HHS Declares H5N1 Emergency: EUA for mRNA Vaccines and Legal Challenges Under the PREP Act
Updated
HHS Secretary Xavier Becerra has declared bird flu (H5N1) as an emergency under the Federal Food, Drug, and Cosmetic Act Section 564(b)(1)(c). The release states that they are amending the act and have determined “that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves biological agents, namely pandemic influenza A viruses and influenza A viruses with pandemic potential.”
The subheading for Section 564(b)(1)(c) is “Risk-Benefit Analysis.” It allows for the consideration of emergency use authorization (EUA) for certain products if the commissioner “determines that the known and potential benefits of the product, when used to diagnose, prevent, or treat the identified disease or condition, outweigh the known and potential risks of the product.” The FDA would “look at the totality of the scientific evidence to make an overall risk-benefit determination.”
EUA is the method by which the mRNA COVID-19 vaccinations were approved for clinical trials and eventually unleashed to the public after the completion of “Operation Warp Speed.” The PREP Act provided immunity to the manufacturers for any harm caused by the product because releasing an immunization quickly is seen as a greater benefit to the public that outweighs potential harm caused by the vaccine.
The PREP Act was not mentioned in the latest declaration by Secretary Becerra, but it would follow in the case of an EUA product that the FDA and Becerra determined was a net benefit for the public. The CDC still considers the risk of H5N1 infection in humans to be low, although the virus is considered to have pandemic potential. Moderna has received $176 million from HHS and BARDA to develop an mRNA vaccine for the Avian flu and expects results later this year. The government has an order of 4.8 million doses of Avian flu vaccines to stockpile in preparation of a potential pandemic.
What started as a bird flu has begun spreading to livestock on farms in several states nationwide. There have been seven cases of humans getting infected with the virus, but the most common symptom is conjunctivitis, most commonly referred to as pink eye. Some statements have suggested that an H5N1 virus would have a fatality rate of up to 50%. That is not the case with the cases that have existed so far, which have been confined to large farming operations with poultry and livestock. There is no evidence that the virus is transmitted between humans. Dr. Robert Redfield, the former director of the CDC, has said that the virus has serious pandemic potential, but it would have to be a laboratory-derived virus.
Aaron Siri, lead attorney for the Informed Consent Action Network (ICAN), is still leading a legal charge against provisions of the PREP Act that may cause the act to be reversed completely. The lawsuit alleges insufficient support for those injured by the medical countermeasures for COVID-19, specifically the mRNA injections that were distributed via Emergency Use Authorization by Pfizer and Moderna. The PREP Act provides vaccine manufacturers with the same immunity from lawsuits that they receive for all other vaccines under the vaccine injury compensation program (VICP). Siri has argued that the program is not working effectively because there is a large backlog of cases and very few payouts for patients who have been harmed by the rollout of the COVID-19 vaccines.
The HighWire has reported extensively about the H5N1 virus that has been spreading via livestock and the concerns about how it may affect the food supply throughout the United States. The USDA took unprecedented steps to control the virus by claiming “permanent authority” to “manage and eradicate,” while also training a segment of employees in FEMA protocols. Nourish Cooperative in Michigan was forced to dispose of $90,000 worth of raw dairy products in response to speculation that the virus is spread to humans via raw milk consumption.
Public health officials have admitted to being unprepared for the COVID-19 pandemic; they are diligently testing and activating procedures that would allow for the stockpiling of vaccines and quick distribution. Some people, including representatives in Colorado, have said that not enough is being done to prevent this from becoming another pandemic. Others are concerned that this will create another profitable campaign for pharmaceutical companies at the expense of the public’s health.
Yadira Caraveo, a Colorado congresswoman, authored a letter to Secretary Becerra to ask the agency to do more in response to the potential virus threat. Caraveo expressed concerns about no vaccines being available to farm workers at a higher risk of contracting the virus. She also mentions the extreme summer heat as a factor that makes it unsafe to wear N95 masks and other personal protection equipment that are perceived to reduce the transmission of the virus.
Since 2022, Colorado has had nine individuals get infected out of the 14 cases positive for H5N1 in the United States. Governor Jared Polis declared a disaster declaration in Weld County for the large poultry farm responsible for the majority of the cases that have tested positive.