The latest iteration of bird flu is worrying enough in itself. It has already demonstrated a formidable ability to jump from one species to another, and its spread to livestock has raised alarms among researchers studying the possibility of mass infection, including in humans.
What is even more worrying in the United States is what happens next. Assuming that the H5N1 outbreak ultimately affects many more people than the three cases confirmed so far linked to dairy cows, how prepared are government agencies to respond to a widespread infection or pandemic ?
Experts are increasingly concerned that the answer to this question is bleak. “Our supply of flu antivirals is insufficient,” says Rick Bright, an immunologist and former director of the Biomedical Advanced R&D Authority. “We need to diversify it – and even that is not enough, with what we have approved (to treat the flu). We need to develop additional treatment options.
An insufficient national stock
The issues are multiple. The antiviral drug the United States has in greatest quantity, Tamiflu, has been questioned not only for its path to government approval (nearly all of its clinical trials have been sponsored by pharmaceutical companies), but also for its ability to reduce the risk of hospitalization or hospitalization. serious complications of the flu. Yet sources told me that in 2018, federal officials reportedly ignored calls to further diversify their antiviral stockpiles, opting instead to place another order of Tamiflu. The U.S. government also approved an extended shelf life for the drug, twice that requested by the manufacturer.
Another drug, Baloxavir, has shown promise in preventing the spread of the flu. However, the US Strategic National Stockpile (SNS) only includes hundreds of thousands of doses of this drug., and the stockpiling process is expected to take between 18 and 24 months. And experts say the country that first puts money on the table often has first access to supplies, so it’s important to get on board.
Viral resistance can develop quite quickly to either drug, highlighting the need for other treatment options. “Given the frequency with which influenza viruses change and the potential for influenza viruses to develop resistance or reduced sensitivity to one or more antiviral influenza medications, there are good more options for treating influenza », declare the federal Centers for Disease Control and Prevention (CDC).
In response to information obtained by the author of this article and consulted by Fortune which has not yet been made public by the CDC, a spokesperson confirmed that oseltamivir (generic for Tamiflu) showed a 16-fold reduction in its ability to inhibit the H5N1 virus collected from a dairy worker infected in Texas, compared to activity against a seasonal virus. This reduction is considered minor, the spokesperson said, and the CDC continues to recommend “rapid antiviral treatment with oseltamivir for patients with confirmed or suspected H5N1 virus infection.”
This discovery, however, has baffled experts. “While this reduction does not mean that the Texas virus will be completely resistant to Tamiflu, it clearly indicates that the virus has reduced susceptibility,” says Bright. “Most likely, a higher treatment dose or longer treatment duration would be required. treatment with Tamiflu to be able to treat a person with this H5N1 virus, but further testing is needed…At this stage, we cannot be sure that what we have in stock will be sufficient, or even sufficiently effective, against the H5N1 virus in humans. (A CDC study found that the virus was sensitive to some of the other antiviral drugs tested, including Baloxavir.)
“Ideally, you would have a multi-drug cocktail like we have for HIV, for example,” says Andy Pekosz, an influenza researcher and director of the Center for Emerging Viruses and Infectious Diseases at Johns Hopkins University. “With just one drug, you have a very limited time before the virus becomes resistant. But if you put two or three together, you build an incredibly high wall so that the virus can actually build up resistance against all these antivirals.
Tamiflu has a shelf life of 10 years, as established by its manufacturer (Roche, now merged with Genentech) and as required by the European Union. But the U.S. Food and Drug Administration has stockpiles dating back to 2004, and the FDA has extended the shelf life of some of the oldest Tamiflu products purchased for emergency response to 20 years — a move that has prompted a Genentech spokesperson to distance himself from the company. he.
“If local governments decide to extend the shelf life of the product, it is based on their own assessment and in accordance with government shelf-life extension programs,” the CDC spokesperson told me. “However, we share the concerns of public health experts regarding the ongoing threat of an influenza pandemic, which could be exacerbated by the expiration of antivirals in the US strategic national stockpile. »
No “miracle drugs”
Even if Tamiflu worked well, the approximately 55 million treatments available in the United States would be insufficient to treat large-scale human infection with the H5N1 virus, especially if it were used as a preventative measure. for close contacts, as currently recommended by the CDC. “I don’t think there is good data right now that supports its use prophylactically,” says Francesca Torriani, medical director of infection prevention and clinical epidemiology at UC San Diego Health. “In my experience as an infectious disease doctor, this is a recipe for developing resistance.”
“Antiviral drugs are not miracle drugs,” says William Schaffner, former medical director of the National Foundation for Infectious Diseases. “The trick is to intervene early, to try to cut off the virus along the way – in other words, to interfere with the multiplication of this virus before it multiplies too much in our body and causes a significant inflammatory reaction,” says Schaffner. Tamiflu must be administered within 24 to 48 hours of the onset of symptoms to be effective; A complete course of treatment includes one pill taken twice a day for five days.
Baloxavir, which requires a single dose and works differently from other flu antivirals, has been shown to be similar in symptom relief to Tamiflu in healthy adult outpatients. This is a viable alternative in case the virus produces resistance to one or another drug. But we don’t have enough to make a significant difference.
And why not a human vaccine?
Health officials say we have very limited supplies of a 2020 H5 vaccine candidate that could provide some level of immunity against the current, mostly avian virus in cows – useful for those most at risk of exposure, such as farm workers. However, experts say the virus would mutate significantly before becoming the human pandemic strain, so we will likely need to update the vaccine quickly and then mass produce it.
Andy Pekosz estimates it would take six to seven months to produce about 150 million doses using the traditional method. So it may be two years or more before we have enough vaccine to immunize the entire country in this way – and we will have to make two doses of vaccine for each person.
Although mRNA vaccines can be made much more quickly — “on the order of three months” to generate a significant number of doses, Pekosz says — they are not yet approved for influenza by the FDA. Meanwhile, thThe government is in talks with Pfizer and Moderna, but whatever is produced will take time – more time than we would have to respond to a massive outbreak.
The United States is unfortunately not prepared for a pandemic
All of this could lead to questions about the United States’ readiness to respond to the next possible pandemic – in this case, H5N1. It turns out that this feeling of unpreparedness is echoed at the highest levels of government.
On May 9, the powerful House Energy and Commerce Committee warned of “a pattern of fiscal mismanagement and a series of failed acquisitions that have left the SNS dangerously underfunded and likely underprepared to respond to future public health emergencies.”
The same day, a letter to Dawn O’Connell, assistant secretary for preparedness and response at the Department of Health and Human Services, laid out the concerns in graphic and detailed terms. Writing on behalf of several Senate committees and subcommittees, the letter denounces what it describes as “mismanagement of the Strategic National Stockpile.”
The letter, from the Subcommittee on Oversight and Investigations and viewed by Fortune, noted that the government’s Administration for Strategic Preparedness and Response (ASPR) had been placed on a list of agencies “vulnerable to waste, fraud, abuse or mismanagement, or in need of transformation”. He pointed out that the ASPR left more than 850 million dollars in Additional emergency SNS funding remains unused. Those funds were ultimately canceled by the Office of Management and Budget, the letter said, due to “lack of proper planning and urgency on the part of ASPR.”
We are well below the government’s repeatedly stated five-year target of 85 million antiviral flu treatments. What’s needed, Bright says, is to urgently place orders for new drugs, refill long-obsolete drugs, diversify SNS holdings to guard against antiviral drug resistance, and accelerate the development of new options treatment.
“A burying your head in the sand approach to antiviral influenza preparedness will not serve the public well when it is necessary to respond to an influenza pandemic,” he says. Now is the time to start taking serious action, not when the country faces the risk of a full-blown pandemic.
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