December 12 coronavirus news

The US reported record-high numbers of fresh Covid-19 cases, deaths and hospitalizations on Friday, according to data from Johns Hopkins University (JHU) and the Covid Tracking Project (CTP).

On Friday, 231,775 new confirmed Covid-19 cases were reported nationwide, according to JHU.

In addition, there were 3,309 more related deaths -- a record since the pandemic began. 

The US also hit a record number of Covid-19 hospitalizations with 108,044 reported by the CTP.

According to JHU data, the top five days for new US cases were all in December:

Mexico’s Federal Commission for the Protection against Sanitary Risk (COFEPRIS) announced Friday it has granted emergency use authorization (EUA) for the Pfizer and BioNTech vaccine.

Deputy Health Minister Hugo López Gatell, who is leading the country’s Covid-19 response, told reporters the announcement is “cause for hope … It is good news.”

The 24-member COFEPRIS committee voted unanimously to approve the EUA.

Mexico announced part of its vaccination distribution plan -- which calls for prioritizing the country’s health care workers -- earlier this week.

A total of 250,000 doses of the vaccine are expected to arrive in Mexico before the end of the month. An additional 15 million doses are expected to arrive by April.

Mexico’s government recently announced it had signed an agreement to secure 34.4 million doses of Pfizer/BioNtech vaccine.

South Korea reported 950 new coronavirus cases on Saturday -- the most infections in a single day since the beginning of the pandemic, the Korea Disease Control and Prevention Agency (KDCA) said in a press release.

Of those, 928 confirmed cases are local infections, while 22 are imported. 

The Seoul Metropolitan Area accounts for the majority of the total with a record 669 new cases, the KDCA said.

Meanwhile, three more cases have been linked to the church cluster in Daegu city, according to the local government’s press release on Saturday.

There have now been 32 cases linked to the church cluster, where contact tracers said members of the choir didn't wear masks and parishioners shared snacks.

Earlier this year, the Daegu branch of the Shincheonji religious group became one of the country’s biggest single clusters, linked to more than 5,200 cases.

The country has recorded 41,736 cases in total so far.

South Korea’s related death toll also increased by six on Saturday, bringing total fatalities to 578.

The US Food and Drug Administration will hold a news conference at 9 a.m. ET Saturday with Commissioner Dr. Stephen Hahn and Dr. Peter Marks, who heads the FDA’s Center for Biologics Evaluation and Research, to discuss the agency’s decision to grant emergency use authorization for Pfizer’s Covid-19 vaccine.

“FDA Commissioner @SteveFDA and @FDACBER Director Dr. Peter Marks will be taking questions,” the agency said on its Twitter account. The news conference will be livestreamed on Twitter, the FDA said.

The US Food and Drug Administration’s approval of an emergency use authorization for Pfizer’s Covid-19 vaccine is “really a monumental moment,” Dr. Leana Wen, a CNN medical analyst and emergency room physician, said Friday. 

“I think it’s really amazing,” Wen, the former Baltimore health commissioner, told CNN’s Chris Cuomo.

“We also need to make sure that every safeguard was followed, and that's what all these scientists and all these committees are here to do,” she added.

FDA vaccine advisers met Thursday and voted to recommend an EUA for the vaccine. Now the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet Saturday. 

The CDC committee must vote to recommend the vaccine, and the agency must accept that recommendation, in order for vaccinations to begin.

Watch:

The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices meeting will now begin at 11 a.m. ET Saturday, according to an update on the CDC’s website.

The meeting was previously scheduled for Sunday.

Following the US Food and Drug Administration’s emergency use authorization of Pfizer and BioNTech’s coronavirus vaccine, the CDC committee must vote to recommend it. The CDC must then accept that recommendation for vaccinations to begin.

The vote is expected to take place about 2:30 p.m. ET Saturday.

The US Food and Drug Administration’s emergency use authorization for Pfizer’s Covid-19 vaccine is a “significant milestone” in fighting a pandemic that has killed nearly 300,000 Americans, FDA Commissioner Dr. Stephen Hahn said Friday.

“The FDA’s authorization for emergency use of the first Covid-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” Hahn said in a statement.

The emergency use authorization allows the Pfizer-BioNTech Covid-19 vaccine to be distributed in the US, the FDA said in a news release.

It’s not an FDA approval, but the EUA “holds the promise to alter the course of this pandemic in the United States,” Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

“With science guiding our decision-making, the available safety and effectiveness data support the authorization of the Pfizer-BioNTech Covid-19 vaccine because the vaccine’s known and potential benefits clearly outweigh its known and potential risks,” Marks said.

The US Food and Drug Administration has authorized Pfizer and BioNTech's coronavirus vaccine for emergency use.

A Pfizer spokesperson confirmed to CNN on Friday that an EUA had been granted, following the recommendation of the FDA’s Vaccines and Related Biological Products Advisory Committee.

On Thursday, 17 committee members voted to recommend the FDA issue an EUA for the vaccine. Four voted no and one abstained.

Dr. Gupta discusses:

Florida health system Orlando Health says it will begin vaccinating its employees against Covid-19 on December 18. 

Orlando Health said vaccinations will be administered at Orlando Regional Medical Center and will continue on December 21-23. 

The first round of vaccinations will go to those at highest risk for Covid-19.

Residents of Orlando Health’s long-term care facilities will be among the first to receive vaccines.

The system’s chief medical officer, Dr. George Ralls, said that after Moderna’s vaccine is available, Orlando Health expects to be able to vaccinate its entire workforce.