EU regulator backs Pfizer's Omicron-adapted vaccine booster

DANIEL LEAL-OLIVAS / AFP

The European Medicines Agency (EMA) on Monday recommended a COVID-19 booster designed to combat Omicron offshoots BA.4/5.

It comes just days after endorsing a pair of boosters tailored to target the older BA.1 variant.

The latest recommendation is for a so-called bivalent vaccine developed by Pfizer and BioNTech, which targets BA.4/5 as well as the strain of the virus that originally emerged in China in December 2019.

The EMA recommendation is to authorize the vaccines for people aged 12 and above who have received at least primary vaccination against COVID.

The final go-ahead will be subject to European Commission approval, which is expected to come in shortly.

If authorized, the BA.4/5-tailored booster will be available in days to all 27 EU member states, Pfizer said in a statement on Monday.

While existing coronavirus vaccines provide good protection against hospitalization and death, their effectiveness was reduced as the virus evolved.

Earlier this month, the EMA endorsed both Pfizer-BioNTech and Moderna's MRNA.O BA.1 updated vaccines.

EU officials signalled in recent months they were open to initially using shots targeting the older BA.1 variant, given those specifically targeting newer Omicron offshoots BA.4/5 are further behind in development.

In contrast, the US Food and Drug Administration (FDA) insisted it was only interested in vaccines targeting BA.4/5.

Last week, Pfizer-BioNTech and Moderna secured US approval for those.

Given BA.1 emerged first, data from human trials testing the adapted vaccines from sets of developers has been submitted to EU regulators.

For the BA.4/5 adapted vaccines, regulatory submissions are largely based on lab and animal data.

Using animal and lab data to solicit regulatory approval for retooled vaccines is not without precedent - it is done regularly for flu vaccines that are revamped each year to combat new variants.

On Monday, the EMA said its backing of the Pfizer-BioNTech updated BA.4/5 shot relied partly on data from human clinical trials available on the companies' BA.1-tailored vaccine.

EU officials have encouraged member states to roll out boosters of the established original vaccines and the bivalent shots - whatever is readily available - this autumn/winter initially for the vulnerable and elderly, following a rise in infections over the summer as protection waned due to the domination of BA.4/BA.5.

But uptake of the updated vaccines could be limited, as people have become less worried about the disease, thanks in large part to the success of first generation of shots.

More from International News

  • Russia and Ukraine complete largest prisoner swap

    Russia and Ukraine completed the exchange of 1,000 prisoners each on Sunday, the Russian Defence Ministry and Ukrainian President Volodymyr Zelenskyy said, in the largest such swap since the war began three years ago.

  • North Korea detains officials over warship accident

    North Korea has detained shipyard officials responsible for a recent major accident during the launch of a new warship, state media said on Sunday.

  • At least 13 killed in Russian air attack on Ukraine

    Russian forces launched a barrage of 367 drones and missiles at Ukrainian cities overnight, including the capital Kyiv, in the largest aerial attack of the war so far, killing 13 people and injuring dozens more, officials said.

  • Russia, Ukraine swap 307 soldiers on second day of POW exchange

    Russia and Ukraine each exchanged 307 of their service personnel on Saturday on the second day of a prisoner exchange that, when completed, is set to be the largest such swap in the three-year war between the two countries. U.S. President Donald Trump has suggested the prisoner swap - which should see 1,000 prisoners released on each side over three days - could herald a new phase in stop-start efforts to negotiate a peace deal between Moscow and Kyiv. Saturday's swap was announced by Russia's defence ministry, and separately by Ukrainian President Volodymyr Zelenskiy in a post on social

  • Police probe arson attack in France power outage

    French police were investigating a possible arson attack as being the main cause for a power outage which hit the Alpes-Maritimes region in southern France on Saturday, including Cannes which is hosting its world-famous annual film festival.

News