Health
In a world first, RSV vaccines wins FDA approval for adults 60 and up
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The Food and Drug Administration issued the world’s first approval of a vaccine against respiratory syncytial virus (RSV), an achievement that researchers have worked toward for decades after a catastrophic clinical trial in the 1960s.
The vaccine, called Arexvy from pharmaceutical giant GSK, is approved for adults aged 60 and over. The Centers for Disease Control and Prevention will need to recommend the vaccine before it will be available for use. The agency’s advisory committee for immunizations is next scheduled to meet June 21 to 22 and could discuss the vaccine then.
RSV is a common, highly contagious seasonal respiratory infection. It’s often associated with infants, who are at especially high risk of developing severe disease. In fact, bronchitis from RSV infections is the leading cause of hospitalization among infants under the age of 1 in the US. But the virus is also dangerous for older adults, causing an estimated 60,000 to 160,000 hospitalizations and 6,000 to 10,000 deaths in older adults each year in the country.
In an ongoing, randomized, placebo-controlled clinical study of adults aged 60 and older—in which about 12,500 participants received Arexvy, and 12,500 participants received a placebo— the vaccine reduced the risk of developing lower-respiratory tract infection from RSV by 82.6 percent, and reduced the risk of developing a severe RSV infection by 94.1 percent, the FDA noted.
“Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by RSV,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. The approval Wednesday of this first RSV vaccine is “an important public health achievement to prevent a disease which can be life-threatening,” he added.
Triumph after tragedy
GSK also celebrated the landmark approval, with GSK’s Chief Scientific Officer Tony Wood saying the approval “marks a turning point in our effort to reduce the significant burden of RSV.”
GSK’s vaccine is just the first of several RSV vaccines in the works. Pfizer has an RSV vaccine for adults 60 and up that was nearly 86 percent effective against severe disease in a phase III trial. It is now being reviewed by the FDA and is expected to gain approval this month. In January, Moderna said its RSV vaccine for older adults was 82 percent effective against severe disease.
Pfizer also has a vaccine to protect infants that is nearing a regulatory decision. When given to pregnant participants in a phase III trial, the vaccine was 82 percent effective at preventing severe RSV in the infant’s first three months and 69 percent effective over the first six months.
The vaccines are a triumph after researchers spent decades working to find a safe and effective design for the immunizations. Small trials of early vaccine candidates in the 1960s led to children developing more severe RSV than unvaccinated children. Two vaccinated children died following their infections.
Subsequent research showed that those early, doomed vaccines presented a key protein—the F protein—in the wrong conformation, spurring the immune system to generate impotent antibodies and exaggerated inflammatory responses that made the disease worse. It wasn’t until decades later that researchers at the National Institutes of Health figured out how to lock the F protein into a conformation that would induce an effective immune response, paving the way for the current vaccine designs.
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The USask Global Institute for Water Security wastewater survey for Prince Albert shows that the COVID-19 viral RNA load in Prince Albert’s has decreased by 46.5 per cent.
This was after there was a single decrease in last week’s report.
The number is based on averages of three individual daily measurements in this reporting period up to May 22 which are then compared to the weekly average of the previous week.
This week’s viral load of approximately 10,000 gene copies / 100 mL SARS-CoV-2 is the 85th-highest value observed during the pandemic.
This concentration of viral particles is considered Low because it is below the range and regarded as low in Prince Albert.
This week’s viral RNA load indicates that the SARS-CoV-2 infections in Prince Albert are reducing.
Whole genome sequencing confirmed the presence of BQ.1, BQ.1.1, BQ.1.1.4, BQ.1.18, XBB.1.5, BA.5.2.1 and BE.1.1 in earlier samples; which have S:Y144del, S:R346T, S:K444T, S:N460K mutations associated with immune escape. In addition, the sequences of the most recently collected sample relative to the previously collected samples indicate the level of presence of BA.2 and BA.5 in Prince Albert’s wastewater to be 94 per cent and 78 per cent stable respectively.
All data has been shared with Saskatchewan health authorities.
USask and Global Water Futures researchers are using wastewater-based epidemiology to monitor for SARS-CoV-2 (the virus causing COVID-19) in Saskatoon, Prince Albert and North Battleford wastewater, providing early warning of infection outbreaks. This work is being done in partnership with the Saskatchewan Health Authority, Public Health Agency of Canada, City of Saskatoon, City of Prince Albert and City of North Battleford.
This variant tracking data should be seen merely as an indicator of trends which need to be verified using sequencing technology through the Public Health Agency of Canada. Because individuals are at varying stages of infection when shedding the virus, the variant levels detected in sewage are not necessarily directly comparable to the proportion of variant cases found in individual swab samples confirmed through provincial genetic sequencing efforts.
editorial@paherald.sk.ca
Health
Just when we were starting to see COVID and RSV rates drop this spring, another type of virus contributed to a spike in respiratory infections
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- Human metapneumovirus spiked this spring as cases of COVID and RSV fell.
- According to the CDC, 19.6% of antigen tests and nearly 11% of PCR tests for HMPV, were positive in the US in early March.
- Symptoms of HMPV include cough, fever, nasal congestion, and shortness of breath.
Cases of another type of respiratory virus have spiked this spring, just as COVID-19 and RSV rates were finally falling in the US.
According to the CDC, 19.6% of antigen tests and nearly 11% of PCR tests for human metapneumovirus, or HMPV, were positive in the US in early March.
The nearly 11% of positive PCR cases is up 36% since before the COVID-19 pandemic when PCR tests for HMPV were coming back with a rate of 7% positivity, according to the CDC.
In contrast, COVID-19 cases were down nearly 30% at the beginning of March, according to the World Health Organization, and the number of people being hospitalized for RSV was down to 1.2 people per 100,000 in March from 4.5 people per 100,000 in January, according to the CDC.
Symptoms of HMPV include cough, fever, nasal congestion, and shortness of breath, according to the CDC. The symptoms could progress into bronchitis, pneumonia, or other similar viruses that cause upper and lower respiratory infections.
The CDC said some might be sicker for longer than others, and the duration of the virus depends on the severity, but for the most part, is similar in length to other respiratory infections caused by viruses.
The virus is spread by coughs and sneezes, close personal contact, and touching surfaces infected with the virus, then touching the mouth, nose, or eyes.
According to CNN, there’s no vaccine for HMPV, nor is there an antiviral drug to treat it.
Health
Just when we were starting to see COVID and RSV rates drop this spring, another type of virus contributed to a spike in respiratory infections
|
|
- Human metapneumovirus spiked this spring as cases of COVID and RSV fell.
- According to the CDC, 19.6% of antigen tests and nearly 11% of PCR tests for HMPV, were positive in the US in early March.
- Symptoms of HMPV include cough, fever, nasal congestion, and shortness of breath.
Cases of another type of respiratory virus have spiked this spring, just as COVID-19 and RSV rates were finally falling in the US.
According to the CDC, 19.6% of antigen tests and nearly 11% of PCR tests for human metapneumovirus, or HMPV, were positive in the US in early March.
The nearly 11% of positive PCR cases is up 36% since before the COVID-19 pandemic when PCR tests for HMPV were coming back with a rate of 7% positivity, according to the CDC.
In contrast, COVID-19 cases were down nearly 30% at the beginning of March, according to the World Health Organization, and the number of people being hospitalized for RSV was down to 1.2 people per 100,000 in March from 4.5 people per 100,000 in January, according to the CDC.
Symptoms of HMPV include cough, fever, nasal congestion, and shortness of breath, according to the CDC. The symptoms could progress into bronchitis, pneumonia, or other similar viruses that cause upper and lower respiratory infections.
The CDC said some might be sicker for longer than others, and the duration of the virus depends on the severity, but for the most part, is similar in length to other respiratory infections caused by viruses.
The virus is spread by coughs and sneezes, close personal contact, and touching surfaces infected with the virus, then touching the mouth, nose, or eyes.
According to CNN, there’s no vaccine for HMPV, nor is there an antiviral drug to treat it.
Read the original article on Insider
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