NEW YORK, January 30, 2023 – Pfizer Inc. (NYSE: PFE) and the International Trachoma Initiative (ITI), a program of the independent nonprofit Task Force for Global Health, today announced the donation of the one billionth Zithromax® (azithromycin) dose as part of the World Health Organization’s (WHO) recommended S.A.F.E. strategy to help prevent and treat trachoma.
Donation of the one billionth dose builds on Pfizer’s June 2022 commitment to extend its antibiotic donation program through 2030, helping to enable 18 countries to continue trachoma elimination programs in 2023 and beyond. The WHO’s Neglected Tropical Diseases Roadmap has set a global elimination goal of 2030, which has already been achieved in 15 countries.
“Pfizer’s donation of one billion doses of Zithromax has been instrumental in the success of the global trachoma program and demonstrates to the world that elimination of this debilitating disease is possible,” said Jason Carter, Chairman, Board of Trustees, The Carter Center. “The Carter Center has been a proud partner in the trachoma elimination journey, which is core to our commitment to expanding simple health interventions that have a life-changing impact.”
This milestone marks a significant achievement and was made possible by decades-long partnerships to eliminate trachoma – the leading infectious cause of blindness globally. Together, trachoma elimination efforts around the world have successfully reduced the trachoma burden by 92 percent since 2002,[i] with an estimated 217.9 million people now believed to live free from the risk of trachoma according to ITI.[ii]
“Through country leadership and the joint efforts of countless partners from around the world, millions of people are no longer at risk of this debilitating disease,” said Dr. Paul Emerson, Director, ITI. “Together, we have greatly reduced the risk of trachoma – including in the hardest-to-reach communities – and now we have a once-in-a-lifetime opportunity to build on this momentum and finally eliminate trachoma as a public health challenge.”
“Everyone, no matter where they live, should have access to life-saving medicines. That is why, for more than two decades, Pfizer has proudly joined researchers, global health partners and dozens of governments in efforts to eliminate trachoma,” said Caroline Roan, Senior Vice President, Global Health & Social Impact, Pfizer. “We celebrate the donation of the one billionth Zithromax dose as a collective accomplishment with the global health community and an important step toward closing the health equity gap.”
Both a cause and a consequence of poverty, trachoma remains a public health threat for 125 million people living in hyperendemic areas of Africa, Latin America, Asia, Australia and the Middle East. An estimated 1.9 million people suffer visual impairment because of infection, and women are up to four times more likely to be blinded by trachoma than men.[iii] Zithromax is not approved in the United States or European Union to treat trachoma.
Trachoma is a neglected tropical disease (NTD) caused by the bacterium Chlamydia trachomatis. After repeated infections, the disease scars the interior of the eyelid and causes it to turn inward (trichiasis), leading to great pain, corneal ulcers and irreversible blindness if not treated by antibiotics or a simple surgical procedure.
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About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
About The Task Force for Global Health
The Task Force for Global Health, founded nearly 40 years ago to advance health equity, works with partners in more than 150 countries to eliminate diseases, ensure access to vaccines and essential medicines, and strengthen health systems to protect populations. For more information, visit www.taskforce.org or see our annual report.
Important Safety Information for Zithromax® (azithromycin)
- Known hypersensitivity to azithromycin, erythromycin, any macrolide, or ketolide drug.
- History of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin.
Warnings and Precautions:
- Serious allergic reactions, including angioedema, anaphylaxis, and dermatologic reactions including Acute Generalized Exanthematous Pustulosis (AGEP), Stevens-Johnson Syndrome, and toxic epidermal necrolysis, have been reported rarely in patients on azithromycin therapy. Discontinue ZITHROMAX and initiate appropriate therapy if reaction occurs.
- Abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis, and hepatic failure have been reported, some of which have resulted in death. Discontinue azithromycin immediately if signs and symptoms of hepatitis occur. Discontinue azithromycin immediately if signs and symptoms of hepatitis occur.
- Following the use of azithromycin in neonates (treatment up to 42 days of life), Infantile Hypertrophic Pyloric Stenosis has been reported. Direct parents and caregivers to contact their physician if vomiting or irritability with feeding occurs.
- Prolongation of QT interval and cases of torsades de pointes have been reported. This risk which can be fatal should be considered in patients with certain cardiovascular disorders including known QT prolongation or history of torsades de pointes, those with proarrhythmic conditions, and with other drugs that prolong the QT interval. Elderly patients may be more susceptible to development of torsades de pointes arrhythmias.
- Clostridium difficile-Associated Diarrhea: Evaluate patients if diarrhea occurs. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
- Exacerbations of symptoms of myasthenia gravis and new onset of myasthenic syndrome have been reported in patients receiving azithromycin therapy.
- Close monitoring for known side effects of azithromycin, such as liver enzyme abnormalities and hearing impairment, is warranted when given with Nelfinavir.
- Warfarin use with azithromycin may increase coagulation times; monitor prothrombin time.
Most common adverse reactions are diarrhea (5 to 14%), nausea (3 to 18%), abdominal
pain (3 to 7%), or vomiting (2 to 7%).
ZITHROMAX is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria:
- Acute bacterial exacerbations of chronic bronchitis in adults
- Acute bacterial sinusitis in adults
- Uncomplicated skin and skin structure infections in adults
- Urethritis and cervicitis in adults
- Genital ulcer disease in men
- Acute otitis media in pediatric patients
- Community-acquired pneumonia in adults and pediatric patients
- Pharyngitis/tonsillitis in adults and pediatric patients
Limitation of Use:
Azithromycin should not be used in patients with pneumonia who are judged to be
inappropriate for oral therapy because of moderate to severe illness or risk factors.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of
ZITHROMAX (azithromycin) and other antibacterial drugs, ZITHROMAX (azithromycin)
should be used only to treat infections that are proven or strongly suspected to be
caused by susceptible bacteria.
Safety and effectiveness in the treatment of patients under 6 months of age have not been established.
The information contained in this statement is as of January , 2023. The Company assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This statement contains forward-looking statements about the donation of the one billionth Zithromax dose as part of the WHO recommended S.A.F.E. strategy to help prevent and treat trachoma, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability of Zithromax, including development of products or therapies by other companies; manufacturing capabilities or capacity; the uncertainties inherent in business and financial planning, including, without limitation, risks related to Pfizer’s business and prospects, adverse developments in Pfizer’s markets, or adverse developments in the U.S. or global capital markets, credit markets, regulatory environment or economies generally; the impact of COVID-19 on the Company’s business, operations and financial results; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.
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[i] WHO Weekly epidemiological record. Weekly Epidemiol Rec. 2019; 94: 317-328
[ii] ITI’s estimated calculation of populations living in districts where the current trachoma infection rate is <5% after intervention as of December 2022
[iii] World Health Organization. https://www.who.int/news-room/fact-sheets/
detail/trachoma. Updated March 7, 2022. Accessed December 20, 2022.
HEADER IMAGE – Photo credit: Sala Lewis/International Trachoma Initiative