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EU Regulator Backs Pfizer's BA.4/5-Adapted COVID Booster

A vial of the Pfizer-BioNTech coronavirus disease (COVID-19) booster vaccine targeting BA.4 and BA.5 Omicron sub variants is pictured at Skippack Pharmacy in Schwenksville, Pennsylvania, US, September 8, 2022. (Reuters)
A vial of the Pfizer-BioNTech coronavirus disease (COVID-19) booster vaccine targeting BA.4 and BA.5 Omicron sub variants is pictured at Skippack Pharmacy in Schwenksville, Pennsylvania, US, September 8, 2022. (Reuters)
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EU Regulator Backs Pfizer's BA.4/5-Adapted COVID Booster

A vial of the Pfizer-BioNTech coronavirus disease (COVID-19) booster vaccine targeting BA.4 and BA.5 Omicron sub variants is pictured at Skippack Pharmacy in Schwenksville, Pennsylvania, US, September 8, 2022. (Reuters)
A vial of the Pfizer-BioNTech coronavirus disease (COVID-19) booster vaccine targeting BA.4 and BA.5 Omicron sub variants is pictured at Skippack Pharmacy in Schwenksville, Pennsylvania, US, September 8, 2022. (Reuters)

The European Medicines Agency (EMA) on Monday recommended a COVID-19 booster designed to combat Omicron offshoots BA.4/5, 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 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 BA.1 updated vaccines.

EU officials signaled 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.

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Varieties

Tunisia Women Herb Harvesters Struggle with Drought and Heat

A woman harvests aromatic and medicinal plants in the mountains of Tbainia village near the city of Ain Drahem, in the northwest of Tunisia on November 6, 2024. (AFP)
A woman harvests aromatic and medicinal plants in the mountains of Tbainia village near the city of Ain Drahem, in the northwest of Tunisia on November 6, 2024. (AFP)
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Tunisia Women Herb Harvesters Struggle with Drought and Heat

A woman harvests aromatic and medicinal plants in the mountains of Tbainia village near the city of Ain Drahem, in the northwest of Tunisia on November 6, 2024. (AFP)
A woman harvests aromatic and medicinal plants in the mountains of Tbainia village near the city of Ain Drahem, in the northwest of Tunisia on November 6, 2024. (AFP)

On a hillside in Tunisia's northwestern highlands, women scour a sun-scorched field for the wild herbs they rely on for their livelihoods, but droughts and rising temperatures are making it ever harder to find the precious plants.

Yet the harvesters say they have little choice but to struggle on, as there are few opportunities in a country hit hard by unemployment, inflation and high living costs.

"There is a huge difference between the situation in the past and what we are living now," said Mabrouka Athimni, who heads a local collective of women herb harvesters named "Al Baraka" ("Blessing").

"We're earning half, sometimes just a third, of what we used to."

Tunisia produces around 10,000 tons of aromatic and medicinal herbs each year, according to official figures.

Rosemary accounts for more than 40 percent of essential oil exports, mainly destined for French and American markets.

For the past 20 years, Athimni's collective has supported numerous families in Tbainia, a village near the city of Ain Draham in a region with much higher poverty rates than the national average.

Women, who make up around 70 percent of the agricultural workforce, are the main breadwinners for their households in Tbainia.

- 'Yield less' -

Tunisia is in its sixth year of drought and has seen its water reserves dwindle, as temperatures have soared past 50 degrees Celsius (122 degrees Fahrenheit) in some areas during the summer.

The country has 36 dams, mostly in the northwest, but they are currently just 20 percent full -- a record low in recent decades.

The Tbainia women said they usually harvested plants like eucalyptus, rosemary and mastic year-round, but shrinking water resources and rare rainfall have siphoned oil output.

"The mountain springs are drying up, and without snow or rain to replenish them, the herbs yield less oil," said Athimni.

Mongia Soudani, a 58-year-old harvester and mother of three, said her work was her household's only income. She joined the collective five years ago.

"We used to gather three or four large sacks of herbs per harvest," she said. "Now, we're lucky to fill just one."

Forests in Tunisia cover 1.25 million hectares, about 10 percent of them in the northwestern region.

Wildfires fueled by drought and rising temperatures have ravaged these woodlands, further diminishing the natural resources that women like Soudani depend on.

In the summer of last year, wildfires destroyed around 1,120 hectares near Tbainia.

"Parts of the mountain were consumed by flames, and other women lost everything," Soudani recalled.

To adapt to some climate-driven challenges, the women received training from international organizations, such as the Food and Agriculture Organization (FAO), to preserve forest resources.

Still, Athimni struggles to secure a viable income.

"I can't fulfil my clients' orders anymore because the harvest has been insufficient," she said.

The collective has lost a number of its customers as a result, she said.

- 'No longer sustainable' -

A recent study by the Tunisian Forum for Economic and Social Rights (FTDES) highlighted how climate-induced damage to forests had severely impacted local communities.

"Women in particular suffer the consequences as their activities become more difficult and arduous," the study said.

Tunisia has ratified key international environmental agreements, including the 2015 Paris Climate Accord.

But environmental justice researcher Ines Labiadh, who oversaw the FTDES study, said implementation "remains incomplete".

In the face of these woes, the Tbainia harvesters, like many women working in the sector, will be forced to seek alternative livelihoods, said Labiadh.

"They have no choice but to diversify their activities," she said. "Relying solely on natural resources is no longer sustainable."

Back in the field, Bachra Ben Salah strives to collect whatever herbs she can lay her hands on.

"There's nothing we can do but wait for God's mercy," she said.