Medical experts are warning the US could face a major public health crisis if a new drug called Liberty Hospital gown fails to curb coronaviruses in a large-scale outbreak.
The coronaviral-preventing drug Liberty is being used by thousands of people in hospitals across the US as part of a national vaccination programme.
In the first case in more than a decade, a person with the coronavillae-causing strain of the coronavectavirus died of a brain haemorrhage in an Atlanta hospital.
However, Liberty has been plagued by problems with the production of its first batch of drugs.
Liberty was supposed to be rolled out nationwide in March, but the US Food and Drug Administration (FDA) is still not allowed to sell it to people who have been vaccinated, according to a report published by the American Journal of Public Health (AJPH).
“In the absence of FDA approval, it would be extremely difficult for Liberty to produce Liberty Hospital Dress, or any other drug of similar potency, in the United States,” said Dr Michael Reichert, director of the infectious diseases and immunology division at the University of California, San Francisco.
“Liberty has had a poor manufacturing history, and it will be difficult to convince the FDA that Liberty has a much better safety record than other competing products.”
The FDA is currently investigating Liberty and will decide whether it should approve the drug within a month.
It is unclear if Liberty’s first batch is in production.
While Liberty has not been approved for use in the West, the company has been able to sell millions of doses of the drug in Europe, according the AJPH.
For a coronavecovirus outbreak, the first step is for people to be vaccinated, said Dr Reichter.
Then, if the virus is not contained in a hospital, it is important for the first stage of infection to be controlled.
Because Liberty is a novel drug, it cannot be used in a clinical trial.
Instead, the drug is used in an experimental vaccine that is supposed to help with the virus.
As a result, Liberty was supposed be ready to be distributed nationwide in February.
But the drug was never distributed in a US trial because it was deemed to be too expensive and too difficult to administer, Dr Reichter told the BBC.
“Liberia is a drug that will not be used by anyone with a diagnosis of acute or chronic acute respiratory syndrome (CRS),” Dr Reichelt said.
Its approval is still a long way off.
Despite its delays, Dr David Begg, a professor of medicine at the Johns Hopkins Bloomberg School of Public Policy, said Liberty was “the biggest unknown” about the coronaves outbreak.
“The drug is supposed be available as soon as the FDA approves it, and the FDA has not announced when that is going to happen,” he said.
“But it could take as long as six months for them to approve it.”
The US Food & Drug Administration is expected to announce its approval of Liberty by the end of the year.
If Liberty does not make it into a clinical test, there is a chance that the drug could not be made available to people, Dr Begg said.
This could lead to an epidemic in the country, with many coronavids still causing significant morbidity and mortality.
Dr Reichett said there was also a possibility that Liberty could not protect people against coronavuses that could infect the brain.
He said Liberty could be a “catalyst” for more severe coronavivirus outbreaks that occur in people who do not have the disease.
“That is a concern,” he told the ABC.
An outbreak of coronavii could take the lives of thousands of Americans.
Dr Reichets warning comes as the US National Institute of Allergy and Infectious Diseases (NIAID) has warned that coronaviremia could lead the country into an epidemic.
This week, the agency also warned that the coronovirus was “a serious global public health problem”, as people were not properly vaccinated.
Cases have increased in recent weeks as coronavides were given an increased dose in the form of nasal sprays.
Health officials have said coronavicide-related deaths are increasing.
There have been nearly 5,000 reported cases of coronivirus in the Americas, the highest level of the pandemic.