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Ready to Respond: Pfizer’s Zithromax® Program & Covid-19

Hundreds of colleagues at Pfizer and partner manufacturing sites have come together to respond to the sudden and urgent need for Zithromax® around the world. The commitment to excellence and equity have driven a global response to ensure supply of one of Pfizer’s essential medicines.

Over the past three months, COVID-19 has stressed supply chains for essential medicines and one of the most dynamic responses has been for Pfizer’s drug, Zithromax® (azithromycin).  Zithromax is an antibiotic approved to treat certain bacterial infections including community acquired pneumonia.  Empirical treatment of pneumonia with azithromycin is often indicated while the diagnosis of COVID-19 is underway.   Zithromax is not approved to treat COVID-19 or other viral infections, and the safety and efficacy of azithromycin, either alone or in combination with other therapies, has not yet been demonstrated in patients with COVID-19.

Outside of US and China, global demand for azithromycin doubled while new requirements for Investigator Sponsored Research (ISRs) and humanitarian channels have increased the complexity of this supply chain. To respond to these urgent needs, colleagues from across Pfizer have collaborated in unprecedented ways to increase network flexibility and deliver Zithromax to impacted areas.

As the pandemic emerged in China, Pfizer’s Kalamazoo, USA and Algete, Spain sites optimized production to respond with an additional 2 million units of intravenous Zithromax® for China. And in Ireland, the Ringaskiddy site adapted the 2020 schedule to ensure continuity of supply for the medicine in the China market throughout 2021.

To address the European market demand surge, Pfizer’s external partner – the Haupt manufacturing facility in Latina, Italy – delivered approximately four-times the typical monthly supply. Adding to the complexity, the supplier for packaging materials was located in Italy’s COVID-19 Red Zone, requiring the team to approve an alternate source in a record two weeks’ time.

“When Covid-19 hit, we knew that we had to find out-of-the-box ways to quickly meet patients’ evolving needs” said Tanya Alcorn, Vice President Supply Chain. “Thanks to hundreds of colleagues teamwork spanning PGS, HBU, Regulatory Affairs, Corporate Affairs, Legal and other divisions, we’ve been able to increase and redirect Zithromax® production to where it’s needed most. This collective effort is something every Pfizer colleague should feel proud of.” 

In the United States, Pfizer was able to redirect tablets originally slated for donation to the International Trachoma Initiative (ITI) to help mitigate drug shortages. Each year, Pfizer manufactures and donates 300 million tablets to fight trachoma, the leading cause of infectious blindness. However, because of social distancing requirements related to COVID-19, the World Health Organization put the trachoma donation program on hold for the time being.

With donation programs paused, Zithromax® tablets originally manufactured for donation, but not yet packaged, could be directed to the United States for Greenstone and Branded supply. This allowed the Vega Baja site to supply US retail channels one month faster and keep Zithromax off backorder while the Barceloneta and Tuas sites could catch up with global demand increases. As of mid-May, Greenstone has supplied more than 140% of the expected annual Zithromax forecast since March.

Building on these efforts, Pfizer worked closely with US FDA to manage supply when Zithromax® went on US drug shortage in April. Pfizer made a one-time donation of Zithromax® (azithromycin) labeled for the trachoma donation program to the humanitarian organization Direct Relief in the United States to provide additional access to the product for more than 1.5M patients. The FDA authorized Pfizer and Direct Relief to distribute the International Trachoma Initiative (ITI) labelled product to hospitals experiencing shortages, accompanied by a communication that explains the labeling differences.  Similar approaches are being reviewed in other countries with significant need.

“We are proud to be long-term supporters of the global effort to eliminate trachoma and remain committed to donating Zithromax to the International Trachoma Initiative through 2025” said Caroline Roan, President of The Pfizer Foundation and Vice President of Global Health and Patient Access. “But with the WHO trachoma program on hold, we’ve been able to redirect medicines that are not immediately needed in the trachoma program to help fight COVID-19.” 

In addition to commercial and donation supply, Pfizer is responding to several Investigator Sponsored Researchers for Zithromax® clinical trials. A cross-functional team is working to flexibly use commercial supply available closest to the trial locations so that these important trials can start as quickly as possible.

“Pfizer colleagues have stepped up in countless ways in the fight against COVID-19” said Alcorn. “This is just another way we’re #InItTogether.”