Kuehn, the CEO of the Ohio treatment center, said that the complicated nature of addiction makes it unlikely that any one treatment will work for all patients, but that any additional treatments could be effective tools."You can't find a magic bullet for this. It would be misleading for the public to think that it can be easily cured," she said.While Janda acknowledged the limitations of the vaccine, he said it's not designed to be a cure-all, but something that could be used in conjunction with current treatments to help addicts."If we think that the treatments we have right now are going to solve our problems, I don't think that's going to be the case," he said. "We've got to start looking outside the box to try to find some alternative or other therapies."<div><div style="position:relative;width:auto;padding:0 0 39.58%;height:0;top:0;left:0;bottom:0;right:0;margin:0;border:0 none" data-break-on="414" data-lg-id="experience-59b313f0dfd7a" data-lg-src="//view.ceros.com/business-insider/desktop-heroin-vaccine-compare-chart-1-1" data-lg-padding="39.58%" data-sm-id="experience-59b31a36105d4" data-sm-src="//view.ceros.com/business-insider/desktop-heroin-vaccine-compare-chart-1-1-1?heightOverride=570" data-sm-padding="47.5%"> </div></div><div><div style="position:relative;width:auto;padding:0 0 56.25%;height:0;top:0;left:0;bottom:0;right:0;margin:0;border:0 none" data-break-on="414" data-lg-id="experience-59b3011f0a5c8" data-lg-src="//view.ceros.com/business-insider/desktop-heroin-vaccine-compare-chart" data-lg-padding="56.25%" data-sm-id="experience-59b313e186356" data-sm-src="//view.ceros.com/business-insider/desktop-heroin-vaccine-compare-chart-1" data-sm-padding="83.33%"> </div></div> <div class="margin-top"> <h3>NOW WATCH: <a href="http://www.businessinsider.com/nasa-footage-hurricane-harvey-threat-texas-2017-8">Terrifying NASA footage from space shows the giant Hurricane Harvey about to slam the Texas coast</a></h3> <div> </div> </div>

You Searched For "clinical trial waiver" and got 6 results

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