The US Food and Drug Administration on Saturday issued anemergency use authorizationfor Regeneron's antibody cocktail to treat Covid-19 in high-risk patients with mild to moderate disease.
President Donald Trump received the therapy, called REGEN-COV2, when he washospitalized for coronavirus. The treatment has to be infused into the bloodstream and is meant to mimic an immune response to infection.
The cocktail reduced Covid-19-related hospitalizations and emergency room visits in some patients within 28 days of treatment, the FDA said in anews release.
Regeneron's chief executive officer, Dr. Leonard S. Schleifer, said in astatementthat demand may initially exceed supply, "making it even more critical that federal and state governments ensure REGEN-COV2 is distributed fairly and equitably to the patients most in need."
Some context: Anemergency use authorization(EUA) is a lower regulatory bar than full approval by the FDA. An EUA allows products to be used under particular circumstances before all the evidence is available for approval.
"When used to treat Covid-19 for the authorized population, the known and potential benefits of these antibodies outweigh the known and potential risks," the FDA said.
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Georgia Republican Sen. Kelly Loeffler has tested positive for Covid-19, her campaign announced.
Loeffler tested positive for the coronavirus on Friday, but a subsequent test came back as inconclusive on Saturday evening, according to campaign spokesperson Stephen Lawson.
Loeffler was maskless with Vice President Mike Pence and Sen. David Perdue during campaign events most of the day Friday. The trio rode on a bus from the airport to two campaign events forGeorgia Senate seat runoff electionsin January.
"Senator Loeffler took two Covid testson Friday morning. Her rapid test results were negative and she was cleared to attend Fridays events. She was informed later in the evening, after public events on Friday, that her PCR test came back positive, but she was retestedSaturday morningafter conferring with medical officials and those results came back inconclusiveon Saturday evening," Lawson said in a statement.
"She has no symptoms and she will continue to follow CDC guidelines by quarantining until retesting is conclusive and an update will be provided at that time, Lawson said.
The campaign official added that Loeffler is notifying those with whom she had direct contact with while she awaits further tests.
Mississippi reported 1,972 new Covid-19 cases on Saturday, the highest single-day jump in infections since the pandemic began.
The previous peak of 1,775 cases was recorded on July 30, according to Mississippi State Department of Health Communications Director Liz Sharlot.
The state also saw 15 virus-deaths Saturday, bringing its death toll to 3,657. It has reported a total of 142,401 coronavirus cases so far, according to thehealth department.
Currently, there are 897 coronavirus patients hospitalized in the state, including 223 in the Intensive Care Unit (ICU), according to the department.
Hong Kong recorded 43 new coronavirus cases on Saturday the biggest daily jump in more than three months, according to a statement from the citys Centre for Health Protection (CHP).
Of the newly reported cases, 36 were locally transmitted, the statement said.
"Given that the situation of Covid-19 infection remains severe, and that there is a continuous increase in the number of cases reported around the world, members of the public are strongly urged to avoid all non-essential travel outside Hong Kong," the CHP spokesperson was quoted saying in the statement.
The CHP also called on members of the public to avoid going out, having social contact and dining out.
The announcement of the new cases comes after Hong Kong postponed a much-hyped "travel bubble" with Singapore due to a rise in coronavirus cases in the city.
Edward Yau, Hong Kong's secretary for commerce and economic development, announced the two-week delay during a press conference on Saturday.
"We had planned to launch the HK-Singapore travel bubble tomorrow, Yau said. But in the light of the recent upsurge of local cases, we have decided together with Singapore government that we would defer the launching of the air travel bubble by two weeks.
The California Department of Public Health announced 15,442 new Covid-19 cases in a press release Saturday.
This marks a record high in newly reported cases in the state, shattering Friday's highest case count of 13,005. The previous high was reported in July with 12,807 new cases.
There have now been a total of 1,087,714 confirmed cases in California, the release said.
The seven-day positivity rate is 6.1% and the 14-day positivity rate is 5.4%, according to the release.
World Health Organization Director-GeneralTedrosAdhanom Ghebreyesus urged world leaders to allocate coronavirus vaccines fairly today during a virtual G20 summit.
Fair allocation of vaccines is central to the pandemic endgame, and a faster global recovery, Tedros said in a copy of his opening remarks, released by WHO.
Tedrossaid there is a need for an immediate investment of $4.5 billion for vaccines.
The Group of 20, or G20, summit is a gathering of world leaders to discuss international issues.
Tedros noted that the G20 -- which represents two-thirds of the worlds population and 80% of the global economy -- will play a vital role in not only ending the coronavirus pandemic, but preventing future pandemics.
To prevent future outbreaks and their impact on lives, livelihoods and economies, all countries must invest in preparedness and universal health coverage, he said.
There have been at least12,019,960cases of coronavirus in the United States, according to data compiled byJohns Hopkins University.
The US has added about 2 million new coronavirus cases in the past 12 days.
Johns Hopkins recorded the first case of coronavirus in the United States on January 21. After that ...
- 98 days later, on April 28, the US hit 1 million cases
- 44 days later, on June 11, the US hit 2 million cases
- 27 days later, on July 8, the US hit 3 million cases
- 15 days later, on July 23, the US hit 4 million cases
- 17 days later, on August 9, the US hit 5 million cases
- 22 days later, on August 31, the US hit 6 million cases
- 25 days later, on September 25, the US hit 7 million cases
- 21 days later on October 16, the US hit 8 million cases
- 14 days later, on October 30, the US hit 9 million cases
- 10 days later, on November 9, the US hit 10 million cases
- 6 days later, on November 15, the US hit 11 million cases
- 6 days later on November 21, the US hit 12 million cases
At least255,414people have died in the United States from coronavirus since the pandemic began.