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.
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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
At least 5 killed after Mexican Navy plane on medical mission crashes in Texas
- The Monday afternoon crash killed at least five people and has set off a search in the waters off the Texas coast
- Mexico’s Navy said in a statement to The Associated Press that four of the people aboard were Navy officers and four were civilians
DALLAS: A small Mexican Navy plane transporting a young medical patient and seven others crashed Monday near Galveston, killing at least five people and setting off a search in waters along the Texas coast, officials said.
Four of the people aboard were Navy officers and four were civilians, including a child, Mexico’s Navy said in a statement to The Associated Press. Two of the passengers were from a nonprofit that provides aid to Mexican children with severe burns, including transports to a Galveston hospital.
US Coast Guard Petty Officer Luke Baker said at least five aboard had died but did not identify which passengers.
The cause of the crash is under investigation.
Mexico’s Marines said in a statement that it is sending “its deepest condolences to the families of those who lost their lives in this tragic accident.”
The crash took place Monday afternoon in Galveston Bay near the base of the causeway that connects Galveston Island to the mainland. Emergency responders and search teams rushed to the scene near the popular beach destination along the Texas coast that is about 50 miles (80.5 kilometers) southeast of Houston.
Sky Decker, a professional yacht captain who lives about a mile (1.6 kilometers) from the crash site, said he jumped in his boat to see if he could help. He said he picked up two police officers who directed him through thick fog to a nearly completely submerged plane. Decker jumped in the water and found a badly injured woman trapped beneath chairs and other debris.
“I couldn’t believe. She had maybe 3 inches of air gap to breathe in,” he said. “And there was jet fuel in there mixed with the water, fumes real bad. She was really fighting for her life.”
He said he also pulled out a man sitting in front of her who had already died. He described both of them as dressed in civilian clothes.
Mexico’s Navy said the plane was helping with a medical mission in coordination with the Michou and Mau Foundation, which provides emergency transports to children with life-threatening burns to Shriners Children’s hospital in Galveston, according to the nonprofit’s website.
The foundation said in a post on social media, “We express our deepest solidarity with the families in light of these events. We share their grief with respect and compassion, honoring their memory and reaffirming our commitment to providing humane, sensitive, and dignified care to children with burns.”
The statement from Mexico’s Navy said the plane had an “accident” during its approach to Galveston but did not elaborate.
Teams from the Federal Aviation Administration and National Transportation Safety Board have arrived at the scene of the crash, the Texas Department of Public Safety said on the social platform X.
A spokesperson from NTSB said they are “aware of this accident and are gathering information about it.” The Galveston County Sheriff’s Office said officials from its dive team, crime scene unit, drone unit and patrol were responding to the crash.
It’s not immediately clear if weather was a factor. The area has been experiencing foggy conditions over the past few days, according to Cameron Batiste, a National Weather Service meteorologist. He said that at about 2:30 p.m. Monday a fog came in that had about a half-mile visibility.
Four of the people aboard were Navy officers and four were civilians, including a child, Mexico’s Navy said in a statement to The Associated Press. Two of the passengers were from a nonprofit that provides aid to Mexican children with severe burns, including transports to a Galveston hospital.
US Coast Guard Petty Officer Luke Baker said at least five aboard had died but did not identify which passengers.
The cause of the crash is under investigation.
Mexico’s Marines said in a statement that it is sending “its deepest condolences to the families of those who lost their lives in this tragic accident.”
The crash took place Monday afternoon in Galveston Bay near the base of the causeway that connects Galveston Island to the mainland. Emergency responders and search teams rushed to the scene near the popular beach destination along the Texas coast that is about 50 miles (80.5 kilometers) southeast of Houston.
Sky Decker, a professional yacht captain who lives about a mile (1.6 kilometers) from the crash site, said he jumped in his boat to see if he could help. He said he picked up two police officers who directed him through thick fog to a nearly completely submerged plane. Decker jumped in the water and found a badly injured woman trapped beneath chairs and other debris.
“I couldn’t believe. She had maybe 3 inches of air gap to breathe in,” he said. “And there was jet fuel in there mixed with the water, fumes real bad. She was really fighting for her life.”
He said he also pulled out a man sitting in front of her who had already died. He described both of them as dressed in civilian clothes.
Mexico’s Navy said the plane was helping with a medical mission in coordination with the Michou and Mau Foundation, which provides emergency transports to children with life-threatening burns to Shriners Children’s hospital in Galveston, according to the nonprofit’s website.
The foundation said in a post on social media, “We express our deepest solidarity with the families in light of these events. We share their grief with respect and compassion, honoring their memory and reaffirming our commitment to providing humane, sensitive, and dignified care to children with burns.”
The statement from Mexico’s Navy said the plane had an “accident” during its approach to Galveston but did not elaborate.
Teams from the Federal Aviation Administration and National Transportation Safety Board have arrived at the scene of the crash, the Texas Department of Public Safety said on the social platform X.
A spokesperson from NTSB said they are “aware of this accident and are gathering information about it.” The Galveston County Sheriff’s Office said officials from its dive team, crime scene unit, drone unit and patrol were responding to the crash.
It’s not immediately clear if weather was a factor. The area has been experiencing foggy conditions over the past few days, according to Cameron Batiste, a National Weather Service meteorologist. He said that at about 2:30 p.m. Monday a fog came in that had about a half-mile visibility.
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