The spring of 2009 marked the beginning of the first flu pandemic in four decades. This pandemic was caused by an H1N1 virus that emerged from pigs, likely originating in Mexico, and quickly spread around the world. Fortunately, the world got lucky in 2009 for two main reasons. Firstly, the “swine flu” virus was distinct enough from previous H1N1 viruses to cause a pandemic, but it also had enough genetic similarities to viruses that had circulated for decades, providing many people with some immune defenses that lessened its severity.
Secondly, multiple flu vaccines targeting H1N1 were already licensed in the U.S. This allowed the Food and Drug Administration to fast-track approval of pandemic vaccines, avoiding the need for extensive clinical trials that could have delayed the distribution of vaccines by up to a year. This fast-track option proved to be crucial in the fight against the H1N1 pandemic.
In light of the success with the H1N1 pandemic, emergency response planners in the federal government had hoped to use a similar approach if the dangerous H5N1 bird flu virus ever caused a pandemic. However, recent news indicates that the Trump administration is reconsidering a government-funded study of an experimental H5N1 vaccine, sparking fears that this decision could hinder preparedness efforts.
The Department of Health and Human Services is re-evaluating a nearly $600 million contract awarded to Moderna to develop vaccines targeting five subtypes of influenza, including H5N1. This contract, signed during the final days of the Biden administration, is critical for the country’s preparedness efforts for a potential bird flu pandemic.
The decision to review the contract has raised concerns, especially given HHS Secretary Robert F. Kennedy Jr.’s skepticism towards vaccines and vaccine manufacturers. Experts believe that canceling this contract could have serious implications for the country’s ability to respond to a potential H5N1 pandemic.
Developing flu vaccines using alternative technologies like mRNA is crucial for quick and efficient vaccine production during a pandemic. Traditional methods of growing viruses in hen’s eggs are slow and reliant on a large quantity of eggs, which could be threatened during a bird flu outbreak. Alternative technologies like mRNA could provide a faster and more scalable solution for vaccine production.
Studies have shown that vaccines targeting H5N1 may require high doses or the use of adjuvants to trigger a strong immune response. This could complicate efforts to vaccinate a large population quickly during a potential pandemic.
The COVID-19 pandemic highlighted the importance of mRNA vaccine platforms, with Pfizer, BioNTech, and Moderna successfully developing and distributing vaccines in record time. The mRNA platform’s ability to quickly adapt to new viruses could be crucial in preparing for future influenza pandemics. Public distrust of mRNA vaccines has grown in recent times, fueled by baseless rumors questioning the safety of this technology. However, the reality is that the speed at which mRNA vaccines can be produced will be crucial in the event that the H5N1 bird flu virus transitions into a strain that can easily spread among humans.
Experts believe that if manufacturers of mRNA vaccines can license H5N1 vaccines before a pandemic, the timeline for delivering these vaccines would be significantly shorter. This is because all necessary trials to determine the immune response triggered by the vaccine and to generate safety data would have been completed in advance.
Creating this advanced safety data would allow for expedited authorization of updated versions of the vaccine targeted at the specific strain of the virus causing the pandemic. This would be done under the same FDA rule used for updating seasonal flu shots.
Preparing in advance would provide a substantial safety database, instilling confidence in the vaccine among the public. This would be crucial in emergency situations where vaccines need to be distributed quickly and efficiently.
Having multiple mRNA vaccine options for a potential pandemic would also provide a safety net against unforeseen outcomes. It would ensure that all eggs are not in one basket, particularly if traditional egg-based vaccines do not work as expected or if safety concerns arise.
The importance of understanding how mRNA vaccines can be used in a pandemic setting cannot be overstated. It is crucial to have multiple options available to ensure preparedness and confidence in the vaccines being distributed.
The fast-track approval process for mRNA vaccines requires a licensed vaccine for the specific subtype of flu. Currently, there are no licensed mRNA flu vaccines available. Moderna is working on seasonal flu shots, but breaking into the seasonal flu market poses challenges due to established manufacturers already meeting demand.
Funding from BARDA to help Moderna conduct advanced studies required to license an H5N1 vaccine is crucial. Without federal assistance, companies may be unwilling or unable to invest in research for vaccines that may never be needed.
While there are currently licensed H5N1 vaccines available, their production time is not as quick as mRNA vaccines. These vaccines have received substantial BARDA assistance, but are not commercially available. The U.S. government has some supplies in the National Pre-pandemic Influenza Vaccine Stockpile, and other countries have also purchased doses for stockpiling or at-risk populations.
In conclusion, the development and licensing of mRNA vaccines for potential pandemics like H5N1 are crucial for preparedness and rapid response. Advancing safety data and understanding the capabilities of mRNA technology are essential for instilling confidence in the public and ensuring multiple options are available in times of emergency. Earlier this month, Canada made headlines by announcing the purchase of half a million doses of H5N1 vaccine. This acquisition is part of the country’s effort to protect individuals most at risk from avian influenza. The decision to secure these doses reflects Canada’s commitment to preparedness in the face of potential pandemics, rare disease outbreaks, and bioterror threats.
The development and procurement of medical tools for emergency situations are crucial, and this is where the Biomedical Advanced Research and Development Authority (BARDA) plays a vital role. According to BARDA spokesperson, Edwards, the agency was established to facilitate the preparation for pandemics by enabling the production, testing, and licensing of vaccines. The recent purchase of the H5N1 vaccine is a step in the right direction towards ensuring that pilot lots can be manufactured, tested, and scaled up for distribution.
It is important to note that the cancellation of contracts, such as the one with Moderna for vaccine development, could have significant implications. Edwards emphasized the importance of BARDA’s role in pandemic preparedness and the potential setback that could result from the termination of contracts with key pharmaceutical companies.
In conclusion, Canada’s proactive approach to securing essential vaccines and BARDA’s commitment to pandemic preparedness are essential components of global health security. The recent purchase of H5N1 vaccine underscores the importance of investing in medical tools and resources to combat potential health crises effectively.
