Experts Say Patent Waivers Aren't Enough To Increase Global Vaccination

Earlier this month, President Joe Biden showed his support in the waiver of intellectual property (IP) protections of the COVID-19 vaccines. The proposed waiver, first introduced by India and South Africa, intends to allow member countries of the World Trade Organization (WTO) to waive IP rights for products and technologies that can prevent, contain, or treat COVID-19—including vaccines—for the duration of the pandemic.

For months, many people have been calling for the U.S. to support this waiver to provide more vaccines to low- and middle-income countries with inadequate vaccine supply, especially since more than 80% of the vaccine doses that have been administered globally were in high- and upper-middle-income countries.

This endorsement from the United States government was lauded by many as a "monumental moment in the fight against COVID-19.” However, waiving patents alone won’t be enough to produce more vaccines. It is unlikely to be a turning point in this pandemic unless wealthy nations actively address other barriers to vaccine manufacturing.

Why Waiving Patents Isn’t Enough to Speed Up Production

Countries looking to produce COVID-19 vaccines face many logistical hurdles even if vaccine patents are waived.

“Waiving intellectual property rights for COVID-19 vaccines is likely to only have a modest impact on global vaccine supply,” William Moss, MD, executive director of the International Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health, tells Verywell. “A vaccine IP waiver is not in itself likely to lead to increased vaccine production in less developed countries because much more needs to be in place to increase the global vaccine supply.”

Lack of Manufacturing Capacity

For several countries outside of the U.S. that have the necessary equipment to produce mRNA vaccines effectively and safely, the IP waiver can be of great help. However, many more countries lack this capacity, and this move still leaves them behind.

“The majority of the world’s countries lack the capacity to produce and distribute COVID-19 vaccines, and especially at the scale required to get this pandemic under control,” Richard Marlink, MD, director of the Rutgers Global Health Institute, tells Verywell. “They need funding, manufacturing facilities, raw materials, and laboratory staff with the technological expertise required.”

We've already seen what can go wrong with substandard vaccine manufacturing. In April, the Food and Drug Administration (FDA) inspected the Emergent BioSolutions factory in Baltimore and consequently shut down their production after concerning observations, which include:

• The factory was not maintained in a clean and sanitary condition.
• Waste handling was found to be inadequate because generated waste was transported through the warehouse before disposal, which can potentially contaminate other areas. 
• Employees were seen dragging unsealed bags of medical waste from the manufacturing area across the warehouse.
• Peeling paint, paint flecks, loose particles/debris were observed. There were also damaged floors and rough surfaces that cannot be properly cleaned and sanitized. 
• Employees were seen removing their protective garments where raw materials were staged for manufacturing.

They reportedly spoiled about 15 million doses of the Johnson and Johnson COVID-19 vaccine, and more than 100 million doses are on hold as regulators inspect them for possible contamination.

“Vaccines are complex biological products, much more complex than drugs, and need to be produced by manufacturers and in facilities with the highest quality control standards,” Moss says. “Adverse events associated with a poorly made or contaminated batch of vaccines would have a devastating impact on vaccine confidence.”

Lack of Technology, Skills, and Raw Materials

In a statement last October, Moderna announced that they will not enforce their COVID-19-related patents against those who will make vaccines during this pandemic. While waiving some vaccine patents may allow third-party manufacturers to make and sell COVID-19 vaccines, the transfer of skills and technology that will allow them to manage production isn't very simple. 

For instance, a spokesperson for Pfizer said that the Pfizer-BioNTech vaccine required 280 different components sourced from 86 suppliers across various countries. Manufacturing the vaccine would require highly specialized equipment and complex technology transfers.

“Technology transfer also would need to be a critical component to expand vaccine manufacturing by other companies as an IP waiver is insufficient to provide the ‘know how’ needed to manufacture mRNA or adenovirus-vectored COVID-19 vaccines,” Moss says. “And supply chains for the reagents, supplies, and equipment would be needed.”

Interested manufacturers would need to have the proper equipment to test the quality and consistency of their manufacturing. At present, the World Health Organization (WHO) has plans to facilitate the establishment of technology hubs to transfer "a comprehensive technology package and provide appropriate training" to manufacturers from lower- and middle-income countries.

While waiving vaccine patents is necessary, it's likely not enough. Additionally, negotiations about it are still ongoing. Even though the U.S. supports the waiver of COVID-19 vaccine patents, other countries like the United Kingdom, Japan, and Germany oppose it.

It's also important to remember that manufacturing vaccines is only one step of the process of vaccinating the global population—distributing it is yet another hurdle.

“Many countries are counting on COVAX, a global collaboration to distribute COVID-19 vaccines more equitably around the world,” Marlink says. “The single largest supplier to COVAX is in India, where exports have been suspended since March due to the country’s COVID-19 crisis.”

What the U.S. Government Can Do

“Manufacturing capacity is the main bottleneck right now for increasing the global COVID-19 vaccine supply, followed by access to the reagents, supplies, and equipment,” Moss says. “The U.S. government can help support the expansion of vaccine manufacturing facilities both at home and abroad through investments in building plants and training personnel, and can facilitate access to critical supplies by relaxing export restrictions.”

Experts say that the U.S. government should incentivize and fund the transfer of technology and know-how to low- and middle-income countries, as well as facilitate the supply of equipment and raw materials.

“In addition to increasing the global vaccine supply, investments need to be made to support low- and middle-income countries in building the capacity to get vaccines into the arms of those who need them,” Moss says.

Scaling up production in manufacturing countries and distributing excess doses is a temporary solution. Last month, the U.S. government pledged to donate 60 million doses of the Oxford-AstraZeneca vaccine. President Joe Biden recently announced that they would also share 20 million doses of federally approved COVID-19 vaccines by the end of June.

“Donating vaccines is not enough for poor countries with insufficient healthcare systems and infrastructure,” Marlink says. “The U.S. government can and should engage with the governments of poorer countries to create bilateral public health efforts, just like it does in its efforts to fight HIV/AIDS around the world. We need to help not only with supply but also with implementation. It is a waste to donate vaccines without working together to ensure the vaccines are safely injected into people’s arms.”

If the proposal to waive IP rights is approved, we might see a significant increase in global vaccine supply by 2022 at the earliest. Meanwhile, there is certainly more work to be done in terms of addressing vaccine inequity.

“The patent waiver is only one piece of what is needed,” Marlink says. “Developing countries are going to need technical know-how, the right skills and materials, and regulatory safeguards in order to produce safe and reliable vaccines, and to scale up that production effectively.”

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.