FDA Proposes New Vaccine Approval Process for Pandemics

Contact Your Elected Officials
The Epoch Times Header

Due to concerns about the H5N1 avian virus, which has been shown to spread to humans, the U.S. Food and Drug Administration (FDA) has proposed a new approach to pandemic vaccines.

At the Vaccines and Related Biological Products Advisory Committee meeting on Thursday, Jerry Weir, director of the FDAโ€™s Division of Viral Products, asked the 11 committee members to discuss changes to the influenza vaccine strain change process.

Under the current plan, vaccines would be developed before a pandemic to target specific high-risk viruses.

These vaccines can be released if a pandemic occurs, assuming they are safe because they follow established manufacturing processes. New seasonal influenza vaccines have an established manufacturing process of being produced in eggs or in cell lines.

These vaccines would not need to undergo a clinical trial as they would be made to the same standard as seasonal influenza vaccines, and there is an assumed history of efficacy and safety for these vaccines for seasonal influenza, according to the FDA.

The new plan suggests that these vaccines should not only be used during a pandemic but also regularly updated.

Should an H5N1 pandemic break out, H5N1 vaccines would be made the same way as current seasonal influenza vaccines and updated accordingly. The new process would also allow the vaccines to be updated during the pandemic, depending on the circulating virus.

Todd Davis, acting chief of the Centers for Disease Control and Preventionโ€™s (CDC) Virology, Surveillance, and Diagnosis Branch for virology surveillance, confirmed at the meeting that there is currently no evidence that the H5N1 avian virus has gained DNA mutations to cause infections in humans, though 16 cases have been reported in humans.

โ€œWe have not seen any mutations that would reduce susceptibility to antiviral drugs,โ€ Davis added.

Christine Oshansky, director of the pandemic vaccine and adjuvant program at the Biomedical Advanced Research and Development Authority (BARDA), announced that the National Pre-pandemic Influenza Vaccine Stockpile currently has partnerships with three pharmaceutical companies that would be able to make traditional egg-based and cell-based influenza vaccines should a pandemic occur.

โ€œmRNA-based vaccines are not a part of the current preparedness activities,โ€ Oshansky said, though there are plans for future potential responses.

Byย Marina Zhang

Read Full Article on TheEpochTimes.com

The Epoch Times
The Epoch Timeshttps://www.theepochtimes.com/
Tired of biased news? The Epoch Times is truthful, factual news that other media outlets don't report. No spin. No agenda. Just honest journalism like it used to be.

Was Texas Storm Manmade?

Another โ€œ1-in-100 yearsโ€ weather event in Kerr County happened next to a Texas designated โ€œWeather Modification Map of Rain-Enhancement Projects in Texasโ€.

The America Party Will Harm Democrats The Most

Elon Musk formed the America Party after an X poll asking his followers if they wanted โ€œindependence from the two-party system!

Democrats Exhibit the Dunning-Kruger Effect (DKE)

โ€œThe Dunning-Kruger effect is a cognitive bias where people with low ability at a task overestimate their competence, while those with high ability underestimate their competence.

250 Countdown

Those 56 intrepid men who signed put their very lives, honor and fortunes on the line. There was no auto-quill to accommodate their signatures.ย 

How the Senate Parliamentarian Changed the OBBB

An unelected bureaucrat does a important job in the U.S. Senate. Elizabeth MacDonough enforces senate rules on Trumpโ€™s โ€œOne Big Beautiful Billโ€.

Trump Administration Ends Deportation Protections for 76,000 From Honduras, Nicaragua

Mondayโ€™s decision is the latest in several temporary protected...

Death Toll From Texas Floods Rises to 82, Including 28 Children; Trump Plans Visit

Days after catastrophic flash floods in central Texas, rescuers are still searching for potential survivors, including 27 girls who went missing from camp.

Trump Signs Major Disaster Declaration Over Texas Flooding

President Trump signed major disaster declaration for Kerr County, TX, following floods leaving dozens dead and FEMA has been activated to respond.

Storm Chantal Makes Landfall in Carolinas, Weakens to Tropical Depression

Chantal weakened into a tropical depression, and tropical storm warnings previously issued for parts of North and South Carolina were discontinued.

US Removes Terrorist Designation for Al Qaeda Affiliate in Syria

The State Department has removed from its list of foreign terrorist organizations Al Qaedaโ€™s affiliate in Syria, Jabhat al-Nusra.

Trump Announces 25 Percent Tariff on Japan, South Korea

President Donald Trump on July 7 issued letters announcing 25 percent tariffs on Japan and South Korea, set to take effect on Aug. 1, 2025.

White House Asks Americans to Pray After Deadly Texas Flooding

White Houseโ€™s Faith Office said in a statement that it is asking people โ€œto join us in prayer for the precious lives lost in the Texas floods,โ€

Trump to Meet With Netanyahu Following Iran Strikes Amid Cease-Fire Talks

President Donald Trump is set to meet with Israeli Prime Minister Benjamin Netanyahu at the White House on the evening of July 7, 2025.
spot_img

Related Articles