‘Too early’ to consider fourth Covid dose for general population – EU regulators

European regulators said it was “too early” to consider offering a second booster vaccine to the general population.

However, the European Center for Disease Prevention and Control (ECDC) and EMA’s Covid-19 Taskforce (ETF) both agreed that adults aged 80 and over can be given a second booster shot or fourth dose after the data to the higher dose, the risk of severe Covid-19 disease in this age group and the protection provided by a fourth dose.

The ruling comes as Ireland’s National Immunization Advisory Committee confirmed this week that a fourth vaccine would be offered to those over 65 and to immunocompromised groups.

ECDC and EMA also noted that there is currently “no clear evidence” in the EU that vaccination protection against major diseases in adults with “normal immune systems” falls significantly between the ages of 60 and 79 and there is “none clear evidence of this is immediate use of a fourth dose”.

“If the current epidemiological situation changes and new signals emerge, it may become necessary to consider a fourth dose in this age group. Meanwhile, national authorities will also consider local data when deciding whether to use a fourth dose in higher-risk individuals,” European regulators said.

“For adults under the age of 60 with normal immune systems, there is currently no conclusive evidence that vaccination protection against serious diseases is reduced or that a fourth dose is of any benefit.

“As renewed vaccination campaigns could begin in the fall, authorities will review the best timing for additional doses and potentially use updated vaccines.”

EU regulators said studies on supplemental boosters to date have “raised no safety concerns”.

ECDC and EMA have urged EU citizens to complete their initial and booster vaccinations according to national recommendations.

By the end of March 2022, 83 per cent of adults in the EU had received full primary vaccinations and only 64 per cent had received a booster.

EU health officials said the evidence on the effects of a fourth dose comes mostly from Israel, where data suggests a second booster dose given at least four months after the first booster dose restores antibody levels without raising new safety concerns .

The data also suggest that a second booster dose provides additional protection against serious illness, although the duration of benefit is not yet known and the evidence is still limited.

ECDC and EMA said they will continue to review the available evidence on the effectiveness of COVID-19 vaccines and will update their recommendations accordingly.

EMA said it will also consider any new data on the safety and efficacy of booster doses to update product information for COVID-19 vaccines as appropriate.