Pfizer and BioNTech are seeking approval of an Omicron-targeted booster for children ages 5-11

Pfizer and German partner BioNTech announced Monday that they are seeking Food and Drug Administration approval for their Omicron-targeted bivalent vaccine for use in children ages 5 to 11.

The application is for a 10 milligram booster dose of the vaccine, which targets omicron’s BA.4 and BA.5 subvariants, which have become dominant in the US and worldwide.

The companies PFE,
-0.57%

BNTX,
-0.55%
have also started a phase 1/2/3 study to evaluate different doses and doses of the bivalent vaccine for use in children aged 6 months to 11 years.

The news comes after Moderna MRNA,
-3.19%
said on Friday that it had submitted a separate application for its bivalent vaccine for children and adolescents aged 12 to 17 and a separate application for 6 to 11 year olds.

The moves come as known cases of COVID in the US continue to ebb and are now at their lowest since late April, although the actual number is likely higher than reported given how many people are testing at home, although data usually isn’t be collected. The daily average for new cases was 54,239, according to data on Sunday a New York Times tracker18% less than two weeks ago.

Cases are rising in 20 states, including New York, New Jersey and Massachusetts, the tracker shows, as well as Washington, DC

The daily average for hospitalizations fell 14% to 29,835, while the daily average for deaths rose 15% to 432.

The Covid-19 pandemic renewed interest in the practice of testing wastewater to track disease outbreaks, including polio, which has been declared a disaster emergency in New York. WSJ visited a Bay Area wastewater facility to find out how testing works and what it can tell us about public health. Photo illustration: Ryan Trefes

From the CDC: Stay up to date with COVID-19 vaccines, including booster shots

Coronavirus update: MarketWatch’s daily roundup has been curating and reporting on the latest developments every weekday since the start of the coronavirus pandemic

Other COVID-19 news you should know:

• the French pharmaceutical company Valneva SE VLA,
-1.01%
on Monday said it was in talks with a potential partner to secure funding for a second-generation COVID vaccine, Dow Jones Newswires reported. Valneva said it intends to deploy the remaining stocks in international markets over the next 12 months and that it is continuing talks with various governments and has initiated regulatory processes. The Company is expected to report additional clinical data, particularly heterologous booster data, in the fourth quarter of the year.

• Macau, a gambling hub in China, has decided to ease COVID restrictions by resuming electronic visas for individual and group travel in late October-early November. The news sent casino shares higher in Monday trading, with Las Vegas Sands LVS,
+11.81%
up 12.5%, Wynn Resorts WYNN,
+11.99%
up 14.8%, MGM Resorts International MGM,
-0.20%
by 4.4% and Caesars Entertainment CZR,
-4.52%
increased by 2.9%. “While it’s difficult to quantify the immediate benefits, we believe the resumption of e-visa and group travel should reduce friction for a trip to Macau and signal to many that it’s okay to visit Macau, which in turn.” will boost demand throughout the year. End of holidays and 2023,” wrote JPMorgan analyst DS Kim in a note to clients. “Finally we feel like we can talk about a return to normal.”

• Chancellor Olaf Scholz has tested positive for the coronavirus, his spokesman told the dpa news agency, the Associated Press reported. Government spokesman Steffen Hebestreit said Scholz had mild symptoms and immediately went into isolation. He has canceled all public appearances this week, but plans to attend government meetings virtually, Hebestreit said. Scholz returned on Sunday from a two-day business trip from the Gulf States and had previously been to the UN General Assembly in New York.

• Scholz is not the only European head of government who has recently contracted the virus. Spanish Prime Minister Pedro Sánchez said Sunday he had tested positive for COVID, the AP reported. The leader of Spain’s Socialist Party and the country’s coalition government said in a Twitter post that he was canceling his appearance at a party event on Sunday marking the start of the new political season after the summer break.

Here’s what the numbers say

The global number of confirmed cases of COVID-19 surpassed 615.1 million on Monday, while the death toll rose to over 6.53 million. based on data from Johns Hopkins University.

The US leads the world with 96 million cases and 1,056,434 deaths.

That Centers for Disease Control and Prevention tracker shows that 224.9 million people in the US are fully vaccinated, which is 67.8% of the total population. Only 109.6 million received a booster, representing 48.7% of the vaccinated population, and 23.1 million of those eligible for a second booster received one, representing 35.5% of those who did got the first refresher.

So far, about 4.4 million people have received a third booster dose of the new bivalent vaccines targeting the latest Omicron subvariants.

https://www.marketwatch.com/story/pfizer-and-biontech-seek-authorization-of-omicron-targeted-booster-for-children-aged-5-to-11-11664205085?rss=1&siteid=rss Pfizer and BioNTech are seeking approval of an Omicron-targeted booster for children ages 5-11

Brian Lowry

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