Record Pace of Coronavirus Trials Could Be New Normal for Vaccines

(Bloomberg Law) -- A potential Covid-19 vaccine’s recording-breaking pace to clinical trial could become the new normal as researchers start looking for vaccines before new infections even break out.

The potential is there to break the decade-long timeline to develop new vaccines, making health professionals more nimble in the face of evolving threats. And it could have happened even sooner if the investment in studying SARS and MERS didn’t dry up when those outbreaks went away, scientists said.

The first clinical trial began March 16 for a candidate vaccine to guard against SARS-Cov-2, the novel coronavirus that causes Covid-19. An actual vaccine won’t be ready for another 12 to 18 months, but the announcement marks a new record in moving to human testing for a disease that nobody knew existed just a few months ago.

National Institutes of Health vaccine researcher Kizzmekia S. Corbett told National Institute of Allergy and Infectious Diseases Director Anthony S. Fauci it would take about 100 days to move into a clinical trial once scientists got the genetic sequence from their Chinese counterparts back in January.

They did it in 66.

‘The New Norm’

“I think that this could be the new norm,” Corbett, scientific lead for coronavirus vaccines team at NIAID, said of a 100-day timeline. “What we’re doing here is actually standardizing the thought process. Right? The thought that you could design a vaccine before a virus is even known to infect a human is something that people are going to have to start to think about.”

By comparison, it took about 20 months to develop a vaccine for the Severe Acute Respiratory Syndrome outbreak in 2002 to 2003. Historically, vaccine development takes 10 to 15 years, according to the History of Vaccines website created by the College of Physicians of Philadelphia.

“If this was five years ago, the process would take five years,” Corbett said.

‘Brilliant Organization’

She credited the speed to two things: including established clinical trials networks with academics across the country and collaborations with companies like Moderna Inc. that could be fired up immediately without having to wait months for contracts. Established relationships with the NIAID’s microbiology and infectious disease division, animal model specialists at various academic laboratories, industry partners, and the Food and Drug Administration were also critical, she said.

“What happened here was just brilliant organization,” Corbett said. “Other places might be thinking that we can do this alone, but you can’t. I don’t even think anyone should want the burden of saving the world alone.”

RNA-Based Vaccines

One of the keys to speeding up the process was a newer method for delivering and developing vaccines that rely on genetic sequencing instead of having to attenuate the virus and grow it in batches to develop a vaccine candidate.

“This is so simple in principle,” Vincent Racaniello, a Columbia University professor who studies how viruses interact with the immune system, said. A piece of RNA is encoded with tiny balls called lipid nanoparticles to stabilize the RNA, and then it’s injected into the body, he explained.

Fauci has been pushing greater adoption of these messenger RNA (mRNA) platforms for years. Novel vaccine technologies will be an essential part of responding to emerging viral diseases, Fauci and two colleagues wrote in the Journal of the American Medical Association two years ago. It was also the basis of his keynote address at the Infectious Disease Society’s annual conference in October.

Moderna, which partnered with NIAID on the vaccine, developed one of those platforms to rely on mRNA, or sets of instructions that direct cells to make proteins to fight off or prevent diseases.

Corbett calls it “plug and play,” taking knowledge about antigen design for cousin viruses such as SARS and MERS and applying those design concepts to the backbone of the spiked protein for the novel coronavirus.

Racaniello cautioned the vaccine is still in phase I testing, which studies a small population of healthy individuals for safety and immune response. It’s the larger phase II studies that will generate date to show if it works.

“If it does, it could be a paradigm shift,” Racaniello said. “It would be a great platform for pandemic newly emerging viruses because when some new virus pops up, you can respond really quickly, which of course doesn’t mean short circuit all the testing.”

When the Work Stopped

While 18 months to a vaccine would be a record, Racaniello said it could have happened more quickly if the work on SARS and MERS hadn’t dried up once those viruses went away.

“I think it’s great, but I also want to point out that we shouldn’t have to be catching up here because we weren’t prepared and we know SARS one was an issue,” he said. “There has to be a way to keep this kind of development going between pandemics. Otherwise we’re stuck rushing like we are now.”

Julie Gerberding, a Merck & Co. executive who led the Centers for Disease Control and Prevention during SARS, agreed.

“Something horrible happens and all of a sudden there’s a big supplemental investment,” she said. When that problem doesn’t seem so big, there are attempts to repurpose that money.

“We start something and we never finish it,” Gerberding said.

To contact the reporter on this story: Jeannie Baumann in Washington at jbaumann@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloomberglaw.com; Andrew Childers at achilders@bloomberglaw.com

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