While the Biden administration and other health advocates have scrutinized Moderna for not doing enough to help immunize low- and middle-income countries, the company said the time constraints it was under to develop the vaccine have partly reduced its ability to help scale up vaccinations. worldwide.
“A year ago, we had the ambitious goal of producing up to 1 billion doses in our own factory, supplemented by partnerships. To date, more than 250 million people have been vaccinated worldwide with the Moderna Covid-19 vaccine, ”said Stéphane Bancel, CEO of the company in a press release on October 8. “We recognize that our job is not done. We are committed to doubling our manufacturing and expanding our supply even further until our vaccine is no longer needed in low-income countries. ”
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The Biden administration’s rush to line up additional doses has so far done little to gain the trust of activists who have warned in the early months of the pandemic that the United States must take action aggressive to keep the rest of the world from falling behind.
“The vast majority of people outside of the highest income countries have yet to receive a first dose, and this deplorable status quo will continue,” said Asia Russell, executive director of Health GAP, Global Access Project.
Russell and others have pushed the administration to take a much more confrontational stance with vaccine makers, arguing that a quick end to the pandemic depends on forcing companies to widely share their patents and vaccine formulations.
“It’s too slow,” Russell said of the administration’s current efforts to attract voluntary donations from Pfizer and Moderna. “And it’s a race of vaccines and variant therapies.”
Joia Mukherjee, chief medical officer at Partners In Health, the Boston-based nonprofit founded by Dr. Paul Farmer, has suggested that Biden use the Defense Production Act to force Pfizer or Moderna to share their technology with others. other American experts, who could then provide the information to low-income countries.
“These experts would then distribute this know-how themselves to competent manufacturers around the world, in the same way that they transferred the technology globally for the influenza vaccine,” Mukherjee said.
The White House has insisted that the Trump-era contract the government signed with Moderna prevents it from forcing the company to share its vaccine recipe – limiting its ability to force a technology transfer or to reproduce the shot by itself.
“We asked dozens of federal government lawyers to review the Moderna contract,” said a White House official. “They made us understand that the [U.S. government’s] contracts with Moderna do not provide the US government with enough information, technology, and human resources for the US government to produce the vaccine itself or have it manufactured by an alternative source.
Pfizer has never participated in Operation Warp Speed, the official added, which allows it to retain all rights to its own vaccine recipe.
Meanwhile, Biden officials say there are situations largely beyond the administration’s control, such as vaccine production delays and distribution roadblocks, which limit the capacity of the United States and COVAX. not only to dispatch doses, but also to ensure that the shots come in arms on the ground.
The United States and the world have been waiting a year for Maryland-based Novavax to market its vaccine. The vaccine is key to the global immunization effort because it is easy to move and store, unlike mRNA vaccine products. Novavax, which has received $ 1.6 billion in federal funding, produces the vaccine using bug cells to produce advanced proteins. The process is familiar to scientists, but it is often difficult to scale. At the end of last month, the company was still struggling to prove to the FDA that it could manufacture its product to the highest degree of quality consistently and on a large scale.
The company has since completed filing for emergency use authorization in several countries, including the UK and Europe. And its permissions have been approved in the Philippines and Indonesia. But it’s not clear whether the company will receive approval in the markets that would allow it to deliver on a large scale.
Additionally, the Biden administration was hoping that a manufacturing deal between Johnson & Johnson and Merck would lead to product delivery by the end of 2021. But that manufacturing process took longer than expected to accelerate. , marking the latest setback for a J&J vaccine that authorities once considered essential to end the pandemic in hard-to-reach parts of the world.
Beyond vaccine production delays, the world faces a major hurdle to help countries that receive donations to obtain shots before the shots expire. Some countries in low-income regions do not have the funding or public health infrastructure to implement an immunization campaign.
Berkley told POLITICO in an interview that between 18 and 25 countries are struggling to absorb the doses.
“We will, if necessary, slow down deliveries to these countries because you don’t want to overwhelm them and lose doses,” he said, adding that some of these countries are in conflict or are experiencing an important vaccine. hesitation, especially in Chad, the Central African Republic and the Democratic Republic of the Congo.
Haiti had to return some 250,000 doses of Moderna received from the United States this summer because it could not use them until they expired in November due to the island nation’s multiple problems, from political instability to natural disasters.
Berkley said COVAX needs an additional 300 to 900 million doses of the vaccine to immunize 70% of the world. While the vaccine group has received enough pledges to secure this supply, fears persist about potential manufacturing disruptions, new variants and diminished immunity.
“It’s a great lineup because there are so many unknowns,” Berkley said.
Sarah Owermohle contributed to this report