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Along with COVID-19 vaccines, Operation Warp Speed also accelerates the development, manufacturing and distribution of therapeutics to treat those who are suffering from the disease.
“It is an incredibly exciting time for therapeutics,” said Operation Warp Speed’s Deputy Lead for Therapeutics Col. Deydre Teyhen. While vaccines aim to prevent the disease, therapeutics treat those who have tested positive for COVID-19.
The FDA has granted several Emergency Use Authorizations for treatments - and other drugs are in various stages of clinical trials in the hopes they will provide relief for those who need it most.
“For COVID-19, we’re really looking at two main types of therapeutics – those that attack the virus and those that help manage the complications that come with COVID-19,” Teyhen said.
Research is ongoing and trials need a diverse patient population to voluntarily participate. Teyhen said hospitalized patients will be approached with the necessary information if their hospital is taking part in a study.
Those who are not hospitalized and test positive can seek clinical trial information at RiseAboveCovid.org or CombatCovid.hhs.gov.
The FDA has granted Emergency Use Authorization for convalescent plasma, drugs and drug combinations targeted specifically for inpatient or outpatient treatment.
Therapeutics that attack the virus include remdesivir, which now has full FDA approval and is shown to shorten hospital stays. For those who are not hospitalized, monoclonal antibodies are laboratory-made proteins that are showing promising results in outpatients who receive the treatment within 10 days of symptom onset.
Many of the drugs have names that are long and unwieldy. Teyhen explained the naming convention is designed to avoid confusion and medical errors. Those that end in “mab” are monoclonal antibodies.
To lessen the complications from COVID-19, Teyhen said researchers are looking at both monoclonal and polyclonal antibodies, antivirals and corticosteroids.
Not everyone is a candidate for therapeutics, Teyhen explained.
“The monoclonal antibody treatments are designed for those who have the highest risk for hospitalization,” Teyhen said. “Early evidence is incredibly encouraging that this treatment can keep those people out of the hospital.”
Operation Warp Speed fast-tracked the production of COVID-19 vaccine candidates by ramping up manufacturing, supporting research and taking a risk on production.
The operation is using a similar approach when it comes to therapeutics – namely in taking a risk to simultaneously support drug production while the research takes place on a parallel track. As with the vaccine candidates, therapeutic candidates endure the same rigor and scrutiny the FDA applies to any drug.
“I liken it to the Super Bowl T-shirt concept,” Teyhen said. “The day after the Super Bowl, championship merchandise is available, regardless of who won. It is because they produced products for both teams – but only the winner’s goods hit the streets.”
Allocations and distribution of the newest authorized treatments are based on the number of cases within a jurisdiction along with the number of hospitalizations.
Teyhen said the U.S. Department of Health and Human Services is using an algorithm to determine how to distribute the therapeutics fairly and equitably. Those allocations are publicly available and updated weekly on the HHS website.
| Date Taken: | 11.27.2020 |
| Date Posted: | 11.27.2020 12:12 |
| Story ID: | 383882 |
| Location: | US |
| Web Views: | 290 |
| Downloads: | 2 |
This work, Not just vaccines – operation fast-tracks treatments too, by Lisa Simunaci, identified by DVIDS, must comply with the restrictions shown on https://www.dvidshub.net/about/copyright.
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