Sarah Bennett
The RSV vaccine has been a topic of controversy due to concerns regarding its safety, particularly in infant vaccines. While the vaccine has been approved for adults and is effective in saving lives, recent clinical trials have revealed unexpected outcomes in infants. In the trials, babies who received the RSV vaccine and subsequently contracted RSV or another respiratory virus experienced more severe symptoms compared to those given a placebo. This finding has prompted further investigations and discussions among scientists, with some trials of infant vaccines being halted. Additionally, the RSV vaccine for adults has been associated with an increased risk of Guillain-Barré syndrome, a rare nervous system disorder, leading to updated guidelines and recommendations from the CDC.
| Characteristics | Values |
|---|---|
| RSV vaccine manufacturers | GSK, Pfizer, Moderna |
| RSV vaccine names | Arexvy, Abrysvo, mResvia |
| Type of vaccine | Traditional, mRNA |
| Concerns | Guillain-Barré syndrome, severe respiratory disease, severe lower respiratory tract infections, hypersensitivity reactions |
| Age groups | 50–59, 60–74, 75 and older, infants and toddlers |
| Risk factors | Chronic heart or lung disease, weakened immune system, diabetes, living in a nursing home, severe obesity, moderate or severe immune compromise, etc. |
| Vaccination rates | 24% of adults 60 and older |
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What You'll Learn
The RSV vaccine may be linked to a heightened risk of Guillain-Barré syndrome
The RSV vaccine has been linked to a heightened risk of developing Guillain-Barré syndrome (GBS), a rare disorder that affects the nervous system. The US Food and Drug Administration (FDA) has mandated that a warning about this potential side effect be included in the prescribing information for two RSV vaccines: Abrysvo (manufactured by Pfizer) and Arexvy (manufactured by GlaxoSmithKline).
The FDA's decision was based on an evaluation of data from clinical trials, reports to the Vaccine Adverse Event Reporting System, and a postmarketing observational study. The observational study, which used Medicare data, estimated nine excess cases of Guillain-Barré syndrome per million doses of Abrysvo and seven per million doses of Arexvy among individuals aged 65 and older.
While the study suggests an association between the vaccines and an increased risk of developing Guillain-Barré syndrome, the FDA notes that the available evidence is insufficient to establish a causal relationship. The FDA has licensed a third RSV vaccine, mResvia, manufactured by Moderna, but post-licensure safety data for this vaccine is not yet available.
The CDC has published updated recommendations for older adults, detailing who should receive the RSV vaccine. The CDC advises that the benefits of the vaccine outweigh the risks for adults aged 60 and older, especially those with certain underlying conditions, such as lung disease, cardiovascular disease, or weakened immune systems. However, the CDC also notes that shared clinical decision-making can be challenging and may contribute to unclear messaging about the need for vaccination.
The RSV vaccine is also recommended for pregnant women to protect their newborns from severe RSV infections during the first few months of life. The vaccine is available from September to January, when infection rates are typically highest.
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The GSK and Pfizer vaccines are associated with GBS
GSK and Pfizer's vaccines were the first immunizations against the common respiratory illness, and a preliminary analysis found a potentially higher risk of GBS in older adults. The rate of GBS among recipients of Pfizer's Abrysvo was 4.6 per million doses, and for GSK's Arexvy, it was 1.1 per million. The companies have said they will conduct further safety studies to evaluate the risk factors of GBS.
The CDC has also revised its RSV vaccine guidelines, noting that there is a small risk of developing GBS after vaccination. The guidelines recommend that people aged 60 and older, especially those with risk factors such as heart disease or living in a nursing home, should consider getting vaccinated against RSV. However, the decision should be made in consultation with a medical provider.
While the increased risk of GBS with these vaccines is uncertain, the Advisory Committee on Immunization Practices (ACIP) believes that the risk is comparable to, and potentially greater than, other licensed adult vaccines. The ACIP and CDC continue to recommend RSV vaccination for adults 75 and older, as the benefits of reducing hospitalizations and deaths outweigh the potential risk of GBS.
The GSK and Pfizer vaccines are traditional platforms, similar to flu shots, that introduce an inactivated RSV protein into the body. This stimulates the immune system to recognize and fight the actual RSV virus.
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The FDA has halted some trials of RSV vaccines for children
Respiratory syncytial virus (RSV) is a leading cause of infant hospitalisations in the United States and kills up to 100,000 children under the age of five worldwide each year. While RSV usually causes mild symptoms in most people, older adults are at a higher risk of severe illness and hospitalisation due to the virus. Vaccines for older adults against RSV have been approved and are saving lives.
However, the prospects for infant vaccines are less promising. In recent clinical trials, two experimental RSV vaccines for babies were found to be potentially harmful. The trials, conducted by Moderna, found that infants who received one of two RSV vaccines had higher levels of severe respiratory disease than those given a placebo injection. Specifically, in a trial in Panama that enrolled children aged 5 to 7 months, five out of 40 who received either RSV vaccine and later became infected with RSV developed severe or very severe cases of lower respiratory tract infections, compared to one out of 20 children in the placebo group.
Based on these findings, the U.S. Food and Drug Administration (FDA) has halted some trials of other experimental RSV vaccines for children. The FDA advisory committee is examining the halt of a trial of two Moderna vaccines due to severe lower respiratory tract infections (LRTIs). The FDA advisory committee has expressed frustration at the knowledge gaps about the disease and has stated that more testing is needed. The halt was triggered by an "imbalance", according to the FDA, in cases of severe LRTIs in children in a phase 1 trial of two Moderna RSV vaccines.
While the need for a safe and effective vaccine for children is pressing, the history of RSV vaccine studies has made researchers cautious about potential problems. A previous RSV vaccine trial in the 1960s resulted in 80% of vaccinated children being hospitalised, with two deaths occurring. This incident has cast a long shadow over RSV vaccine development, but recent advances in vaccines for older adults and pregnant women have helped to alleviate concerns.
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The RSV vaccine may cause hypertensive disorders of pregnancy
The RSV vaccine has been a topic of controversy due to concerns about its side effects and safety, particularly in pregnant women and infants. The debate centres on the benefits of the vaccine in preventing severe RSV infections versus the potential risks associated with its use.
In terms of its effects on pregnant women, the Pfizer RSV vaccine (Abrysvo) has been associated with a non-statistically significant increase in hypertensive disorders during pregnancy. This observation was made during clinical trials among pregnant women at 24-36 weeks of gestation. While the difference was not considered statistically significant, the FDA has still addressed this concern. They have required Pfizer to conduct post-marketing studies to assess the risk of hypertensive disorders of pregnancy, including pre-eclampsia.
The Advisory Committee on Immunization Practices (ACIP) has judged that the benefits of the maternal Pfizer RSV vaccine at 32-36 weeks of gestation outweigh the potential risks for hypertensive disorders of pregnancy and preterm birth. This approval provides an option for healthcare providers and pregnant individuals to protect infants from RSV, which is a potentially life-threatening disease.
The controversy surrounding the RSV vaccine in pregnant women is a complex issue that involves weighing the benefits of disease prevention against potential risks. While the increase in hypertensive disorders was not statistically significant, it is essential to continuously monitor the safety of the vaccine and conduct further studies to ensure the well-being of pregnant women and their infants.
In addition to the concerns about hypertensive disorders, the RSV vaccine has also faced controversy due to its potential link to an increased risk of preterm births. This risk was observed in clinical trials, and the FDA has labelled it as a warning. The vaccine was approved for use in pregnant women at 32-36 weeks of gestation to avoid the potential risk of preterm birth before 32 weeks, which is associated with higher morbidity and mortality rates.
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The RSV vaccine may not be safe for infants
The respiratory syncytial virus (RSV) is a common respiratory virus that usually causes mild, cold-like symptoms. However, RSV can cause severe illness, especially in infants and older adults with certain risk factors. While vaccines for older adults have been approved and are saving lives, the prospects for infant vaccines are less promising.
In recent clinical trials, two experimental RSV vaccines for infants not only failed to protect them but may have made them more susceptible to the virus. Out of 40 infants who received either RSV vaccine and later became infected with RSV, five developed severe or very severe cases of lower respiratory tract infections. This is compared to one out of 20 infants in the placebo group.
Among the 27 infants who received the combo vaccine, three later became seriously ill from hMPV infections, while none in the placebo group did. While the numbers are small, researchers are concerned about the potential risks of the vaccine. The history of RSV vaccine studies has made researchers cautious about potential problems.
Based on the findings, the U.S. Food and Drug Administration (FDA) has suspended enrollment in 11 RSV vaccine trials that present F or other RSV proteins to the immune system. However, the FDA did not restrict 15 other trials testing various live, weakened forms of RSV. These "attenuated" vaccines most closely mimic the first natural infection in children and do not increase their risk of developing severe disease from subsequent RSV encounters.
While the need for a safe and effective infant RSV vaccine remains pressing, the recent trial results suggest that further research and caution are necessary to ensure the safety of this vulnerable population.
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Frequently asked questions
The RSV vaccine has been linked to a heightened risk of a rare nervous system condition called Guillain-Barré syndrome. This condition is a rare disorder where the body's immune system damages nerve cells, causing muscle weakness and sometimes paralysis. The FDA has mandated that this risk be included in the prescribing information for the vaccines.
RSV usually causes mild, cold-like symptoms such as a runny nose, cough, and headache. However, it can cause severe illness, especially in infants and older adults, and is the leading cause of infant hospitalizations in the United States.
There are currently three RSV vaccines available: GSK's Arexvy, Pfizer's Abrysvo, and Moderna's mResvia. The first two use traditional platforms similar to a flu shot, while the third uses an mRNA platform similar to Moderna's COVID-19 vaccine.
