Can Pfizer and Moderna Finish the Pandemic by Sharing Their Vaccine Designs? It’s Not that Easy

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Can Pfizer and Moderna End the Pandemic by Sharing Their Vaccine Designs? It’s Not that Simple

"Pfizer and Moderna could share their design with dozens of other drug companies ready to make their vaccines and end the pandemic."

– February 3rd in a Facebook post

This story was produced in collaboration with PolitiFact. It can be republished for free.

Vaccine manufacturers Pfizer and Moderna were recognized for developing highly effective Covid-19 vaccines in record time. But are they accidentally hurting the public by not sharing their technology with other drug companies to expedite the manufacture and distribution of vaccines?

This is what a post on social media claims.

"The vaccine shortage doesn't have to exist," reads a picture of a tweet shared thousands of times on Facebook. "Pfizer and Moderna could share their design with dozens of other drug companies ready to make 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 in its newsfeed. (Read more about PolitiFact's partnership with Facebook.)

The tweet doesn't mention that the two drug makers are already working with other companies to make the vaccine. It also looks like dozens of companies that manufacture vaccines are regulated and have the raw materials, equipment, and storage necessary to manufacture them efficiently and effectively. Experts say this is not the case.

When PolitiFact reached out to the author of the tweet, Dr. James Hamblin, professor of public health policy at Yale University and writer on the Atlantic, admitted that the use of the words "Stand Ready" in the tweet imprecisely implied that the process could begin immediately.

"It takes time and investment to begin manufacturing mRNA vaccines," Hamblin told PolitiFact. "Companies need to be reassured that if they get into this room, they won't lose any money, possibly similar to what they did during the research phase of (Operation) Warp Speed."

Vaccine technology narrows the field

Both Pfizer and Moderna vaccines are based on newer messenger RNA technologies. (It has been studied for some time but has not yet been used in a vaccine.) The mRNA is fragile and must be handled carefully, with specific temperatures and humidity levels, so that it does not break down.

Experts say it is highly unlikely that "dozen" manufacturing facilities will be able to get this type of production up and running right away. Even if Pfizer-BioNTech and Moderna made their vaccine designs open source today, pharmaceutical researchers would estimate that it would take other companies a few more months to produce the images, and by then mass distribution and vaccination would be in full swing.

PolitiFact asked both companies to comment but received no response.

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 about the complexities and risks of vaccine manufacturing.

According to Venyakka, vaccines are complex biologics, among many other problems, and it is difficult to predict whether changes in the manufacturing process will affect the vaccines' effectiveness or safety.

“Many vaccines are made by viruses growing in cells. Failure to do so as expected can result in lost production and delayed deadlines. This is an area where the production of cell- and virus-free mRNA vaccines has a great advantage, ”Venkayya wrote.

"For these reasons, every aspect of vaccine manufacturing is strictly controlled: raw materials, equipment, production processes, training, operating procedures, etc. All of this is done in accordance with Good Manufacturing Practice (GMP) regulations and the facilities are checked regularly."

According to the Food and Drug Administration, manufacturers can share information or data about their products that they choose as they own the information. However, it is the company's responsibility to ensure that each contract manufacturer adheres to FDA regulations for good manufacturing practices.

These rules lay down minimum requirements for the methods, facilities and controls used in the manufacture and packaging of medicinal products. They are designed to make sure that a product is safe and has the ingredients and strength it is said to have.

Existing partnerships are already accelerating production

John Grabenstein, assistant director of scientific communications for the Immunization Action Coalition, a vaccine information organization that works in partnership with the Centers for Disease Control and Prevention, told PolitiFact that the tweet incorrectly assumes the companies aren't already manufacturing outsource. Grabenstein pursues partnerships between pharmaceutical companies and contract manufacturers.

He said Pfizer-BioNTech worked with biopharmaceutical companies Rentschler and Polymun while Moderna worked with Rovi, Recipharm and Lonza. Some of the companies are solely based overseas while others have factories in the US.

Typically, the contractors do one of the main parts of the production, Grabenstein said, such as making the mass product, formulating the mass product into the final preparation, filling the drug into vials, or completing the final packaging, which could include vial, inlay and labeling Boxing paperwork and assembling boxes for a box.

For example, Rovi, one of the companies working with Moderna, signed a contract in July to fill and package 100 million doses of the vaccine in early 2021.

In fewer cases, a full-fledged manufacturer is hired to create a mirror image of the original product from start to finish.

One example is the Serum Institute of India – the world's largest vaccine maker – which is already making a parallel version of the Oxford-AstraZeneca vaccine that the institute will market under the trade name CoviShield. The institute started building new facilities in June to make this possible. The organization recently announced a similar partnership with Novavax.

"It's incredibly complicated and the number of facilities and trained staff is really very, very small," said Grabenstein. “It's not that you give just one recipe to another restaurant. That 'recipe' is thousands and thousands of pages in length. Then you need to validate and demonstrate that you meet all of the really strict performance specifications and demonstrate the consistency of the process before doing so You can distribute the vaccine from one of the regulators. "

Hamblin, the author of the Twitter post, said the companies were unlikely to share their vaccine designs given the current system of intellectual property and funding, though he noted exceptions like Sanofi.

Sanofi, a French multinational pharmaceutical company, announced in January that it has partnered with BioNTech, the company that co-developed the vaccine with Pfizer. Sanofi said it would give the company access to its "established infrastructure and expertise to manufacture over 125 million doses of COVID-19 vaccine in Europe". The first deliveries will come from the Sanofi production facilities in Frankfurt this summer.

Hamblin noted that by opening up intellectual property permanently and unconditionally – and not on a limited scale, for a limited period of time – vaccine manufacturers could help more companies and governments "get more companies and governments into production in more permanent and cheaper ways." ”

"If we need to make boosters in certain areas, for example for new strains or for the next coronavirus, we could be there right away," said Hamblin. "Talking about it hypothetically again – not implying that it will happen or it will be quick or easy or anything else."

The Defense Production Act allows for closer cooperation but takes time

Couldn't that help speed things up if President Joe Biden invokes the Defense Production Act? Yes, but the law is not as comprehensive as some think.

The Defense Production Act of 1950 gives the president the power to advance national defense by expediting and expanding the supply of materials and services from the US industrial base.

Dr. George Siber, a vaccine expert on the advisory board of CureVac, a German mRNA vaccine company, told KHN that the government could use the law to order a suitable facility to expand production, but it would take about a year to get started.

Companies would first need to thoroughly clean their equipment and facilities to prevent cross-contamination, and set up, calibrate and test equipment, and train scientists and engineers to operate them, Siber told KHN.

"Do you want glass? Aluminum? Filter resins? What do you need? "Said Grabenstein." For example, vaccine manufacturers say, "If I just had more vials, I could increase my weekly production." OK, the government is bringing you more vials. Then it shows the next bottleneck. "

He added, “Is there any production that could be stopped or delayed and do you let these machines be used for that purpose? Sure, but you still need to clean it and do quality control to make it really clean, and then transfer and validate the process. It's months or years of commitment. These are no frills. "

According to the CDC, nearly 66 million doses of the Moderna and Pfizer-BioNTech vaccines were distributed and around 45 million administered in the second week of February.

The United States has about 10% of the population vaccinated, ranks sixth in the world according to a tracker maintained by the New York Times.

Our decision

One post claims the Covid-19 vaccine shortage doesn't have to exist as Pfizer and Moderna can share their vaccine designs with "dozen" other drug companies ready to make the vaccines and end the pandemic.

This premise over-simplifies the vaccine manufacturing process.

First, the publication does not mention that Pfizer-BioNTech and Moderna have already partnered with various contract manufacturers to expedite vaccine production. Second, industry experts say it is highly unlikely that "dozens" of pharmaceutical companies that are not yet making the vaccines will be ready. Deliveries, staff training and facility compliance are just a few of the aspects that make the process complex and tedious.

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

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

Bibliography:

Facebook post, February 3, 2021

Science Magazine, "Vaccine Manufacturing Myths," Feb. 2, 2021

KHN, "Why Even President's Pressure Can't Help Get More Vaccines To Market Faster," January 26, 2021

Twitter, Dr. Rajeev Venkayya Thread, February 1, 2021

The Centers for Disease Control and Prevention, "COVID-19 Vaccinations In The United States," accessed on February 8, 2021

It was accessed in the New York Times, "Tracking Coronavirus Vaccinations Around the World" on February 8, 2021

PolitiFact, "The state of vaccine supply is" opaque "," difficult to determine ", experts say on February 4, 2021

Modernatx.com, "Moderna and ROVI Announce Collaboration for OUS Manufacturing of Moderna's COVID-19 Vaccine Candidate," July 9, 2020

Food and Drug Administration, "Current Regulations on Good Manufacturing Practice (CGMP)," updated September 21, 2020

Message from Dr. James Hamblin, February 8, 2021

Telephone interview with John Grabenstein, Assistant Director of Scientific Communications, Immunization Action Coalition, February 5, 2021

Email interview, Alison Hunt, Food and Drug Administration spokesperson, February 5, 2021

KHN (Kaiser Health News) is a non-profit health news service. It is an editorially independent program of the KFF (Kaiser Family Foundation) that is not affiliated with Kaiser Permanente.

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