How Manufacturing is Saving Vaccine Production in the USA
Vaccine coverage and distribution is top-of-mind globally. Today, we explore a case study in US vaccine production – specifically, how it sparked the renewal of the country’s on-shore drug manufacturing processes.
What do manufacturing facilities have to do with vaccine production and distribution? Expanding the coverage of vaccines globally is a critical goal, and expanding vaccine production simply wouldn’t be possible without the help of manufacturing facilities. Let’s take a look at key ways in which manufacturing is contributing to vaccine production and distribution in the United States.
Onshoring effects on vaccine production and distribution
The COVID-19 crisis has put a spotlight on the need to begin onshoring drug manufacturing back in the United States. The pandemic has played a large role in alerting Americans to the importance of shifting away from heavy dependence on other countries like India and China for active pharmaceutical ingredients (APIs), medical devices, and finished pharmaceutical products.
With COVID-19 vaccine production being a top priority, opening more manufacturing facilities on U.S. soil could help better facilitate efficient production and distribution. In addition, taking advantage of advanced manufacturing technologies can help ensure greater efficiency and better quality control in manufacturing facilities.
Challenges of onshoring vaccine manufacturing
Onshoring operations are helping with vaccine production and delivery, but it is facing its own set of challenges. While the U.S. is a global leader in drug research and development, manufacturing has become less of a focus over the last few decades. Pharmaceutical manufacturing facilities often require large sites that come with a high potential for environmental liabilities and high labour costs. These are two of the biggest reasons for the push toward offshoring for pharmaceutical manufacturing.
Another key challenge for today’s manufacturing companies is filling highly technical positions. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), almost 2 million positions are slated to remain vacant until 2025 as a result of a shortage of STEM professionals. In addition, the Bureau of Labor Statistics estimates that almost 450,000 manufacturing jobs remain unfilled.
This is largely the result of moving vaccines and other medical manufacturing processes offshore. A lack of skilled workers has, in part, contributed to the push toward offshoring in the past. With renewed interest in onshoring though, it is possible these trends could see a reversal.
Recovering supply chains amid global shutdowns
As nations around the world began to close their borders early on in the COVID-19 crisis, supply chains were at risk of being disrupted and drug shortages were inching closer to becoming a reality in the United States. The pharmaceutical supply chain was at a real risk of breaking at one point.
Data from the first four months of 2020 reveals that U.S. imports from China plummeted in February and March before recovering slightly in April. While large importers were able to maintain their relationships amid global shutdowns, smaller entities suffered. Evidence suggests that some U.S. importers are still struggling to fully replace their suppliers.
Recovering supply chains in the midst of the ongoing COVID-19 crisis requires specific strategies, especially where onshoring pharmaceutical manufacturing to the U.S. is involved. Some of the specific challenges this presents include:
- Lobbying against powerful pharmaceutical industry lobbyists on Capitol Hill
- Addressing the fact that onshoring may be much more costly than offshoring
- Disrupting already established global supply chains
- Ensuring consistent quality control across all pharmaceutical manufacturing facilities
To overcome the challenges associated with recovering supply chains and begin onshoring pharmaceutical manufacturing, determining key manufacturing activities that would benefit the most from onshoring is going to be critical.
Fortunately, a number of steps have already been taken to recover these supply chains. First, vaccine manufacturers have dedicated onshore facilities to the production and distribution of their products. Moderna and Pfizer, specifically, have taken great strides in shortening supply chains for critical vaccine production and distribution.
Moderna has dedicated manufacturing facilities in New Hampshire, Pennsylvania, and Indiana that are all working to create, pack, and ship vaccines. Pfizer has taken a similar approach to shorten its COVID-19 vaccine manufacturing supply chain. With manufacturing facilities in Kalamazoo, Michigan, distribution to other U.S. states is much more efficient.
In addition, vaccine manufacturers have expanded their relationships to ensure effective distribution practices. For example, Pfizer is working with the U.S. Postal Service (UPS) and FedEx to ensure each thermal box of vials is shipped safely and kept at the appropriate temperature. The expansion of the supply chain to government-funded organisations like UPS is a key strategic move in improving supply chain efficiency for vaccines.
Strategic moves like onshoring and working with large, government-funded organisations can drastically reduce the amount of time it takes to get vaccines in the hands of pharmacists across the nation. Implementing these changes might have taken a little bit of time, but they’re also our best bet to improve long-term performance by mitigating very real and very costly supply chain disruptions.
Quality control provides peace of mind
During a time when critical medical equipment (goggles, gloves, face shields, face masks, air-purifying respirators, etc.) is in high demand, offshoring has created a scarcity of these products. As a result, people may turn to homemade solutions that don’t have the same standards of quality control.
Shortening the supply chain is one thing, but cold chain distribution requires even more care and attention to detail. There is an urgent need for acceleration in the manufacturing process, but with acceleration can often come lapses in quality control. Manufacturing facilities, especially when producing pharmaceuticals and vaccines, must be held to strict quality standards. The Food and Drug Administration (FDA) is responsible for overseeing quality control, safety, and effectiveness of all drugs in the U.S., including those manufactured offshore. During the COVID-19 crisis, the FDA has limited both domestic and foreign inspections with employee safety in mind.
To combat this challenge, alternative inspection tools are available to ensure manufacturing quality remains consistent across the board. With COVID-19 still spreading rapidly, manufacturing facilities are taking steps to be even more vigilant about maintaining quality standards in their products.
When it comes to vaccine production and distribution, temperature consistency plays a major role in quality assurance. If vaccines aren’t packaged or shipped properly, they could be rendered useless. Medical refrigeration technology helps, but ultimately it’s the packaging that will ensure each vaccine stays intact and at the correct temperature. Most vaccines require refrigeration under 10 degrees Celsius while newer formulas can require refrigeration at temperatures of -70 degrees Celsius.
So, how is manufacturing saving vaccine production?
As we covered earlier, shortening the supply chain by onshoring critical manufacturing processes can help reduce time in transit for vaccines and provide more efficient means of distribution. Combined with excellent quality control and onshore supply chains, manufacturing could drastically help improve vaccine production and distribution.
Manufacturing is a large and varied industry, but there’s no denying that it’s a critical one. Pharmaceutical manufacturing is undergoing changes to ensure better vaccine production and distribution — we may even see more onshoring in the near future.
This article was originally published at Surplus Record.
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