Why can’t even presidential pressure bring more vaccines to market faster?

Thousands of Americans are dying from covid-19, but efforts to increase production of potentially life-saving vaccines are hitting a brick wall.

Vaccine makers Moderna and Pfizer-BioNTech are at full capacity and are under great pressure to increase production or work with other pharmaceutical companies to set up additional assembly lines. The pressure is only increasing when new viral variants of the virus threaten to plunge the country into the deadly stage of a pandemic.

President Joe Biden said he plans to exercise the authority of the Cold War Defense Production Act to provide more vaccines to millions of Americans. Consumer advocates, who had called for Donald Trump to use the Defense Production Act more aggressively as president, are now calling on Biden to do the same.

But even forcing a company to prepare for production does not immediately provide the required dose. It takes time to expand the production line. It can take several months to establish a line in a reused facility.

“The big question is, even if you can get the raw materials and set up your infrastructure, how can a company that is already producing at its maximum capacity exceed that maximum capacity?” Georgetown University Lawrence Gostin, a professor of global health law at Georgetown University, said.

Dr. Nicole Lurie, senior adviser to the CEO of the Infectious Disease Control Innovation Coalition, an international group funding emerging infectious disease vaccines, said ordering companies to work 24 hours a day, 7 days a week is “naive. It will be a good solution. ” “They probably already do it to the extent they have the raw materials.”

Lully added: “When a person is completely tired, mistakes are made. You need to balance speed with quality and safety.”

The technical challenges involved are daunting, and companies haven’t announced what they need to do to overcome supply shortages.

“I don’t know what the holdup is. Capacity? Ingredients? People? Glass vials? I don’t know what the bottleneck is,” said a senior director of drug information and support services at the University of Utah Health Hospital. One Erin Fox says.

Getting other companies to start producing vaccines may not work, Gostyn said.

“I don’t know if Biden can require a private company to transfer its technology to another company,” Gostyn said. “It’s legally very suspicious …. President Biden’s maneuverability isn’t as great as people think.”

Pharmaceutical companies broadly define “corporate secrets,” Fox said. “In general, pharmaceutical companies don’t have to tell us who makes the product, where it’s made, or the location of the factory … it’s considered proprietary.”

Part of the challenge is related to how these vaccines are made. The first two licensed products use lipid nanoparticles to deliver fragments of the coronavirus genetic material (called messenger RNA or mRNA) to cells.Viral genes teach our cells how to make proteins Stimulates immune response to coronavirus..

Messenger RNA is fragile and degradable and should be handled with care at specific temperature and humidity levels.

The vaccine is “not a widget,” said Lurie, an assistant secretary to the Department of Health and Human Services’ preparation and response under the Obama administration.

According to experts, every step in getting a vaccine to market is complex. Build the facility to the exact specifications. Purchase disposable products such as tubes and plastic bags to line stainless steel bioreactors. Hire employees with the necessary training and expertise. Companies also need to pass safety and quality inspections and arrange transportation.

For example, the Defense Production Act allows the government to direct plants that already have fermenters — there are many in the biotechnology industry — to expand production. But that’s just the first step in making an mRNA vaccine, and it will still take about a year to get started, said Dr. George Siber, a vaccine expert on the advisory board of the German mRNA vaccine company CureVac.

According to Shiver, businesses first need to do breathtakingly thorough cleaning to prevent mutual pollution. Next, you need to set up, calibrate, test the equipment, and train scientists and engineers to do it. Finally, Siber says, unlike drugs that can test the purity of ingredients, there is no way to confirm that a vaccine produced in a new facility is what it claims unless it is tested in animals and humans. Said.

“Making a vaccine is more important than making a car, and quality control is paramount,” said Dr. Stanley Plotkin, a vaccine industry consultant renowned for the invention of the rubella vaccine. “We are expecting other vaccines within a few weeks, so it may be faster to use them.”

However, it still requires patience.Johnson & Johnson will announce the results of the clinical trial this month, but said it could not provide the planned number of shots for it. Manufacturing delay.. The company refused to answer the question without confirming the manufacturing delay.

AstraZeneca’s vaccine, partly funded by U.S. taxpayers and already in use in the UK and India, is here until spring as the Food and Drug Administration has questioned late-stage trials. It may not be available at.

Another US-funded vaccine maker, Novavax, is suffering from delays and has just recently begun recruiting volunteers for its large-scale trials. Merck, the latest company to get federal support for Covid Vaccines, Announced on Monday It discarded the two candidates after they failed to produce a proper immune response in early tests.

“None of the vaccine makers make it in the amount they ultimately want,” Lully said. “They all have manufacturing delays.”

Pfizer, which promised the US government 200 million doses by the end of July, said last week it expected shipments from major US covid manufacturing plants in Kalamazoo, Michigan, to be “uninterrupted.” Pfizer spokeswoman Sharon Castillo said the company has expanded its manufacturing facilities to include suppliers and contract manufacturers. These efforts and the company’s announcement that the five-dose vial actually contains additional doses mean that “by the end of 2021, we may be able to administer approximately two billion doses worldwide.” I will.

The US government has the option of inoculating another 400 million more Pfizer-BioNTech vaccines, but the company refused to provide details of that option when requested.

But countries around the world are competing for the same supply and raw materials, Gostyn said.

Biden said, “We can use the Defense Production Act to give Pfizer a priority on US contracts, but it is politically dangerous, given that other countries may store supplies and retaliate. is”. Pfizer, an American company, has partnered with BioNTech in Germany to provide vaccines. “It will lead to global turmoil.”

Experts say that trying to hunt down the global market with vaccine ingredients and supplies doesn’t look good given that the United States is only this week. Join Covax An international venture that procures and distributes vaccines to prevent poor countries from being left behind.

Paradoxically, the rush to bring the vaccine to market may have reduced the efficiency of the manufacturing process.

Vaccine companies usually spend months trying to run their factories as efficiently as possible, finding the ideal dose and the most effective interval between doses, Lurie said. However, given the urgency of the pandemic, they delayed part of this process and started mass production.

Pfizer angered European countries last week. Vaccine production suspended at Belgian factory To Upgrade capacity.. Pfizer said a week-long closure would reduce vaccine deliveries to Europe by three to four weeks before increasing supply in February. This move does not affect US vaccine supply.

“The United States does not always have easy access to what is held for vaccines in other countries,” Lurie said.

Dr. Ameshua Darja, a senior scholar at the Johns Hopkins Health and Security Center, said forcing other companies to produce the Covid vaccine could jeopardize the production of other important injections such as measles. Said. During the pandemic, normal childhood vaccination rates decreased and the risk of epidemics increased.

By using the law to prioritize the production of corona vaccines, Fox said the supply of at least one drug has already been cut off. During December Horizon Therapeutics Doctors and patients warned against a shortage of a drug called Tepetza used to treat thyroid-related eye diseases. The manufacturer was ordered to prioritize Covid Shot.

With a member of the Diet Consumer advocates such as Public Citizen He urged the government to use the Defense Production Act more aggressively.so Letter sent earlier this month, Senator Elizabeth Warren (D-Mass.) And Katie Porter (D-Calif.) Have developed a technique for Moderna to stabilize vaccines. Normal refrigerator temperature, No “ultra-low temperature” freezer.

Moderna officials say the technology is difficult to share due to the essential differences between the two companies’ mRNA materials. What’s more, they say Pfizer refused to share data with Moderna. Pfizer declined to comment on this issue.

Since Modana’s efforts are funded by the federal government, the government probably has the right to march and could take over production, said Mike Watson, the former president of Modana’s subsidiary Valera. Said in the email. “In reality, no matter how much you boost your production capacity, sooner or later it will become a bottleneck.”

Experts say, for example, Corning, a glass maker, is not as easy as requiring them to step up and make glass vials. Of course, the vial must meet stringent requirements.But there is also: The United States faces a shortage of mining Principal component sand Required to make a glass vial.