
<h2 class="wp-block-heading" id="h-topline">TOPLINE</h2>



<p>The Food and Drug Administration&nbsp;<a href="https://www.fda.gov/news-events/press-announcements/fda-takes-action-updated-mrna-covid-19-vaccines-better-protect-against-currently-circulating" target="_blank" rel="noreferrer noopener">gave its approval</a>&nbsp;for emergency use Monday to new updated Covid-19 vaccines from Pfizer-BioNTech and Moderna that are specially designed to protect against the latest dominant strain of the coronavirus, Omicron variant XBB.1.5—the latest effort of drugmakers, regulators and doctors to keep up with the virus’ ever evolving nature.</p>



<h2 class="wp-block-heading" id="h-key-facts">KEY FACTS</h2>



<p>Anyone 5 or older is eligible to receive a single booster dose of the newly updated vaccines regardless of how many shots they’ve received before, as long as it’s at least 2 months since the last dose they received of any Covid-19 vaccine, the FDA announced.</p>



<p>Children between the ages of six months and four years are eligible to receive one or two doses of the new vaccines if they’ve been vaccinated against Covid-19 before, but if they’ve never received a vaccine, they’re eligible to receive three doses of the new Pfizer-BioNTech shot or two doses of Moderna, the FDA said.</p>



<p>This comes after the new XBB lineage of coronavirus, a group of new variants that emerged in late 2022, became the most common strain.</p>



<p>After the emergence of this new lineage, the FDA encouraged Pfizer-BioNTech, Moderna and Novavax to create new vaccines specialized to defend against it.</p>



<p>These will be the first Covid-19 vaccines that aren’t free and paid for by the U.S. government, with&nbsp;<a href="https://apnews.com/article/science-health-business-covid-medicare-1a5d65356ebc7b5bc76524ae99deb55e" target="_blank" rel="noreferrer noopener">Pfizer</a>&nbsp;and&nbsp;<a href="https://www.reuters.com/business/healthcare-pharmaceuticals/moderna-expects-price-its-covid-vaccine-about-130-us-2023-03-20/" target="_blank" rel="noreferrer noopener">Moderna</a>&nbsp;both estimating their shots will cost between $110 and $130 per dose, though many health insurances plans will cover it and the&nbsp;<a href="https://www.cdc.gov/vaccines/programs/bridge/index.html" target="_blank" rel="noreferrer noopener">CDC’s Bridge Program</a>&nbsp;will pay for some uninsured Americans’ vaccines.</p>



<h2 class="wp-block-heading" id="h-key-background">KEY BACKGROUND</h2>



<p>Drugmakers have released a number of new iterations after the first Covid-19 vaccines were administered in late 2020. In fall 2021, the first booster shots were authorized by the FDA and were meant to help replenish waning immunity to the virus months after people received their initial doses. Then, after a new variant of the virus called Omicron, which was more resistant to the original vaccines, sparked a vicious new wave of the pandemic, drugmakers released a modified “bivalent” booster shot in fall 2022. That vaccine was designed to protect against both the original virus as well as Omicron. This new booster will attempt to do what that bivalent booster did with Omicron, but with the new XBB strains.</p>



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<h2 class="wp-block-heading" id="h-what-to-watch-for">WHAT TO WATCH FOR</h2>



<p>Now that the FDA has approved the drugs, the Centers for Disease Control and Prevention is&nbsp;<a href="https://www.federalregister.gov/documents/2023/08/25/2023-18288/advisory-committee-on-immunization-practices" target="_blank" rel="noreferrer noopener">scheduled to meet</a>&nbsp;on Tuesday to decide whether it will recommend people receive the new booster shots, an additional standard regulatory step that each of the previous iterations of the vaccines have had to complete. People won’t be able to receive the new vaccines until the CDC gives its signoff.</p>



<h2 class="wp-block-heading" id="h-surprising-fact">SURPRISING FACT</h2>



<p>While Pfizer-BioNTech and Moderna’s new vaccines were approved on Monday, the FDA still hasn’t approved Novavax’s. The company, which was a late entry into the Covid-19 vaccine market, had its&nbsp;<a href="https://www.yalemedicine.org/news/covid-19-vaccine-comparison#:~:text=Status%3A%20The%20vaccine%20was%20authorized,it%3A%20People%2012%20and%20older." target="_blank" rel="noreferrer noopener">first vaccines approved</a>&nbsp;in July 2022. Its vaccines, unlike Pfizer-BioNTech and Moderna’s do not use mRNA technology, but rather are subunit vaccines that use a piece of the virus to invigorate a body’s immune response. The company said in an email Monday its vaccines have already arrived in the U.S. and, despite not being approved alongside Pfizer-BioNTech and Moderna’s, are still awaiting FDA approval. The company reiterated that its vaccines will be widely available across the country, but “timing is ultimately at the discretion of the FDA.” By 2:45 p.m. Eastern Time, Novavax’s stock price had fallen 10% to around $8 a share. Neither Pfizer nor Moderna’s stock moved significantly. Both fell less than 1.5%.</p>



<h2 class="wp-block-heading" id="h-news-peg">NEWS PEG</h2>



<p>This comes as Covid-19 hospitalizations begin to rise across the U.S. In the week ending August 27, the most recent data available, hospital admissions for Covid-19 were up 15.7%, according to&nbsp;<a href="https://covid.cdc.gov/covid-data-tracker/#maps_new-admissions-rate-county" target="_blank" rel="noreferrer noopener">the CDC</a>. That’s 17,418 hospital admissions during that week, and while that is still a far cry from the peak in January 2022, when there were around 150,000 hospitalizations a week, doctors believe it signals that a new wave could be coming in the fall.</p>



<h2 class="wp-block-heading" id="h-tangent">TANGENT</h2>



<p>These new vaccines follow doctors’ long held predictions that Covid-19 vaccines will likely become similar to the influenza vaccine, where a new iteration is released annually to keep up with new strains of the virus. At a September 2022 White House briefing, Anthony Fauci, former director of the National Institute of Allergy and Infectious Diseases and the leader of the federal government’s response to the pandemic, said: “We likely are moving towards a path with a vaccination cadence similar to that of the annual influenza vaccine, with annual updated Covid-19 shots matched to the currently circulating strains for most of the population.”</p>



<h2 class="wp-block-heading" id="h-further-reading">FURTHER READING</h2>



<p><a href="https://www.forbes.com/sites/ariannajohnson/2023/09/01/its-ok-to-get-your-covid-flu-and-rsv-shots-at-the-same-time-experts-say/?sh=7a857a4c3099">It’s Okay To Get Your Covid, Flu And RSV Shots At The Same Time, Experts Say</a>&nbsp;(Forbes)</p>



<p><a href="https://www.forbes.com/sites/roberthart/2023/09/06/modernas-updated-covid-vaccine-is-effective-against-pirola-variant-as-concern-over-new-strain-grows/?sh=18b82c3a1a06">Moderna’s Updated Covid Vaccine Is Effective Against Pirola Variant—As Concern Over New Strain Grows</a>&nbsp;(Forbes)</p>



<p><a href="https://www.forbes.com/sites/ariannajohnson/2023/09/06/fda-may-approve-new-covid-boosters-by-friday-as-deaths-spike-report-says/?sh=5bc3a51b54f2">FDA May Approve New Covid Boosters By Friday As Deaths Spike, Report Says</a> (Forbes)<a href="https://www.forbes.com/sites/willskipworth/"></a></p>


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

FDA Approves New Covid Vaccines To Target Latest Strains


<p id="h-topline"><strong>TOPLINE</strong> The Food and Drug Administration on Thursday said it would attempt to ban menthol cigarettes nationwide, renewing a proposal that has long been pushed for by anti-tobacco groups and civil rights advocates.</p>



<h3 class="wp-block-heading" id="h-key-facts">KEY FACTS</h3>



<p>The&nbsp;<a href="https://www.fda.gov/news-events/press-announcements/fda-commits-evidence-based-actions-aimed-saving-lives-and-preventing-future-generations-smokers" target="_blank" rel="noreferrer noopener">announcement</a>&nbsp;marked the launch of a federal rule-making process that could take years and face challenges from the tobacco industry.</p>



<p>For decades, the tobacco industry has aggressively&nbsp;<a href="https://www.tobaccofreekids.org/assets/content/what_we_do/industry_watch/menthol-report/2021_02_tfk-menthol-report.pdf" target="_blank" rel="noreferrer noopener">marketed</a>&nbsp;menthol cigarettes to Black communities.&nbsp;</p>



<p>Nearly 85% of Black smokers smoke menthol cigarettes, according to the FDA.&nbsp;</p>



<h3 class="wp-block-heading" id="h-crucial-quote">CRUCIAL QUOTE</h3>



<p>&nbsp;“For far too long, certain populations, including African Americans, have been targeted, and disproportionately impacted by tobacco use,” Mitch Zeller, the director of the Center for Tobacco Products at the FDA, said in a statement.&nbsp;“Despite the tremendous progress we’ve made in getting people to stop smoking over the past 55 years, that progress hasn’t been experienced by everyone equally.”</p>



<h3 class="wp-block-heading" id="h-key-background">KEY BACKGROUND</h3>



<p>A court had ordered the FDA to respond by Thursday to a 2013 lawsuit that called for a ban on menthol cigarettes. The move would also prohibit flavors in mass-produced cigars and cigarillos.</p>



<p><strong><em>By Gina Heeb, Forbes Staff</em></strong></p>


Health Campaigners Call For A Tobacco Levy To Help Smokers Quit

FDA Proposes Menthol Cigarette Ban


<p><strong><span class="has-inline-color has-vivid-red-color">TOPLINE</span></strong> The Food and Drug Administration Thursday <a rel="noreferrer noopener" href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-drug-combination-treatment-covid-19" target="_blank">issued</a> an emergency use authorization for Eli Lilly’s rheumatoid arthritis drug baricitinib and remdesivir for coronavirus treatment, the first drug combination authorized by the FDA as a therapeutic for the virus. </p>



<h4 class="wp-block-heading"><span class="has-inline-color has-vivid-red-color">KEY FACTS</span></h4>



<p>Baricitinib is an existing FDA-approved drug for rheumatoid arthritis, but it has benefits for coronavirus patients used in combination with Gilead Sciences’ remdesivir, which has already been given&nbsp;<a href="https://www.forbes.com/sites/rachelsandler/2020/10/22/fda-approves-remdesivir-for-covid-19-treatment/?sh=680206fe63c8">full FDA approval</a>.</p>



<p>The emergency authorization only applies to hospitalized patients in need of supplemental oxygen.</p>



<p>The drug combination was given emergency approval based on a randomized double-blind trial that found it reduced median recovery time by one day and increased the chances of survival by 35% compared to patients taking remdesivir alone.</p>



<p>Scientists are also interested in the combination of baricitinib and the steroid dexamethasone, the latter of which was taken by President Donald Trump when he was infected, as a potential coronavirus therapeutic.&nbsp;</p>



<h4 class="wp-block-heading"><span class="has-inline-color has-vivid-red-color">CRUCIAL QUOTE</span></h4>



<p>“The FDA’s emergency authorization of this combination therapy represents an incremental step forward in the treatment of COVID-19 in hospitalized patients, and FDA’s first authorization of a drug that acts on the inflammation pathway,” Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research, said in a statement.&nbsp;</p>



<h4 class="wp-block-heading"><span class="has-inline-color has-vivid-red-color">KEY BACKGROUND</span></h4>



<p>&nbsp;Eli Lilly has also earned emergency approval for bamlanivimab, a monoclonal antibody treatment for early cases of Covid-19. Other promising therapeutics, including Regeneron’s antibody cocktail and dexamethasone have yet to receive FDA approval. Hydroxychloroquine had its emergency authorization rescinded after data showed it had no benefit for Covid-19 patients.</p>



<h4 class="wp-block-heading"><span class="has-inline-color has-vivid-red-color">WHAT TO WATCH FOR</span></h4>



<p>Eli Lilly is conducting a clinical trial for baricitinib by itself, and the company may pursue an emergency use authorization for the drug depending on the results.</p>



<p><em>-By Rachel Sandler, Forbes Staff</em></p>


Pharmaceutical research into infectious disease and pandemics, scientist pipetting a sample of a new drug formula into a vial during a clinical trial with the infectious disease on the computer screen

FDA Gives Emergency Approval To Covid-19 Treatment That Combines Eli Lilly Arthritis Drug With Remdesivir


<p>The Food and Drug Administration on Thursday approved remdesivir as a treatment for hospitalized coronavirus patients, Gilead Sciences said, making it the first FDA-approved drug for Covid-19.</p>



<h4 class="wp-block-heading">KEY FACTS</h4>



<p>The drug was previously granted an emergency use authorization in May, which allowed healthcare providers to administer the treatment even though it wasn’t formally approved by the FDA.</p>



<p>Remdesivir, which is sold under the brand name Veklury, “should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care,” Gilead said.</p>



<p>The drug is approved for adults and children 12 and older weighing at least 88 lbs. for coronavirus treatment requiring hospitalization.</p>



<p>Clinical trial data has been mixed: A&nbsp;<a href="https://clinicaltrials.gov/ct2/show/NCT04292730" target="_blank" rel="noreferrer noopener">randomized</a>&nbsp;trial from the National Institute of Allergy and Infectious Diseases found remdesivir improved recovery time, but a study from the World Health Organization, which has not yet been peer reviewed,&nbsp;<a href="https://www.forbes.com/sites/mattperez/2020/10/15/antiviral-drug-remdesivir-proves-ineffective-in-treating-covid-19-who-study-finds/#ff60bb95d01d">found</a>&nbsp;last week the drug did not increase the chances of survival or result in faster recovery.</p>



<p>Gilead shares jumped 3.8% in after hours trading following the announcement.&nbsp;</p>



<h4 class="wp-block-heading">CRUCIAL QUOTE</h4>



<p>“It is incredible to be in the position today, less than one year since the earliest case reports of the disease now known as COVID-19, of having an FDA-approved treatment in the U.S. that is available for all appropriate patients in need,” said Gilead CEO Daniel O’Day in a statement.</p>



<h4 class="wp-block-heading">KEY BACKGROUND</h4>



<p>President Donald Trump took remdesivir when being treated for the coronavirus earlier this month.</p>



<p>&#8211;<em>By Rachel Sandler, Forbes Staff</em></p>


GERMANY-HEALTH-VIRUS

FDA Approves Remdesivir For Covid-19 Treatment


<p>The U.S. Food and Drug Administration announced approval Wednesday of the world’s first <a rel="noreferrer noopener" href="https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-ebola-virus" target="_blank">successful</a> treatment for the Ebola virus, one of the deadliest pathogens on the planet.</p>



<h4 class="wp-block-heading">KEY FACTS</h4>



<p>The drug, Inmazeb, is a mixture of three monoclonal antibodies produced by U.S. pharmaceutical company Regeneron.</p>



<p>Inmazeb was approved for both adults and children after a trial among 382 adult and pediatric patients in the Democratic Republic of the Congo, which recently declared its 11th Ebola outbreak in just over 40 years, according to&nbsp;<a href="https://www.msf.org/drc-ebola-outbreaks" target="_blank" rel="noreferrer noopener">Doctors Without Borders</a>.</p>



<p>While the approval does mark a significant breakthrough, Ebola is still extremely life-threatening – just over 33% of patients in the trial who were given Inmazeb died after 28 days, compared to 51% who were given a control, according to the FDA.</p>



<p>Inmazeb was funded by a joint partnership between Regeneron and the Biomedical Advanced Research and Development Authority while The National Institutes of Health and Congo’s Health Ministry helped administer the study, according to&nbsp;<a href="https://thehill.com/policy/healthcare/521097-fda-approves-first-ebola-treatment" target="_blank" rel="noreferrer noopener"><em>The Hill</em></a>.</p>



<h4 class="wp-block-heading">KEY BACKGROUND</h4>



<p>The last major Ebola outbreak in the DRC was in August, 2018. Some 3,470 people were infected and; 2,287 were killed. It was the country&#8217;s largest-ever Ebola outbreak, and is also the second-biggest Ebola epidemic ever recorded. The largest outbreak recorded was the 2014-2016 epidemic in West Africa, which saw 28,652 and 11,325 deaths spread across 10 countries, including 11 cases and one casualty in the United States, according to the&nbsp;<a href="https://www.cdc.gov/vhf/ebola/history/2014-2016-outbreak/index.html#anchor_1515001464100" target="_blank" rel="noreferrer noopener">Centers for Disease Control</a>. Ebola is transmitted through direct contact with blood, bodily fluids, and tissues of infected people or contaminated surfaces making those who live in third world countries and healthcare workers extremely high-risk for infection. The FDA approved&nbsp;<a href="https://www.fda.gov/news-events/press-announcements/first-fda-approved-vaccine-prevention-ebola-virus-disease-marking-critical-milestone-public-health" target="_blank" rel="noreferrer noopener">Ervebo</a>, a vaccine for Ebola, in 2019.</p>



<h4 class="wp-block-heading">TANGENT</h4>



<p>President Donald Trump was given an experimental antibody cocktail produced by Regeneron after he was diagnosed with&nbsp;<a href="https://www.forbes.com/sites/joewalsh/2020/09/29/new-drug-might-speed-up-covid-19-recovery-pharma-company-reports/#153be08bc440">Covid-19</a>.</p>



<h4 class="wp-block-heading">FURTHER READING</h4>



<p><a href="https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-ebola-virus" target="_blank" rel="noreferrer noopener">FDA Approves First Treatment for Ebola Virus</a>&nbsp;(FDA)</p>



<p><a href="https://www.forbes.com/sites/joewalsh/2020/09/29/new-drug-might-speed-up-covid-19-recovery-pharma-company-reports/#153be08bc440">Trump Takes Experimental Regeneron Drug Cocktail Days After It Received Positive Reports</a> (Forbes)</p>



<p><em>By Daniel Cassady, Forbes Staff</em></p>


Tag: FDA

FORBES AFRICA SOCIAL MEDIA

FDA Approves New Covid Vaccines To Target Latest Strains

FDA Proposes Menthol Cigarette Ban

FDA Gives Emergency Approval To Covid-19 Treatment That Combines Eli Lilly Arthritis Drug With Remdesivir

FDA Approves Remdesivir For Covid-19 Treatment

World’s First Ebola Treatment Approved By FDA