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.
Treatments
- 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 ReadyAnyone 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
- 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.