Moderna, one of the three companies authorized to provide COVID-19 vaccines to Americans on an emergency basis, announced Tuesday that it has begun applying for a full license from the Food and Drug Administration.
In December, the FDA authorized the use of Moderna and Pfizer/BioNTech vaccines on an emergency basis, enabling them to skip providing long-term data to get their vaccines out to the public faster. Now, both companies, which have together been used to vaccinate 168 million Americans with at least one shot, have collected that data and begun providing it to the regulatory agency. Last month, Pfizer/BioNTech applied for full approval for anyone over 16 years of age.
Both vaccines have been shown to be very safe and more than 90% effective in preventing symptomatic COVID-19 and are not expected to have a problem receiving a full Biologics License from the FDA. The process, however, could take weeks to a few months.
Both groups have released data showing their vaccines are also safe and effective in adolescents 12 and up, though they do not yet have long-term data in this age group. Some Americans have said they would prefer to wait until vaccines are fully approved before getting vaccinated.
– Karen Weintraub
Also in the news:
►Antoinette Chinonye Nwandu’s “Pass Over” is set to become the first Broadway show audiences can watch live, with performances at the August Wilson Theatre on Aug. 4. The show involves just three actors and an intermission-less 85-minute running time.
►Italians are eating and drinking indoors at bars and restaurants for the first time in months. Until Tuesday, businesses had to either offer outdoor seating or serve only grab-and-go customers.
►The World Health Organization has issued an emergency use listing for the COVID-19 vaccine made by Sinovac in adults 18 and over, the second such authorization it has granted to a Chinese company.
►India, after a spike in cases that began in February and surged in April and early May, has reported plummeting infections for the past three weeks. But the death toll is still high and began to drop slightly last week, according to Johns Hopkins University data.
📈 Today's numbers: The U.S. has more than 33.2 million confirmed coronavirus cases and 594,500 deaths, according to Johns Hopkins University data. The global totals: Over 170.8 million cases and 3.55 million deaths. More than 135 million Americans have been fully vaccinated – 40.7% of the population, according to the CDC.
📘 What we're reading: The COVID-19 vaccines are among the best ever created. Drug companies are trying to make them even better.
Keep refreshing this page for the latest updates. Want more? Sign up for our Coronavirus Watch newsletter for updates to your inbox and join our Facebook group.
Wisconsin, once a hot spot, now sees record low hospitalizations
Hospitalizations from COVID-19 are at their lowest recorded levels in Wisconsin, a 92% drop from the peak less than seven months ago in what was once a national hot spot. The Wisconsin Hospital Association said that as of Monday, there were 186 people reported as hospitalized statewide because of the virus. The high was 2,277 patients on Nov. 17, 2020. The 186 patients was down by 68 from the week before.
The good news comes as mask mandates ended Tuesday in Milwaukee and in state buildings, including the Capitol. The mask order for Dane County, including the city of Madison, was expiring on Wednesday.
Heathrow to separate travelers returning from high-risk nations
London’s Heathrow Airport has reopened a mothballed terminal to handle passengers arriving from high-risk countries. U.K. nationals and residents returning from a “red list” of 43 coronavirus hot spots including India, Brazil and Turkey face a mandatory 10-day quarantine in a hotel. But critics have complained that red list passengers have been using the same massive airport arrivals hall as travelers from other, safer destinations. Starting Tuesday, red list arrivals will pass through the airport’s Terminal 3, closed in April 2020 as international air travel plummeted.
"Red list routes will likely be a feature of UK travel for the foreseeable future as countries vaccinate their populations at different rates," the airport said in a statement. "We're adapting Heathrow to this longer-term reality."
Your office is probably reopening – but you may not need to go
More than 70% of companies say employees will be able to return to the workplace over the next five months, and 50% will reopen between August and October, according to a Conference Board survey of 231 human resource leaders taken April 5-16. The results, provided exclusively to USA TODAY, show that 79% of the mostly large businesses say 10% or more of their employees will be able to work remotely at least three days a week as the pandemic subsides. That's about three times the percentage of firms before the health crisis.
“Remote work is really going to stay here,” says Frank Steemers, senior economist for the Conference Board. It’s “probably going to be one of the main organizational legacies of the pandemic.” Read more here.
– Paul Davidson
WHO chief calls for 'pandemic treaty,' effort to vaccinate the world
World Health Organization Tedros Adhanom Ghebreyesus warned that the coronavirus is "deepening divergence in economic fortunes, and there will be negative consequences for all." Tedros stressed that access to vaccination, no longer a major problem in the U.S. but a big problem in the developing world, is key to ending the health crisis and driving a broad-based global recovery. He call for a stepped-up, coordinated strategy, bankrolled by new financing, to vaccinate the world.
"A #PandemicTreaty is a promise to future generations," Tedros tweeted. "This is a moment for exceptional leadership, for doing the unusual and the unprecedented. We must approach the future with open eyes and open arms."
California, Maryland latest states to inoculate 70% of adults
California and Maryland are the 11th and 12th states to make the July 4 benchmark set by President Joe Biden, who announced last month that he was making it a goal to inoculate 70% of U.S. adults with at least one COVID-19 shot by that date. So far, at least 62% of adults are there, according to data from the Centers for Disease Control and Prevention. 70% of adults in California have received at least one dose of the coronavirus vaccine, Gov. Gavin Newsom announced Monday. Maryland also reached the milestone Monday.
But many states are lagging behind. Alabama, Idaho, Louisiana, Mississippi, and Wyoming all have vaccination rates under 40%. In Alabama, 36% of the state has received at least one dose.
“It’s very distressing because we have vaccines and we have it in every corner of Alabama,” said Dr. Karen Landers, assistant state health officer.
Peru says death toll nearly triple official numbers
Petu's pandemic death toll reached 180,764 through May 22, almost triple the official death toll, which had been 68,000 until now. The country of 32.6 million has been hard hit by the pandemic. Scenes of cemeteries filling up with new burials and hospitals buying refrigerated containers to act as makeshift morgues suggested the situation was far worse than the official data showed, even at the beginning of the pandemic.
“What is being said is that a significant number of deaths were not classified as caused by COVID-19,” Health Minister Oscar Ugarte said, adding that the criteria for assigning the coronavirus as a cause of death were changed.
Ugarte said that previously only those who “had a positive diagnostic test” were considered to have died from the virus, but other criteria have since been incorporated.
Mobile vaccination units hit tiny US towns to boost immunity
Two Federal Emergency Management Agency mobile trailers have meandered through Nevada to towns without pharmacies, clinics or other vaccination sites, giving doctors, nurses and National Guardsmen a first-hand look at rural and tribal communities where finding vaccinations has been difficult for residents.
To preserve the vaccine, the trailers are equipped with ultra-cold refrigerators powered by generators-on-wheels. On Monday, the two mobile clinics completed six-week loops through Nevada that included returning to finish two-shot regimens in the state that covers an area that would stretch from Boston to Baltimore and Buffalo, New York.
Initially, the goal was to vaccinate 250 people a day at each stop. But the numbers have varied, as vaccine supply has increased and demand has fallen.
“Just a month ago, people were still having a hard time finding vaccination sites. That’s really changed in the last three or four weeks and now we’re trying to find people that are more vaccine-hesitant,” said Marc Reynolds, a doctor from Fallon who has volunteered at the mobile clinic in his hometown and the state prison in Lovelock.
The clinics have delivered 7,600 shots during two tours of Nevada and have also been used in Arizona, Illinois, Kentucky and other states. Nevada Division of Emergency Management Chief Dave Fogerson said people in the remote communities of the state “probably would not have got it any other way.”
Contributing: The Associated Press.
This article originally appeared on USA TODAY: COVID: Moderna vaccine seeks full FDA approval; California meets goal
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