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Sept. 16, 2022, 11:51 a.m. EDT

Europe may give COVID vaccines full marketing authorization; WHO backs Gilead’s Veklury for severe disease

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By Ciara Linnane

A flurry of regulatory announcements relating to COVID-19 treatments, vaccines and boosters dominated pandemic-related headlines Friday, with Europe now considering giving vaccines full marketing authorization in order to avoid having to review them every year.

The Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency (EMA), is making that recommendation for Pfizer /zigman2/quotes/202877789/composite PFE +0.74% and BioNTech’s /zigman2/quotes/214419716/composite BNTX -0.88% Comirnaty mRNA vaccine, according to a statement from the companies.

“The European Commission (EC) will review the CHMP recommendation and is soon expected to make a final decision,” the statement said.

Separately, the CHMP recommended approval of Comirnaty as a booster dose for children ages 5-11, to be administered at least six months after completion of a primary series of shots.

AstraZeneca PLC /zigman2/quotes/200304487/composite AZN +0.08% /zigman2/quotes/203048482/delayed UK:AZN +0.27% said the CHMP is recommending its Evusheld drug for use in COVID patients ages 12 and older who don’t need supplemental oxygen but who are at risk of developing severe disease. The EMA’s recommendation is based on the Tackle Phase 3 treatment data, which showed that Evusheld reduced risk of severe COVID-19 or death, as Dow Jones Newswires reported.

The World Health Organization on Thursday expanded its recommended guide for Gilead’s /zigman2/quotes/210293917/composite GILD +0.98% Veklury COVID-19 treatment.

The WHO updated its guidelines to recommend the drug to treat patients with severe COVID, an expansion from “those with non-severe COVID-19 at the highest risk of hospitalization.” In late July,  European Commission regulators  recommended that Veklury be used as an expanded COVID-19 treatment. 

On Friday, the CHMP recommended extending Veklury, also called remdesivir, for use in pediatric patients. The European Commission will review the recommendation, and if adopted, Veklury could become the only authorized treatment for adolescents at high risk of developing severe disease and for children with COVID who require supplemental oxygen.

Novavax /zigman2/quotes/202614340/composite NVAX -2.88% said Friday that Israel has granted an import and use permit for the company’s COVID vaccine for use in people 12 and older. The vaccine is protein-based, a more traditional technology than the mRNA used in the vaccines developed by Pfizer and Moderna /zigman2/quotes/205619834/composite MRNA -0.23% .

Separately, the company said it had also won emergency use authorization in Taiwan for adolescents ages 12-17.

The news comes as known cases of COVID are continuing to ease in the U.S., although the true tally is likely higher given how many people are testing at home, where data are not being collected. The daily average for new cases stood at 64,308 on Thursday, according to  a New York Times tracker , down 28% from two weeks ago.

The daily average for hospitalizations was down 11% to 33,143, while the daily average for deaths was down 4% to 491.

From the CDC:  Stay Up to Date with COVID-19 Vaccines Including Boosters

Coronavirus update:   MarketWatch’s daily COVID-19 roundup has been curating and reporting all the latest developments every weekday since the start of the pandemic

Other COVID-19 news you should know about:

• Thousands of nurses at Minnesota hospitals returned to work Thursday following a three-day strike over wage increases and staffing and retention issues made worse by the coronavirus pandemic, the Associated Press reported. Members of the Minnesota Nurses’ Association at 15 hospitals in the Minneapolis and Duluth areas  walked off the job Monday.  The nurses could soon learn what impact the strike may have had on efforts to reach a new contract.

• Munich’s storied Oktoberfest is back after a two-year pandemic interruption, but visitors can expect pressure from inflation that could hardly have been imagined in 2019, the last time the event was held, the AP reported separately. A 1-liter (2-pint) mug of beer will cost between 12.60 and 13.80 euros ($12.84-$14.07) this year, an increase of about 15% compared with 2019, according to the official Oktoberfest homepage. The event opens at noon Saturday, when Munich’s mayor taps the first keg and announces “O’zapft is,” or “It’s tapped” in Bavarian dialect.

• Widespread infections and food shortages have rocked the small city of  Lhasa  in Tibet after more than a month of extreme  COVID  measures, the South China Morning Post reported. Food is running out, and people have been locked in their homes or sent to makeshift isolation centers after the first local cases were detected on Aug. 8.

• Mainland China’s southwestern municipality of Chongqing reported a case of the monkeypox virus on Friday in an individual who arrived in the country from abroad, marking the country’s first known monkeypox infection, Reuters reported. The transmission risk of the case is low, as the individual was put in quarantine upon arrival in Chongqing, the municipal health commission said in a statement. All close contacts had been put under medical observation in isolation.

Here’s what the numbers say

The global tally of confirmed cases of COVID-19 topped 611.1 million on Friday, while the death toll rose above 6.52 million,  according to data aggregated by Johns Hopkins University .

The U.S. leads the world with 95.6 million cases and 1,052,960 fatalities.

The  Centers for Disease Control and Prevention’s tracker  shows that 224.6 million people living in the U.S. are fully vaccinated, equal to 67.7% of the total population. Just 109.2 million have had a booster, equal to 48.6% of the vaccinated population, and 22.5 million of those 50 and over who are eligible for a second booster have had one, equal to 34.7% of those who had a first booster.

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$67.93 billion
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