While many people have recently learned about the clinical trial research process, most are unaware these studies are conducted according to a plan containing an essential fourth type of study: phase four.
These late-stage studies, often called post-marketing research, are conducted after the U.S. FDA has approved a vaccine or medication.
Clinical research leaders wrote a comprehensive Perspective, suggesting an innovative method for increasing the number of phase four studies.
Funding for Phase Four Vaccine Studies Needed
Portfolio of Influenza Vaccines Shipped Ahead of 2024-2025 Flu Season
According to Stefan Merlo, Vice President of Commercial Operations, North America, CSL Seqirus, pharmacies in the United States will soon offer updated flu shots.
Mr. Merlo exclusively informed Precision Vaccinations News that as of July 9, 2024, CSL Seqirus was already shipping its differentiated influenza vaccines for the 2024/25 Northern Hemisphere flu season.
"This year, we've transitioned to trivalent vaccine formulations, aligning with U.S. FDA guidelines."
Fewer Flu Shots Distributed, Fewer Influenza Deaths Reported
During the second day of the U.S. Centers for Disease Control and Prevention (CDC) recent Advisory Committee on Immunization Practices (ACIP) meeting, influenza vaccines became the main focus.
As the current flu season comes to a close, the ACIP reported that the next round of influenza vaccines, which are scheduled to arrive in pharmacies in August 2024, will be different.
On June 27, 2024, the ACIP confirmed all influenza vaccines marketed in the U.S. for the 2024-25 flu season would be trivalent, not quadrivalent.
Doctors Can Digitally Dispel Vaccine Dis-and Mis-Information
Since the early days of AOL and Yahoo, digital information has transformed how people access and share health information. While the digital age has increased access, it has also accelerated the spread of disinformation and misinformation.
To address this issue, Dr. C. Everett Koop spearheaded an industry initiative in 1999 to protect people from unreliable health information by involving doctors, nurses, and pharmacists in the content creation.
Fewer Flu and Pneumonia Deaths Reported
In the 20th century, influenza and pneumonia constituted the most significant proportion of infectious disease deaths in the United States. However, in the 21st century, that trend changed.
On May 20, 2024, a Major Article published by the journal AJIC analyzed crude death rates (CR) and age-adjusted mortality rates (AAMR) per 100,000 individuals calculated using influenza and pneumonia mortality data (ICD-10 Codes: J09-J18) from the U.S. CDC WONDER database.
Cell-Based Flu Shot Effectiveness Surpass Egg-Produced Vaccines
Vaccines have proven to be the primary means of reducing influenza infections over decades. Although many people think all flu shots are the same, there are significant differences between cell—and egg-based vaccines, which provide different health benefits.
Consuming Bird Flu Contaminated Cow Milk Discouraged
Over the past few years, significant media attention has been paid to detecting avian influenza (bird flu). While the overall human health risk is being evaluated, the World Health Organization (WHO) recently shared clarifying data points.
During 2020, highly pathogenic avian influenza (HPAI) A(H5N1) clade 2.3.4.4b viruses arose from previously circulating influenza A(H5Nx) viruses. They spread predominantly via migratory birds to many parts of Africa, Asia, and Europe.
In late 2021, these bird flu viruses crossed to North America and, in late 2022, to South America.
Consuming Unpasteurized Bird Flu Contaminated Cow Milk Discouraged
Over the past few years, significant media attention has been paid to detecting avian influenza (bird flu). While the overall human health risk is being evaluated, the World Health Organization (WHO) recently shared clarifying data points.
During 2020, highly pathogenic avian influenza (HPAI) A(H5N1) clade 2.3.4.4b viruses arose from previously circulating influenza A(H5Nx) viruses. They spread predominantly via migratory birds to many parts of Africa, Asia, and Europe.
In late 2021, these bird flu viruses crossed to North America and, in late 2022, to South America.
Technically, the HPAI A(H5N1) Outbreak Risk Remains Low
Although avian influenza (bird flu) viruses usually do not infect people, there have been some rare cases of human infection.
Human infections with bird flu viruses can happen when the virus gets into a person's eyes, nose, or mouth or is inhaled.
Texas Confirms Its First Human Bird Flu Case
Recent reports indicate that the multi-year, global outbreak of the highly pathogenic avian influenza (HPAI) virus has reached the state of Texas.
In late March 2024, the Texas Animal Health Commission announced that dairy cattle in the Texas Panhandle had tested positive for avian influenza A(H5N1).
Subsequently, on April 1, 2024, the Texas Department of State Health Services (DSHS) reported one confirmed human case of avian influenza A(H5N1) virus in Texas. The affected person had direct exposure to dairy cattle suspected of being infected with avian influenza.