A closer look at partnerships in vaccine production

Samantha Putterman, Tribune News Service

Vaccine makers Pfizer and Moderna earned praise for creating highly effective COVID-19 vaccines in record time. But are they inadvertently hurting the public by not sharing their technology with other pharmaceutical companies to help speed up vaccine manufacturing and distribution?

That’s what one post circulating on social media claims.

“The vaccine shortage doesn’t need to exist,” reads an image of a tweet shared thousands of times on Facebook. “Pfizer and Moderna could share their design with dozens of other pharma companies who stand ready to produce their vaccines and end the pandemic.”

In short, the situation is not that simple. The post was flagged as part of Facebook’s efforts to combat false news and misinformation on its News Feed.

The tweet doesn’t mention that the two drugmakers are already partnering with other companies to produce the vaccine. It also makes it appear as if dozens of companies are regulated to make vaccines and have a ready supply of the raw materials, equipment and storage needed to efficiently and effectively produce them. Experts say that’s not the case.

When PolitiFact reached out to the tweet’s author, Dr. James Hamblin, a public health policy lecturer at Yale University and writer at The Atlantic, he acknowledged that using the words “stand ready” in the tweet inaccurately implied the process could begin immediately.

“It takes time and investment to begin making mRNA vaccines,” Hamblin told PolitiFact. “The companies would need the assurance that they not lose money by getting into that space, possibly in some way similar to the assurances given during the research phase of [Operation] Warp Speed.”

Vaccine technology narrows the field: Both Pfizer and Moderna’s vaccines rely on newer messenger RNA technology. (It has been studied for some time but hasn’t been used in a vaccine until now.) The mRNA is fragile and needs to be handled carefully, with specific temperatures and humidity levels to keep it from breaking down.

It’s highly unlikely, experts say, that “dozens” of manufacturing plants have the capability to get this type of production off the ground immediately. Even if Pfizer-BioNTech and Moderna made their vaccine designs open source today, pharmaceutical researchers estimate, it would still take several months for other companies to produce the shots, and by then mass distribution and inoculation will be well underway.

PolitiFact reached out to both companies for comment but did not hear back.

Dr. Rajeev Venkayya, president of the Global Vaccine Business Unit at Takeda Pharmaceuticals and former director of vaccine delivery at the Bill & Melinda Gates Foundation’s Global Health Program, wrote a Twitter thread addressing the complexity and risk of vaccine manufacturing.

Among many other issues, Venyakka said, vaccines are complex biologics and it’s hard to predict whether changes to the manufacturing process will affect the vaccines’ effectiveness or safety.

“Many vaccines are made by growing viruses in cells, and when that doesn’t happen as expected, it can lead to losses in production and delayed timelines. This is an area where cell- and virus-free mRNA vaccine production has a major advantage,” Venkayya wrote.

“For these reasons, every aspect of vaccine manufacturing is tightly controlled: raw materials, equipment, production processes, training, operating procedures etc. All of it happens under GMP [good manufacturing practice] regulations, and facilities are regularly inspected.”

According to the Food and Drug Administration, manufacturers may share any information or data about their products they choose, as they are the owners of the information. But the company is responsible for ensuring that any contract manufacturer is in compliance with the FDA’s good manufacturing practice regulations.

These rules establish minimum requirements for the methods, facilities and controls used in making and packing pharmaceuticals. They aim to ensure that a product is safe for use and that it has the ingredients and strength it claims to have.

Existing partnerships are already speeding production: John Grabenstein, associate director for scientific communications at the Immunization Action Coalition, a vaccine information organization that works in partnership with the Centers for Disease Control and Prevention, told PolitiFact the tweet wrongly presumes that the companies aren’t already outsourcing production. Grabenstein tracks partnerships between pharmaceutical companies and contract manufacturers.

He said Pfizer-BioNTech is working with biopharmaceutical companies Rentschler and Polymun, while Moderna has partnered with Rovi, Recipharm and Lonza. Some of the companies are located exclusively overseas, while others have plants in the US.

Typically, the contractors are doing one of the major portions of production, Grabenstein said, such as manufacturing the bulk product, formulation of the bulk into the final preparation, filling the drug product into vials, or finishing the final packaging, which could include labeling vials, inserting them and paperwork into boxes, and assembling boxes for a carton.

For example, Rovi, one of the companies working with Moderna, signed a contract in July to start filling and packaging 100 million doses of the vaccine in early 2021. In fewer cases, a full-fledged manufacturer is commissioned to make a mirror image of the original product, from start to finish. One example of this is the Serum Institute of India — the world’s largest vaccine manufacturer — which is already producing a parallel version of the Oxford-AstraZeneca vaccine that the institute will market with the trade name CoviShield. The institute launched the construction of new facilities in June to make that happen. The organization recently announced a similar partnership with Novavax.

“This is incredibly intricate and the number of facilities and trained personnel is really, really small,” Grabenstein said. “It’s not like you’re just giving a recipe to another restaurant. That ‘recipe’ is thousands and thousands of pages long, and then you have to validate and show that you meet all the really tight performance specifications and prove consistency of process before any of the regulators will let you distribute any of the vaccine.”

Our ruling: A post claims the COVID-19 vaccine shortage doesn’t need to exist because Pfizer and Moderna can share their vaccine designs with “dozens” of other pharmaceutical companies that are ready to produce the vaccines and end the pandemic.

This premise oversimplifies the vaccine manufacturing process.

First, the post doesn’t mention that Pfizer-BioNTech and Moderna already have partnerships with various contract manufacturers to help speed up vaccine production. Second, industry experts say it’s highly unlikely “dozens” of pharmaceutical companies that aren’t already producing the vaccines stand ready to do so. Supplies, personnel training and facility compliance are just a few aspects that make the process complex and lengthy.

So, while such partnerships are clearly an asset to rapid vaccine production, they are not entirely practical in the grand sense that this tweet implies.

The statement contains an element of truth but ignores critical facts that would give a different impression. We rate it Mostly False.