WASHINGTON: The US Food and Drug Administration granted emergency authorization Friday for the use of Pfizer and Moderna Covid-19 vaccines in the youngest children, the final age group awaiting immunization in most countries.
The agency authorized Moderna’s two-dose vaccine for children aged six months to five years, and three doses of Pfizer’s shots for those between six months and four years old.
“Many parents, caregivers and clinicians have been waiting for a vaccine for younger children and this action will help protect those down to six months of age,” Food and Drug Administration chief Robert Califf said in a statement.
“We expect that the vaccines for younger children will provide protection from the most severe outcomes of Covid-19, such as hospitalization and death.”
The Centers for Disease Control and Prevention (CDC) must now also recommend the vaccines before they are put into use — a final green light that will be given after a meeting of an advisory committee of experts that is expected to be held shortly.
But the US government has said that as soon as the FDA decision is made, 10 million doses could immediately be sent around the country, followed by millions more in subsequent weeks.
Both vaccines are based on messenger RNA, which delivers genetic code for the coronavirus spike protein to human cells that then grow it on their surface, training the immune system to be ready. The technology is now considered the leading Covid vaccination platform.
The vaccines were tested in trials of thousands of children. They were found to cause similar levels of mild side effects as in older age groups and triggered similar levels of antibodies.
Efficacy against infection was higher for Pfizer, with the company placing it at 80 percent, compared to Moderna’s estimates of 51 percent for children aged six-months to two years old and 37 percent for those aged two to five years.
But the Pfizer figure is based on very few cases and is thus considered preliminary. It also takes three doses to achieve its protection, with the third shot given eight weeks after the second, which is given three weeks after the first.
Moderna’s vaccine should provide strong protection against severe disease after two doses, given four weeks apart, and the company is studying adding a booster that would raise efficacy levels against mild disease.
However, Moderna’s decision to go with a higher dose is associated with higher levels of fevers in reaction to the vaccine compared to Pfizer.
There are some 20 million children aged four years and under in the United States.
US approves Pfizer and Moderna vaccines for youngest children
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US approves Pfizer and Moderna vaccines for youngest children
- The agency authorized Moderna's two-dose vaccine for children aged six months to five years
- Three doses of Pfizer's shots for those between six months and four years old
Malaysia’s Najib to face verdict in mega 1MDB graft trial
PUTRAJAYA: Former prime minister Najib Razak faces judgment on Friday for his alleged involvement in Malaysia’s 1MDB mega-graft scandal, with a guilty verdict likely to add years to a sentence already being served.
The 72-year-old stands accused of four counts of abuse of power and 21 counts of money laundering linked to the plunder of hundreds of millions of dollars from the Southeast Asian nation’s 1MDB sovereign wealth fund, sparking probes in several countries.
If found guilty, the man once seen as political royalty faces years more behind bars, already serving a six-year jail term after a conviction in a separate case relating to the 1MDB fund.
Friday’s hearing opened around 9:00 am (0100 GMT) before the Kuala Lumpur High Court, sitting in the country’s administrative capital of Putrajaya.
Presiding judge Collin Lawrence Sequerah started reading a lengthy verdict, before breaking for Friday afternoon prayers three hours later, with the hearing to resume at 3:00 pm.
It was not known whether sentencing would immediately follow a guilty verdict, but if acquitted, Najib will return to Kajang Prison outside Kuala Lumpur to continue serving his prior sentence.
- ‘Unmeritorious’ -
During the morning’s reading, Judge Sequerah slapped down several of the defense’s arguments, including that Najib was duped by his close associate, the shadowy businessman Low Taek Jho, better known as Jho Low.
“The evidence clearly points to the fact that this was no coincidence but was evident of a relationship in which Jho Low operated as a proxy or agent of the accused (Najib) with regard to the running of the affairs of 1MDB,” Sequerah said.
The defense’s argument that Najib was “misled and duped by management and by Jho Low is unmeritorious,” the judge said.
Low, who is currently on the run, is seen as the mastermind behind the scheme to plunder the country’s investment vehicle and spend the proceeds on everything from high-end real estate to pricey art, including a Monet and a Van Gogh.
Sequerah also dismissed arguments that money flowing into Najib’s accounts was “donations” from Middle East funders, calling it a “tale that surpassed even those from the Arabian Nights.”
The verdict will continue Friday afternoon in the marathon trial, seen as the main case in the 1MDB affair and which involves some 2.28 billion ringgit ($563 million).
Prosecutors say Najib abused his position as prime minister, finance minister and 1MDB advisory board chairman to move large amounts of money from the fund to his personal accounts more than a decade ago.
The prosecution presented bank records, testimony from over 50 witnesses and documentary evidence.
Najib “paints himself as a victim of rogue subordinates, when in truth, he was the single most powerful decision-maker,” deputy public prosecutor Ahmad Akram Gharib told the court during closing arguments.
“The accused wielded absolute financial, executive and political control,” he said.
- ‘No fair trial’ -
Najib’s lawyers have previously said the politician was unaware that 1MDB’s management was working hand in glove with Low to suck out large amounts of money from the fund, ostensibly established to foster economic growth in Malaysia.
Najib’s lawyer, Muhammad Shafee Abdullah, last week told journalists his client “never got a fair trial.”
He again blamed Low for the scandal, which sparked probes internationally, from neighboring Singapore to Europe and the United States, and rocked Malaysia’s image abroad.
Najib has issued an apology for the 1MDB scandal happening during his tenure, but maintains he knew nothing about illegal transfers from the now-defunct state fund.
His legal battle was dealt a blow on Monday after he lost a bid to serve the remainder of his current jail term at home.
Each count of abuse of power is punishable by up to 20 years in jail and a fine of up to five times the amount of the bribe.
The 72-year-old stands accused of four counts of abuse of power and 21 counts of money laundering linked to the plunder of hundreds of millions of dollars from the Southeast Asian nation’s 1MDB sovereign wealth fund, sparking probes in several countries.
If found guilty, the man once seen as political royalty faces years more behind bars, already serving a six-year jail term after a conviction in a separate case relating to the 1MDB fund.
Friday’s hearing opened around 9:00 am (0100 GMT) before the Kuala Lumpur High Court, sitting in the country’s administrative capital of Putrajaya.
Presiding judge Collin Lawrence Sequerah started reading a lengthy verdict, before breaking for Friday afternoon prayers three hours later, with the hearing to resume at 3:00 pm.
It was not known whether sentencing would immediately follow a guilty verdict, but if acquitted, Najib will return to Kajang Prison outside Kuala Lumpur to continue serving his prior sentence.
- ‘Unmeritorious’ -
During the morning’s reading, Judge Sequerah slapped down several of the defense’s arguments, including that Najib was duped by his close associate, the shadowy businessman Low Taek Jho, better known as Jho Low.
“The evidence clearly points to the fact that this was no coincidence but was evident of a relationship in which Jho Low operated as a proxy or agent of the accused (Najib) with regard to the running of the affairs of 1MDB,” Sequerah said.
The defense’s argument that Najib was “misled and duped by management and by Jho Low is unmeritorious,” the judge said.
Low, who is currently on the run, is seen as the mastermind behind the scheme to plunder the country’s investment vehicle and spend the proceeds on everything from high-end real estate to pricey art, including a Monet and a Van Gogh.
Sequerah also dismissed arguments that money flowing into Najib’s accounts was “donations” from Middle East funders, calling it a “tale that surpassed even those from the Arabian Nights.”
The verdict will continue Friday afternoon in the marathon trial, seen as the main case in the 1MDB affair and which involves some 2.28 billion ringgit ($563 million).
Prosecutors say Najib abused his position as prime minister, finance minister and 1MDB advisory board chairman to move large amounts of money from the fund to his personal accounts more than a decade ago.
The prosecution presented bank records, testimony from over 50 witnesses and documentary evidence.
Najib “paints himself as a victim of rogue subordinates, when in truth, he was the single most powerful decision-maker,” deputy public prosecutor Ahmad Akram Gharib told the court during closing arguments.
“The accused wielded absolute financial, executive and political control,” he said.
- ‘No fair trial’ -
Najib’s lawyers have previously said the politician was unaware that 1MDB’s management was working hand in glove with Low to suck out large amounts of money from the fund, ostensibly established to foster economic growth in Malaysia.
Najib’s lawyer, Muhammad Shafee Abdullah, last week told journalists his client “never got a fair trial.”
He again blamed Low for the scandal, which sparked probes internationally, from neighboring Singapore to Europe and the United States, and rocked Malaysia’s image abroad.
Najib has issued an apology for the 1MDB scandal happening during his tenure, but maintains he knew nothing about illegal transfers from the now-defunct state fund.
His legal battle was dealt a blow on Monday after he lost a bid to serve the remainder of his current jail term at home.
Each count of abuse of power is punishable by up to 20 years in jail and a fine of up to five times the amount of the bribe.
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