The Perfect Enemy | Donations of Emergency Use Authorization Covid-19 Medical Products Reach Over 19 Million Worldwide - Direct Relief
January 29, 2023

Donations of Emergency Use Authorization Covid-19 Medical Products Reach Over 19 Million Worldwide – Direct Relief

Donations of Emergency Use Authorization Covid-19 Medical Products Reach Over 19 Million Worldwide  Direct Relief

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Editor’s note: This story first appeared in Fierce Pharma.

Direct Relief has donated enough Covid-19 vaccines to reach more than 19 million people, along with enough innovative therapies to treat more than 350,000 patients with mild to moderate Covid infections and treat more than 80,000 patients hospitalized with severe Covid infections. The products primarily benefited people in low- and middle-income countries in all regions of the world, as well as Native American communities within the USA.

The Covid-19 products provided had Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) and/or the European Union’s European Medicines Agency (EMA). Prior to the Covid-19 pandemic, Direct Relief had never donated Emergency Use Authorization (EUA) medicines or vaccines. Because these medicines hadn’t yet received standard regulatory approval, Direct Relief needed to secure special humanitarian import authorization from the government of each recipient country.

  • Direct Relief’s humanitarian provision of critical Covid-19 products under Emergency Use Authorization (EUA) includes:
  • Covid-19 vaccines made by Pfizer, Moderna, Johnson & Johnson, and AstraZeneca and provided by Direct Relief in coordination with the U.S., Mexican, and other overseas governments and partners
  • Cold-chain monoclonal antibodies from Eli Lilly and Company administered via infusion for high-risk patients with mild to moderate Covid-19 infections to reduce progression to hospitalization
  • Oral therapies from Lilly for hospitalized patients requiring supplemental oxygen with severe Covid-19 infections
  • Covid-19 therapies from Merck & Co. and Pfizer that reduce progression to hospitalization for those with mild to moderate Covid-19 infections

According to the WHO Coronavirus (Covid-19) Dashboard, globally since early 2020, there have been over 657 million confirmed Covid-19 cases that have resulted in the death of over 6.6 million individuals. A significant percentage of deaths have taken place in the developing world, where it is assumed given the lack of Covid-19 test diagnostics, that not all cases were confirmed and or deaths attributed to Covid-19. Direct Relief has focused the majority of its Covid-19 Rx support outside of the U.S. and Europe, instead focusing on countries that lacked access to vaccines and therapies to address Covid-19.

“Egypt’s Ministry of Health welcomed Direct Relief’s donations of the combination monoclonal antibodies bamlanivimab + etesevimab and the orally administered antiviral drug molnupiravir which were utilized to help treat Egyptians with mild to moderate Covid-19 infections, as well as the baricitinib used to treat our Covid-19 hospitalized patients,” stated Egypt’s Minister of Health and Population, Honorable Prof. Khaled Abdel Ghafaar. “These donated therapies represented an important and vital tool in fighting the Covid-19 epidemic in our country at times when we had high caseloads, which led to decreasing the pressure on the dedicated Covid-19 hospital units and improving patient care and outcomes.”

In addition, Direct Relief provided to its overseas partners in the developing world over 2,500 shipping pallets of antibiotics, vasopressors, blood thinners, steroids, inhalers, intravenous fluids and other prescription medicines required in treating patients hospitalized with serious Covid-19 infections. Many of these patients were hospitalized with pneumonia or cardiovascular conditions. Direct Relief also provided over 35,000 oxygen concentrators for improved breathing for patients with serious Covid-19 infections.

“Direct Relief’s ability to work through the toughest logistics challenges in global drug delivery, combined with the generosity of our pharmaceutical partners, enabled many millions of individuals around the globe to be treated for Covid-19 infections or avoid becoming infected,” said Tom Roane, Direct Relief’s vice president of corporate engagement. “This was especially challenging during an era of mandatory shutdowns and limited staff in many of the countries receiving these EUA products.”

The monoclonal antibodies initially provided were challenging to deliver to the developing world, as they required consistent refrigerated temperature control during distribution, as well as infusion facilities for systemic administration of the medicines. The oral therapies that emerged later have been significantly more straightforward to provide to lower-income countries. Access to these innovative therapies has been vitally important given the very low Covid-19 vaccine rates in most of the recipient countries.

For the Covid-19 vaccines, shipping and logistics were an even greater challenge, as these products required either cold-chain (2° to 8° Celsius) and or ultra-cold-chain (either -20° C or -80° C) throughout their storage and shipping. Direct Relief’s transportation department had to establish or validate shipping lanes to countries little served by commercial transportation, and to use sophisticated software to ensure that the products were packed in a way that would maintain consistent temperature throughout the medicine’s journey. Direct Relief takes these measures for all of its cold-chain shipments in order to maintain the integrity of the products.

“Lilly is incredibly grateful for the collaboration with Direct Relief that enabled patients around the world to be treated with our Covid therapies,” said Ilya Yuffa, president of Lilly International. “We are committed to equitable access to our medicines and nonprofit collaborations like this one are essential to making life better for all people, including those in resource-limited settings.”

“Pfizer remains firmly committed to continue working towards equitable and affordable access for COVID-19 vaccines and therapeutics for people around the world,” said Caroline Roan, senior vice president of Global Health & Social Impact at Pfizer Inc. “We are proud of Direct Relief’s work to reach underserved communities, including people living in low- and middle-income countries.”