Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Off label use, Product use issue
Clinical narrative: causing our nanny share to resume (with one other family, which takes place in our home)/she has likely been exposed; Off label use; 7 month old/ nanny alerting us to the fact that she has likely been exposed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 7 month-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPOSURE TO SARS-COV-2 (medically significant), outcome "unknown", described as "causing our nanny share to resume (with one other family, which takes place in our home)/she has likely been exposed"; OFF LABEL USE (non-serious), outcome "unknown", described as "Off label use"; PRODUCT USE ISSUE (non-serious), outcome "unknown", described as "7 month old/ nanny alerting us to the fact that she has likely been exposed". She was sure you receive many requests a day regarding vaccines. She was writing to you as a mother of a 7 month old (name) who was born with one kidney. The news frequently touts that infants and small children were at a lower risk of severe infections from COVID-19. She acknowledge the recent studies that show that young children were even less likely to be admitted into the ED or put on a ventilator with the Omicron variant as opposed to the Delta variant. The problem with the foregoing was that it doesn't acknowledge the actual number of children that were admitted into the ED will actually increase as Omicron blazes through the population and increases the rate of actual infection. So, while the percentage was smaller, the actual number of small children with severe COVID-19 will actually be higher.  Her son was born last May with one kidney. They have read some studies that say COVID-19 may potentially cause kidney degradation. Given he only has one, they were terrified of COVID-19. In the past they were told that they could protect their son by getting vaccinated and boosted. They have taken every precaution since the Omicron variant rose to prominence before Christmas. Her husband and she were both vaccinated and boosted. They canceled their Christmas plans and have barely left the house since 20Dec. However, this past Monday they had to go back to work, causing their nanny share to resume (with one other family, which takes place in our home). Their nanny, they and the other parents agreed to take rapid tests every few days to ensure the two small babies were not exposed. Today they received a call from their nanny alerting them to the fact that she has likely been exposed. Her husband and she were fortunate that they can both work from home to take care of their small son and will be doing so until they hear that their nanny has been cleared. However, this scare has made evident that even though they may take every precaution they may not be able to protect their son from COVID-19. What could help protect him. a vaccine. One that you have ready. One that you have tested and has been proven safe and effective. Yet, one that you are sitting on because the 2-, 3-, and 4-year-old cohort did not exhibit an immune response.  Given the prevalence of the Omicron variant and the way it was ripping through American society she urge you to rethink your decision. Submit for emergency authorization for 6 month - 2 year olds. Why risk their lives by waiting to make sure it was effective for 2-, 3-, and 4-year-olds as well. At the very least please please make the vaccine available for 6 month - 2 year olds with underlying conditions. Omicron has changed the landscape. As a result, please change your thinking.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200021609 Same reporter/product/event, different patient