Pfizer and its German partner BioEntech said Monday they are seeking Food and Drug Administration approval for the Omicron-targeted bivalent vaccine for use in children ages 5 to 11.
The application is for a 10-milligram booster dose of the vaccine targeting omicron’s BA.4 and BA.5 subunits, which are dominant in the US and around the world.
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It has also initiated a phase 1/2/3 study to evaluate the dosage and dosage of the bivalent vaccine for use in children 6 months to 11 years of age.
The news comes after Moderna MRNA.
He said on Friday that he has submitted his request for the bivalent vaccine for children and adolescents aged 12 to 17 years, as well as a separate entry for children aged 6 to 11 years.
The measures come as the number of known cases of COVID in the U.S. is easing and is now at its lowest level since late April, although the exact data on how many people are testing at home may be higher than reported, as the data is not typically collected. The daily average of new cases stood at 54,239 on Sunday, down 18% from two weeks ago, according to a New York Times tracker.
Cases are on the rise in 20 states, including New York, New Jersey and Massachusetts, tracking shows, as well as in Washington, D.C.
The daily average of hospitalizations fell by 14% to 29,835, while the daily average of deaths fell by 15% to 432.
The Covid-19 pandemic has revived the practice of testing sewage to track disease outbreaks, including polio, which was declared a public health emergency in New York. The WSJ visited a Bay Area wastewater facility to learn how testing works and what it can tell us about public health. Photo example: Ryan Trefes
From the CDC: Stay up to date with covid-19 vaccines including incentives
Coronavirus update: The MarketWatch Daily Roundup has been monitoring and reporting all the latest developments every weekday since the start of the coronavirus pandemic.
Other Covid-19 news you should know:
• French pharmaceutical company Valneva SE VLA,
Dow Jones Newswires is in talks with a potential partner to fund a second-generation Covid vaccine. Valneva said it aims to deploy the remaining inventory to international markets in the next 12 months and has continued discussions with various governments and initiated regulatory processes. The company is expected to report additional clinical data, particularly heterologous stimulation data, in the fourth quarter of the year.
• China’s gambling hub Macau has decided to ease Covid restrictions by reintroducing electronic visas for individual and group visits from late October to early November. The news sent casino stocks higher in Monday trading, along with Las Vegas Sands LVS;
12.5%, Wynn Resorts WYNN;
up 14.8%, MGM Resorts International MGM;
4.4% and Caesar’s Entertainment CZR;
It rose 2.9 percent. Although it is difficult to quantify the immediate benefits, we believe that the re-introduction of e-visas and group tours should ease confusion for Macao travel and signal to many that it is no longer a problem to visit Macao, which will increase demand heading into the year. The end of the holidays and 2023,” JPMorgan analyst DS Kim wrote in a note to clients. Finally, we feel we can talk about a return to normalcy.
• German Chancellor Olaf Scholz is infected with the Corona virus, according to the Associated Press, his spokesman told the news agency Dipa. Government spokesman Stephen Hebstreit said Scholes had mild symptoms and was immediately put into neutral. He has canceled all public events this week but plans to attend internal government meetings properly, Hebestreit said. Scholes returned to the Gulf states on Sunday for a two-day official visit, before attending the United Nations General Assembly in New York.
• Scholes is not the only European government leader who has been infected of late. Spanish Prime Minister Pedro Sánchez confirmed that he has been infected with Covid-19 on Sunday, according to AP. The leader of Spain’s Socialist Party and the country’s coalition government announced on Twitter that his attendance at a party event marking the start of the new political season after the summer break has been cancelled.
Here’s what the numbers say
According to data collected by Johns Hopkins University, the number of confirmed cases of COVID-19 worldwide has reached 615.1 million, while the death toll has risen to more than 6.53 million.
The United States leads the way with 96 million cases and 1,056,434 deaths.
According to the Centers for Disease Control and Prevention, 224.9 million people living in the United States are fully vaccinated, which is equal to 67.8% of the total population. Only 109.6 million received a booster, equal to 48.7% of the vaccinated population, and 23.1 million had one among those eligible for a second booster, equal to 35.5% of those who received a first booster.
So far, 4.4 million people have received the third additional dose of the new bivalent vaccines targeting the latest Omicron subunits.