Long-time director of the National Institutes of Health, Francis Collins, and other top Biden advisors, such as infectious disease expert Anthony Fauci and David Kessler, who directs vaccine distribution, have been looking for effective early Covid-19 therapies high Priority given to three senior health officials. President Joe Biden’s advisors outlined a $ 3.2 billion plan during the transition to fund more research, particularly regarding antiviral treatments that could contain early disease, one of the officials said. The plan was included in the $ 1.9 trillion Covid relief package that Congress passed this spring.
However, effective Covid treatments have proven to be an elusive goal. The Department of Health’s early countermeasures funding agency, the Biomedical Advanced Research and Development Authority, suspended calls for new therapies in May, partly due to tight budgets that a senior HHS official said could be with dollars from the American rescue plan HR 1319 (117). Previous attempts have given mixed results from a number of potential products. BARDA continues to fund nine ongoing projects, eight of which target more severe Covid cases. Only one early project on potential antiviral formulas targets mild illnesses.
There are some therapies for more common ailments like seasonal flu. However, effective antivirals are hard to find: those approved for use are imperfect and, in some cases, difficult to administer. For example, Tamiflu can only be given in the correct window to prevent patients from being hospitalized. And the Trump administration’s decision to prioritize Covid vaccine development soon after the coronavirus hit meant that new product development would lag well behind the worst of the pandemic.
Biden stepped up the vaccination boost within weeks of taking office. Most of the remaining funds were used to develop medicines for hospitalized and critically ill patients.
Drugs like Veklury infusion, also known as remdesivir, are impractical for early intervention when someone may not even experience Covid symptoms: Veklury’s maker Gilead completed a late-term study of the drug in mild to moderately ill patients in April with low enrollment. In the meantime, a readily available and cheap steroid, dexamethasone, is only helpful for the seriously ill and can actually cause harm if given too early.
An HHS spokesman said working on Covid therapies was an integral part of the government’s pandemic response. “We are pulling out all the stops to accelerate clinical development and manufacturing of therapy candidates that are most likely to complement vaccination efforts, including a focus on antivirals,” the spokesman said.
Fighting the virus would ideally result in patients taking a pill either after learning they’ve been exposed to the coronavirus or when they’re just starting to get sick. This would mimic the approach used by researchers during the AIDS crisis and would be preferable to the use of infused or inhaled medication.
“We are really putting a significant amount of resources into the same approach we took to direct-acting, antiviral, targeted drug development for HIV,” said Fauci, a pioneer in the fight against HIV / AIDS.
Antivirals takes a long time to perfect, however – a big reason why the current field is so sparse. The development of the drugs requires a highly specific knowledge of the viruses Biology to help them Steal the machinery of the virus to make millions of copies of the antiviral agent. These copies eventually burst from the cell, destroy it, and go in search of others to infect it.
The tricky part is making sure the drug is working just in the virus – and does not defeat healthy cells. “It just has to be extremely selective for the target,” Matthew Hall, a biologist at the National Center for the Advancement of Translational Sciences, told POLITICO.
“It’s highly technical, a little molecular pill. It’s hard to do,” said a senior administration official.
With hospital stays and deaths increasing at the start of the pandemic, it made sense for the government to ditch antivirals and instead focus on finding a treatment that could save the lives of seriously ill people before scientists knew much about the virus.
It also made sense to avoid developing completely new drugs and instead look for drugs that were already approved for other conditions that could be used for other purposes, or for compounds that are already in the development pipeline. Such was the case with dexamethasone, a generic steroid, and remdesivir, an antiviral drug designed to fight other viruses. Both received emergency approval from the FDA last year to treat Covid-19 patients in hospital.
However, these therapies weren’t a big deal, especially for patients with mild illnesses. BARDA invested $ 6 billion in novel therapies specifically targeting SARS-CoV-2. Most of the money went to large pharmaceutical companies whose products are already in the pipeline. However, most work best for severe infections. In fact, only one BARDA contract goes towards a therapy that is more suitable for people with mild symptoms, and that in preclinical studies.
A senior health official believes that there is little incentive to develop new treatments because there is no market for products that treat people who are not bedridden or worse.
“The coronaviruses that cause colds don’t make people very sick,” the NCATS hall said. When the SARS pandemic hit in 2001, pharmaceutical companies showed a short-lived interest in antiviral drugs. But as the threat from the virus subsided, so too did drug development. “When SARS went away … there was no disease to develop antivirals for.”
Companies like Pfizer and Merck have revived some of their previous coronavirus antiviral investigations – albeit without government help. However, these therapies are in early trials and may be years away from approval if they prove safe and effective. McMillan, the virologist in Australia, is working on a therapy that is expected to be ready in 2023.
Therefore, there is a lack of early treatments for Covid-19 for the time being – a situation that could have been avoided. “If the US government and other agencies and pharmaceutical companies had continued to develop coronavirus therapies after SARS, we would have been in a much better place,” said a senior health official.
While it may be too late to have antivirals on hand for this pandemic, the government could prepare for future ones. This requires working with pharmaceutical companies before a pandemic starts.
“No pharmaceutical company is going to develop pandemic preventive therapy from the start,” said a senior health official.