THE parents of a 16-year-old girl given wrongly given a Covid vaccine which is still only authorised in the UK for use in adults say they have been “fobbed off” by the health board.
They say they are running out of time to decide what to do about their daughter’s second vaccination, and feel angry that “the onus has unfairly been put on us to make a decision”.
The Edinburgh teenager, who did not want to be identified, was given the Moderna vaccine at Leith Community Centre on June 28 despite assurances that stocks of Pfizer would be available.
She had turned 16 days before and was eligible as a household contact of her mother, who is severely immuno-compromised.
The schoolgirl told the Herald she wanted her mother, who has been shielding, to “feel safer at home” and stressed that she did not want her own experience to deter others from getting protected.
She said: “I do think that 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 a clinical trials involving more than 3,700 adolescents.
The schoolgirl attended the appointment in Leith with her father, who was told he could not accompany his daughter to the cubicle during vaccination.
Had he been present, he says he knew that the Moderna vaccine was not yet authorised for use in teenagers and would have intervened.
Speaking to the Herald 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 my 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 within Edinburgh’s Health and Social Care Partnership (HSCP), who she says admitted to a “breach of safeguarding policy” regarding the girl’s father being excluded.
“I was informed I would receive a letter outlining everything we had discussed,” said the girl’s mother.
“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 (MHRA) 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 the “last thing we want to do is put anyone off attending for vaccination”, but that they did want to ensure procedures are put in place to avoid the situation being repeated.
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.
He said: “The vaccine is not authorised for use in the UK for my daughters 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 Ms Doyle’s 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.”
The Moderna vaccine – also known by the brand name Spikevax in Europe – is being trialled in an ongoing study involving 3,732 children aged 12 to 17 in the United States.
In May, the manufacturer reported that there had been no cases of Covid among teenagers given both doses of the vaccine compared to four cases in the placebo group.
It added that the vaccine was “generally well tolerated”, with headache, fatigue, muscle pain and chills the most common side effects following a second dose.
Both the Pfizer and Moderna vaccines are also being tested in children under-12 in ongoing clinical trials.
They are each built around messenger RNA technology which provides instructions to cells on how to make a harmless piece of the Covid virus spike protein, triggering an immune response that produces antibodies.
To date, however, only the Pfizer vaccine has been deemed “safe and effective” by UK regulators for use in the 12 to 17 age group, but is only currently being administered routinely to 16 and 17-year-olds and to 12 to 15-year-olds with serious health conditions.
On Wednesday, the European Medicines Agency (EMA) confirmed that they are investigating a possible link between the Pfizer and Moderna vaccines and cases of an allergic skin reaction, kidney inflammation, and a renal disorder known as nephrotic syndrome. It did not disclose how many cases had been recorded.
In July, the watchdog said there was a possible link between mRNA vaccines and very rare heart inflammation, but stressed that the benefits outweigh any risks.