(The Defender) The U.S. Department of Health and Human Services (HHS) this month issued a declaration of emergency, announcing that some flu viruses — including H5N1 bird flu — could cause a pandemic and threaten national security.
The announcement by HHS Secretary Xavier Becerra amended a 2013 section of the Federal Food, Drug, and Cosmetic (FD&C) Act, which allows the agency to extend the availability of medical countermeasures to pandemic influenza A viruses, including the currently circulating H5N1 strain of bird flu.
Prior to the amendment, the declaration covered only the previous H7N9 strain of bird flu.
The announcement specified that current circumstances justify the emergency use authorization (EUA) of in vitro diagnostics such as RT-PCR tests to detect bird flu and other pandemic influenza A viruses.
“This paves the way for more EUA vaccines, devices and products to possibly be effective against these new and unknown viruses,” attorney Ray Flores told The Defender.
He added:
“Just as EUA PCR tests exaggerated the COVID-19 pandemic, the detection of avian influenza and influenza A viruses with pandemic potential via unlicensed PCR tests is destined to justify lockdowns, masking, invasive nasal swabs, and wide-scale vaccination with experimental mRNA technology.
“The stage is set for RT-PCR tests to take the pivotal role of determining false positives with amped up cycle thresholds designed to declare asymptomatic, otherwise healthy people to be infected — just like last time.”
Under the FD&C Act, HHS can take steps to facilitate countermeasures only after the secretary of either the U.S. Department of Homeland Security, U.S. Department of Defense or HHS determines there is an emergency or potential for an emergency involving a chemical, biological, radiological or nuclear agent that may threaten the national or health security of U.S. citizens.
After that determination, the HHS secretary can declare that existing circumstances justify an EUA that would allow the FDA to authorize previously unlicensed drugs or vaccines or previously unapproved uses of licensed drugs.
The amendment covers animal or human flu viruses — circulating in wild birds, humans, or domestic animals — that may infect humans, may have caused pandemics in the past or may mutate to cause a pandemic in humans for which they have no prior immunity.
Becerra said in the amendment that the bird flu viruses may pose a public health threat, despite acknowledging that it “may initially only be occasionally transmitted to or between humans.” However, he added that bird flu viruses may “have the potential to become highly transmissible in humans and can cause significant morbidity and mortality.”
The currently circulating H5N1 virus is one in a series of bird flu viruses that pose such a threat, although the virus is not easily transmissible to humans and none of the human cases reported to the Centers for Disease Control and Prevention (CDC) involved severe disease, the announcement said.
“We cannot be sure,” Becerra said, that the mild cases associated with dairy cattle represent the full spectrum of the disease, “nor can we be assured that the virus will not mutate to cause more severe disease and/or to become more transmissible.”
The CDC reports the current public health risk is low and that surveillance shows “no indicators of unusual influenza activity in people, including avian influenza A(H5).”
There have been a total of 14 reported human cases since 2022, according to the agency. Four occurred after exposure to dairy cows, 10 after exposure to poultry and none have been serious.
AMA updates vaccine codes for potential EUA vaccine
The day after Becerra’s announcement, on July 19, the American Medical Association (AMA) announced an update to its Current Procedural Terminology (CPT) codes to include a new code for bird flu vaccines, should they receive EUA from the FDA.
CPT codes are used by providers to report healthcare procedures and services and to update medical records.
The AMA said it is publishing the code update now “to ensure electronic systems across the U.S. health care system are prepared in advance for the potential FDA authorization.”
The update included new codes for administering the potential bird flu vaccine to both children and adults.
The new code is for a cell-culture-derived vaccine adjuvanted for intramuscular use, which refers to an inactivated flu virus grown in cultured mammalian cells.
Cell-culture vaccines are a newer technology developed to replace the traditional egg-based vaccine production for flu vaccines. It is said to be cleaner, faster and more scalable than its predecessor.
Vaccine producer contracted to produce millions of doses of bird flu vaccines
The creation of the codes also follows an agreement, announced May 30, between the U.S. government and CSL Seqirus — one of the largest vaccine producers in the world — to complete 4.8 million doses of a “pre-pandemic vaccine that is well-matched to the H5 of the currently circulating H5N1 strain,” as part of the U.S. National Pre-Pandemic Influenza Vaccine Stockpile program.
HHS Assistant Secretary for Preparedness and Response Dawn O’Connell told reporters some of those shots could be available as early as this month, Reuters reported.
This was the fourth contract awarded to CSL Seqirus under a multi-year agreement with the Biomedical Advanced Research and Development Authority (BARDA), which largely pays for the vaccines.
Marc Lacey, CSL Seqirus global executive director for the pandemic, said in the press release that the CDC maintains that bird flu poses a low risk to public health. However, “This agreement, building upon prior agreements with BARDA, will help support the U.S. government’s ability to respond swiftly in the event that the current avian flu situation changes.”
Seqirus manufactures the vaccines in Holly Springs, North Carolina, at a $1 billion facility built in 2009 and opened in 2013 through a partnership between Novartis and BARDA that was in part facilitated by grants and tax incentives from local government.
CSL Seqirus’ parent company acquired Novartis’ facility in 2014.
The facility is the largest producer of cell-based vaccines in the world, with the capacity to deliver up to 150 million flu vaccines within six months of an emergency pandemic declaration. Then it could continue to produce large quantities of vaccines.
Their massive vaccine production capacity, the company said, is dependent on continued research and development along with seasonal vaccine manufacturing, which provides a “warm base” for pandemic production. That means the production of seasonal vaccines makes it possible for the company to maintain the materials and personnel necessary to produce massive vaccine quantities.
CSL Seqirus’ H5N8 avian influenza vaccine received the European Union’s marketing authorization in April. The vaccine requires a two-dose series, with the second dose administered at least three weeks after the first.
The European Commission Health Emergency Preparedness and Response (HERA) program in June announced the purchase of 665,000 doses of CSL Seqirus’ H5N8 avian influenza vaccine, with an option to acquire another 40 million doses over the next four years.
Finland already plans to offer the CSL Seqirus H5N8 bird flu vaccine to approximately 10,000 people deemed at high risk of exposure to the virus.
