AFP

WTO seeks shot in the arm with Covid jab IP idea

The WTO’s search for a role in fighting the pandemic sharpened up on Monday as ministers seek a compromise to lift intellectual property rights on Covid-19 vaccines.

The World Trade Organization’s first ministerial meeting since December 2017 is wrestling with the wording of a text that would temporarily waive patents on coronavirus jabs.

It is the main pandemic-combating idea being negotiated at MC12, the global trade body’s 12th ministerial conference, being held from Sunday to Wednesday at its headquarters in Geneva.

But serious objections remain from some of the countries that host major pharmaceutical companies, like Britain and Switzerland — a problem at the WTO, where decisions are taken by consensus rather than by majority.

The world’s big pharma firms are dead set against the idea, insisting that stripping patents will cripple investment and innovation.

They also say the plan — first proposed in October 2020 when the pandemic was raging and before jabs were even rolled out — has gone past its sell-by date as the world now has a surplus of vaccine doses rather than a dearth.

After Sunday’s opening ceremony and countries setting out their positions, ministers from the 164 WTO members went into rooms at the organisation’s HQ — the grand 1920s, classical Florentine-style Centre William Rappard on Lake Geneva — to start talking it out face to face.

– Birthday present? –

This week’s conference is a crunch moment for WTO chief Ngozi Okonjo-Iweala, who has staked her leadership on breathing new life into the crippled organisation, where progress has been stumbling for years.

The Nigerian former finance and foreign minister took over in March 2021 on a mission to make the WTO relevant again.

But on her 68th birthday Monday, there was no immediate sign of a breakthrough on vaccine patents.

“A broad-ranging IP waiver is a red line,” Swiss ambassador Markus Schlagenhof told reporters.

“Pretending that a sweeping IP waiver would solve the problem does not correspond to reality. IP is not part of the problem but part of the solution.”

British trade minister Anne-Marie Trevelyan said the challenge was to reach a “workable decision” on the waiver “which supports business and governments”.

Public interest groups say the draft text falls far short of what is needed, by time-limiting and complicating the vaccine patents waiver — and by leaving out Covid treatments and diagnostics.

Non-governmental organisations staged a protest in the WTO’s central atrium, chanting slogans and unfurling banners reading: “No monopolies on Covid-19 medical tools” and “End vaccine apartheid”.

“The WTO rules are contributing to exacerbating the pandemic, because it’s the WTO that enforces IP rules,” demonstration organiser Deborah James told AFP.

“Folks have been campaigning on this for two years and it’s been a complete wall by a few countries,” she said.

“It’s an indictment of the WTO system: it’s completely broken, it can’t respond to a pandemic, it has no ability to put anything other than maximising profits for corporations ahead of anything else.”

– ‘We are choosing death’ –

In October 2020, India and South Africa began pushing for the WTO to lift IP rights on Covid-19 vaccines, tests and treatments to help ensure more equitable access in poorer nations.

After multiple rounds of talks, the United States, the European Union, India and South Africa hammered out a compromise.

The text would allow most developing countries, although not China, to produce Covid vaccines without authorisation from patent holders.

Beijing has promised not to use the facilities granted to developing countries in the draft agreement, but, according to several diplomats, Washington wants this commitment in writing.

“In a pandemic, sharing technology is life or death and we are choosing death,” said the UNAIDS agency’s executive director Winnie Byanyima.

Besides production, a second text being negotiated seeks to tackle some of the supply constraints faced by certain countries in getting hold of Covid-fighting tools.

And beyond the pandemic, the WTO faces pressure to eke out long-sought trade deals on a range of issues and show unity amid an impending global hunger crisis.

Okonjo-Iweala voiced cautious optimism on Sunday that ministers could reach agreement on food security threatened by Russia’s invasion of Ukraine, overfishing and on Covid vaccines.

She said to expect a “rocky, bumpy road with a few landmines along the way”.

US Supreme Court deals migrant rights setback on detention

The US Supreme Court dealt a setback to the rights of undocumented migrants detained after crossing into the country in cases that pitted the administration of President Joe Biden against immigration advocates.

The high court ruled that migrants do not have a constitutional right to a bond hearing that could permit their release after spending six months in detention.

Two cases decided in tandem by the court Monday addressed the bond hearing requests of Mexican citizens who had been arrested by US officials after illegally crossing the southern border.

In both cases, the men had been previously deported from the United States and attempted to reenter the country.

The detainees argued against being sent back to Mexico on grounds that they faced threats of persecution or torture, and in one of the cases sought asylum.

US authorities, holding the men for months ahead of official removal proceedings, opposed a bond hearing on the grounds that it could lead to the men’s release and disappearance.

But their attorneys argued that denying them a bond hearing after lengthy detention was unjust and unconstitutional.

In 2019 lower courts ruled they had rights to such hearings after being held for six months.

But the high court ruled Monday that US law in these cases does not guarantee migrants like them that right. 

The original case was brought to the Supreme Court by the administration of president Donald Trump, who, as part of his fight against immigration, took a hard line against rights for undocumented migrants.

The case was inherited by the Biden administration, which although more sympathetic to migrants, continued to pursue it.

The American Civil Liberties Union criticized Biden at the time as being “decidedly on the wrong side of this fight.”

The ACLU noted that one of the men after being sent back to Mexico the first time had been kidnapped by police officers and held for ransom.

Another was tortured by gang members “because of his sexual orientation,” the ACLU said.

The Supreme Court justices said their ruling applied only to the claim of a right to a bond hearing, and not to the broader issue of constitutional protection against indefinite detention.

Ukraine forces pushed back from Severodonetsk centre

Ukraine said Monday its forces had been pushed back from the centre of key industrial city Severodonetsk, where President Volodymyr Zelensky described a fight for “literally every metre”.

The cities of Severodonetsk and Lysychansk, which are separated by a river, have been targeted for weeks as the last areas still under Ukrainian control in the eastern Lugansk region.

Regional governor Sergiy Gaiday said Monday Russian forces were “gathering more and more equipment” to “encircle” Severodonetsk.

Moscow’s troops had “pushed our units from the centre and continue to destroy our city”, he said.

Severodonetsk had been “de facto” blocked off after Russian forces blew up the “last” bridge connecting it to Lysychansk on Sunday, Eduard Basurin, a representative for pro-Russian separatists, said Monday.

Ukrainian forces in the area had two choices, he said, “to surrender or die”.

The capture of Severodonetsk would open the road for Moscow to Slovyansk and another major city, Kramatorsk, in their push to conquer the whole of Donbas, a mainly Russian-speaking region partly held by pro-Kremlin separatists since 2014.

Ukrainian forces were fighting for “every town and village where the occupiers came”, Zelensky said on Monday in a message to mark the eighth anniversary of the liberation of Mariupol in the earlier conflict.

In May, Russian troops captured the port city in southern Ukraine after a weeks-long siege.

“We are once again fighting for it and all of Ukraine,” Zelensky said.

– ‘War crimes’ –

On Monday, Amnesty International accused Russia of war crimes in Ukraine, saying that attacks on the northeastern city of Kharkiv — many using banned cluster bombs — had killed hundreds of civilians. 

“The repeated bombardments of residential neighbourhoods in Kharkiv are indiscriminate attacks which killed and injured hundreds of civilians, and as such constitute war crimes,” the rights group said in a report on Ukraine’s second biggest city.

In Bucha, a town near Kyiv synonymous with war crimes allegations, local police said Monday they had discovered another seven bodies in a grave.

“Several victims had their hands tied and knees bound,” Kyiv regional police chief Andriy Nebytov said on Facebook.

Dozens of bodies in civilian clothing were found in the town in April after Russian troops withdrew from the area following a month-long occupation.

Elsewhere in northern Ukraine on Monday, Russian rocket strikes hit the town of Pryluky, local authorities said. 

Pryluky, which lies about 150 kilometres (90 miles) east of the capital, is home to a military airfield.

In Lysychansk, Russian bombardments killed three civilians in the last 24 hours, including a six-year-old boy, Lugansk governor Gaiday said Monday.

While in the city of Donetsk, separatist authorities said three people were killed and four wounded in Ukrainian shelling on a market in the Budonivskyi district of the city.

– Weapons call –

Russia’s invasion of its neighbour has prompted Finland and Sweden to give up decades of military non-alignment and seek to join the NATO alliance. 

In terms of security, Sweden was “in a better place now than before it applied”, NATO chief Jens Stoltenberg said on Monday, even though its application is in limbo with Turkey currently withholding its approval.

In a joint press conference with Swedish Prime Minister Magdalena Andersson, Stoltenberg said NATO was working “hard and actively” to resolve Ankara’s concerns “as soon as possible” ahead of a meeting on June 15.

It was at the summit in Brussels that Kyiv said Monday it was hoping for a decision on further Western arms deliveries to support its war effort.

“Being straightforward — to end the war we need heavy weapons,” Ukrainian presidential advisor Mikhaylo Podolyak said on Twitter.

Podolyak listed items he said the Ukrainian army requires, including hundreds of howitzers, tanks and armoured vehicles.

Russian forces said Sunday they had struck a site in the town of Chortkiv in western Ukraine storing US- and EU-supplied weapons. 

The strike — a rare attack by Russia in the relatively calm west of Ukraine — left 22 people injured, regional governor Volodymyr Trush said.

– WTO meeting –

Away from the battlefield, World Trade Organization members gathered in Geneva Sunday, with the threat posed to global food security by Russia’s war top of the agenda.

Tensions ran high during a closed-door session, in which around three dozen delegates “walked out” before a speech by Russia’s deputy economic development minister Vladimir Ilichev, WTO spokesman Dan Pruzin told journalists.

On a farm near the southern Ukrainian city Mykolaiv, the harvest has been delayed by the need to undo the damage done by Russian troops that passed through the area in March.

“We planted really late because we needed to clear everything beforehand,” including bombshells, Nadiia Ivanova, 42, told AFP.

The farm’s warehouses currently hold 2,000 tonnes of last season’s grain but there are no takers.

The railways have been partially destroyed by the Russian army, while any ship that sails faces the threat of being sunk.

burs-sea/spm

Scientists map brain network linked to addiction

Researchers said on Monday they had mapped the network in the brain linked to addiction by studying long-time smokers who abruptly quit after suffering brain lesions.

They hope the research will give future treatments a target to aim for in the fight against addiction to a range of substances.

To find out where addiction resides in the brain, the researchers studied 129 patients who were daily smokers when they had a brain lesion.

While more than half kept on smoking as normal after getting the lesion, a quarter immediately quit without any problem — even reporting an “absence of craving”, according to a new study in the journal Nature Medicine.

While the lesions of those who stopped smoking were not located in one specific region of the brain, they mapped them to a number of areas — what they called the “addiction remission network”.

They found that a lesion that would cause someone to give up an addiction would probably affect parts of the brain like the dorsal cingulate, lateral prefrontal cortex and insula — but not the medial prefrontal cortex.

Previous research has shown that lesions affecting the insula relieve addiction. But it failed to take into account other parts of the brain identified in the new study.

To confirm their findings, the researchers studied 186 lesion patients who completed an alcohol risk assessment. 

They found that lesions in the patients’ addiction remission network also reduced the risk of alcoholism, “suggesting a shared network for addiction across these substances of abuse”, the study said.

Juho Joutsa, a neurologist at Finland’s University of Turku and the study’s author, told AFP “the identified network provides a testable target for treatment efforts”.

“Some of the hubs of the network were located in the cortex, which could be targeted even with non-invasive neuromodulation techniques,” he added.

Neuromodulation involves stimulating nerves to treat a range of ailments. 

One such technique is the transcranial magnetic stimulation (TMS) coil, which was approved by the US Food and Drug Administration last month for obsessive-compulsive disorder. 

It already targets many of the same areas of the brain as the addiction remission network identified in Monday’s study.

Joutsa said he hoped his research would contribute to a TMS coil targeting addiction.

“However, we still need to figure what is the best way to modulate this network and conduct carefully designed, randomised, controlled trials to test if targeting the network is clinically beneficial,” he added. 

Heatwave grips Spain as France braces for soaring temperatures

Spain was on Monday in the grips of a heatwave expected to reach “extreme” levels with France set to follow suit as meteorologists blame the unusually high seasonal temperatures on global warming.

The “unusual” temperatures in the first-half of June come after Spain experienced its hottest May in at least 100 years, Ruben del Campo, spokesman for the Spanish Meteorological Agency (Aemet) said.

He told AFP that the current heatwave would bring “extreme temperatures” and “could last until the end of the week”.

Temperatures are forecast to rise above 40 degrees Celsius (around 104 degrees Fahrenheit) in the centre and south of the country on Monday, and even climb as high as 43 degrees in the southern Andalusia region, especially in the cities of Cordoba or Seville, according to Aemet.

The heatwave is also set to spread elsewhere in Europe, such as France, in the next few days, del Campo warned.

France’s weather service said the heatwave would hit southern regions from late Tuesday, worsening a drought across much of the country that is threatening farm harvests.

From Wednesday, much of France will swelter in temperatures that could reach 38 or even 40C — “extremely early” for the season — forecaster Frederic Nathan of Meteo-France told AFP.

Water use restrictions are already in place in around a third of France — and utilities are urging farmers, factories and public service providers to show “restraint” in their water use.

– ‘Not normal’ – 

In Portugal, hot weather began last Friday, prompting the civil protection authority to raise the alert level over the risks of forest fires.

Portugal was among several European nations to have faced fierce fires last summer, which climate scientists warn will become increasingly common due to manmade global warming.

In 2017, fires killed dozens of people in Portugal.

Recent science has shown beyond any doubt that climate change has already increased the frequency and intensity of heatwaves, and that worse is on the horizon no matter how quickly humanity draws down carbon pollution.

Earth has already warmed 1.1 degrees C since pre-industrial times.

The decade from 2011 to 2020 was the warmest on record, and the last six years the hottest ever registered.

Spain has experienced four episodes of extreme temperatures in the last 10 months.

A heatwave last August set a new record, with the temperature hitting 47.4 degrees C in the southern city of Montoro.

“This extreme heat is not normal at this time during the spring,” del Campo said, attributing it to global warming.

Temperatures were also “exceptionally high” between Christmas and New Year’s Day.

– Summer ‘one-month longer’ –

Since the pre-industrial era, Spain has seen temperatures rise by 1.7 degrees C on average, del Campo said.

Not only have temperatures become more extreme, he said, but periods of heat have become more frequent.

Summers in Spain, he added, “are a bit hotter every year and getting longer and longer. A summer lasts one month longer than in the 1980s.”

Apart from the consequences on human health, he warned of the environmental impact, with a high risk of drought and water supply problems, and more fires.

In September, a huge wildfire raged for seven days in the Sierra Bermeja area, killing a firefighter and forcing 2,600 people from their homes as it burned through some 10,000 hectares (24,700 acres) of land. 

Turkey, meanwhile, braced for strong rains, wind and flash floods in the north and centre of the country on Monday, after a weekend of flooding left five people dead, authorities said on Monday.

Greece, too, saw widespread flooding at the weekend.

Kevin Spacey due in London court on Thursday: police

Hollywood actor Kevin Spacey has been formally charged with sexual assault and will appear before a court in London later this week, police said on Monday.

The Metropolitan Police said the 62-year-old actor would appear at Westminster Magistrates Court at 0900 GMT on Thursday to face four counts of sexual assault against three men.

Prosecutors announced last month that they had authorised charges against the two-time Oscar winner, who was artistic director of The Old Vic theatre in London between 2004 and 2015.

Spacey said in response he was “disappointed” with the decision, but promised to voluntarily appear in the UK to defend himself.

He said in a statement to the Good Morning America TV show that he was confident of proving his innocence.

Allegations against Spacey first emerged in the wake of the #MeToo movement that saw numerous claims of sexual assault and harassment in the movie industry.

That prompted an investigation by the Met and a review by The Old Vic of Spacey’s time in charge there.

Reporting restrictions are in place that prevent the media going into detail about the charges to avoid prejudicing a jury at any trial.

The Met has said that the first two charges of sexual assault date from March 2005 in London, and concern the same man, who is now in his 40s.

The third is alleged to have happened in London in August 2008 against a man who is now in his 30s. 

Spacey has also been charged “with causing a person to engage in penetrative sexual activity without consent” against the same man.

The fourth sexual assault charge is alleged to have occurred in Gloucestershire, western England, in April 2013 against a third man, who is now in his 30s.

None of the alleged victims can be identified under English law.

Major markets tumble on heightened recession fears

Global equities, oil prices and bitcoin plunged Monday on heightened recession fears triggered by runaway inflation.

The dollar, however, gained versus major rivals, benefiting from its status as a haven investment and expectations of aggressive interest-rate hiking from the Federal Reserve. 

Bond yields also rose, with 10-year US Treasuries above 3.3 percent and Italy’s 10-year debt breaking four percent for the first time in more than eight years.

The US currency struck a 24-year peak against the yen before retreating, while it broke above 78 Indian rupees for the first time. It jumped one percent versus the pound.

“The hangover from a higher-than-expected US inflation reading is continuing to cause scissoring pain throughout the markets, as it extinguishes the hope the US Federal Reserve might be able to take its foot off the pedal on interest rate rises,” noted AJ Bell investment director Russ Mould.

US and European stocks had already tumbled Friday following the inflation data, with Asia following suit Monday.

European stock markets extended pre-weekend losses with drops of over two percent, while London took a hit also from data showing the UK economy contracted in April for a second month in a row.

Wall Street also tumbled, with the blue-chip Dow down around 2.3 percent in late morning trading and the tech-heavy Nasdaq falling nearly four percent.

World oil prices, whose surge has contributed massively to soaring inflation, slid around 1.5 percent as the high cost of living increased recession expectations.

The possibility of more Covid restrictions in China’s biggest cities also weighed on crude futures as the country is a major oil consumer.

Fresh coronavirus outbreaks in Shanghai and Beijing have seen authorities reimpose containment measures.

“This has fed into a narrative that the global economy will slow even further at a time when prices are showing little sign of doing the same,” said market analyst Michael Hewson at CMC Markets UK.

– Bitcoin crash –

Bitcoin tumbled to an 18-month low of under $23,000 as investors shunned risky assets in the face of the vicious global markets selloff. 

The unit took a heavy knock also from news that cryptocurrency lending platform Celsius Network paused withdrawals, citing volatile conditions.

“It is not very surprising to see such a strong downturn as we have noticed an increased correlation over the last few years between traditional stocks, which have also tanked recently, and the cryptocurrency market,” noted XTB chief market analyst Walid Koudmani.

Patrick O’Hare, analyst at Briefing.com, said the carnage in the crypto market “is compounding worries about growth prospects due to the reduced wealth effect that also incorporates falling stock and bond prices.”

Investors were left surprised Friday when data showed US inflation jumped to 8.6 percent in May, the fastest pace in more than 40 years, as the Ukraine war further fuelled energy and food prices.

The reading has led to fervent speculation that the Fed will now be contemplating a single interest-rate lift of 75 basis points at its meeting this week.

With the central bank forced to be more aggressive, there is heightened concern that the US economy could be sent into recession next year.

“The market is now thinking much more about the Fed driving rates sharply higher to get on top of inflation and then having to cut back as growth drops,” said SPI Asset Management’s Stephen Innes.

– Key figures at around 1530 GMT –

New York – Dow: DOWN 2.3 percent at 30,663.44 points

EURO STOXX 50: DOWN 1.9 percent at 3,444.93

London – FTSE 100: DOWN 1.5 percent at 7,205.81 (close)

Frankfurt – DAX: DOWN 2.4 percent at 13,427.03 (close)

Paris – CAC 40: DOWN 2.7 percent at 6,022.32 (close)

Tokyo – Nikkei 225: DOWN 3.0 percent at 26,987.44 (close)

Hong Kong – Hang Seng Index: DOWN 3.4 percent at 21,067.58 (close)

Shanghai – Composite: DOWN 0.9 percent at 3,255.55 (close)

Dollar/yen: DOWN at 134.13 yen from 134.42 yen late Friday

Euro/dollar: DOWN at $1.0433 from $1.0526

Pound/dollar: DOWN at $1.2161 from $1.2309

Euro/pound: UP at 85.78 pence from 85.39 pence

Brent North Sea crude: DOWN 1.5 percent at $120.13 per barrel

West Texas Intermediate: DOWN 1.6 percent at $118.72 per barrel

burs-rl/pvh

Cautious optimism at high-stakes WTO meet

The World Trade Organization chief voiced cautious optimism Sunday as global trade ministers gathered to tackle food security threatened by Russia’s invasion of Ukraine, overfishing and equitable access to Covid vaccines.

Opening the WTO’s first ministerial meeting in nearly five years, Ngozi Okonjo-Iweala said to “expect a rocky, bumpy road with a few landmines along the way”.

But she told journalists she was “cautiously optimistic” that the more than 100 attending ministers would manage to agree on at least one or two of a long line of pressing issues, and that would be “a success”.

The WTO faces pressure to eke out long-sought trade deals on a range of issues and show unity amid the still raging pandemic and an impending global hunger crisis.

But since the global trade body only makes decisions by consensus, it can be more than tricky to reach agreements.

Top of the agenda at the four-day meeting is the toll Russia’s war in Ukraine, traditionally a breadbasket that feeds hundreds of millions of people, is having on food security. 

– Walkout –

Tensions ran high during a closed-door session, where a number of delegates took the floor to condemn Russia’s war in Ukraine, including Kyiv’s envoy, who was met with a standing ovation, WTO spokesman Dan Pruzin told journalists.

Then, right before Russia’s deputy economic development minister Vladimir Ilichev spoke, around three dozen delegates “walked out”, he said.

Even before the conference began, the European Union gathered representatives from 57 countries for a show solidarity with Ukraine, with EU trade commissioner Valdis Dombrovskis slamming Russia’s “illegal and barbaric aggression”

Despite the contentious atmosphere, ministers are expected to agree on a joint declaration on strengthening food security, in which they will “commit to take concrete steps to facilitate trade and improve the functioning and longterm resilience of global markets for food and agriculture”.

According to the draft text, countries would vow that “particular consideration will be given to the specific needs and circumstances of developing country Members”.

“I hope you will collectively do the right thing,” Ngozi told the delegates.

– Fisheries deal in sight? –

The WTO hopes to keep criticism of Russia’s war in Ukraine to the  first day of talks, allowing ministers to focus in the following days on nailing down trade deals, after nearly a decade with no major agreements. 

There is some optimism that countries could finally agree on banning subsidies that contribute to illegal and unregulated fishing, after more than two decades of negotiations.

“Will our children forgive us… if we allow our oceans to be depleted?” Okonjo-Iweala said. 

One of the main sticking points has been so-called special and differential treatment (SDT) for developing countries, including major fishing nation India, which can request exemptions.

The duration of exemptions remains undefined, with environmental groups warning anything beyond 10 years would be catastrophic.

– India blocking  –

India has demanded a 25-year exemption, and is so far refusing to budge.

Indian Commerce and Industry Minister Piyush Goyal insisted in a video address that most fishing in India is vital for survival, and that fishermen use “sustainable methods”.

“Their right to life and livelihood cannot be curtailed in any manner.”

Angered by lacking follow-through on promises made at a WTO ministerial meeting nearly a decade ago for food policy measures, India is proving intransigent on other issues as well, jeopardising the chances of locking down deals.

“There is not a single issue that India is not blocking,” a Geneva-based ambassador said, singling out WTO reform and agriculture.

– Patent waiver? –

India has also struck a harsh tone on another key issue on the table: WTO response to the Covid crisis.

“The rich countries need to introspect. We need to bow our heads in shame for our inability to respond to the pandemic in time,” he said.

India and South Africa began in October 2020 pushing for the WTO to temporarily lift intellectual property rights on Covid-19 medical tools like vaccines to help ensure more equitable access in poorer nations.

After multiple rounds of talks, the EU, the United States, India and South Africa hammered out a compromise.

The text, which would allow most developing countries, although not China, to produce Covid vaccines without authorisation from patent holders, still faces opposition from both sides.

The pharmaceutical industry insists the waiver would undermine investment in innovation, while public interest groups charge the text falls far short of what is needed, by limiting and complicating the vaccine waiver and not covering Covid treatments and diagnostics.

US FDA says Pfizer Covid vaccine effective in kids under five

The US Food and Drug Administration (FDA) has said the Pfizer Covid vaccine is safe and effective in children under five, ahead of a meeting to weigh its authorization later this week.

Children under five are the only age group not yet eligible for vaccination in the United States and most countries, a pressing need since rates of hospitalization and death “are higher than among children and adolescents 5-17 years of age,” the FDA said in a document posted on its website Sunday.

The agency has called a meeting of experts on June 15 to decide whether to recommend the Pfizer vaccine, given as three shots to children aged six months through four years, as well as the Moderna vaccine, given as two shots to children aged six months through five years.

Pfizer’s first two shots are given three weeks apart, then the third is given eight weeks after the second. They are all dosed at three micrograms, as opposed to 30 micrograms the company gives those 12 and up, and 10 micrograms to those five and up, levels chosen to mitigate adverse reactions.

Both Pfizer and Moderna had previously posted their results in press statements, but the FDA then had to review the data in detail and carry out its own evaluation. It posted a favorable analysis about Moderna on Friday.

Its comments towards Pfizer also appear favorable, based on the levels of infection-blocking antibodies it evoked in trial participants, and a similar side-effect profile to higher age groups. The total trial population was around 4,500 children.

A preliminary estimate placed vaccine efficacy at 80.3 percent, but the FDA noted this was based on very few positive cases — just 10, as opposed to the 21 sought for a more accurate figure.

There are some 20 million US children aged four years and under, or six percent of the population. If, as expected, the FDA-appointed experts recommend the two vaccines, then the matter will go to another committee convened by the Centers for Disease Control and Prevention for a final say.

White House officials last week said rollout of millions of shots at pharmacies and doctors’ offices could begin as soon as June 21, following the Juneteenth holiday on June 20.

Of the total US Covid deaths, 481 have come in children under five, according to the latest official data. Obesity, neurological disorders and asthma are associated with increased risk of severe disease, “however, a majority of children hospitalized for Covid-19 have no underlying medical conditions,” the FDA said.

Children can also go on to contract multisystem inflammatory syndrome in children (MIS-C), a rare but serious post-viral condition. Data on long Covid in children is sparse, but “a national survey in the United Kingdom found that among children ages two to 11 years who tested positive for COVID-19, 7.2 percent reported continued symptoms at 12 weeks,” the document said.

US FDA says Pfizer Covid vaccine effective in kids under five

The US Food and Drug Administration (FDA) has said the Pfizer Covid vaccine is safe and effective in children under five, ahead of a meeting to weigh its authorization later this week.

Children under five are the only age group not yet eligible for vaccination in the United States and most countries, a pressing need since rates of hospitalization and death “are higher than among children and adolescents 5-17 years of age,” the FDA said in a document posted on its website Sunday.

The agency has called a meeting of experts on June 15 to decide whether to recommend the Pfizer vaccine, given as three shots to children aged six months through four years, as well as the Moderna vaccine, given as two shots to children aged six months through five years.

Pfizer’s first two shots are given three weeks apart, then the third is given eight weeks after the second. They are all dosed at three micrograms, as opposed to 30 micrograms the company gives those 12 and up, and 10 micrograms to those five and up, levels chosen to mitigate adverse reactions.

Both Pfizer and Moderna had previously posted their results in press statements, but the FDA then had to review the data in detail and carry out its own evaluation. It posted a favorable analysis about Moderna on Friday.

Its comments towards Pfizer also appear favorable, based on the levels of infection-blocking antibodies it evoked in trial participants, and a similar side-effect profile to higher age groups. The total trial population was around 4,500 children.

A preliminary estimate placed vaccine efficacy at 80.3 percent, but the FDA noted this was based on very few positive cases — just 10, as opposed to the 21 sought for a more accurate figure.

There are some 20 million US children aged four years and under, or six percent of the population. If, as expected, the FDA-appointed experts recommend the two vaccines, then the matter will go to another committee convened by the Centers for Disease Control and Prevention for a final say.

White House officials last week said rollout of millions of shots at pharmacies and doctors’ offices could begin as soon as June 21, following the Juneteenth holiday on June 20.

Of the total US Covid deaths, 481 have come in children under five, according to the latest official data. Obesity, neurological disorders and asthma are associated with increased risk of severe disease, “however, a majority of children hospitalized for Covid-19 have no underlying medical conditions,” the FDA said.

Children can also go on to contract multisystem inflammatory syndrome in children (MIS-C), a rare but serious post-viral condition. Data on long Covid in children is sparse, but “a national survey in the United Kingdom found that among children ages two to 11 years who tested positive for COVID-19, 7.2 percent reported continued symptoms at 12 weeks,” the document said.

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