
<h2 id="h-topline">TOPLINE</h2>



<p>Pfizer&nbsp;<a href="https://investors.pfizer.com/Investors/News/news-details/2022/Pfizer-Initiates-Phase-3-Study-of-mRNA-Based-Influenza-Vaccine/default.aspx" target="_blank" rel="noreferrer noopener">announced</a>&nbsp;on Wednesday it has launched a late-stage clinical trial to test a flu vaccine built using the same mRNA technology behind its Covid-19 shot, one of the most advanced studies for this kind of vaccine as firms push to expand beyond Covid and build upon the successes of the pandemic.</p>



<h2>KEY FACTS</h2>



<p>Pfizer said it had dosed the first participants in the Phase 3 clinical trial designed to test an mRNA-based influenza vaccine designed using the same technology used in its widely-used Covid-19 vaccine, which it developed with German firm BioNTech.</p>



<p>The trial, which is based in the U.S., will assess the safety and effectiveness of the shot and will recruit around 25,000 healthy adults.&nbsp;</p>



<p>The shot—known as a quadrivalent vaccine—is designed to protect against four different flu viruses and covers the strains the World Health Organization recommends vaccine makers target for the 2022-2023 flu season.</p>



<p>Annaliesa Anderson, senior vice president and chief scientific officer of Pfizer’s vaccine research and development, said the firm’s experience with mRNA vaccines give it an edge in the quest to develop more effective flu vaccines.&nbsp;</p>



<p>Pfizer added that the nature of the mRNA technology in the vaccine could enable more flexible and responsive vaccine production for seasonal influenza in the future or against pandemic flu.</p>



<h2>KEY BACKGROUND</h2>



<p>The flu is a major killer and a significant driver of ill health. Every year in the U.S., seasonal flu sickens an estimated 9 million to 41 million people, hospitalizes 140,000 to 710,000 and kills 12,000 to 52,000,&nbsp;<a href="https://www.cdc.gov/flu/about/burden/index.html" target="_blank" rel="noreferrer noopener">according</a>&nbsp;to the CDC. Influenza is also a pathogen of known and demonstrated pandemic potential—there were&nbsp;<a href="https://www.euro.who.int/en/health-topics/communicable-diseases/influenza/pandemic-influenza/past-pandemics" target="_blank" rel="noreferrer noopener">three</a>&nbsp;influenza pandemics in the 20th century, one of which killed an estimated 50 million people—and experts&nbsp;<a href="https://www.emro.who.int/pandemic-epidemic-diseases/news/the-next-flu-pandemic-a-matter-of-when-not-if.html" target="_blank" rel="noreferrer noopener">caution</a>&nbsp;the next flu pandemic is a matter of “when,” not “if.” Numerous influenza viruses can cause the disease and these mutate rapidly, meaning that pharma firms and public health officials must try to predict what strains will circulate that season and match vaccines accordingly. The guessing game varies and shots typically offer between 40% to 60% protection, according to the CDC,&nbsp;<a href="https://www.cdc.gov/flu/vaccines-work/vaccineeffect.htm" target="_blank" rel="noreferrer noopener">less</a>&nbsp;if the vaccines are not well-matched to circulating strains. The need to constantly update flu vaccines on an annual basis and the long lead times to produce shots (the virus is usually grown in chicken eggs or mammalian cells) make the shots good candidates for a shot using mRNA technology, which introduce genetic material that prompts the body to make a safe part of the virus that it is then trained to respond to in the future. As only the genetic sequence is needed, the process is more flexible and can be easily edited.&nbsp;</p>



<h2>BIG NUMBER</h2>



<p>290,000 to 650,000. That’s about how many people worldwide are killed by the seasonal flu every year,&nbsp;<a href="https://www.who.int/news-room/fact-sheets/detail/influenza-%28seasonal%29" target="_blank" rel="noreferrer noopener">according</a>&nbsp;to the World Health Organization. It causes between 3 million and 5 million cases of severe illness.&nbsp;</p>



<h2>WHAT TO WATCH FOR</h2>



<p>Moderna, Pfizer’s mRNA vaccine rival, is also trailing its own mRNA-based flu vaccine. It&nbsp;<a href="https://www.biopharma-reporter.com/Article/2022/06/07/moderna-takes-mrna-influenza-candidate-into-phase-3-trial" target="_blank" rel="noreferrer noopener">launched</a>&nbsp;Phase 3 trials in June and is one of the company’s most&nbsp;<a href="https://www.modernatx.com/research/product-pipeline?" target="_blank" rel="noreferrer noopener">advanced</a>&nbsp;vaccine&nbsp;<a href="https://www.forbes.com/sites/roberthart/2022/01/14/moderna-starts-human-trials-of-mrna-vaccine-for-virus-that-likely-causes-multiple-sclerosis/?sh=1aca56f01a04">candidates</a>&nbsp;beyond its Covid-19 shots. It is one of a number of flu shots the Massachusetts-based firm is developing, including shots that combine vaccines for flu, Covid and respiratory syncytial virus, or RSV, a respiratory illness that can cause serious illness in infants and older adults.</p>



<h2>FURTHER READING</h2>



<p><a href="https://www.theguardian.com/news/2019/jan/24/endless-hunt-for-the-perfect-influenza-vaccine-flu-jab" target="_blank" rel="noreferrer noopener">The endless hunt for the perfect flu vaccine</a>&nbsp;(Guardian)</p>



<p><a href="https://www.nature.com/articles/d41586-022-02776-8" target="_blank" rel="noreferrer noopener">Billion-dollar project aims to prep drugs before the next pandemic</a>(Nature)</p>



<p><a href="https://www.forbes.com/sites/roberthart/2022/01/05/pfizer-biontech-will-develop-mrna-shingles-vaccine-after-covid-19-shot-success/?sh=183a091e1d7b">Pfizer, BioNTech Will Develop mRNA Shingles Vaccine After Covid-19 Shot Success</a>&nbsp;(Forbes)</p>



<p><a href="https://www.forbes.com/sites/roberthart/2022/01/14/moderna-starts-human-trials-of-mrna-vaccine-for-virus-that-likely-causes-multiple-sclerosis/?sh=1aca56f01a04">Moderna Starts Human Trials Of mRNA Vaccine For Virus That Likely Causes Multiple Sclerosis</a>&nbsp;(Forbes)</p>



<p><strong><em>By Robert Hart, Forbes Staff</em></strong></p>


Injection of the third dose of the covid 19 vaccine at a Covid-19 vaccination center in Dinan, Brittany

mRNA Flu Shot Moves Forward As Pfizer Launches Late-Stage Trial, Builds On Covid Vaccine Success


<h2 id="h-topline">TOPLINE</h2>



<p>Modern&nbsp;<a href="https://investors.modernatx.com/Statements--Perspectives/Statements--Perspectives-Details/2022/Statement-on-COVID-19-Vaccine-Clinical-Studies-in-Children--Adolescents/default.aspx" target="_blank" rel="noreferrer noopener">announced</a>&nbsp;Wednesday it aims to report data of the efficacy of its Covid-19 vaccine in children ages 2-5 by March, and hopes to evaluate its booster shot for those ages 12-17 as Covid-related hospitalizations for children have reached record levels.</p>



<h2 id="h-key-facts">KEY FACTS</h2>



<p>If data from the 2 to 5 age group trials is promising, the company says it will proceed with regulatory filings to seek approval from the U.S. Food and Drug Administration.</p>



<p>The FDA has yet to approve any Covid-19 vaccine for those ages 2 to 5, with only&nbsp;<a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/children-teens.html" target="_blank" rel="noreferrer noopener">Pfizer</a>’s vaccine authorized for those ages 5 to 11.&nbsp;</p>



<p>Despite not yet having its initial two-dose vaccine approved for those ages 12 to 17, Moderna said it has been evaluating a booster dose for the age group.</p>



<p>Pfizer’s is also the only Covid-19 vaccine approved for those ages 12 to 17 in the U.S., though Moderna’s has received authorizations in Europe, Australia and Canada.</p>



<p>The FDA&nbsp;<a href="https://www.reuters.com/business/healthcare-pharmaceuticals/moderna-says-fda-needs-more-time-complete-review-its-covid-19-shot-adolescents-2021-10-31/" target="_blank" rel="noreferrer noopener">told</a>&nbsp;Moderna in October the agency needed more time to assess the company’s vaccine before approving it for the adolescent age group, with an update possibly coming later this month.&nbsp;</p>



<p>Moderna says it began evaluating a lower dosage for the 6-to-11 and 12-to-17 age groups in order to meet regulatory guidance.</p>



<h2 id="h-key-background">KEY BACKGROUND</h2>



<p>Pfizer has also been conducting trials on the efficacy of its Covid-19 vaccine for those ages 2 to 5, as well as babies ages 6 months to 2 years. In December, it&nbsp;<a href="http://pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-provide-update-ongoing-studies-covid-19" target="_blank" rel="noreferrer noopener">announced</a>&nbsp;initial trials showed the vaccine was not providing the same level of immunity in those ages 2 to 5 as it does in older age groups, though it proved effective for the 6- to 24-month group. The company said it would evaluate the efficacy of a third dose in an attempt to reach the desired immunity in this group, as well as a third dose for children ages 5 to 12.</p>



<h2 id="h-big-number">BIG NUMBER</h2>



<p>&nbsp;7 million. That’s how many children ages 5 to 11 have received at least one dose of the Covid-19 vaccine as of January 5,&nbsp;<a href="https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/children-and-covid-19-vaccination-trends/" target="_blank" rel="noreferrer noopener">according</a>&nbsp;to the CDC, representing a quarter of all 5- to 11-year-olds in the U.S. Experts&nbsp;<a href="https://www.cnn.com/2022/01/12/health/us-coronavirus-wednesday/index.html" target="_blank" rel="noreferrer noopener">fear</a>&nbsp;this figure is not nearly high enough as children return to school in the new year. Hospitals&nbsp;<a href="https://covid.cdc.gov/covid-data-tracker/#new-hospital-admissions" target="_blank" rel="noreferrer noopener">averaged</a>&nbsp;870 new Covid-related pediatric admissions per day last week—the highest rate since the pandemic began.&nbsp;</p>



<h2 id="h-chief-critic">CHIEF CRITIC</h2>



<p>Dr. Robert Murphy, executive director for the Institute for Global Health at Northwestern University’s Feinberg School of Medicine,&nbsp;<a href="https://apnews.com/article/kids-low-covid-vaccine-rate-impact-a3f24f27f39ab198755eff8f8e0e5493" target="_blank" rel="noreferrer noopener">told</a>&nbsp;the Associated Press Wednesday the age group’s low vaccination rates are “very disturbing.” Murphy pointed to hesitation by some parents, who believe their children are not at risk for a severe reaction to the virus, stating they are “taking an enormous risk and continuing to fuel the pandemic.”</p>



<h2 id="h-related-articles">RELATED ARTICLES</h2>



<p><a href="https://www.forbes.com/sites/williamhaseltine/2022/01/12/time-to-expand-vaccination-to-infants-and-toddlers-and-boosters-for-children/?sh=577327072c7c">Time to Expand Vaccination to Infants and Toddlers and Boosters for Children (Forbes)</a></p>



<p><a href="https://www.forbes.com/sites/joewalsh/2022/01/11/us-covid-hospitalizations-set-new-record---especially-in-these-states/?sh=5c83f3c348c1">U.S. Covid Hospitalizations Set New Record — Especially In These States (Forbes)</a></p>



<p><strong><a href="https://www.forbes.com/coronavirus/">Full coverage and live updates on the Coronavirus</a></strong></p>



<p><strong><em>By Mason Bissada, Forbes Africa</em></strong></p>


Vaccination bus Dortmund

Moderna Expects Vaccine Data For Kids Ages 2-5 By March


<h2 id="h-topline">TOPLINE</h2>



<p>Moderna shares plummeted Friday morning after the Cambridge, Massachusetts-based biotech firm reported early data for its seasonal flu vaccine that failed to impress investors, intensifying a crash that&#8217;s wiped out nearly 50% of the value in one of the year&#8217;s best-performing stocks.</p>



<h2>KEY FACTS</h2>



<p>Shares of Moderna fell 8% Friday by 11:30 a.m. ET after the company&nbsp;<a href="https://finance.yahoo.com/news/moderna-announces-positive-interim-phase-120000491.html" target="_blank" rel="noreferrer noopener">reported</a>&nbsp;early data for its seasonal flu vaccine that showed robust increases in antibody concentration among patients in the study.&nbsp;</p>



<p>Though Moderna touted the results as positive, Morgan Stanley analyst Matthew Harison said the initial data looked &#8220;undifferentiated&#8221; with biotech firm Sanofi&#8217;s flu vaccine, which is already on the market—a disappointment for investors seeking data that &#8220;supported clearly better efficacy.&#8221;</p>



<p>Shares plunged as much as 13% after the early morning report, pulling prices to near one-month lows until they pared losses after Moderna&nbsp;<a href="https://finance.yahoo.com/news/moderna-announces-additional-20-million-140000120.html" target="_blank" rel="noreferrer noopener">announced</a>&nbsp;a new agreement to supply 20 million more Covid-19 vaccine doses to the World Health Organization&#8217;s Covax initiative, which is now on track to receive about 54 million Moderna vaccine doses in 2021.</p>



<p>At current prices of about $250, shares of Moderna have plunged 48% from an all-time closing high of $484 on August 9, wiping out about $97 billion from the firm&#8217;s market capitalization, which now stands at roughly $101 billion.</p>



<p>Despite its recent weakness, Moderna is still the S&amp;P’s third-best-performing component this year, with shares skyrocketing about 127% thanks to the company’s Covid-19 vaccine becoming widely available across the world.</p>



<h2>BIG NUMBER</h2>



<p>$8 billion. That’s how much Moderna CEO&nbsp;<a href="https://www.forbes.com/profile/stephane-bancel/?sh=339a33a73742">Stéphane Bancel</a>, who joined the firm in 2011, is worth as of 11:30 a.m. Friday, according to&nbsp;<em>Forbes</em>. The French native owns a roughly 8% stake in Moderna.</p>



<h2>KEY BACKGROUND</h2>



<p>Covid-19 vaccines, which are Moderna’s only commercialized product, have proven to be a massive boon for businesses heading up their development, but Moderna shares have struggled in recent months as critics increasingly question whether or not sales of Covid-19 vaccines alone will prove a viable revenue stream in years to come. Last month, the company reported third-quarter sales and earnings that failed to meet analysts’ expectations, with revenue falling short of $5 billion despite average analyst projections calling for $6.2 billion. In addition to lower sales projections, supply chain constraints and the development of antiviral Covid-19 treatments have also triggered Moderna stock sell-offs.&nbsp;</p>



<h2>TANGENT</h2>



<p>Diverse product offerings have helped Moderna&#8217;s biggest Covid-19 vaccine competitors earn high marks on Wall Street. Wells Fargo recently initiated Pfizer coverage with a “buy” rating and $60 price target, implying an upside of around 16% from current levels. The vaccine-maker’s new oral antiviral pill, Paxlovid, “provides another avenue for Covid-related growth” and will be a “game changer” for the company’s profits, the analysts said, forecasting nearly $18 billion in sales from the product next year.&nbsp;</p>



<h2>FURTHER READING</h2>



<p><a href="https://www.forbes.com/sites/sergeiklebnikov/2021/12/09/this-vaccine-maker-can-dominate-the-covid-market-for-years-to-come-wells-fargo-predicts/?sh=1e4fd1851181">This Vaccine Maker Can &#8216;Dominate&#8217; The Covid Market For Years To Come, Wells Fargo Predicts</a>&nbsp;<em>(Forbes)</em></p>



<p><a href="https://www.forbes.com/sites/jonathanponciano/2021/11/04/moderna-crash-wipes-out-another-24-billion-after-supply-chain-issues-dent-covid-vaccine-sales/">Moderna Crash Wipes Out Another $24 Billion After Supply-Chain Issues Dent Covid Vaccine Sales</a> <em>(Forbes)</em></p>



<p><strong><em>By Jonathan Ponciano, Forbes Staff</em></strong></p>


In this photo illustration the medical syringe is seen with

Moderna Stock Crash Has Wiped Nearly $100 Billion As Flu Vaccine Results Trigger Latest Plunge

Noubar Afeyan

The Billionaire Chairman Of Vaccine Maker Moderna Wants To Reinvent Scientific Entrepreneurship


<p><strong>TOPLINE</strong> Moderna has reached an agreement to sell up to 110 million shots of its Covid-19 vaccine to member nations of the African Union, the drugmaker announced on Tuesday, a move that comes at a time when vaccine makers and wealthy nations face increasing pressure to fulfill their commitments to poorer nations whose vaccination rates are vastly lower.</p>



<h2 id="h-key-facts">KEY FACTS</h2>



<p>In a press release on Monday, Moderna announced that it would deliver 15 million shots by the end of this year and an additional 35 million doses by the end of March.</p>



<p>The company said it’s working on plans to bottle doses of its vaccine in Africa sometime in 2023 and is also working to build a mRNA vaccine manufacturing facility in the continent.</p>



<p>Moderna’s fresh commitment is on top of its existing commitment to supply 500 million vaccine doses through 2022 to the WHO-backed Covax program, which was created to ensure equitable vaccine access, but that has since been criticized for&nbsp;<a href="https://www.ft.com/content/0e240929-033a-457f-a735-ec7cf93b2f3c" target="_blank" rel="noreferrer noopener">failing</a>&nbsp;poorer nations.</p>



<p>A White House official told Forbes that the U.S. government will defer delivery of approximately 33 million doses of the Moderna vaccine between December and February—originally intended for the U.S.—so that the African Union can instead purchase and take delivery of those doses.</p>



<h2 id="h-crucial-quote">CRUCIAL QUOTE</h2>



<p>Natalie Quillian, the White House’s Deputy Covid-19 Response Coordinator said: “We are grateful to have helped negotiate this encouraging step forward between Moderna and the African Union that will significantly expand access to vaccines on the continent in the near-term.”</p>



<h2 id="h-big-number">BIG NUMBER</h2>



<p>14%. That’s the percentage of the 1.8 billion doses of Covid-19 vaccines—promised by the G7 and Europe to poorer nations—which have been delivered so far, according to a report&nbsp;<a href="https://app.box.com/s/kygk0i850bo18l33vk5p3qwyq9umk527" target="_blank" rel="noreferrer noopener">published</a>&nbsp;last week by the People’s Vaccine Alliance. The report noted that Moderna has not delivered any of the vaccines it has pledged to Covax.</p>



<h2 id="h-key-background">KEY BACKGROUND</h2>



<p>Tuesday’s agreement comes as Moderna faces growing criticism for not sharing its vaccine recipe or transferring its technology to manufacturers in poorer nations who could manufacture doses of its vaccine for their local markets. The drugmaker has previously said it is unable to directly supply more doses of its vaccine quickly to poorer nations as it has a limited manufacturing capacity and its current production is tied to existing orders placed by the U.S. and the European Union. A South African group called Afrigen Biologics and Vaccines is currently&nbsp;<a href="https://apnews.com/article/coronavirus-pandemic-technology-business-cape-town-health-48046e5255cc3e4fa27455fc12ab5e52" target="_blank" rel="noreferrer noopener">leading an effort&nbsp;</a>to replicate Moderna’s vaccine so it can be manufactured and distributed in the continent. The effort involves an attempt to reverse engineer the vaccine from bits of publicly available information. But experts have said the process would be a lot simpler if companies like Moderna or Pfizer simply agreed to share their expertise. The companies have so far not shared their know-how despite facing public pressure—including the Biden administration’s demands on Moderna.</p>



<h2 id="h-what-to-watch-for"><strong>WHAT TO WATCH FOR</strong></h2>



<p>BioNTech on Tuesday&nbsp;<a href="https://www.globenewswire.com/news-release/2021/10/26/2320560/0/en/BioNTech-Plans-to-Initiate-the-Construction-of-an-mRNA-Vaccine-Manufacturing-Facility-in-Africa-in-mid-2022.html" target="_blank" rel="noreferrer noopener">announced</a>&nbsp;plans to begin construction of a manufacturing site for their mRNA vaccine in the African Union in mid-2022. The company noted that the facility’s first production line will manufacture around 50 million mRNA vaccine doses and it could eventually expand to an annual manufacturing capacity of several hundred million doses. The facility will initially be staffed, owned, and operated by BioNTech itself and it plans to eventually transfer the manufacturing capacity and know-how to local partners.</p>



<h2 id="h-tangent">TANGENT</h2>



<p>Last week, Reuters&nbsp;<a href="https://www.reuters.com/business/healthcare-pharmaceuticals/exclusive-who-led-programme-aims-buy-antiviral-covid-19-pills-10-document-2021-10-19/" target="_blank" rel="noreferrer noopener">reported</a>&nbsp;that a WHO-backed initiative plans to seek funding of $22.8 billion to deliver Covid vaccines, antiviral drugs and tests to poorer nations. Earlier in the month, the WHO&nbsp;<a href="https://www.un.org/sg/en/node/259952" target="_blank" rel="noreferrer noopener">outlined</a>&nbsp;its new global vaccination strategy, aimed at getting 40% of people in all countries vaccinated by the end of this year and 70% by mid-2022. WHO chief Tedros Adhanom Ghebreyesus also noted that vaccine scarcity wasn’t an issue as currently, 1.5 billion vaccine doses are being manufactured per month. “This is not a supply problem; it’s an allocation problem,” he said.</p>



<h2 id="h-further-reading">FURTHER READING</h2>



<p><a href="https://www.nytimes.com/2021/10/26/world/africa/covid-moderna-african-union.html" target="_blank" rel="noreferrer noopener">Moderna agrees to sell up to 110 million Covid vaccine doses to African countries</a>. (New York Times)</p>



<p><a href="https://apnews.com/article/coronavirus-pandemic-technology-business-cape-town-health-48046e5255cc3e4fa27455fc12ab5e52" target="_blank" rel="noreferrer noopener">Africa tries to end vaccine inequity by replicating its own</a> (Associated Press)</p>



<p><strong><em>By Siladitya Ray, Forbes Staff</em></strong></p>


Mayor Mpho Moerane launches mass vaccination programme in South Africa

Moderna Agrees To Sell 110 Million Covid Vaccine Doses To African Nations Amid Questions About Vaccine Equity


<p><strong>TOPLINE</strong> Moderna CEO Stéphane Bancel believes that the Covid-19 pandemic could be over in a year as vaccine production ramps up to meet global demand, he said in an interview on Thursday, an ambitious statement considering <a href="https://ourworldindata.org/grapher/share-people-vaccinated-covid?country=High+income~Upper+middle+income~Lower+middle+income~Low+income" target="_blank" rel="noreferrer noopener">only 2%</a> of people in low-income countries have received a vaccine dose.</p>



<h2 id="h-key-facts">KEY FACTS</h2>



<p>In an&nbsp;<a href="https://www.nzz.ch/wirtschaft/moderna-chef-bancel-in-einem-jahr-ist-die-pandemie-vorbei-ld.1646709?reduced=true" target="_blank" rel="noreferrer noopener">interview</a>&nbsp;with Swiss newspaper&nbsp;<em>Neue Zuercher Zeitung,&nbsp;</em>Bancel said the continuing expansion of global vaccine production capacity will make sure that enough doses are available to cover the entire world’s population by the middle of next year.</p>



<p>When asked about when things could return to normal he said: “In a year, I assume.”</p>



<p>Bancel noted that people who choose not to get vaccinated will likely “immunize themselves naturally” as the highly contagious delta variant spreads rapidly across the world.</p>



<p>The pharmaceutical executive added that people who get vaccinated will enjoy a good winter while those who don’t will have to live with the risk of getting sick or even hospitalized due to delta.</p>



<p>Bancel said he believed that people will need a booster shot soon and the company’s version will be half a dose of the original formulation.</p>



<p>Moderna is also currently testing what Bancel called a “Delta-optimized variant” of the vaccine which will form the basis of booster shots in 2022.</p>



<h2 id="h-big-number">BIG NUMBER</h2>



<p>43.9%. That’s the percentage of the world population that has received at least one dose of a Covid-19 vaccine,&nbsp;<a href="https://ourworldindata.org/covid-vaccinations" target="_blank" rel="noreferrer noopener">according to</a>&nbsp;a tracker run by Our World In Data. But this number is&nbsp;<a href="https://ourworldindata.org/grapher/share-people-vaccinated-covid?country=High+income~Upper+middle+income~Lower+middle+income~Low+income" target="_blank" rel="noreferrer noopener">heavily skewed</a>&nbsp;by high vaccination rates in high-income and upper-middle-income nations where more than 60% have received at least one dose. The number slips down to just under 30% of lower-middle-income countries and just 2.1% for lower-income countries.</p>



<h2 id="h-key-background">KEY BACKGROUND</h2>



<p>The global inequity in vaccine distribution was on display at the United Nations General Assembly earlier this week. In her address to the assembly, Norwegian Prime Minister Erna Solberg noted that fewer than 1 in 20 people in Africa were fully vaccinated while in Europe that number stood at one in two. Under pressure to rectify this problem, U.S. President Joe Biden&nbsp;<a href="https://www.reuters.com/world/us/biden-pledges-new-vaccine-donations-bid-rally-global-pandemic-fight-2021-09-22/" target="_blank" rel="noreferrer noopener">announced</a>&nbsp;in his UNGA address that America would purchase an additional 500 million doses of Pfizer vaccines to share with the world, on top of the existing commitment of 500 million shots.</p>



<h2 id="h-further-reading">FURTHER READING</h2>



<p><a href="https://www.reuters.com/business/healthcare-pharmaceuticals/moderna-chief-executive-sees-pandemic-over-year-newspaper-2021-09-23/" target="_blank" rel="noreferrer noopener">Moderna chief executive sees pandemic over in a year &#8211; newspaper</a>&nbsp;(Reuters)</p>



<p><a href="https://www.forbes.com/sites/forbesfellows/2021/06/08/moderna-ceo-says-vaccine-boosters-and-flucovid-combo-shots-are-likely-for-the-future/?sh=44031f943347">Moderna CEO Says Vaccine Boosters And Flu/Covid Combo Shots Are Likely For The Future</a>&nbsp;(Forbes)</p>



<p><strong><a href="https://www.forbes.com/coronavirus/">Full coverage and live updates on the Coronavirus</a></strong></p>



<p><strong><em>By Siladitya Ray, Forbes Staff</em></strong></p>


2019 Forbes Healthcare Summit

Moderna CEO Says Pandemic Could Be Over Next Year As Vaccine Production Ramps Up


<p><strong>Stéphane Bancel says data showing 95% efficacy for his company’s vaccine means that it may be able to start distributing its vaccine in late December, pending a green light from the FDA.</strong></p>



<p class="has-drop-cap"><span class="has-inline-color has-vivid-red-color">M</span>oderna CEO Stéphane Bancel slept for 3 hours on Sunday night. At 4:00 am, he went for a run, and then a few hours later led an all-company meeting. The subject: preliminary data from Moderna’s phase 3 trial of a Covid-19 vaccine, which found that the vaccine was about 95% effective at preventing the illness. Bancel says that some people in America may start getting vaccinated as early as next month.  </p>



<p>“I couldn’t have expected better results,” Bancel says. To top it off, the data showed that 11 people in the placebo arm of the trial contracted severe Covid-19, but no one in the vaccinated group got a severe form of the disease. “It means that if you get the Moderna vaccine, you have a 95% chance of getting no disease, and if you do get it you will get a mild disease,” he says. “That’s fantastic.”</p>



<p>It’s also good news for Bancel personally, who owns roughly 9% of the company. As the stock rose 10% today, Bancel’s&nbsp;<a href="https://www.forbes.com/profile/stephane-bancel/?sh=5b3965e73742">net worth</a>&nbsp;increased to $3 billion. Others have profited as well. MIT scientist&nbsp;<a href="https://www.forbes.com/sites/giacomotognini/2020/11/12/mit-scientist-bob-langer-becomes-a-billionaire-thanks-to-moderna-stock-rally/?sh=4d1864563a90">Robert Langer</a>, who cofounded Moderna and has a 3% stake in the company, saw his net worth increase to about $1.2 billion. Harvard professor and 3.5% equity stake owner&nbsp;<a href="https://www.forbes.com/sites/giacomotognini/2020/05/16/exclusive-harvard-professor-who-became-a-billionaire-thanks-to-moderna-talks-about-his-investing/?sh=4b3044a36b8d">Timothy Springer</a>, an early investor in the company, is now worth $1.6 billion.&nbsp;</p>



<p>The key to success seems to be Moderna’s&nbsp;<a href="https://www.forbes.com/sites/leahrosenbaum/2020/05/08/fueled-by-500-million-in-federal-cash-moderna-races-to-make-1-billion-doses-of-an-unproven-cure/?sh=21eae65d79dc">mRNA technology</a>, which relies on messenger RNA to deliver instructions to the cells in your body. These cells then produce small parts of the Covid-19 virus that are just enough to trigger the immune system, producing antibodies and memory cells that will leap into action if you come in contact with the virus again. The study data seems to suggest this should help people across the board. The trial consisted of 30,000 people in total, with broad diversity in racial and ethnic makeup, as well as age (around 7,000 were over 65, the group most at risk for severe forms of the disease).</p>



<p>Moderna began work on its Covid-19 vaccine in January, and shipped its first batch to the National Institute of Health for a phase one study just 42 days later. That’s incredibly fast, considering that most vaccines take years to make. (For more detail, see our<a href="https://www.forbes.com/sites/leahrosenbaum/2020/05/08/fueled-by-500-million-in-federal-cash-moderna-races-to-make-1-billion-doses-of-an-unproven-cure/?sh=21eae65d79dc"> in-depth feature</a> from May.) And Moderna isn’t the only one making swift progress: Last week, Pfizer released results that found its mRNA vaccine, produced in partnership with German company BioNTech, was 90% effective at preventing Covid-19. The results validated a <a href="https://www.forbes.com/sites/nathanvardi/2020/05/20/the-man-betting-1-billion-that-pfizer-can-deliver-a-vaccine-by-this-fall/?sh=602b2677382e">$1 billion bet</a> that Pfizer CEO Albert Bourla made last spring on the project.</p>



<p>“[It’s a] pretty impressive outcome,” says Alan Carr, a biotech analyst at Needham, about Moderna’s data. “There seems to be a pattern with the two mRNA vaccines which suggests the technology is pretty helpful for infectious diseases.”&nbsp;</p>



<p>But Bancel doesn’t feel like he’s in competition with Pfizer — or any other vaccine company, for that matter. “As I’ve said all along since we started chasing this virus in January, no one company can supply the planet,” Bancel says. “We need three or four vaccines to make it to the finish line&#8230;the success of Pfizer is a great thing for the world and for the country.”&nbsp;</p>



<p>Carr agrees: “For Covid-19, I think demand is going to outstrip supply,” he says. “Both of these vaccines will be sought after.”</p>



<p>Perhaps some of the lack of competitive feeling stems from Moderna’s global partnerships. The company has already entered agreements to supply several countries with Covid-19 vaccines, including the U.S., the E.U., Japan and Canada. While the deals with several of the countries remain a secret, the Trump administration announced in August that it reached a deal to buy 100 million doses of Moderna’s vaccine for about $1.5 billion.</p>



<p>Unlike Pfizer, which has done most of its research and clinical trials in-house, Moderna has partnered closely with the U.S. government since the early days of the pandemic. Bancel says that the company worked closely with Dr. Fauci’s team at the National Institute of Allergy and Infectious Disease to conduct its clinical trials. The federal government’s Biomedical Advanced Research and Development Authority (BARDA), gave the company a little less than $1 billion to study the vaccine. All of this government money leads to a vaccine that costs the government about $25 per dose, and will likely be given for free to the public according to Bancel. He says that they have “millions of doses” that are ready to distribute. Pharmacy chains like Walgreens and CVS, plus McKesson Corporation, the largest distributor of the flu vaccine in the U.S, are already studying how to most efficiently distribute the vaccine.</p>



<p>Moderna still has a few hurdles to overcome before the vaccine will be available to the public. First, it needs to finish its phase three clinical trial, provide the data to the Food and Drug Administration (FDA), and get emergency authorization to distribute the vaccine. Bancel estimates that the phase three trial will meet a key data target within the next two weeks, and plans to file with the FDA for an emergency use authorization in late November or early December (the trial itself will last another two years as participants’ health continues to be monitored). If that time frame holds, some people in the U.S. — likely healthcare workers at first — could start receiving the vaccine by the end of 2020.&nbsp;</p>



<p>Experts have also worried that Moderna’s vaccine will need to be refrigerated at low temperatures, around -4° Fahrenheit<strong>,&nbsp;</strong>which could cause issues with the supply chain. The company put at least some of those fears to rest this morning, when it announced new data that shows its vaccine can be kept in a standard refrigerator for up to 30 days. This could be an advantage over Pfizer, whose Covid-19 vaccine must be stored at -94° Fahrenheit.</p>



<p>Finally, there is also the risk that the Covid-19 virus could mutate, rendering the current vaccine ineffective. This doesn’t worry Bancel. “The adaptation to new strains is possible” he says, “but mRNA is fantastic because you can just swap a new strain and run with it.” He expects that if another version of Covid-19 began making the rounds, it would take Moderna even fewer than its current 42 days to create a vaccine.&nbsp;</p>



<p>Right now, however, all those worries are for the future. After a hectic day, Bancel is excited about the prospect of finally getting some rest this evening. “I’m looking forward to going home tonight and having a nice bottle of wine and going to bed early,” he says.</p>



<p><em>-By Leah Rosenbaum, Forbes Staff</em></p>


Moderna CEO: Covid-19 Vaccine’s ‘Fantastic’ Results Mean It Could Be Ready Next Month


<p><strong><span class="has-inline-color has-vivid-red-color">TOPLINE</span></strong>: Moderna’s Covid-19 vaccine is 94.5% effective in preventing the disease, preliminary data from large-scale phase three trials shows, the company announced in a <a rel="noreferrer noopener" href="https://investors.modernatx.com/news-releases/news-release-details/modernas-covid-19-vaccine-candidate-meets-its-primary-efficacy" target="_blank">press release</a> on Monday.</p>



<h3><strong><span class="has-inline-color has-vivid-red-color">KEY FACTS</span></strong></h3>



<p>The preliminary data is based on an evaluation of 95 confirmed Covid-19 infections among the trial’s 30,000 participants.</p>



<p>According to the company, 90 of the participants who got infected with Covid-19 are from the placebo group while only 5 cases of infection were seen in the group that received two doses of the vaccine.</p>



<p><em>This is a developing story. Check back for updates.</em></p>



<p><em>-By Siladitya Ray, Forbes Staff</em></p>


Moderna’s Covid-19 Vaccine Is More Than 94% Effective, Preliminary Data Shows


<p>Pharmaceutical company Moderna, one of the companies in the lead pack in the race to develop a coronavirus vaccine, won&#8217;t be in a position to widely distribute it until at least next spring, CEO Stéphane Bancel told the Financial Times, echoing public health experts who predict a similar timeline for other vaccine candidates.</p>



<h4>KEY FACTS</h4>



<p>&#8220;November 25 is the time we will have enough safety data to be able to put into an emergency use authorization file that we would send to the FDA,&#8221; Bancel said, adding that an approval wouldn&#8217;t be expected until late first quarter or early second quarter of 2021.</p>



<p>The timeline matches up with what public health experts have previously laid out, which is that a vaccine could be found to be safe and effective by the end of the year at the earliest but widespread distribution wouldn&#8217;t occur until further into 2021.</p>



<p>One of the frontrunners to develop a safe vaccine first, Moderna earlier in the month said it was slowing its trial enrollment to ensure it was representing disproportionately affected minority groups but later added it could have enough data by November to know if its vaccine candidate works.</p>



<p>The comments follow President Trump’s claim during Tuesday&#8217;s U.S. presidential debate that, &#8220;We&#8217;re weeks away from a vaccine,&#8221; citing Moderna as well as Pfizer and Johnson &amp; Johnson.</p>



<p>Pfizer is another frontrunner—Johnson &amp; Johnson are further behind their late-stage clinical trials—and while its CEO Albert Bourla said it will have an &#8220;answer&#8221; by the end of October on its candidate&#8217;s efficacy, a spokesperson for the company later told the&nbsp;<em>New York Times&nbsp;</em>that Pfizer wouldn&#8217;t be close to the completion of its clinical trial by then.</p>



<p>There are currently 11 vaccines in expansive Phase 3 clinical trials, according to data from the&nbsp;<em>Times</em>.</p>



<h4>CHIEF CRITIC</h4>



<p>Trump has pushed the notion that a vaccine will be ready before the November election, fueling fear in the U.S. that anything approved could have been rushed. Even with wide distribution of a vaccine, the upwards of 60% to 70% will need to be immunized to put an end to the pandemic. That could take until 2022, according to billionaire and philanthropist Bill Gates and Dr. Soumya Swaminathan, the World Health Organization&#8217;s chief science officer.</p>



<h4>KEY BACKGROUND</h4>



<p>A Covid-19 vaccine is being developed at an unprecedented speed, with a typical immunization taking 10 years to develop, test, approve, and distribute. The U.S. leads the world in confirmed cases of the coronavirus with 7,221,278, as well as reported deaths with 206,693. In total, there are 33,802,841 global infections and 1,010,477 deaths.</p>



<p><em>-By Matt Perez, Forbes Staff</em></p>


Coronavirus Covid-19 vaccine concept –  three glass vials on black table, hypodermic syringe needle near, closeup detail (label own design – dummy data and barcode, not real product)

Tag: Moderna

FORBES AFRICA SOCIAL MEDIA