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
https://arab.news/bjrq5
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
Coast Guard is pursuing another tanker helping Venezuela skirt sanctions, US official says
- US oil companies dominated Venezuela’s petroleum industry until the country’s leaders moved to nationalize the sector, first in the 1970s and again in the 21st century under Maduro and his predecessor, Hugo Chávez
WEST PALM BEACH, Florida: The US Coast Guard on Sunday was pursuing another sanctioned oil tanker in the Caribbean Sea as the Trump administration appeared to be intensifying its targeting of such vessels connected to the Venezuelan government.
The pursuit of the tanker, which was confirmed by a US official briefed on the operation, comes after the US administration announced Saturday it had seized a tanker for the second time in less than two weeks.
The official, who was not authorized to comment publicly about the ongoing operation and spoke on the condition of anonymity, said Sunday’s pursuit involved “a sanctioned dark fleet vessel that is part of Venezuela’s illegal sanctions evasion.”
The official said the vessel was flying a false flag and under a judicial seizure order.
The Pentagon and Department of Homeland Security, which oversees the US Coast Guard, deferred questions about the operation to the White House, which did not offer comment on the operation.
Saturday’s predawn seizure of a Panama-flagged vessel called Centuries targeted what the White House described as a “falsely flagged vessel operating as part of the Venezuelan shadow fleet to traffic stolen oil.”
The Coast Guard, with assistance from the Navy, seized a sanctioned tanker called Skipper on Dec. 10, another part of the shadow fleet of tankers that the US says operates on the fringes of the law to move sanctioned cargo. It was not even flying a nation’s flag when it was seized by the Coast Guard.
President Donald Trump, after that first seizure, said that the US would carry out a “blockade” of Venezuela. It all comes as Trump has ratcheted up his rhetoric toward Venezuelan President Nicolás Maduro.
This past week Trump demanded that Venezuela return assets that it seized from US oil companies years ago, justifying anew his announcement of a “blockade” against oil tankers traveling to or from the South American country that face American sanctions.
Trump cited the lost US investments in Venezuela when asked about his newest tactic in a pressure campaign against Maduro, suggesting the Republican administration’s moves are at least somewhat motivated by disputes over oil investments, along with accusations of drug trafficking. Some sanctioned tankers already are diverting away from Venezuela.
US oil companies dominated Venezuela’s petroleum industry until the country’s leaders moved to nationalize the sector, first in the 1970s and again in the 21st century under Maduro and his predecessor, Hugo Chávez. Compensation offered by Venezuela was deemed insufficient, and in 2014, an international arbitration panel ordered the country’s socialist government to pay $1.6 billion to ExxonMobil.
Maduro said in a message Sunday on Telegram that Venezuela has spent months “denouncing, challenging and defeating a campaign of aggression that goes from psychological terrorism to corsairs attacking oil tankers.”
He added: “We are ready to accelerate the pace of our deep revolution!”
Sen. Rand Paul, R-Kentucky, who has been critical of Trump’s Venezuela policy, called the tanker seizures a “provocation and a prelude to war.”
“Look, at any point in time, there are 20, 30 governments around the world that we don’t like that are either socialist or communist or have human rights violations,” Paul said on ABC’s’ “This Week.” ”But it isn’t the job of the American soldier to be the policeman of the world.”
The targeting of tankers comes as Trump has ordered the Defense Department to carry out a series of attacks on vessels in the Caribbean and eastern Pacific Ocean that his administration alleges are smuggling fentanyl and other illegal drugs into the United States and beyond.
At least 104 people have been killed in 28 known strikes since early September. The strikes have faced scrutiny from US lawmakers and human rights activists, who say the administration has offered scant evidence that its targets are indeed drug smugglers and that the fatal strikes amount to extrajudicial killings.
Trump has repeatedly said Maduro’s days in power are numbered. White House chief of staff Susie Wiles said in an interview with Vanity Fair published last week that Trump “wants to keep on blowing boats up until Maduro cries uncle.”
Sen. Tim Kaine, D-Virginia, told NBC’s “Meet the Press” on Sunday that Trump’s use of military to mount pressure on Maduro runs contrary to Trump’s pledge to keep the United States out of unnecessary wars.
Democrats have been pressing Trump to seek congressional authorization for the military action in the Caribbean.
“We should be using sanctions and other tools at our disposal to punish this dictator who is violating the human rights of his civilians and has run the Venezuelan economy into the ground,” Kaine said. “But I’ll tell you, we should not be waging war against Venezuela. We definitely should not be waging war without a vote of Congress.
