US vaccine manufacturing capacity assessed at Senate HELP Committee hearing

By June 26, 2020

At the Senate Health, Education, Labor, and Pensions Committee hearing on Tuesday, Members of Congress and witnesses evaluated whether the U.S. will be able to manufacture enough COVID-19 vaccines to protect the population, as well as be able to distribute them equitably. Vaccine manufacturers are racing to increase their capacity to produce what will likely be billions of doses, but it might take months to years from when the vaccine is approved to produce enough doses to vaccinate the number of people necessary (about 70% of the world’s population) to achieve herd immunity.

Infrastructure for producing vaccines

Committee Chair Lamar Alexander (R, TN) asked witnesses for recommendations on what type of manufacturing capacity the federal government should have on hand to produce and distribute doses of a potential COVID-19 vaccine. Former Governor of Utah Michael Leavitt explained (1:03:30) that while the infrastructure exists to scale up U.S. vaccine manufacturing capacity, the plants were not effectively maintained after they were built. Additionally, maintaining such manufacturing facilities costs a significant amount of money, and, prior to the pandemic, pharmaceutical companies were reluctant to spend so much on facilities that are specific to only one vaccine, which may not ultimately be approved or sold.

Dr. Julie Gerberding, Executive Vice President of Merck & Co., added (1:05:00) that most pharmaceutical companies manufacturing large quantities of vaccines are nearly at capacity producing doses of other vaccines, such as those for the flu. Moderna’s CEO, Stephane Bancel, who is overseeing one of the leading experimental COVID-19 vaccine efforts, mentioned this problem in a May 12 interview with CNBC. He stated, “The odds that every [vaccine] program works are really low, obviously, but I really hope we have three, four, five vaccines, because no manufacturer can make enough doses for the planet.” To put this in perspective, pharmaceutical companies estimated they provided between 162 to 169 million doses of the flu vaccine for the U.S. during the 2019-2020 flu season. To protect the U.S. population from COVID-19, about 230 million Americans would have to be vaccinated. This also does not account for the possibility that each person may need multiple doses to be fully vaccinated or the fact that many manufacturers in the U.S. supply vaccines to other countries.

Besides overall capacity, one of the largest challenges is that the manufacturing infrastructure will differ depending on which type of vaccine(s) are the most effective. The vaccines may need to be produced by processes requiring large vats of cells or other organisms, such as tobacco plants. If a successful vaccine is based on inactivated virus, vaccine production might require highly secure facilities, of which there are very few. This means that until one or more vaccine candidates are closer to being approved by the Food and Drug Administration (FDA), vaccine manufacturers will have a difficult time tailoring their existing facilities, or building new ones, that have the necessary equipment ready to produce the vaccines.

Some pharmaceutical companies are relying on public-private partnerships to develop and scale their vaccines, such as Johnson & Johnson with the Biomedical Advanced Research and Development Authority (BARDA). These flexible agreements allow the federal government to help the pharmaceutical companies invest money and talent into the most promising vaccine candidates. They also make it possible for companies to overhaul their production facilities and build new ones to accommodate the new vaccines, a complex and costly process for these organizations by themselves.

Equitable distribution of a potential COVID-19 vaccine

Even if companies are able to develop and produce enough doses of a COVID-19 vaccine, there are concerns that the doses may not be distributed equitably among the global population. For example, during the 2009 H1N1 pandemic, Australia was the first to manufacture a vaccine but did not export it immediately because it wanted to inoculate its citizens first. Additionally, wealthier countries have the advantage of being able to purchase large quantities of vaccines at much higher rates than countries with fewer resources.

However, even in wealthy countries like the U.S., care must be taken to ensure that vaccines get to the country’s most vulnerable communities. The pandemic has devastated minority communities in cities across the country due to deep-seated public health disparities. Dr. Joneigh Khaldun, Chief Medical Executive for the Michigan Department of Health and Human Services, noted (1:06:40) during her testimony that people of color are more likely to be impoverished and more likely work in occupations that are deemed essential, but they also have the least access to healthcare. Both Dr. Khaldun (45:25) and former Governor Leavitt (40:20) emphasized that the U.S. should develop a national procurement and distribution strategy not only to reduce the competition for vaccines, but also competition for supplies in future pandemics.

Currently, pharmaceutical companies are working to adapt their vaccine manufacturing facilities to accommodate the production of the large number of doses that will be needed to protect against COVID-19, but they have a long way to go. As Chair Alexander noted (2:50:00), Congress will be reviewing the U.S. response to COVID-19 regularly, so stay tuned for more opportunities to engage with Capitol Hill.

To review the full hearing, click here.