Mattie McGrath (Tipperary, Independent)
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1725. To ask the Minister for Health if HIQA has re-examined the emerging evidence regarding the efficacy of ivermectin as a prophylactic and treatment for Covid-19; if not, if he will instruct HIQA to re-examine the matter given the growing evidence of the success of ivermectin; if HIQA will outline the studies it has examined as a basis for its decision on the matter; and if he will make a statement on the matter. [35121/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Deputy is advised that, previously at the request of the NPHET, HIQA conducted a rapid evidence review to identify studies on the effectiveness of (i) pharmaceutical and (ii) non-pharmaceutical interventions, in the ambulatory setting, aimed at reducing progression to severe disease in individuals with confirmed or suspected COVID-19. This evidence review included a review of relevant studies in relation to Ivermectin.

As confirmed by HIQA’s COVID-19 Expert Advisory Group (www.hiqa.ie/sites/default/files/2021-02/Interventions-to-prevent-progression_Advice.pdf ), evidence regarding the effectiveness of pharmaceutical treatments intended for systemic use, must be subject to the highest standards of rigour. Where a pharmaceutical intervention is recommended in the absence of appropriate supportive evidence, there is a significant potential for harm to the patient. Whereas this risk of harm may be justified in certain circumstances (e.g. the intervention poses minimal risk, or the setting involves patients with high potential to gain due to almost certain risk of severe adverse consequences in absence of any intervention) this is less likely to be the case in the setting of mild disease, where a great number of otherwise well patients would potentially receive the intervention.

HIQA has also advised my Department that several international health technology assessment or guideline development organisations have specifically reviewed the evidence to date on ivermectin in COVID-19 and have cautioned or advised against the use of ivermectin outside the setting of clinical trials on the basis of the current evidence. HIQA has also advised that the pharmaceutical company MSD (Merck, USA), which holds a license in the USA for the use of ivermectin as an antiparasitic agent, on 4 February 2021 published a statement including the following:

“It is important to note that, to-date, our analysis has identified:

- No scientific basis for a potential therapeutic effect against COVID-19 from pre-clinical studies;

- No meaningful evidence for clinical activity or clinical efficacy in patients with COVID-19 disease, and;

- A concerning lack of safety data in the majority of studies.

We do not believe that the data available support the safety and efficacy of ivermectin beyond the doses and populations indicated in the regulatory agency-approved prescribing information.”

Further research was undertaken by HIQA and updated advice was provided to the NPHET on 12 May: COVID-19 - Interventions and health related factors that prevent infection or minimise progression to severe disease. This document was subsequently published by HIQA on the 23 June 2021:

www.hiqa.ie/sites/default/files/2021-06/Advice-to-NPHET_Interventions-to-prevent-COVID-19.pdf

One of the key findings of the review was that Ivermectin is not currently licensed for the treatment of COVID-19. From this evidence summary, there is currently insufficient information on whether it can be safely used to prevent or reduce the severity of COVID-19. Ivermectin should therefore not be used as prophylaxis outside well-designed, regulated clinical trials as the benefits and harms are not yet clear when taken in the context of COVID-19 treatment.

Low certainty or very low certainty evidence was identified in relation to a small number of interventions. However, HIQA noted the low quality of the evidence available including the high risk of bias, small sample sizes and short durations of follow-up, different trials and advised that results from these studies should not be used to inform decision-making with respect to effectiveness.

HIQA’s overall finding was that there is currently insufficient evidence of either effectiveness or safety to support the use of any pharmaceutical intervention outside of well conducted, well-regulated clinical trials. Furthermore, no evidence was identified for the effectiveness or safety of any non-pharmaceutical interventions.

I trust that the above information satisfactorily addresses your question.

Mattie McGrath (Tipperary, Independent)
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1726. To ask the Minister for Health his plans to remove the UAE from the MHQ or to exempt those Irish citizens who have received a vaccine (details supplied) from MHQ considering it is approved by the World Health Organisation; and if he will make a statement on the matter. [35198/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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The United Arab Emirates was removed from the list of designated states on Friday, 16 July 2021.

Ireland procures COVID-19 vaccines through its participation in an EU procurement process and their approval is by the Commission following recommendation by the EMA.

At present, the Sinopharm vaccine has not received EMA approval.

COVID-19 vaccines can only be approved and used if they comply with all the requirements of quality, safety and efficacy set out in the EU pharmaceutical legislation. No vaccine will be used until Market authorisation from the European Medicines Agency (EMA) is obtained and any authorised vaccine will be subject to ongoing monitoring in Ireland by the Health Product Regulatory Authority (HPRA).

Passengers who are fully vaccinated in accordance with the table below and have the documents to confirm this are not required to complete mandatory hotel quarantine on arrival in Ireland. Dependents, including children, will also be exempted from the requirement to complete mandatory hotel quarantine.

What 'fully vaccinated' means: