Search our Blog

Search our Blog

Friday, May 29, 2020

COVID-19 Treatment, Vaccines Update



As Americans long for a return to normalcy in the wake of the pandemic, a variety of treatment and vaccine candidates for the coronavirus are showing promise.


We all yearn to go to restaurants again, to work out at the gym, to go to a concert or get together with friends without thinking about an imaginary six-foot ring. Some states are starting to reopen, but nobody will be able to rest easy until a reliable vaccine is developed or at least an effective treatment can allow us to avoid thinking the worst. New information seems to come out daily, but where are we really? 

Treatments


Farther along than you might think, it turns out. Let’s start with treatments for COVID-19. Fortunately, a handful of drugs that have been developed to ameliorate the symptoms produced by other diseases are finding initial success against the coronavirus. Some may be familiar to you, others not so much.

  • Remdesivir. The drug continues to look promising after several small studies. Allowed on a “compassionate use” program that fast-tracks likely treatments, the majority of a 53-person trial “demonstrated clinical improvement and no new safety signals were identified,” according to maker Gilead Sciences. While more studies need to be done, the company is ramping up production to treat more than half a million patients by October and twice that by December.
  • Kevzara. Currently approved to treat immune disorders like rheumatoid arthritis, Kevzara may reduce COVID-19’s damage to lungs by stifling the body’s overreaction to the virus. Suppressing the immune system may allow some individuals to avoid ventilation and recover faster. A partnership between Regeneron Pharmaceuticals and Sanofi, the drug is currently in U.S. trials that were anticipated to include as many as 400 patients.
  • Baricitinib. Another immunosuppressant drug, baricitinib is currently under study with hospitalized patients in the U.S. Maker Eli Lilly hopes its anti-inflammatory properties could ease symptoms. The study will expand abroad, with results anticipated at the end of June. 
  • Famotidine. A common medication for heartburn, famotidine is in a trial with 200 patients receiving a daily dose nine times the amount used to treat heartburn in common over-the-counter medications like Pepcid. COVID-19 patients receive the drug intravenously, rather than by mouth. Conducted by Northwell Health at the Feinstein Institutes for Medical Research, the trial is only one of several underway at the hospital, which is also looking at remdesivir and sarilumab, another drug approved to treat arthritis.
  • Chloroquine, derivative hydroxychloroquine. Anti-malaria drug chloroquine and sister drug hydroxychloroquine were among the first to be touted as a possible treatments for the coronavirus, but a recent study in Brazil was cut short after several patients developed irregular heartbeats and more than 20 died after taking daily doses. The findings serve as a cautionary tale after the drug was upheld by the president as a potential “game changer” before adequate testing. While it is approved to treat auto-immune diseases such as Lupus and rheumatoid arthritis, serious side effects include arrhythmia and muscle weakness, and the drug is toxic at high doses.
  • Lopinavir and ritonavir. Part of what the World Health Organization (WHO) terms a “solidarity study,” these drugs and some of those mentioned above are involved in studies in 90 countries around the world. These two (used together) inhibit an enzyme that the coronavirus needs to survive. So far, results are not promising.




Antibody Tests Not Ready


Anyone who’s had the virus is anxious to get a coronavirus “passport” signifying that he or she is cleared to go anywhere, anytime, and around anyone. The theory is that once you’ve had the disease, antibodies circulating in your body will keep you protected against exposure to positive individuals for some time, perhaps years. And since you can’t get the coronavirus, you won’t be passing it along to anyone, either. Not so fast.

For one thing, there isn’t yet a test available that is reliable enough to use. While companies are working toward one that gives proven results, experts warn that current tests “may give a false reading and put you, your family or others at risk,” according to John Newton, the UK’s testing coordinator. He adds. “As soon as we have found a test that works for this purpose, we will be in a position to roll them out across the country as a back-to-work test.”

A study of 12 antibody tests in the U.S. performed by the COVID-19 Testing Project showed that one gave false positives more than 15% of the time, and three others gave false positives more than 10% of the time. “That’s terrible. That’s really terrible.” says Dr. Caryn Bern, one of the study authors. She notes that while no test is perfect, an acceptable rate must be less than 5%, and preferably under 2%.


Vaccines

 
The world is waiting for a vaccine, possibly followed by a booster dose, that will eliminate fear of the coronavirus for anyone who gets immunized. But scientists actually think a variety of vaccines will be created to battle the virus. 

“Ultimately, there will be more than one vaccine,” according to Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine and co-director of the Texas Children’s Hospital Center for Vaccine Development, where he is working on a COVID-19 vaccine. “There could be several vaccines that have different uses. Some vaccines might be used for older Americans at risk of disease or those with underlying comorbid conditions like diabetes or obesity. There might be some use for younger adults. Maybe some for health-care workers. Same with the other technologies that we’re talking about, like remdesivir, there may be a prophylactic use for it as well. All of this is being accelerated through a lot of studies in parallel and we’ll have to see how the target product profiles will look.”

As the coronavirus destroys economies and livelihoods, laboratories around the world are hard at work to get products out in record time. Here are several leading candidates, followed by some lesser-known contenders.

  • Oxford University shocked many medical professionals when it announced it may have a vaccine that will be “widely available” by September. Researchers there had already been working on a vaccine for a similar virus, so they were able to pivot quickly to COVID-19. “Well personally I have a high degree of confidence about this vaccine, because it’s technology that I’ve used before,” says Sarah Gilbert, professor of vaccinology at the university. It’s already been found effective in animal trials and is currently being tested in humans. Before that study is complete, millions of doses will be produced in hopes of success.
  • Johnson & Johnson has announced that it, too, is about to begin production of a its vaccine on an “at risk” basis, i.e. before it’s proven to work. It will be made at a facility in the Netherlands and here in the U.S. J&J partnered with subsidiary Janssen Vaccines & Prevention B.V. back in January, working with a drug platform that had been developed for Ebola, Zika and influenza.
  • Moderna biotech has a vaccine candidate that recently was approved for further testing. Phase 2 will begin in the second quarter to evaluate safety, adverse reactions and efficacy of two vaccinations given 28 days apart. It will involve about 600 healthy adults and older adults. A third phase could start in the fall. 
  • Dynavax Technologies Corporation is making its adjuvant technology available to other companies. The tech boosts immune response to a vaccine. In addition, Dynavax has partnered with the University of Queensland, Australia, on a coronavirus vaccine of its own.
  • GlaxoSmithKline is also allowing access of its vaccine adjuvant platform technology, which strengthens the response to a vaccine and decreases the amount needed per dose.
  • Heat Biologics, in partnership with the University of Miami Miller School of Medicine, is in the preclinical stage of vaccine development.
  • Inovio Pharmaceuticals is in a Phase 1 trial of its DNA-based vaccine that is backed by a $5 million grant from the Bill & Melinda Gates Foundation. It has launched human trials in the U.S., China and South Korea with 3,000 doses of the vaccine. It expects to have 1 million doses ready for further testing or emergency use by year’s end.
  • Novavax has developed several vaccine candidates. The preclinical biotech expects at least one Phase 1 trial to start this month, with results to begin coming out in July. 
  • Vaxart announced plans to work on a vaccine back in January, and it’s developing an oral vaccine in the form of a room-temperature stable pill. Such a product would offer enormous advantages over injectables, which are normally refrigerated.

Whether or not a vaccine is available by the fall, it may be longer until it’s in widespread use. “Our vaccine could be ready by the fall as well,” says Dr. Hotez. “We’ll have up to 200,000 doses. But unless you’ve shown that it actually works and unless you’ve shown that it’s safe, you’re not going to do that (make it widely available). Without having the efficacy and safety data, I think you have to be really careful about bold statements (about having a vaccine ready this year). As I often like to say, these nucleic acid vaccines have been around for 30 years and offer great promise, they work in laboratory animals, but, historically, they have not worked well in people. Maybe now there’s been modifications to improve that. Let’s wait and see.”

So, the jury’s still out on both treatments and vaccines for now. But scientists are working around the clock to treat and prevent the coronavirus. That’s good news for a weary world that is looking for hope and a return to socializing with friends. It may not come this summer, but the future is looking brighter all the time.

Sources:

https://www.cnbc.com/2020/04/28/stock-market-futures-open-to-close-news.html?__source=iosappshare%7Ccom.apple.UIKit.activity.Mail
https://www.marketwatch.com/story/modernas-coronavirus-vaccine-candidate-advances-to-next-stage-of-testing-2020-04-27
https://nymag.com/intelligencer/2020/04/what-to-expect-from-the-race-to-develop-coronavirus-vaccines.html
https://www.bbc.com/news/uk-52335210
https://www.cnbc.com/2020/04/18/the-stock-market-is-rising-on-hope-for-a-pharma-solution-to-coronavirus-heres-how-close-we-are.html?__source=iosappshare%7Ccom.apple.UIKit.activity.Mail
https://finance.yahoo.com/news/jj-coronavirus-vaccine-we-plan-to-begin-production-at-risk-imminently-210204457.html
https://www.cbsnews.com/news/coronavirus-vaccine-oxford-university-scientists-september/
https://www.cbsnews.com/live-updates/coronavirus-latest-updates-2020-04-29/
https://www.cnbc.com/2020/04/28/heartburn-drug-trial-shows-reasonable-confidence-famotidine-could-help-treat-coronavirus-hospital-ceo-says-.html?__twitter_impression=true&recirc=taboolainternal 




Blog posting provided by Society of Certified Senior Advisors