A top Wall Street analyst sees less than a 20% chance of having a widely available coronavirus vaccine in 2021 - he told us why he's 'deeply skeptical' of Anthony Fauci's 18-month timeline
- The idea of having a coronavirus vaccine ready within 18 months has been widely accepted by many federal officials and lawmakers, as well as investors.
- But one top Wall Street biotech analyst told Business Insider that he is "deeply skeptical" about this timeline.
- SVB Leerink analyst Geoffrey Porges sees a less than 20% chance that we will have a widely available vaccine that is proven effective in 2021.
- Porges said no one has given a detailed timeline that tackles all the testing, regulatory, and manufacturing challenges facing a vaccine candidate.
- "No one's done all those pieces and then said 18 months," Porges said. "They've just effectively taken Tony Fauci's 'not for 18 months' and that's become gospel."
- Porges has covered the industry for nearly two decades and previously worked in the vaccine business for one of the world's largest drugmakers.
- Visit Business Insider's homepage for more stories.
It'll likely take a vaccine for life to get back to 'normal' after the coronavirus pandemic.
Dozens of research programs are now underway to develop a vaccine for this crisis. Vaccines have historically faced costly, multiyear development timelines, but there's widespread optimism that the urgency of this pandemic will speed up the process this time.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, has repeatedly stated it will take at least a year to 18 months to make a vaccine available.
"Ultimately, the answer is going to be a vaccine he said in a recent interview.
That timetable may sound cautious, but it's actually optimistic by historical standards. And one top Wall Street biotech analyst, who used to work in the vaccines business, is "deeply skeptical "of this 18-month timeline.
Geoffrey Porges, an analyst at SVB Leerink, told Business Insider he predicts a less than 20% chance we have an effective, widely available vaccine in 2021.
Porges has covered the biotech industry for 18 years for various research firms. Before that, he worked in the drug industry on vaccines, spending six years in the vaccine unit of Merck, one of the world's largest drugmakers. He also has a medical degree from the University of Sydney.
Porges said no one has laid out a detailed timeline of all the testing, manufacturing, and regulatory hurdles that come before we can have a coronavirus vaccine that's widely available.
"No one's done all those pieces and then said 18 months," Porges said. "They've just effectively taken Tony Fauci's 'not for 18 months' and that's become gospel."
"There is now a gospel around vaccines that the market, the economy and policymakers are reliant on, and there is just no substance to it," he added.
Other prominent leaders have echoed Fauci's timeline. Melinda Gates said there's a "high likelihood" that we have a vaccine in 18 months. New York Gov. Andrew Cuomo has also stated a vaccine is 18 months away.
But people with in-depth experience of developing vaccines are more skeptical of that timeline.
Dr. Paul Offit, who helped invent the rotavirus vaccine, told CNN that timeline is "ridiculously optimistic." Peter Hotez, dean of Baylor University's National School of Tropical Medicine, told National Geographic the 18-month timeline "would be absolutely unprecedented."
We still don't know a lot about this virus, leaving vaccine developers to take 'shots in the dark'
Porges predicted there is less than a 20% chance there is a widely available vaccine proven to be effective in 2021. Even by 2023, he estimates the likelihood of achieving that to a coin toss, or 50%.
Vaccine efforts are like shots in the dark against this virus, he said, emphasizing how much we still don't know about this novel coronavirus.
The critical unknowns are focused on the body's reaction to being infected with the virus. The body responds to the virus by making antibodies, which are proteins crafted to fight it off.
Understanding how the body's immune system responds to the virus is important to the effort to craft a vaccine, because the vaccine will likely work by triggering these same immune responses, without causing an infection. If the virus doesn't trigger the production of long-lasting antibodies, it may be difficult to craft a vaccine, for example.
We need to better understand how robust the immune response is, how protective it is against reinfection, and how long-lasting this protection is, Porges said.
"In the case of this coronavirus, the answer to all of those questions right now is we don't know," he said, adding that research is now "narrowing the bounds of uncertainty" on the answers.
The immune response to the virus seems to track with the severity of the disease. As Porges put it simply, an emerging theory is that asymptomatic or mild cases of COVID-19 generate bad immunity, while severe disease brings good immunity.
A small study from China found nearly one-third of people who recovered from mild infections had low or undetectable levels of antibodies. About 6% had no detectable antibodies in their systems.
"The immune response to this virus is squishy," he said. "It's not robust."
It's also unclear if having these antibodies even protects people. China and Japan have both reported COVID-19 patients that have been discharged after recovering and subsequently tested positive. A recent overview in the Journal of the American Medical Association said "the evidence on reinfection is evolving," cautioning those reports may be false positives.
Finally, how long this antibody protection lasts may be the biggest black box for this virus. Porges put it bluntly: "We have no idea."
Other coronaviruses have shown a wide range in lasting immunity. Seasonal coronaviruses, responsible for common colds, generate antibodies that bring immunity for months, instead of years. But the 2002-2003 SARS outbreak generated a durable immune response that lasted for years.
"My instinct is it is likely to be durable if you've had significant infection," he said.
An effective vaccine still faces a massive distribution challenge in addressing a pandemic
Large-scale clinical testing will figure out if a vaccine works. Typically, these trials take years, but researchers are now working to devise ways to shorten the process.
Even if the testing determines a vaccine is safe and effective, the next problem is manufacturing enough product for a pandemic.
"The idea of producing billions is a challenge," said David Weiner, the director of the Wistar Institute's vaccine and immunotherapy center and a longtime vaccine developer.
Weiner is a cofounder and board member of Inovio Pharmaceuticals, which is now testing a coronavirus vaccine in humans. He argued that mass manufacturing has to start being ramped up now to meet the 18-month timeline.
"If you want to have that possibility, then that production has to to be funded now," he said.
That echoes what Bill Gates recently outlined: the need to build manufacturing plants for multiple vaccine candidates, knowing several of those facilities likely won't be used. The sunk cost is worth it, Gates said, in order to be prepared.
Gates' foundation is funding several vaccine efforts, including Inovio's. But it remains to be seen how these companies will raise the billions of dollars needed to all scale up manufacturing.
It's possible that the coronavirus could be 'just too hard to vaccinate against'
There are lots of diseases that take massive tolls on society and don't have vaccines. Many of them are RNA viruses, just like the novel coronavirus.
"It's not a foregone conclusion we will have an effective vaccine," Porges said, later adding that "each one of these vaccines is a shot in the dark."
Weiner pointed out that other RNA viruses like HIV and Hepatitis C are extremely variable pathogens. In contrast, this coronavirus has been slow to mutate, increasing the chances we can come up with a workable vaccine, he said.
There's also the potential that a vaccine doesn't prevent infections but could lower the risk of developing severe disease. This mixed efficacy would be similar to the flu vaccine.
"If it doesn't prevent for infection, and it still prevents for serious disease, it's still very valuable," Johnson & Johnson Chief Scientific Officer Paul Stoffels said in a recent interview with Business Insider.
Vaccine data will start to trickle in, although Porges questions the significance
Even with these challenges, vaccine efforts are moving ahead at record speed. The upstart biotech Moderna leads the early race, having started dosing healthy volunteers with an experimental vaccine about a month ago.
Moderna CEO Stephane Bancel outlined a development strategy to be prepared to deploy its vaccine in an emergency use situation this fall.
Porges said he's skeptical of that timeline, particularly in the ability to generate convincing data by then on whether the vaccine works.
Moderna plans to have safety data from its small initial study later this spring. That will help the company design a subsequent larger trial that would help show if the vaccine is activating people's immune systems.
In that case, Porges wondered what it will mean if the mid-stage study shows the vaccine produced a level of neutralizing antibodies in people. Porges said we still don't know how well that correlates with protection.
"In the absence of that clinical correlation, if we release this into society and give it to thousands who are desperate, do they say, 'I'm protected?' he said. "Or do they just say 'I've got neutralizing antibody?' Until you establish a correlation between a level of antibody and clinical protection, you're just creating a mess."
Some may wonder why all this matters, given the urgency of the pandemic. Why not just give people the best chance we have at protection? But the history of vaccines shows why the regulatory path is a long and difficult one.
Vaccines face a particularly high safety bar because they're widely distributed to healthy people.
Safety problems are littered through vaccine history. These are legitimate, unlike the debunked theory of vaccines causing autism, for instance, that have driven an anti-vaccine movement.
In the 1950s, several thousand children were given a potential polio vaccine that accidentally contained the live virus, paralyzing some of the kids. In the 1970s, a mass vaccination against the swine flu was stopped early, but not before several hundred people developed a rare neurological disorder called Guillain-Barre syndrome.
Even in 2009, several European countries used an H1N1 flu vaccine that was later found to increase the risk of narcolepsy, according to the Centers for Disease Control and Prevention.
Rigorous clinical testing will help lower the risk of a similar situation happening with a coronavirus vaccine. But that testing requires time, which may stretch beyond an 18-month timeline.
Featured Health Articles:
- Telehealth Industry Explained
- Value-Based Care Explained
- Senior Care & Assisted Living Market
- Smart Medical Devices & Wearable Tech
- AI in Healthcare
- Remote Patient Monitoring Explained- AI in Medical Diagnosis Systems