DUBAI: Pfizer Inc. and partner BioNTech have completed the filing with the US drugs regulator seeking authorization for their COVID-19 vaccine in children under 5 years of age.
The filing with the US Food and Drug Administration (FDA), completed on Wednesday, included data showing three lower-dose shots of the vaccine generated a strong immune response in children as young as 6 months of age.
No COVID-19 shot is yet approved for children in that age group in most parts of the world. It remains unclear how many parents will get their young ones vaccinated as demand has been low in kids aged 5 to 11.
Pfizer and BioNTech on May 23 said their trial showed a 3 microgram version of the vaccine generated a similar immune response in under 5-year-olds as two doses of 30 micrograms each in 16 to 25-year-olds in an earlier trial.
Rival Moderna in March released trial data that showed a two-dose formulation of its vaccine was safe and generated a similar immune response in young children as in adults.
The FDA’s independent advisers will discuss the two applications in a meeting set for June 15.
Pfizer seeks US authorization of COVID-19 vaccine for young children
https://arab.news/4efq7
Pfizer seeks US authorization of COVID-19 vaccine for young children
- No COVID-19 shot is yet approved for children in that age group in most parts of the world
- It remains unclear how many parents will get their young ones vaccinated
Indonesia reaffirms Yemen’s territorial integrity, backs stability efforts amid tensions
- Statement comes after Saudi Arabia bombed a UAE weapons shipment at Yemeni port city
- Jakarta last week said it ‘appreciates’ Riyadh ‘working together’ with Yemen to restore stability
JAKARTA: Indonesia has called for respect for Yemen’s territorial integrity and commended efforts to maintain stability in the region, a day after Saudi Arabia bombed a weapons shipment from the UAE at a Yemeni port city that Riyadh said was intended for separatist forces.
Saudi Arabia carried out a “limited airstrike” at Yemen’s port city of Al-Mukalla in the southern province of Hadramout on Tuesday, following the arrival of an Emirati shipment that came amid heightened tensions linked to advances by the UAE-backed Southern Transitional Council in the war-torn country.
In a statement issued late on Wednesday, the Indonesian Ministry of Foreign Affairs said it “appreciates further efforts by concerned parties to maintain stability and security,” particularly in the provinces of Hadramout and Al-Mahara.
“Indonesia reaffirms the importance of peaceful settlement through an inclusive and comprehensive political dialogue under the coordination of the United Nations and respecting Yemen’s legitimate government and territorial integrity,” Indonesia’s foreign affairs ministry said.
The latest statement comes after Jakarta said last week that it “appreciates the efforts of the Kingdom of Saudi Arabia, as well as other relevant countries, working together with Yemeni stakeholders to de-escalate tensions and restore stability.”
Saudi Arabia leads the Coalition to Restore Legitimacy in Yemen, which includes the UAE and was established in 2015 to combat the Houthi rebels, who control most of northern Yemen.
Riyadh has been calling on the STC, which initially supported Yemen’s internationally recognized government against the Houthi rebels, to withdraw after it launched an offensive against the Saudi-backed government troops last month, seeking an independent state in the south.
Indonesia has also urged for “all parties to exercise restraint and avoid unilateral action that could impact security conditions,” and has previously said that the rising tensions in Yemen could “further deteriorate the security situation and exacerbate the suffering” of the Yemeni people.
Indonesia, the world’s biggest Muslim-majority country, maintains close ties with both Saudi Arabia and the UAE, which are its main trade and investment partners in the Middle East.
