Covid-19 vaccine: Redress scheme recommended for extreme reactions to jab 

A redress scheme for those who suffer extreme reactions to the Covid-19 vaccine is still being developed, the Oireachtas Health Committee will hear today.

A redress scheme for those who suffer extreme reactions to the Covid-19 vaccine is still being developed, the Oireachtas Health Committee will hear today.

The opening statement to the committee from Professor Karina Butler, a consultant paediatrician and chair of the National Immunisation Advisory Committee, notes that such a scheme has been recommended by the World Health Organization (WHO).

"A further challenge is to finalise the development of a national injury redress programme to provide support and care in the event that any vaccine recipient develops a serious vaccine reaction as recommended by the World Health Organization," her statement reads.

Regarding safety, local site reactions and, less commonly, more general short‐term reactions –  fatigue, flu-like symptoms, fever – can be anticipated. 

"These events occurred at increased frequency following the second vaccine dose and were more common in the younger age groups.

"These effects are partly a result of the efficacy of the vaccines in stimulating the immune system. 

"We will know more detail about the side‐effects when the licence documentation is published by the EMA [European Medicines Agency].

"Reports from the regulatory agencies in the US, UK and Canada raised no significant safety concerns. 

"Report of anaphylactic reaction in two vaccines in the UK outside of the clinical trial naturally draw attention. Vaccine-associated anaphylaxis [severe immediate allergic reaction] is extremely rare, estimated at 1.31 per million vaccine doses. Its occurrence in the UK is being investigated."

According to reports, the two reactions in the UK were suffered by individuals who have a history of allergic reactions and have both since recovered.

Investigation this week identified polyethylene glycol (PEG) as likely reason 2 people in UK suffered anaphylaxis after receiving #Pfizer’s #vaccine. In Sept, I warned #FDA that PEG in #COVID vaccines could lead to severe allergic reactions. #TheDefender https://t.co/zJtM17aRGf

— Robert F. Kennedy Jr (@RobertKennedyJr) December 11, 2020

Ireland's plan to vaccinate the population was laid out in two separate documents – a high‐level strategy and a ‘living’ implementation plan ‐ approved by Government at Tuesday’s Cabinet meeting.

Professor Brian MacCraith, chair of the High-Level Task Force on Covid‐19 Vaccination, adds in his statement that the programme to roll out the vaccine is "unparalleled".

"The challenge in devising and implementing a vaccination programme of this scale, complexity and desire for speed is unparalleled here and around the world," the statement reads.

"Successful roll‐out of the vaccination programme is dependent upon careful and precise coordination across Government, several State agencies, the HSE and a wide range of advisory, regulatory and delivery partners across the health sector and private sector providers.

Given the range of responsibilities and actors and the level of responsiveness that will be required as the programme rolls out, there will be a need to augment and support existing arrangements.

"The implementation plan is designed to be a ‘living document’ in that it needs to be agile, flexible and capable of evolving over time ‐ for example, to accommodate vaccines with differing characteristics or to respond to lessons learned in our local experience or internationally. 

"It describes the logistical, operational and human resource requirements for Ireland to begin vaccinations in line with Government guidance in early 2021, assuming that one or more safe and effective Covid‐19 vaccines are approved for use."