Pfizer and German partner BioNTech said Monday they’re seeking Food and Drug Administration authorization for their omicron-targeting bivalent vaccine for use in children 5 to 11 years of age.
The application is for a 10-milligram booster dose of the vaccine targeting omicron’s BA.4 and BA.5 subvariants, which have become dominant in the U.S. and around the world.
The companies
PFE,
BNTX,
have also started a Phase 1/2/3 study to evaluate different doses and dosings of the bivalent vaccine for use in children from 6 months through 11 years old.
The news comes after Moderna
MRNA,
said Friday that it has submitted its own request for its bivalent vaccine for children and adolescents aged 12 to 17, as well as a separate submission for 6- to 11-year-olds.
The moves come as U.S. known cases of COVID are continuing to ease and now stand at their lowest level since late April, although the true tally is likely higher than reported given how many people are testing at home, with data typically not collected. The daily average for new cases stood at 54,239 on Sunday, according to a New York Times tracker, down 18% from two weeks ago.
Cases are rising in 20 states, including New York, New Jersey and Massachusetts, the tracker shows, as well as in Washington, D.C.
The daily average for hospitalizations was down 14% at 29,835, while the daily average for deaths is up 15% to 432.
From the CDC: Stay Up to Date with COVID-19 Vaccines Including Boosters
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Other COVID-19 news you should know about:
• French drug company Valneva SE
VLA,
on Monday said it is in discussions with a prospective partner to get funding for a second-generation COVID vaccine, Dow Jones Newswires reported. Valneva said that it aims to deploy remaining inventory into international markets in the next 12 months, and that is continuing discussions with various governments and has initiated regulatory processes. The company is expected to report additional clinical data, notably heterologous booster data, in the fourth quarter of the year.
• Macau, a gambling center in China, has decided to ease COVID restrictions, by resuming electronic visas for individuals and group tours, around late October to early November. The news sent casino stocks higher in Monday trading, with Las Vegas Sands
LVS,
up 12.5%, Wynn Resorts
WYNN,
up 14.8%, MGM Resorts International
MGM,
up 4.4% and Caesars Entertainment
CZR,
up 2.9%. “Although it’s tough to quantify the immediate benefit, we believe the resumption of e-visa & group tours should alleviate friction for a Macau trip, as well as signal to many that it’s OK to visit Macau, in turn boosting demand into the year-end holidays and 2023,” JPMorgan analyst D.S. Kim wrote in a note to clients. “Finally, we feel we can talk about a return to normalcy.”
• German Chancellor Olaf Scholz has tested positive for the coronavirus, his spokesman told the news agency dpa, the Associated Press reported. Government spokesman Steffen Hebestreit said Scholz has mild symptoms and immediately entered isolation. He has canceled all public appearances this week but plans to take part virtually in internal government meetings, Hebestreit said. Scholz returned from a two-day official trip to the Gulf states on Sunday and before that was at the U.N. General Assembly in New York.
• Scholz is not the only European governmental leader to have contracted the virus of late. Spanish Prime Minister Pedro Sánchez said Sunday he has tested positive for COVID, the AP reported. The leader of Spain’s Socialist Party and of the country’s coalition government said in a Twitter post that he was canceling his appearance at a party event Sunday marking the beginning of the new political season after the summer recess.
Here’s what the numbers say
The global tally of confirmed cases of COVID-19 topped 615.1 million on Monday, while the death toll rose above 6.53 million, according to data aggregated by Johns Hopkins University.
The U.S. leads the world with 96 million cases and 1,056,434 fatalities.
The Centers for Disease Control and Prevention’s tracker shows that 224.9 million people living in the U.S. are fully vaccinated, equal to 67.8% of the total population. Just 109.6 million have had a booster, equal to 48.7% of the vaccinated population, and 23.1 million of those who are eligible for a second booster have had one, equal to 35.5% of those who received a first booster.
So far, some 4.4 million people have had a third booster dose of the new bivalent vaccines that target the latest omicron subvariants.
Published at Mon, 26 Sep 2022 08:11:00 -0700
