Vaccine Production: A Fraught Rush to Market

In mid-May there was a big announcement regarding the development of a vaccine for COVID-19. Moderna, the pharmaceutical company at the head of the race, released a statement saying the results from phase 1 clinical trials were positive. The patients in the trial had similar concentrations of antibodies in their blood to those that have recovered from COVID-19, which may be an early sign of a successful vaccine for this novel coronavirus. 

There is no doubt that vaccines are a necessary medical advancement, and are essential for saving lives. They give patients immunity to a particular virus or bacteria, and when the majority of the population is vaccinated, those in the population who can’t get the vaccine are still protected by herd immunity. Without vaccines, many more lives all over the world would be lost to infections like smallpox, rabies, measles, or polio. And without a vaccine for COVID-19, the daily onslaught of infections, hospitalizations and death continues.

But, as recently stated by the World Health Organization (WHO), there is no evidence to suggest that recovered patients have immunity against reinfection of COVID-19. Although researchers still do not know why, antibody concentrations from recovered patients vary widely. We also do not know what concentration of antibodies are needed to grant immunity to patients. 

After stepping down from his previous role as a member of the board of directors for Moderna, the newly appointed vaccine czar and chief scientist for Trump’s “Operation Warp Speed,” Moncef Slaoui promised the president that there will be hundreds of millions of vaccines available by the end of the year. It sounds like exactly what we need right now.

But, developing a vaccine in 12-18 months would be totally unprecedented. Vaccines take an average of almost 11 years to develop, and for good reason. It’s a medicine that’s designed to be given to wide sections of the population through an injection into the body. If something goes wrong in the production process, people could have negative reactions or even die. An Oxford study last year outlined just how hard it is to create a safe and effective vaccine under pre-pandemic conditions. Novel vaccines that have successfully reached clinical trials only have a 33% success rate. There is a lot of room for error in the production of vaccines and medicines. When the polio vaccine was developed in 1955, there was a defect in the manufacturing process which ended up giving 40,000 people polio instead of giving them immunity.

Moderna has been at the forefront of vaccine production in the U.S. for a few reasons. The FDA is helping to speed the entire process by giving a fast-track designation to their vaccine candidate, SARS-CoV-2 by skipping phase 1. Moderna is bypassing a major part of clinical trials, not testing on animals before going straight into testing human subjects. The pharmaceutical company argued that research they’ve done on a vaccine for MERS-CoV, a virus in the same family as COVID-19, is similar enough that they can use the data from that trial for this one. No other vaccine in the running has received this approval from the FDA. Moderna has also been awarded $483 million from the federal agency Biomedical Advanced Research and Development Authority (BARDA), which gives it a significant boost over other pharmaceutical companies working on their vaccine for COVID-19. Rushing through a process like creating a vaccine is as safe as rushing through open heart surgery.

Vaccine prices in the U.S., as well as health care overall, have ballooned over the past decades. In fact, the New York Times reported that from the years 1986 to 2014, the average immunization schedule rose from $100 to $2,000. Through the Bayh-Dole Act of 1980, the U.S. government reserves the right to ownership in patents for inventions created through federal funding. Although there has been a law on the books for several decades to protect the population from price gouging of products created through our tax dollars, the government rarely flexes its muscle and retains the patent rights on these products. Moderna stands to gain a lot from the development of this vaccine, especially if the market is left to determine the optimal price of such a life-saving vaccine. The CEO for Moderna recently proposed vaccine prices similar to those of other respiratory-virus vaccines, which is to say around $200 for each shot

Public funding by way of federal grants is the bread and butter of nearly all pharmaceutical research in the U.S. Without this funding, the private sector would deem all drugs and therapies too expensive to invest “their” money in. The development of life-saving drugs, therapies and vaccines would stagnate due to lack of innovation. There were 210 new drugs approved by the FDA from the years 2010-2016, and all of the pharma companies that developed them received funding from the National Institute of Health (NIH). 

Of course, we are in a race to create a vaccine to fight COVID-19, in order to save tens of thousands and perhaps hundreds of thousands of lives, but with the profit motive at work, and a government promoting these corporations, it is very hard to untangle what is being done to promote a particular company’s profits, and what is being done to save lives.

Just like everything in life, if you rush things, you’ll make mistakes.

Addendum:

Since this was written it was revealed that one of the people involved in the trial admitted that he experienced an adverse reaction to the vaccine. Trial volunteer Ian Haydon, a 29-year-old in Seattle, had a fever and later fainted after taking the vaccine. He is one of three people to have had an adverse reaction to his second dose.

According Matthew Herper writing for CNBC, “He supports the trial, but decided to speak now because he hopes his story counterbalances the desperation that some people feel to push a vaccine to market regardless of the consequences.” Haydon points out that the whole purpose of the study he was in, known as a Phase 1 clinical trial, is to find the right dose of the vaccine going forward. That means to find a dose that causes the body to produce antibodies, but does not result in too many side effects.

“As we rush to get a vaccine developed as quickly as possible, the reality of vaccine development is that it can only be rushed so much and the trial still needs to take place,” Haydon said. “They have to move at the speed they move at. And stories like what happened to me, they matter because they shape the approval process.”

At the same time, the price of Moderna’s stock jumped 30 percent.

Featured image credit: Alex Hogan / STAT