Moderna Says Infant Covid Vaccine Succeeded in Trial

Moderna said it would submit authorization requests to the US Food and Drug Administration, European Medicines Agency and other global regulators for its Covid vaccine in children aged six months to six years Joseph Prezioso AFP/File
Moderna said it would submit authorization requests to the US Food and Drug Administration, European Medicines Agency and other global regulators for its Covid vaccine in children aged six months to six years Joseph Prezioso AFP/File
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Moderna Says Infant Covid Vaccine Succeeded in Trial

Moderna said it would submit authorization requests to the US Food and Drug Administration, European Medicines Agency and other global regulators for its Covid vaccine in children aged six months to six years Joseph Prezioso AFP/File
Moderna said it would submit authorization requests to the US Food and Drug Administration, European Medicines Agency and other global regulators for its Covid vaccine in children aged six months to six years Joseph Prezioso AFP/File

US biotech firm Moderna on Wednesday said it was pursuing regulatory approval for its Covid vaccine in children under six years old after the two-shot regimen was found to be safe and produced a strong immune response.

Specifically, two doses of 25 micrograms given to babies, toddlers and preschoolers generated similar levels of antibodies to two doses of 100 micrograms given to young people aged 18-25, indicating there would be similar levels of protection, AFP said.

Children under six are the only age group that has yet to gain access to a Covid-19 vaccine in the United States.

Based on the data, Moderna said it would submit authorization requests to the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and other global regulators in the coming weeks.

The results "are good news for parents of children under six years of age," said CEO Stephane Bancel in a statement.

"We now have clinical data on the performance of our vaccine from infants six months of age through older adults."

The company did however find relatively low vaccine efficacy against infection, with its trial taking place during the Omicron wave.

Vaccine efficacy in children six months up to age two was 43.7 percent, and efficacy was 37.5 percent in the two to five years age group.

The majority of these cases were mild and the two doses still provided very strong protection against severe outcomes. There were no hospitalizations or deaths.

Moderna said this was consistent with what had been observed among adults, and the company was evaluating a third dose as a booster, to increase efficacy against Omicron infection.

The trial included 4,200 aged two to six years and 2,500 aged six months to two years.

Side effects were generally mild and consistent with those seen in older age groups.

Rates of fever greater than 38 degrees Celsius (100.4 Fahrenheit) were around the same as commonly used and recommended pediatric vaccines: 17 percent in the six months to two years group, and 15 percent in the two years to six years group.

The company added that, after consulting with the FDA, it is also applying to be authorized among children six to 11 for two doses of 50 micrograms, and updating its application for authorization in kids aged 12 through 17.

The EMA and other regulators have already authorized the Moderna vaccine in these age groups.

Last month, the FDA postponed a meeting of a panel to consider the Pfizer-BioNTech Covid vaccine for children younger than five, saying it required additional data on third doses. The companies said they expected that data to be ready by April.



Blinken Meets China’s Wang after Chiding Beijing’s ‘Escalating Actions’ at Sea

US Secretary of State Antony Blinken speaks at the 57th ASEAN Foreign Ministers' Meeting at the National Convention Center, in Vientiane, Laos, July 27, 2024. (Reuters)
US Secretary of State Antony Blinken speaks at the 57th ASEAN Foreign Ministers' Meeting at the National Convention Center, in Vientiane, Laos, July 27, 2024. (Reuters)
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Blinken Meets China’s Wang after Chiding Beijing’s ‘Escalating Actions’ at Sea

US Secretary of State Antony Blinken speaks at the 57th ASEAN Foreign Ministers' Meeting at the National Convention Center, in Vientiane, Laos, July 27, 2024. (Reuters)
US Secretary of State Antony Blinken speaks at the 57th ASEAN Foreign Ministers' Meeting at the National Convention Center, in Vientiane, Laos, July 27, 2024. (Reuters)

US Secretary of State Antony Blinken met his Chinese counterpart Wang Yi on Saturday during a regional summit in Laos, hours after criticizing Beijing's "escalating and unlawful actions" in the South China Sea.

Blinken and Wang shook hands and exchanged greetings in front of cameras but made no comments before moving to closed-door talks in what will be their sixth meeting since June 23, when Blinken visited Beijing in a significant sign of improvement for strained relations between the world's two biggest economies.

Though Blinken had singled out China over its actions against US defense ally the Philippines in the South China Sea during a meeting with Southeast Asian counterparts earlier on Saturday, he also lauded the two countries for their diplomacy after Manila completed a resupply mission to troops in an area also claimed by Beijing.

The troop presence has for years angered China, which has clashed repeatedly with the Philippines over Manila's missions to a grounded navy ship at the Second Thomas Shoal, causing regional concern about an escalation.

The two sides this week reached an arrangement over how to conduct those missions.

"We are pleased to take note of the successful resupply today of the Second Thomas shoal, which is the product of an agreement reached between the Philippines and China," Blinken told ASEAN foreign ministers.

"We applaud that and hope and expect to see that it continues going forward."

GAZA SITUATION 'DIRE'

Blinken and Wang attended Saturday's security-focused ASEAN Regional Forum in Laos alongside top diplomats of major powers including Russia, India, Australia, Japan, the European, Britain and others, before heading to their meeting.

Blinken said earlier the United States was "working intensely every single day" to achieve a ceasefire in Gaza and find a path to more enduring peace and security.

His remarks follow those of Indonesian Foreign Minister Retno Marsudi, who said the need for sustainable peace was urgent and international law should be applied to all. The comment from the world's largest Muslim-majority nation, was a veiled reference to recent decisions by two international courts over Israeli's Gaza offensives.

"We cannot continue closing our eyes to see the dire humanitarian situation in Gaza," she said.

More than 39,000 Palestinians have been killed in the fighting in Gaza since Israel launched its incursion, according to Palestinian health authorities, who do not distinguish between fighters and non-combatants.

Israeli officials estimate that some 14,000 fighters from armed groups including Hamas and Islamic Jihad, have been killed or taken prisoner, out of a force they estimated to number more than 25,000 at the start of the war.

The war began when Hamas fighters attacked Israel on Oct. 7, killing 1,200 people and abducting some 250 others, according to Israeli tallies.

Also in Laos, Russia's Foreign Minister Sergei Lavrov said guidelines on the operation of US nuclear assets on the Korean peninsula were certain to add to regional security concerns.

Lavrov, according to South Korean news agency Yonhap, said he had not been briefed on the details of the plan, which was of concern to Russia.

"So far we can't even get an explanation of what this means, but there is no doubt that it causes additional anxiety," Russia's state-run RIA new agency quoted him as saying.

'THIS IS NOT SUSTAINABLE'

Ahead of Saturday's two summits, Australian Foreign Minister Penny Wong urged Myanmar's military rulers to take a different path and end an intensifying civil war, pressing the generals to abide by their commitment to follow ASEAN's five-point consensus peace plan.

The conflict pits Myanmar's well-equipped military against a loose alliance of ethnic minority rebel groups and an armed resistance movement that has been gaining ground and testing the generals' ability to govern.

The junta has largely ignored the ASEAN-promoted peace effort, and the 10-member bloc has hit a wall as all sides refuse to enter into dialogue.

"We see the instability, the insecurity, the deaths, the pain that is being caused by the conflict," Wong told reporters.

"My message from Australia to the regime is, this is not sustainable for you or for your people."

An estimated 2.6 million people have been displaced by fighting. The junta has been condemned for excessive force in its air strikes on civilian areas and accused of atrocities, which it has dismissed as Western disinformation.

ASEAN issued a communique on Saturday, two days after its top diplomats met, stressing it was united behind its peace plan for Myanmar, saying it was confident in its special envoy's resolve to achieve "an inclusive and durable peaceful resolution" to the conflict.

It condemned violence against civilians and urged all sides in Myanmar to cease hostilities.

ASEAN welcomed unspecified practical measures to reduce tension in the South China Sea and prevent accidents and miscalculations, while urging all stakeholders to halt actions that could complicate and escalate disputes.

The ministers described North Korea's missile tests as worrisome developments and urged peaceful resolutions to the conflicts in Ukraine, as well as Gaza, expressing concern over the dire humanitarian situation and "alarming casualties" there.