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European Medicines Agency approves first Omicron-specific Covid vaccines

The so-called “bivalent” vaccines protect against the earlier BA.1 strain of Omicron, but do not target the latest strains.

Updated Sep 1st 2022, 2:42 PM

COVID-19 VACCINES BY Pfizer/BioNTech and Moderna adapted to provide broader protection against the Omicron variant have been approved by the EU’s drug regulator. 

The so-called “bivalent” vaccines target both the original virus that emerged in in 2019 and the BA.1 subvariant of Omicron, the European Medicines Agency (EMA) said.

The vaccines are not updated for the newer and more infectious BA.4 and BA.5 types that have become dominant worldwide. A decision on a jab to counter those variants is expected within weeks.

The EMA said that the two jabs backed for people aged 12 and above today were the “first adapted Covid-19 booster vaccines recommended for approval in the EU”.

“These vaccines are adapted versions of the original vaccines Comirnaty (Pfizer/BioNTech) and Spikevax (Moderna) to target the Omicron BA.1 subvariant in addition to the original strain of SARS-CoV-2,” it said.

European nations have been keen to rush through the new generation of jabs so they can start booster campaigns ahead of a feared Covid surge in the latter part of this year.

EU Health Commissioner Stella Kyriakides hailed the decision as “important to protect Europeans against the likely risk of autumn and winter waves of infections”.

“We need to be ready to face another winter with Covid-19,” she said in a statement.

The EMA said that studies showed that the new jabs could “trigger strong immune responses” against Covid.

It said that “in particular, they were more effective at triggering immune responses against the BA.1 subvariant than the original vaccines”.

New strains

The EU’s Kyriakides said she expected the EMA to rule on vaccines adapted for the now-dominant BA.4 and 5 strains “in the coming weeks”.

Pfizer recently applied for authorisation for a vaccine adapted against the two newer types.

The US authorised its first anti-Omicron vaccines yesterday, approving Pfizer and Moderna jabs for the BA.4 and BA.5 strains.

Britain authorised the Moderna vaccine for the BA.1 type in mid-August.

The 27-nation EU is currently still using the same Covid-19 vaccines that were approved nearly two years ago for use against the original strain.

While they offer some protection against newer variants, the race has been on to produce jabs that also target the milder but more infectious Omicron strains.

Boosters in Ireland

Appointments have today opened in Ireland for people aged from 12 to 49 years-old with long term health conditions and healthcare workers to book their next Covid-19 booster vaccine.

Those who have long-term conditions – such as diabetes, asthma or heart disease – are being encouraged to come forward for their second booster.

This second booster vaccine will be available to those who have already received their initial vaccine course and one booster dose.

The latest shot is available once it has been four months since the person’s last Covid-19 vaccine or since they they were last infected with the virus

People can book an appointment online for a HSE vaccination clinic or check with participating GPs and pharmacies to receive their dose.

The HSE and Children’s Health Ireland will soon make a first booster dose available to children aged 5-11 years who are immunocompromised.

The health service said it will continue to be active over the next few weeks in its services, in the media and online, encouraging people to come forward for Covid-19 vaccines.

The HSE said it strongly urges people who have not yet received a coronavirus vaccine to consider attending a walk-in clinic or to register for an appointment.

With reporting by Céimin Burke and © AFP 2022

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