At risk groups offered booster Covid-19 jabs must be informed it is ‘off label’ and not formally approved – Dr Tony Holohan



Some at risk groups who will be offered booster Covid-19 vaccines need to be informed that it is being done “off label” and not formally approved for this purpose, chief medical officer Dr Tony Holohan has said.

r Holohan, in a letter to Health Minister Stephen Donnelly, said he was giving the green light to offering booster vaccines to people over 65 in long term residential care and the over 80s.

They will also be offered to people with medical conditions leaving them very immunocompromised, following recommendations by the National Immunisation Advisory Committee (Niac).

He said they need to be given “information regarding the evidence available (and as yet unknown) in regard to the safety and efficacy of a booster dose as part of the informed consent procedure.”

He added: “I note that the European Centre for Disease Control (ECDC) in their interim public health considerations for the provision of additional Covi-19 vaccine doses, published on September 1,2021, recommend that consideration be given to providing an additional dose as a precautionary measure to older frail individuals, in particular to those living in closed setting, citing resident of LTC (long term care) as an example.

“The European Medicines Agency (EMA) has not authorised additional or booster doses for any Covid-19 vaccine to date. “However, the EMA has begun assessing data on booster doses to be given six months after the second dose of Comirnaty® (Pfizer) and will consider whether to update the licensed product information to allow for booster doses in near future.

The move comes amid concern around waning vaccine effectiveness in older age groups and the risk of breakthrough infections.

He said that Niac has have indicated that these recommendations are interim in nature and that they will continue to actively examine the evidence regarding waning immunity and reduced vaccine effectiveness in other groups, including older persons (under 80 years), those with underlying medical conditions, as well as health care workers.

The current advice is that there is consistent evidence currently of continued vaccine effectiveness against breakthrough infections in healthcare workers.

He pointed to data from the US and Canada signal a concerning trend whereby the proportion of breakthrough cases increases with age and are highest in those aged over 80 years, with protection against hospitalisation as a result of Covid-19 reduced in those over 75 years.

“This decline may be due to waning immunity in older persons over time; data from Israel indicates that those aged 60 years or older who were fully vaccinated in March 2021 were 1.7 times more protected against severe Covid-19 compared to those who were fully vaccinated in January 2021

” As noted by Niac, those residing in long term residential care aged over 65 years may also have altered vaccine protection due to their age and underlying conditions which put them at increased risk of severe disease should they contract SARS-CoV2.

“While there is evidence of high vaccine effectiveness against severe disease in this group against the Alpha variant, it is slightly lower when compared with estimates of vaccine effectiveness in the general population.”

Visit our Covid-19 vaccine dashboard for updates on the roll out of the vaccination program and the rate of Coronavirus cases Ireland



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