Pharma's warp drive

Oct. 5, 2020
The key factors helping drugmakers develop a vaccine in record time

In the world of sci-fi fandom, a debate has long simmered about the possibility of traveling in hyper-speed like the Star Trek Enterprise, which could blast through space in “warp drive” — or, faster than the speed of light.

So when the time came to decide if pharma could move faster than ever before to develop a coronavirus vaccine, it’s perhaps no surprise that one of the industry’s top regulators drew from that idea and dubbed the White House’s vaccine initiative Operation Warp Speed (OWS).

Since being announced in April, OWS has doled out billions of dollars to help companies develop candidates, ramp up manufacturing and prepare distribution to meet the government’s lofty goal of delivering 300 million doses of a SARS-CoV-2 vaccine by January 2021. But as several drugmakers approach the finish line, concerns are also mounting that the industry could be moving too fast.

Although the flurry of action is aimed at shrinking the typical 10-year timeline for developing a new vaccine down to less than 18 months, Phyllis Arthur, vice president of Infectious Diseases and Diagnostics Policy at the Biotechnology Innovation Organization (BIO), argues that the process shouldn’t be called “rushed.” Rather than speeding through the clinical trials that test safety and efficacy, Arthur says that the FDA has come up with new efficiencies that streamline the often lengthy regulatory process.

Here are some of the key factors Arthur says are helping pharma along:

Master protocols: Instead of having each individual vaccine developer work directly with the FDA to create a protocol for their clinical trials, the agency has created a “master protocol” for all companies developing a SARS-CoV-2 vaccine. According to Arthur, the master protocol establishes uniform criteria for assays and primary endpoints that makes it easier to compare vaccines without having to do a head-to-head trial.

Earlier this year, the FDA also released a guidance to the industry called “Development and Licensure of Vaccines to Prevent COVID-19,” that explains what the requirements will be for a SARS-CoV-2 vaccine to be approved. In the guidance, the agency lists the parameters for chemistry, manufacturing and controls, toxicity studies and licensing, and standardizes primary endpoints for clinical trials.

With hundreds of coronavirus vaccines in development, Arthur says that these efforts to streamline the development of a vaccine have been critical to speeding the regulatory review process for companies in the hunt.

“Having regulators gain agreement across industry and across regulatory agencies on what all the companies would do the same [in clinical trials] was certainly helpful in speeding the research process,” Arthur says.

Clinical trial networks: Setting up clinical trials is an “arduous and complex set of activities,” Arthur says. In addition to finding trial sites and health care professionals, pharma companies also have to recruit enough participants.

So, the National Institutes of Health (NIH) has set up clinical trial networks that have helped streamline this process for vaccine developers. By working with a network of contract research organizations and other government agencies, the NIH has propped up a coronavirus vaccine trial network that now spreads to every corner of the country. Collaboration between the major arms of the government under OWS — including the NIH, the CDC, the FDA, BARDA and others — is also playing a critical role in creating a network of support for drug developers.

The NIH has also made it easier for drugmakers to find volunteers, which Arthur says is one of the longest parts of the clinical trials process. To sign up for a clinical trial, volunteers can now fill out an online application through the NIH website.

Arthur says that the NIH has also increased its outreach efforts to make sure that trials include volunteers with different ethnic backgrounds and underlying health conditions. These efforts have not only helped companies find enough volunteers to move them quickly through the different phases of clinical trials, it could also play a role in getting more people to take a coronavirus vaccine once one is approved.

“Doing outreach to communities of color and showing how clinical trials are done is one of the most important things to building trust and having the broadest reach,” Arthur says.

Long-term follow-up: Although the industry has been aided by these new efficiencies, there’s no getting around the fact that in order to develop, test, manufacture and distribute a vaccine by the target date set by OWS, pharma companies won’t be able to conduct long-term safety studies before approval.

“There is going to be less long-term safety data than what you would see with vaccines in the past,” Arthur admits.

But serious side effects associated with vaccines are rare. Companies will also be expected to conduct post-market safety analysis of their vaccine if it’s approved, and Arthur says there is a “very strong commitment among regulators to robustly follow-up on these vaccines.”

Arthur also argues that people should consider the unique nature of the situation.

“It’s important to note that this is a pandemic,” she says. “You have to think about it in terms of a risk/benefit ratio, and especially consider the risks of an unknown pathogen and its bad outcomes on individuals, the community and the economy.”

Although Arthur acknowledges that questions and concerns about safety should be addressed, she also contends that approving a vaccine before long-term safety studies can be conducted is not a “short cut” — it’s a tradeoff.

“I think that people are right to ask these questions,” she says. “But my question is: How long do you want to live in this pandemic state? That is the tradeoff that needs to be made.”

About the Author

Meagan Parrish | Senior Editor

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