Lodge a complaint against the HSE for the information provided to parents/guardians on Covid 19 vaccine for 5 – to 11-years olds

Source: Lawyers for justice

We have been contacted by several parents who have expressed a concern about the information circulated by their child’s School on the Covid-19 vaccine for children aged 5 to 11. This information was circulated by the Department of Education on behalf of the HSE and forwarded by the School to parents/guardians. The parents are concerned that the information provided by the HSE is not sufficiently clear on the status of the Covid-19 vaccines for this age group. We have drafted a complaint that a parent/guardian can adapt and lodge by emailing the HSE on yoursay@hse.ie. PM or email us on lawyersforjustice@yahoo.com for further assistance.

Dear Sir/Madam

Re: HSE Information on COVID-19 vaccine for parents of children aged 5 -11

I write further to the information forwarded to Parents/Guardians which the Department of Education disseminated to Schools on behalf of the HSE on 21st December 2021.

This information consisted of an unsigned letter titled ‘Parents/Guardians’ with links to HSE ‘screening and vaccinations/covid-19-vaccinations for children’ and ‘Important information for parents and guardians about the COVID-19 vaccine for children aged 5-11 (Comirnaty Pfizer/BioNTech)’.

I wish to lodge a complaint about this information published by the HSE on the grounds that it does not provide adequate information on Covid-19 vaccines for 5-11 year olds which were granted conditional marketing authorisation by the European Medical Agency (‘EMA’) on 25th November 2021.

The HSE link to ‘screening and vaccinations/covid 19-vaccinations for children’ is titled ‘Deciding on COVID-19 vaccination for children’. I note that under the heading ‘benefits of getting a COVID-19 vaccine’ it is stated that ‘it may also protect healthy 5 to 11 year old children from multisystem inflammatory syndrome due to COVID-19’. However, when one clicks on this highlighted reference it takes you to a further page titled ‘multisystem inflammatory syndrome’ lastly updated on 21st December 2021 which stipulates:

‘We don’t know if these children developed MIS-C because they have COVID-19. It is too early to tell if there is a link’.

It is my submission that this should be clearly stated under the heading ‘benefits of getting a COVID-19 vaccine’ as there is a risk that a Parent/Guardian may not read this further highlighted link.

When one clicks on the link ‘Important information for parents and guardians about the COVID-19 vaccine for children aged 5-11 (Comirnaty Pfizer/BioNTech)’ it brings you to a publication titled ‘Comirnaty (Pfizer/BioNTech) vaccine for children aged 5 to 11’ (‘HSE Comirnaty publication’) At Page 12 point 3 under the heading ‘the risks of the vaccine’ it states:

‘We don’t yet have information about longer term effects of COVID-19 vaccines in children’.

Although the HSE Comirnaty publication makes reference to information on the longer-term effects it does not make it sufficiently clear that Covid-19 vaccinations for 5-11 year olds are subject to conditional marketing authorisation by the EMA.

I refer to Page 5 of the HSE Comirnaty publication that states:

‘While the work to develop COVID-19 vaccines has moved much faster than usual, the vaccine we are offering your child has gone through all the usual steps needed to develop and approve a safe and effective vaccine’.

A link is provided to the EMA as regulator at Page 5 for a Parent/Guardian to obtain further information. I trust that you will agree, however, that it may be difficult for many Parents/Guardians to navigate the EMA website and to therefore access more detailed information on the status of Covid-19 vaccinations for 5 -11-year-olds.

The HSE Comirnaty publication should therefore be amended so that a Parent/Guardian is provided with clear information to enable them to make an informed decision in relation to the Covid-19 vaccine for this age group.

In particular, I refer to the EMA/702084/2021 publication entitled: ‘Comirnaty (COVID-19 m RNA vaccine [nucleoside modified] (‘EMA Comirnaty publication’) at Page 4 that states under the heading ‘What information is still awaited for Comirnaty?’

‘As Comirnaty received a conditional marketing authorisation, the company that makes Comirnaty will continue to provide results from the main trial in adults, which is ongoing for 2 years, as well as the trial in children’.

Under Article 5(1) of Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of the Regulation (EC) No 726/2004 of the European Parliament the holder of a conditional marketing authorisation:

‘…shall be required to complete ongoing studies, or to conduct new studies, with a view to confirming that the risk-benefit balance is positive and providing the additional data referred to Article 4(1)’.

A Parent/Guardian should therefore be fully informed by the HSE Comirnaty publication of the conditional marketing authorisation status of the Covid-19 vaccine for 5 to 11 year olds.

I also refer to Page 12 of the HSE Comirnaty publication under the heading ‘Benefits of the vaccine’:

‘May help prevent the spread of COVID-19 to others. This is especially important if children and young people are living with a younger child or an adult who is at risk of severe COVID-19’

It is noteworthy that the EMA Comirnaty publication stipulates under the heading: ‘Can Comirnaty reduce transmission of the virus from one person to another’:

‘The impact of vaccination with Comirnaty on the spread of the SARS-CoV-2 virus in the community is not yet known. It is not known how much vaccinated people may still be able to carry and spread the virus’.

With regards to efficacy at Page 5 of the HSE Comirnaty publication it is stated under the heading: ‘Is the vaccine effective for children aged 5 to 11 years’.

‘The clinical trial for the Comirnaty (Pfizer/BioNTech) vaccine showed it was highly effective at preventing COVID-19 in children this age’.

The reference to ‘highly effective’ should be qualified by referencing Page 2 of the EMA’s Comirnaty publication so that Parents/Guardians are aware that the efficacy of this Covid-19 vaccine for 5-11 year olds was based on clinical trials of ‘almost’ 2000 children.

Page 7 of the HSE Comirnaty publication under the heading ‘What are the side effects of the vaccine?’ states:

‘More than 1 in 1,000 people will develop itchiness where the vaccine was given, generalised itchiness, a rash, swelling of the lymph glands, sleeplessness, excessive sweating, night sweats, decreased appetite, lack of energy’ lethargy or pain in the hands or feet’.

‘Bell’s Palsy is a rare side effect seen in more than 1 in 10,000’

I refer to the EMA’s Comirnaty publication at Page 4:

‘Itching at the injection site, pain in the arm where the vaccine was injected, enlarged lymph nodes, difficulty sleeping, feeling unwell, decreased appetite, lethargy (lack of energy), hyperhidrosis (excessive sweating), night sweats, asthenia (weakness) and allergic reactions (such as rash, itching, itchy rash, and rapid swelling under the skin) were uncommon side effects (affecting less than 1 in 100 people). Weakness in muscles on one side of the face (acute peripheral facial paralysis or palsy) occurs in less than 1 in 1,000 people’.

The reference to a more detailed list of potential side effects should therefore be clarified in the HSE Comirnaty publication as should the calculated risk as there appears to be a discrepancy with the information provided by the EMA as regulator.

I look forward to hearing from you with regards to this complaint as a matter of urgency.

Yours sincerely

Insert Name