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Holohan warns boosters not approved by regulators

Data on the efficacy of a ‘third Covid jab’ still at a limited stage


Dr Tony Holohan.

Dr Tony Holohan.

Dr Tony Holohan.

There is limited data on the safety and efficacy of Covid-19 booster shots, chief medical officer Dr Tony Holohan has said.

However, some studies show the booster improved people’s defences against different forms of the virus, including the Delta variant.

And there appears to be a “favourable safety profile”, with over 1.5 million doses of booster Pfizer vaccines administered in Israel to date, he added.

Dr Holohan outlined the restricted evidence around boosters so far in a letter to Health Minister Stephen Donnelly, saying people need to know boosters have not been approved by the European medicines regulator.

However, he gave the green light to offer booster shots to residents in long-term care over 65, and to people over 80 living in the community, following an assessment by the National Immunisation Advisory Committee (Niac).

It comes against evidence of waning immunity in the fully vaccinated, among older age groups in particular, although they still have very good protection against getting seriously ill.

It will be necessary to tell people offered the booster that the vaccine is being used “off label” and it has yet to be approved for this use, he added.

The HSE is expected to start offering boosters along with the flu vaccine, which will be rolled out from next month although people in some poorer countries will not get a first jab until 2023.

He said people 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”.

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He added: “I note that the European Centre for Disease Control (ECDC) in their interim public health considerations for the provision of additional Covid-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 settings, 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 and will consider whether to update the licensed product information to allow for booster doses in the near future.

There is particular concern around nursing homes at a time of high levels of virus circulating despite the fall in the incidence.

Vaccine breakthrough – where fully vaccinated get the virus – is most likely in older people, particularly the over-80s.

Niac said that in developing its recommendations it is conscious of the global demands on vaccine supplies.

It recognises that facilitating vaccination on a global level is not only important on a humanitarian and global equity basis, but essential to limit the threat of Covid-19.

“Vaccines are a global public good for the benefit of all. As Niac considers if and to whom a booster vaccine should be offered, it is mindful that low and middle income countries (LMIC) have insufficient doses to protect those most at risk, such as older people and frontline healthcare workers.

“Less than 2pc of people in LMICs have received a first dose of vaccine; it is estimated that many will not have received even one vaccine be until late 2023.”

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