WASHINGTON: Pfizer and BioNTech said Tuesday they began submitting a formal request to US health regulators for emergency use of their Covid vaccine for children aged over six months and under five years.
If the Food and Drug Administration (FDA) authorizes the two-shot regimen, it will become the first Covid vaccine available to this age group in the United States.
In a tweet soon after the announcement, the FDA said it will hold a meeting on February 15 to consider the request.
The companies are seeking authorization for only two doses of their vaccine, but believe a third will be needed “to achieve high levels of protection against current and potential future variants,” Pfizer CEO Albert Bourla said in a statement.
“If two doses are authorized, parents will have the opportunity to begin a Covid-19 vaccination series for their children while awaiting potential authorization of a third dose,” he added.
To limit side effects for this young age group, Pfizer chose to significantly decrease the dosage of its vaccine, opting for only three micrograms per jab versus 30 for those over 12 years old, and 10 for ages five to 11.
The company’s researchers concluded last fall that low doses of the vaccine provided protection in children up to two years old but not in those aged two to five, and announced in December they would add a third dose to their trials.
Data on the three-dose regimen is “expected in the coming months and will be submitted to the FDA to support a potential expansion” of this initial request, Pfizer and BioNTech said in a press release.
Two years into the pandemic, many parents are waiting impatiently to vaccinate their young children against the coronavirus.
The Pfizer-BioNTech vaccine was approved three months ago for emergency use in children from five to 11.
Pfizer seeks US approval of Covid vaccine for children under 5
https://arab.news/5thyn
Pfizer seeks US approval of Covid vaccine for children under 5
- If the Food and Drug Administration (FDA) authorizes the two-shot regimen, it will become the first Covid vaccine available to this age group in the US
Italian police fire tear gas as protesters clash near Winter Olympics hockey venue
- Police vans behind a temporary metal fence secured the road to the athletes’ village, but the protest veered away, continuing on a trajectory toward the Santagiulia venue
MILAN: Italian police fired tear gas and a water cannon at dozens of protesters who threw firecrackers and tried to access a highway near a Winter Olympics venue on Saturday.
The brief confrontation came at the end of a peaceful march by thousands against the environmental impact of the Games and the presence of US agents in Italy.
Police held off the violent demonstrators, who appeared to be trying to reach the Santagiulia Olympic ice hockey rink, after the skirmish. By then, the larger peaceful protest, including families with small children and students, had dispersed.
Earlier, a group of masked protesters had set off smoke bombs and firecrackers on a bridge overlooking a construction site about 800 meters (a half-mile) from the Olympic Village that’s housing around 1,500 athletes.
Police vans behind a temporary metal fence secured the road to the athletes’ village, but the protest veered away, continuing on a trajectory toward the Santagiulia venue. A heavy police presence guarded the entire route.
There was no indication that the protest and resulting road closure interfered with athletes’ transfers to their events, all on the outskirts of Milan.
The demonstration coincided with US Vice President JD Vance’s visit to Milan as head of the American delegation that attended the opening ceremony on Friday.
He and his family visited Leonardo da Vinci’s “The Last Supper” closer to the city center, far from the protest, which also was against the deployment of US Immigration and Customs Enforcement agents to provide security to the US delegation.
US Homeland Security Investigations, an ICE unit that focuses on cross-border crimes, frequently sends its officers to overseas events like the Olympics to assist with security. The ICE arm at the forefront of the immigration crackdown in the US is known as Enforcement and Removal Operations, and there is no indication its officers are being sent to Italy.
At the larger, peaceful demonstration, which police said numbered 10,000, people carried cardboard cutouts to represent trees felled to build the new bobsled run in Cortina. A group of dancers performed to beating drums. Music blasted from a truck leading the march, one a profanity-laced anti-ICE anthem.
“Let’s take back the cities and free the mountains,” read a banner by a group calling itself the Unsustainable Olympic Committee. Another group called the Association of Proletariat Excursionists organized the cutout trees.
“They bypassed the laws that usually are needed for major infrastructure project, citing urgency for the Games,” said protester Guido Maffioli, who expressed concern that the private entity organizing the Games would eventually pass on debt to Italian taxpayers.
Homemade signs read “Get out of the Games: Genocide States, Fascist Police and Polluting Sponsors,” the final one a reference to fossil fuel companies that are sponsors of the Games. One woman carried an artificial tree on her back decorated with the sign: “Infernal Olympics.”
The demonstration followed another last week when hundreds protested the deployment of ICE agents.
Like last week, demonstrators Saturday said they were opposed to ICE agents’ presence, despite official statements that a small number of agents from an investigative arm would be present in US diplomatic territory, and not operational on the streets.
