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Why Vaccine Dosage Can’t Be Faster — ProPublica

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President Joe Biden I ordered enough vaccine To vaccinate all Americans against COVID-19, and his administration says it is using the full power of the federal government to get doses By July.. There is a reason he can’t promise them right away.

The vaccine supply chain is highly specialized and sensitive, relying on expensive machinery, highly trained staff, and grumpy ingredients.According to the manufacturer, the manufacturer encountered an intermittent shortage of major materials US Government Accountability OfficeA combination of booming demand and a pandemic workforce disruption caused delays in goods previously shipped within a week when consumers were scrambled for household staple foods such as: It was 4-12 weeks late, just as it happened. flour, Chicken wings And Toilet Paper..

People often wonder why the government cannot use the powerful Defense Production Act, which empowers the government to demand significant supplies before anyone else, to supercharge production. However, the law has its limits. Every time a manufacturer adds a new device or new raw material supplier, it performs extensive testing to ensure that the hardware or ingredients work consistently as intended and submits the data to the Food and Drug Administration. is needed. Jennifer Pancorvo, director of industrial programs and research at the Center for Biomanufacturing Training and Education at North Carolina State University, said the capacity addition “doesn’t happen in a blink of an eye.” “It will take quite a few weeks.”

Also, adding supplies at any given time is only useful if production can be expanded up and down across the chain. “Thousands of components may be needed,” said a former senior official at the Department of Health and Social Welfare, director of the Pandemic and Biosecurity Policy Program at the Skawcroft Institute for International Affairs at the University of Texas A & M, and for preparation and response. Gerald W. Parker said. .. “The Defense Production Act cannot be enabled and realized.”

There are no spare facilities in the United States waiting to manufacture vaccines and other types of factories. General Motors has started production of ventilators last year. GAO said the Army Corps of Engineers is supporting the expansion of existing vaccine facilities, but that cannot be done overnight.

It takes a couple of months to build a new capacity. At that point, the new production line will face weeks of testing to ensure that the vaccine can be administered correctly before the company begins to offer more shots.

“It’s not like making shoes,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said in an interview with ProPublica. “And the reason I use that somewhat joke analogy is that people say,” Oh, do you know what we should do? Let DPA build another factory within a week and of the mRNA Production must begin. Well, by the time the new factory is ready to produce the mRNA vaccine exactly according to the FDA’s very strict guidelines and requirements … we are already between Moderna and Pfizer. I have 600 million doses. I have a contract. It will be too late. “

Fauci added that DPA works best to “promote something rather than build something from scratch.”

The Trump administration has developed the Defense Production Act last year Prioritize access to critical production supplies by vaccine manufacturers before anyone else buys them. The Biden administration has also helped Pfizer obtain special needles that can squeeze a sixth dose from the company’s vials, as well as two key manufacturing components: filling pumps and tangential flow. Used it for the filtration unit. The pump assists in the supply of lipid nanoparticles that retain and protect mRNA (the active ingredient of the vaccine, as it were) and fills the vial with the finished vaccine. The filtration unit removes unwanted solutions and other materials used in the manufacturing process.

Matthew Johnson, Senior Director of Product Management at the Human Vaccine Institute at Duke University, is working on the development of mRNA vaccines, but not on COVID-19, and these highly accurate devices are usually available on demand. can not. “Currently, biopharmacy is growing very fast and there is a pandemic pinch,” he said. “Many equipment suppliers are sold out, and even products that are planned to be manufactured can be sold out in a year or so.”

Vaccine shortages, on the other hand, are widespread frustration as qualified people struggle to get promises and wonder how long it will take millions of people to take their turn. It creates anxiety. As of February 17, The United States distributed 72.4 million doses and 56.3 million injections, but 16 million people received both the two doses needed for the Pfizer and Moderna vaccines to be fully protected. Less than a person.

The Biden administration said it would increase vaccine shipments to the state by 20% to 13.5 million times a week, encouraging the state to give all injections instead of continuing the second dose. However, as the second dose is imminent, many jurisdictions must focus on them and stop vaccination of unvaccinated people. Data from the US Centers for Disease Control and Prevention show that despite an increase in the total number of vaccinations last week, the number of initial vaccinations has dropped from 7.8 million three weeks ago to 6.8 million.

According to official statements from both companies, it will take at most June for manufacturers to provide sufficient doses to approximately 266 million eligible Americans over the age of 16.

This includes the expected delivery of a single-dose Johnson & Johnson vaccine. It is widely expected to obtain an emergency permit from the FDA shortly after the Public Advisory Board meeting on February 26. However, Johnson & Johnson is lagging behind in production.The company said GAO Only 2 million times are ready before the vaccine is approved, but it’s $ 1 billion. Contract HHS is scheduled to be administered 12 million times by the end of February. It’s not clear what hampered Johnson & Johnson’s production line. According to senior management close to the manufacturing process, the company benefits from top-priority purchases thanks to DPA. A Johnson & Johnson spokesman declined to comment on the cause of the delay, but said the company still plans to ship 100 million US doses by July.

Vaccine supply does not cover all Americans until the end of spring at best

Official statements from vaccine developers Pfizer, Moderna, Johnson & Johnson show the number of people available from the current to the end of summer with US supplies available.

Source: US Census 2020 Demographic Analysis Estimate, Company press releases and statements, news reports, GAO.. Information as of February 16th.

Note: The graph assumes that the supply increases evenly each week, but the actual supply may vary.


credit:
Graphics: Lena V. Groeger / ProPublica

Modana declined to comment on the “operational” aspects of manufacturing, but a spokesman said in a statement that he was “confident in his ability to meet contract volumes” for vaccines to the United States and other countries. Pfizer did not answer ProPublica’s written questions.

Increasing production is especially difficult for Pfizer and Moderna, who use mRNA technology for which vaccines have never been mass-produced. The two companies started production before the end of the trial to see if the vaccine worked. However, they had to effectively invent new manufacturing processes, so they were not always able to drive millions of vaccines at once.

Johnson, Product Manager at Duke University’s Vaccine Research Institute, said: “It was a big problem for raw material suppliers to put together a plan for Phase 1 and Phase 2 trials 12 months ago and make enough to administer to hundreds of patients.“ Numbers a year ago. From administration to 100 patients, it has grown to 1 billion. “

Ingredients for Pfizer and Modana vaccines are also limited. According to Pancorvo, a biomanufacturing expert at North Carolina State University, the manufacturing process is a “plasmid” (standalone) that contains instructions for making vaccine genetics using common gut bacterial cells. It starts with growing what is called a DNA fragment.

Next, certain enzymes cultured from the bacteria are added to trigger a chemical reaction that assembles the strands of mRNA, Pancorbo said. These strands are then packaged into lipid nanoparticles, which are fine bubbles of fat made using petroleum or vegetable oil. Fat bubbles protect the genetic material inside the human body and help deliver it to cells.

Few companies specialize in manufacturing these materials, which were previously sold in kilograms, according to Pancorbo. But they are currently needed in metric tons — an increase of 1000 times. Moderna and Pfizer need bulk, but they also need the highest quality possible.

“There are many tissues that make these enzymes and their nucleotides and lipids, but they may not be of a grade that is satisfactory for human consumption,” Pancorbo said. “It may be a satisfactory grade for animal consumption and research, but for injection into humans? That’s another thing.”

Johnson & Johnson vaccines follow a slightly more traditional method of growing cells in large tanks called bioreactors. This is time consuming and even the slightest contamination can damage the entire batch. The process deals with living things, so it’s more like growing plants than making shoes. “Maximizing yields is both a science and an art, as the manufacturing process itself depends on biological processes,” said Parker, a former HHS employee.

Vaccine developers continue to look for tweaks that can boost production without cutting corners. Pfizer is currently giving each vial 6 doses instead of 5, and Moderna is seeking permission to give each bottle 10 to 15 doses. If approved by the regulator, the production switch will take a couple of months. Moderna spokesman Ray Jordan said on February 13th.

“It helps speed up and lighten the logistical side of vaccine delivery,” said Lawrence Ganti, president of SiO2, an Alabama company that manufactures glass vials for Moderna vaccines. SiO2 $ 143 million With funding from the federal government last year, Ganti said his last line was okay.

Despite the potential for sporadic bottlenecks and delays in the coming months, companies appear to be lining up their supply chains to a level that they are happy with their ability to meet their current production goals.

Massachusetts-based Snapdragon Chemistry has received approximately $ 700,000 from HHS’s Biomedical Advanced Research and Development Authority to develop a new method for producing ribonucleoside triphosphate (NTP), the key ingredient in mRNA vaccines. .. Snapdragon’s technology uses a continuous production line rather than the traditional process of creating batches with large bats, making it easy to scale up just by running production for long periods of time.

According to Matthew Bio, the company’s president and chief executive officer, the supplier has told Snapdragon that it currently covers raw materials. “They say they have set up a supplier to meet this year’s demand,” says Bio.

Molly Simon And Caroline Chen Contribution report.

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