16-year-old Edinburgh girl given a Moderna jag not yet approved in the UK for teens under-18 prompting her parents to fight for answers
A 16-year-old girl in Edinburgh was given a Moderna jab not yet approved in the UK for teens under-18 prompting her parents to fight for answers.
The girl was given the Moderna vaccine at Leith Community Centre, Leith, Edinburgh, on June 28 despite assurances that stocks of Pfizer would be available.
She was eligible as her mother is severely immuno-compromised.
With the date of her second jab approaching on August 23, the family are in the dark about whether the schoolgirl can receive a second dose of the unauthorised jab, and are worried about adding a Pfizer innoculation into the mix.
The girl said: "I do think people my age should get vaccinated but I would like to know what I should do now.
"People in my vaccine group should receive their second dose within eight weeks.
"It has been nearly seven weeks since I received my first dose.
"I was given an unauthorised vaccine for my age in error.
"I don't know if I can get a second dose because the NHS have not confirmed their advice in writing.
"I am really quite worried about this situation."
The Moderna vaccine has not yet been recommended for use in under-18s by UK or US regulators, with European regulators only authorising it for 12 to 17-year-olds on July 23 based on clinical trials involving more than 3,700 adolescents.
The schoolgirl attended her appointment in Leith with her father, who was told he could not accompany his daughter to the cubicle during vaccination - and who says he would have challenged the decision had he been able to go in.
Speaking on condition of anonymity, the girl's mother said: "He thought this was for Covid-secure reasons so did not object.
"My daughter was given the Moderna vaccine.
"She did not know this was not authorised for under-18s and only discovered this when reading the leaflet she was given while sitting on her own for 15 minutes in the observation area.
"My daughter left and told her dad who was waiting outside."
Their conversation was overheard by a member of staff and they were reassured, incorrectly, that the vaccine was already being routinely administered to under-18s in the US.
The girl's mother subsequently telephoned the hub and received verbal apologies from the vaccinator and later from a senior member of staff in Edinburgh's Health and Social Care Partnership, who she says admitted to a "breach of safeguarding policy" regarding the girl's father being excluded.
The mum said: "I was informed I would receive a letter outlining everything we had discussed.
"Six weeks later and, as yet, I still have not received a letter."
The couple have repeatedly requested formal advice about what to do about their daughter's second vaccine dose, due on August 23.
While the Moderna vaccine is not authorised by the Medicines and Healthcare products Regulatory Agency for use in under-18s, nor is a mix-and-match regime combining Moderna and Pfizer.
The girl's mother says that she and her partner have been encouraged, verbally, by officials within NHS Lothian, including a public health consultant, to proceed with a second dose of Moderna but, despite repeated requests for advice in writing, nothing has been provided.
They have instead been directed to submit a complaint.
The girl's mother said this had infuriated her partner, adding that the lack of communication from the health board has been "extremely unnerving" and only exacerbated their uncertainty.
The teenager has not experienced any adverse side-effects and her mother stressed that while "the last thing we want to do is put anyone off attending for vaccination", they also wanted to ensure procedures are put in place to avoid a repeat of the situation.
It is understood that Pfizer supplies were showing as available at the Leith site at the time the girl's appointment was booked, but that the system is not always updated quickly enough if stocks are moved.
The girl's mother said: "We feel the onus has unfairly been put on us to make a decision we should never have had placed on us due to the series of avoidable errors that led to my daughter receiving an unauthorised vaccine. We are not prepared to do that.
"We want the public health consultant to confirm in writing the advice she happily offered verbally for my daughter to take the second dose.
"I have experienced every emotion possible from distress to guilt and anger.
"My daughter has had her life on hold for over a year. She attended school only and did nothing else while her friends were all socialising.
"She did this to keep me safe. I am so proud of her. It's not fair what happened to her.
"It should never have happened."
The girl's father said he felt "frustrated and disappointed" by the lack of clinical advice.
The dad said: "The vaccine is not authorised for use in the UK for my daughter's age group, which has led to worries.
"My daughter was looking forward to getting the vaccine, that's the world we live in now, where a teenager wants a vaccination.
"I feel the onus should not be on us as a family to decide what the best way forward is.
"I thought that the NHS would have treated this as a priority."
Dona Milne, director of public health at NHS Lothian, said: "We are currently investigating an open complaint regarding vaccination and will respond to the family shortly.
"We are unable to comment any further on the details of the case while this process is ongoing.
"Ensuring patient safety is our priority and we take any complaints extremely seriously."