US to make 4.8 million doses of bird flu vaccine as cases increase

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NEW YORK, June 1: As the United States grapples with a surge in highly pathogenic avian influenza, or H5N1, health officials are mobilizing resources to combat the escalating threat. Authorities have announced the preparation of 4.8 million doses of flu vaccine in response to the unprecedented outbreak of the virus, which has seen a concerning rise in human cases linked to infected dairy cattle.

The initiative, spearheaded by the Centers for Disease Control and Prevention (CDC), involves tapping into a “pre-pandemic” stockpile funded by the federal Administration for Strategic Preparedness and Response (ASPR). Vaccine maker CSL Seqirus has been entrusted with manufacturing the doses at its North Carolina plant, utilizing a highly scalable production method.

“These doses combine bulk stockpiles of two key ingredients: an ‘antigen’ targeted at the H5 portion of the H5N1 virus with an ‘adjuvant’ designed to boost the immune response triggered by the vaccine,” CSL Seqirus stated in a release.

While manufacturing of the bird flu doses is expected to be completed “later this summer,” regulatory approval remains a critical step before the vaccines can be deployed for use. David Boucher from ASPR emphasized the regulatory component required for authorization of vaccine usage.

The Food and Drug Administration (FDA) plays a pivotal role in granting authorization for vaccine deployment. Although previous vaccines have been approved in anticipation of potential H5N1 pandemics, including one by Seqirus, the timeline for authorization of the new shots remains uncertain.

Addressing concerns regarding vaccine distribution and prioritization, Boucher stated, “If it is determined that the U.S. population needs to be vaccinated to prevent H5N1 influenza, then the FDA will use its regulatory pathways to take the appropriate steps to ensure vaccines are available in the timeliest manner possible.”

As discussions continue, the CDC’s outside vaccine advisory panel is slated to convene in June to deliberate on H5N1 alongside routine votes on recommendations for seasonal flu vaccines. While the agency reassures the general public of the low risk posed by H5N1, it underscores the heightened vulnerability of workers in settings such as dairy farms and production facilities.

Recent cases of infection among workers underscore the urgent need for precautionary measures. Despite respiratory symptoms observed in some cases, the CDC maintains there is currently no evidence of person-to-person spread. However, ongoing surveillance is crucial to monitor potential mutations that could impact the virus’s transmissibility.

As the nation navigates this evolving public health challenge, vigilance and proactive measures remain paramount in mitigating the risks posed by the H5N1 outbreak.

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