Reckless in the Extreme’: FDA Panel Recommends New RSV Shot for Use in Healthy Infants
Advisors to the U.S. Food and Drug Administration on Thursday recommended approval of AstraZeneca’s new monoclonal antibody, which the drugmaker said is designed to protect infants and toddlers up to age 2 from respiratory syncytial virus, but medical experts interviewed by The Defender called the move “reckless” and “preposterous.”
RSV (Respiratory Syncytial Virus) is a common respiratory virus that typically causes mild, cold-like symptoms in older children and adults. However, RSV can be more serious in infants, particularly those younger than six months old. In fact, RSV is the most common cause of bronchiolitis (inflammation of the small airways in the lungs) and pneumonia in infants.
The severity of RSV in infants can vary. Some infants may only experience mild symptoms, such as a runny nose, cough, and low-grade fever, similar to a common cold. However, in other cases, RSV can lead to more severe respiratory symptoms, including:
1. Rapid or difficult breathing: Infants may breathe rapidly, struggle to catch their breath, or show signs of labored breathing.
2. Wheezing: RSV can cause wheezing, which is a high-pitched whistling sound during breathing.
3. Cyanosis: Infants with severe RSV infection may develop a bluish coloration of the lips, face, or fingernails due to inadequate oxygen supply.
4. Poor feeding: Infants may have difficulty feeding or show a decrease in appetite due to breathing difficulties.
5. Dehydration: Severe RSV infection can lead to dehydration if the infant is unable to take in enough fluids.
Certain factors can increase the risk of severe RSV infection in infants, including premature birth, a weakened immune system, and underlying medical conditions such as congenital heart disease or chronic lung disease.
If you suspect that your infant has RSV or is experiencing severe respiratory symptoms, it's essential to seek medical attention promptly. Healthcare professionals can evaluate the severity of the infection, provide supportive care, and monitor the infant's breathing and overall condition. In severe cases, hospitalization may be required for infants with significant breathing difficulties or dehydration.
Prevention is also crucial in reducing the risk of RSV in infants. Practicing good hand hygiene, avoiding close contact with sick individuals, and keeping infants away from crowded places during the RSV season (typically fall and winter in temperate climates) can help minimize the risk of infection. Additionally, certain high-risk infants may be eligible for palivizumab medication, which can provide temporary protection against severe RSV disease. It's important to consult with a healthcare professional to determine if your infant is a candidate for this preventive treatment.
Remember, if you have concerns about your infant's health or suspect RSV, it's always best to consult with a healthcare professional for an accurate diagnosis and appropriate management.
Here we go again ! 99% of infants who contract RSV have cold-like signs and symptoms.
Advisors to the U.S. Food and Drug Administration (FDA) on Thursday recommended approval of AstraZeneca’s new monoclonal antibody, which the drugmaker said is designed to protect infants and toddlers up to age 2 from respiratory syncytial virus (RSV).
Monoclonal antibodies are not vaccines and do not give long-lasting immunity, but only last as long as t he synthetic antibody is present. The titers decrease rapidly and must be given annually
The drug, nirsevimab, would be delivered to newborns in a single shot at birth or “just before the start of a baby’s first RSV season, or as a larger dose in a second RSV season in children who are highly vulnerable,” CNN reported.
Here lies another COVID scenario, overreacting to a perceived nonexistent threat.
Common sense on the part of pediatricians should make this 'shot' unnecessary in almost all cases. Some children with serious pulmonary problems, such as cystic fibrosis, would be suitable for this prophylactic drug.
But medical experts interviewed by The Defender raised a number of concerns, including what they said was inadequate safety testing.
“It’s preposterous to give this drug prophylactically, especially without adequate safety testing,” said Brian Hooker, Ph.D., P.E., senior director of science and research for Children’s Health Defense (CHD).
AstraZeneca reported only 48% efficacy for the drug. And Hooker noted that the “circulating half-life of the antibodies is probably less than one month, so the protection would be minimal at best.”
Hooker also commented on the fact that 12 infant deaths were recorded during the clinical trial, which the FDA committee claimed were “unrelated” to the antibody:
“It appears that this vote was meant to bolster the uptake and popularity of the RSV vaccines that are now approved for maternal use. The very low rate of effectiveness for such a therapy is troubling as the conservative estimate is below 50%, which is usually a hard metric for drug approval.
“Also, it seems odd that four infants in the trial would die of cardiac arrest — with no information given, it leaves one to wonder why these children would die in such a way. Also, there should be further investigation into the two SIDS [sudden infant death syndrome] deaths that occurred during the trial.”
Since the monoclonal AB
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