What type of vaccine was given to pregnant women and infants?
During this winter, a significant milestone occurred as two vaccines became accessible to protect against respiratory syncytial virus. This virus poses a greater risk to older adults and infants. However, only one of these vaccines, Abrysvo from Pfizer, was authorized for pregnant women. Unfortunately, neither of the vaccines was approved for use in young children.
How many people were affected by this incident?
Some clinicians and pharmacists seemed to have missed the distinction.
The Centers for Disease Control and Prevention has issued a warning stating that a minimum of 128 pregnant women were unintentionally given the alternative vaccine, known as Arexvy, produced by GSK. Additionally, at least 25 children under the age of 2 also received this vaccination.
What actions were taken to address this incident?
Dr. Sarah Long, who is both a pediatric infectious disease doctor and an advisor to the organization, expressed feeling completely caught off guard by the mentioned reports. She expressed her deep dismay over the occurrence of such a situation.
Testing of Arexvy on pregnant women and children has not taken place, leading to limited knowledge about its effects on these specific groups. Although no significant negative consequences stemming from the errors have been officially verified, the results were indeterminate in most of the cases that were reported.
What health risks can these vaccines pose to pregnant women and infants?
Dr. Long expressed greater concern for young children who were given an R.S.V. vaccine than for pregnant women who received Arexvy and their infants, based on the data at hand. The Food and Drug Administration has found evidence from animal experiments that strongly indicates that Arexvy could potentially worsen R.S.V. infection in children under 2 years old, rather than alleviate it.
In order to avoid this situation, the Centers for Disease Control and Prevention (C.D.C.) has advised that children who were mistakenly given either vaccine should also receive nirsevimab (marketed as Beyfortus), a powerful monoclonal antibody that offers robust immune protection for the duration of the R.S.V. season.
What measures are being taken to prevent a recurrence of this incident?
Each year in the United States, around 80,000 children under the age of 5 are admitted to the hospital due to R.S.V. infections. This virus is also a major cause of death among children worldwide.
GSK stopped conducting clinical trials on their vaccine for pregnant women in 2022 due to concerns about the safety of the product. A thorough examination revealed that there was a higher chance of preterm birth associated with its use. Additionally, the company observed a rise in neonatal deaths, but attributed them to the preterm births rather than the vaccine itself.
What measures should the authorities take to allay people’s fears?
According to the company’s spokesperson, Alison Hunt, GSK is currently observing the individuals involved in those experiments and providing the information to the F.D.A.
During Pfizer’s study, Abrysvo exhibited a slightly elevated chance of delivering prematurely before reaching 37 weeks of pregnancy, yet the rise did not reach a significant statistical level.
What support do these people need?
However, to address the potential danger of giving birth prematurely, the F.D.A. has granted approval for Abrysvo exclusively to pregnant women in the gestational period of 32 to 36 weeks. This decision is aimed at enabling the women to generate antibodies that can be transferred to their newborns, offering them immediate protection upon delivery.
The C.D.C.’s advisors narrowed down the time frame even more by suggesting that pregnant women receive the shots only between September and January. This is done with the intention of safeguarding babies who are born during the peak R.S.V. season.
Dr. Camille Kotton, a medical professional at Massachusetts General Hospital and a science advisor for the agency, mentioned that while reviewing the data, they were experiencing a somewhat cautious mindset.
She stated that if preterm labor were to occur, it would have a smaller effect if it happened in the final eight weeks of pregnancy compared to earlier stages.
What challenges do these people face?
A number of infants were given the wrong vaccine for R.S.V., as they were supposed to receive nirsevimab instead. The GSK vaccine was mistakenly given to pregnant women, as Pfizer’s vaccine was not as easily accessible and pharmacists believed they could be used interchangeably.
Amy Gardner, who used to teach kindergarten in Cleveland, Tenn., explained that she made efforts to find Pfizer’s R.S.V. vaccine at various pharmacies for her pregnant daughter. Ms. Gardner discovered a drugstore on the final day her daughter was eligible for the shot, and they confirmed to have the vaccine available.
However, her daughter was given Arexvy instead.
“We are all human, however, there must be additional systems in place to ensure fairness,” Ms. Gardner mentioned. She holds the belief that the injection caused her daughter to experience early childbirth just a few hours after.
What recommendations have been given to pregnant women and infants who have received these vaccines?
Experts said that the mistakes were documented in a federal database known as the Vaccine Adverse Event Reporting System. The confusion among the vaccine administrators may have been caused by the similarity between the two names.
Dr. Long expressed his disapproval, questioning the reasons behind the terrible actions. He couldn’t comprehend why significant amounts of money were paid to create these names.
Dr. Kotton recommended that the FDA should incentivize companies to use distinct names for similar products. She suggested that it would be beneficial to have different names for vaccines that are released simultaneously, whenever feasible.
Dr. Long expressed her confusion over the fact that young children were given R.S.V. vaccines, as these vaccines are not authorized for use in children. She pointed out that since pediatrician offices, which are responsible for administering vaccines, should not have had these vaccines in their inventory.
She expressed the need to investigate the cause of that occurrence in order to prevent its recurrence.
