Regulators give green light to vaccine that targets dominant variant of Covid-19

Adapted boosters to be available within days following recommendation by EMA

Pfizer said the new vaccines could be available in Ireland and other European countries within days of authorisation. Photograph: AFP/Getty Images
Pfizer said the new vaccines could be available in Ireland and other European countries within days of authorisation. Photograph: AFP/Getty Images

The European Medicines Agency (EMA) has recommended a new adapted Covid-19 vaccine that targets the variant currently dominant in Ireland.

On Monday, the EMA’s human medicines committee recommended authorising an adapted vaccine targeting the Omicron subvariants BA.4 and BA.5 in addition to the original strain of the virus.

This is the first time in the pandemic that a vaccine designed to tackle a currently dominant variant has been recommended in Europe.

BA.5 accounts for the vast majority of infections in Ireland at present, with BA.4 responsible for most of the rest, according to the latest data from the Health Protection Surveillance Centre. Both are subvariants of the Omicron variant.

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The opinion of the EMA’s human medicines committee will be sent to the European Commission for a final decision. This is likely to come soon. Any decision is legally binding in Ireland.

Irish health officials are currently finalising their plans for the next phase of the Covid-19 vaccine programme, mindful of the threat posed by the virus and flu this winter.

In accordance with advice from the European Commission, the adapted vaccines are expected to be targeted at higher-risk groups, with existing supplies of the original vaccine used for people at lower risk and those not already vaccinated.

Those at higher risk are expected to be offered the Covid-19 booster and the flu vaccine at the same time in special winter clinics from next month.

All forms of the Pfizer and Moderna vaccines provide good protection against serious illness and death but are subject to waning immunity, particularly since Omicron superseded previous variants.

Earlier this month, the EMA recommended the first adapted vaccines, designed to target the BA.1 variant that was in circulation before the summer, as well as the original wild-type strain.

Announcing its latest recommendation, the EMA said the BA.4/BA.5 vaccine from Pfizer is for use as a booster in people aged 12 and over who have already been vaccinated.

The Department of Health said the adapted vaccines would play an important role in Ireland’s autumn-to-winter vaccination campaign. Acting chief medical officer Prof Breda Smyth has written to the chairwoman of the National Immunisation Advisory Committee, Prof Karina Butler, requesting that “active consideration” be given to the role these adapted vaccines play, according to a spokeswoman.

The Health Service Executive said it would operationalise the extension of the vaccine programme once Prof Smyth gives her advice. In the past, such changes to the vaccine programme have taken weeks to implement.

Pfizer said the new vaccines could be available in Ireland and other European countries within days of authorisation. The company has already stopped production of the original version of its vaccine.

Paul Cullen

Paul Cullen

Paul Cullen is a former heath editor of The Irish Times.