Coronavirus

Virus Updates: FDA Approves Vaccine Emergency Use

NBCUniversal Media, LLC An advisory committee met Thursday and voted in favor of endorsing the Pfizer-BioNTech COVID-19 vaccine for emergency authorization, saying that the benefits outweigh the risks.

The United States continues to set new pandemic records – on Thursday, the country reported more than 225,000 new coronavirus cases and 3,100 deaths, according to a tally by NBC News.

The nationwide crisis is pushing medical centers to the breaking point and leaving staff members and public health officials burned out and plagued by tears and nightmares.

The developments come as the U.S. Food and Drug Administration approved the emergency use of the Pfizer-BioNTech COVID-19 vaccine.

FDA Authorizes Pfizer Vaccine for Emergency Use

The Food and Drug Administration on Friday said it had authorized the first Covid-19 vaccine for emergency use in the United States — the first major, tantalizing indication for Americans that the pandemic's days may be numbered.

A letter from the FDA to Pfizer reads that "the known and potential benefits of Pfizer-BioNTech COVID‑19 vaccine" outweigh its potential risks for people ages 16 and older.

"It's nothing short of a medical miracle to have FDA authorization of a vaccine for Covid-19 just over 11 months since the virus was made known to the world," Health and Human Services Secretary Alex Azar said in a statement.

FDA commissioner Dr. Stephen Hahn said in a statement late Friday that the "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."

Read the full story at NBCNews.com.


California's Rich and Famous Won't Cut Vaccine Line, Promise State Officials

As California awaits its first batch of COVID-19 vaccines, totaling 327,000 doses, the state is attempting to quash concerns that the wealthy and well connected will somehow be able to obtain vaccines ahead of frontline health care workers and other prioritized groups during the arduous vaccine distribution process.

While the rich and famous have benefited from better access to COVID-19 testing, Dr. Eric Toner, who has studied pandemic preparedness for 20 years and currently serves as a Senior Scholar at the Johns Hopkins Center for Health Security, noted the coronavirus vaccine "is owned by the government and tightly controlled. So, I think it’ll be harder to do that. Nothing’s impossible, but I think it would be harder.”

Gov. Gavin Newsom said state officials would be aggressive in ensuring those with money, influence, or connections won’t be given preferential treatment as vaccines are doled out across California.

“Those that think they can get ahead of the line and those that think because they have resources or they have relationships that will allow them to do it, we will be monitoring that very, very closely,” Newsom said at a virtual press conference earlier this month.

Read the full story here.


Biogen Conference in Boston Linked 300,000 COVID-19 Cases

A study published by the journal Science says as many as 300,000 COVID-19 cases around the world can be traced to a two-day biotech meeting at a hotel in downtown Boston last February.

The study published Thursday says the meeting of Biogen managers resulted in 100 people returning home with the coronavirus who spread it to 29 states and Australia, Slovakia and Sweden.

The study estimates the conference is responsible for about 1.6% of all cases in the United States. It tracked the unique genetic signatures of the virus that could be traced to the Boston event.

The lead author was Jacob Lemieux, an infectious disease doctor at Massachusetts General Hospital, but more than 50 researchers were credited.

“If there is a public health message here, it is that the conditions that enable these types of massive super-spreading events to occur are still with us,” Lemieux told The Boston Globe.

Biogen says in a statement it hoped the study would “continue to drive a better understanding of the transmission of this virus and efforts to address it.”


Gov. Cuomo Suspends Indoor Dining in NYC to Limit Virus Spread

Gov. Andrew Cuomo said Friday he is suspending indoor dining in New York City as of Monday, a result of sustained increases in the five boroughs' hospitalization and COVID-19 positivity rates, NBC New York reports. The potential for harsher shutdowns looms.

Only takeout orders and outdoor dining will be allowed in the city, the governor said at a news conference in Albany.

The governor’s order comes despite opposition from the beleaguered restaurant industry, which warned of holiday season lay-offs at a time when the federal government has yet to pass additional COVID-19 relief. 

Read the full story here.


Study: 2-Drug Treatment Helpful for Coronavirus Patients

Doctors are reporting that a two-drug treatment is especially helpful for COVID-19 patients who need extra oxygen.

Adding the anti-inflammatory drug baricitinib to the antiviral medicine remdesivir helped these patients recover eight days sooner, in 10 days on average versus 18 for those given remdesivir alone, according to a study.

The medicines have been recommended since September, when early results from this U.S. government-sponsored study suggested the combination shortened recovery time for hospitalized patients by one day.

Full results published Friday by the New England Journal of Medicine show the benefit was even greater for those needing oxygen or other respiratory support short of a breathing machine. Serious side effects and new infections also were fewer in the combo treatment group.

The study involved more than 1,000 COVID-19 patients. All were given Gilead Sciences’ remdesivir, sold as Veklury, and half also received baricitinib, a drug Eli Lilly sells as Olumiant to treat rheumatoid arthritis, the less common form of arthritis that occurs when a mistaken or overreacting immune system attacks joints, causing inflammation. An overactive immune system also can lead to serious problems in some coronavirus patients.


FDA Tells Pfizer It's Working 'Rapidly' to Issue Emergency Use Authorization for Its Vaccine

The Food and Drug Administration said Friday it will work rapidly toward finalizing and issuing an emergency use authorization for Pfizer COVID-19 vaccine following an endorsement of the shot by a government advisory panel.

The agency also notified the Centers for Disease Control and Prevention and Operation Warp Speed so they can execute their plans for timely vaccine distribution.

The FDA advisory panel endorsed widespread use of Pfizer’s coronavirus vaccine Thursday in a 17-4 vote with one abstention. The government advisers concluded that the vaccine from Pfizer and its German partner BioNTech appears safe and effective for emergency use in adults and teenagers 16 and over.

Health and Human Services Secretary Alex Azar said on ABC's "Good Morning America" Friday that the Pfizer vaccine will be approved, they are just wrapping up the details and finalizing the fact sheet on allergy warnings. He said COVID-19 vaccinations could begin Monday or Tuesday and expect 20 million Americans to be vaccinated by the end of the month.


City of Miami to Enforce Midnight Curfew Starting This Weekend

Miami city commissioners unanimously passed a resolution Thursday to enforce Miami-Dade County’s midnight curfew again, NBC South Florida reports.

Starting this weekend, the city will enforce, once again, the 12 a.m. to 6 a.m. curfew until further notice.

Violators -- individuals and businesses -- will be subject to fines and other enforcement actions, the city said in a statement. Commissioners had previously decided back in October to stop enforcing the county's curfew.


3,110 COVID Deaths Reported Across the US on Thursday

The United States on Thursday broke another single-day record for COVID-19 cases and deaths, according to NBC News' count.

Nearly 230,000 new infections and 3,110 deaths were reported.  

It was the eighth day in December that saw more than 200,000 new cases; the first was Dec. 2. There have been only two days so far this month in which daily reported cases did not break that threshold.

The new record for deaths came just one day after the previous was set. On Wednesday, 3,102 deaths were reported, according to NBC News' count.

Overall, the U.S. has seen more than 15.6 million cases of COVID-19, and more than 292,900 people have died.


California's Health Order Falling on Many Deaf Ears

In the Southern California oceanside city of Manhattan Beach, one arm of government is urging residents to stay home except for essential needs while another is encouraging them to get out and shop and even providing places where they can sit down to relax, eat takeout and watch the sun set on the Pacific.

It’s one example of confusing messages from governments as most of California is under a broad shutdown order that includes an overnight curfew to try to stem record-breaking coronavirus cases that threaten to overwhelm the hospital system.

While state and county health officials are pleading with residents to stay home and only mingle with those in their household, the order allows all retailers to remain open with 20% capacity and encourages people to get outside to exercise.

Manhattan Beach Mayor Suzanne Hadley said her community saw an opportunity to aid local businesses while meeting the stipulations of the order. The solution: repurposing city-owned patio areas set up to allow restaurants to serve diners outdoors -- which no longer is allowed -- into “public seating areas” where downtown shoppers can relax.

“Shopping for a Christmas gift, buying a to-go meal, watching a sunset are allowed, and even the outdoor activities are encouraged by the state,” she said.

Manhattan Beach is in Los Angeles County, the state’s largest county with 10 million residents and disproportionately large numbers of California's coronavirus cases, hospitalizations and deaths.


Virginia to Set Curfew, Add Stricter Mask Mandate

Virginia Gov. Ralph Northam announced new measures to combat the coronavirus Thursday that include a stricter mask mandate and a curfew that will require most Virginians to stay home between midnight and 5 a.m., NBC Washington reports.

Residents also are asked to stay home at other hours whenever they can as the virus continues to devastate the state. 

“If you don’t need to go out, stay home,” Gov. Ralph Northam said at a news conference Thursday.

The executive order is set to take effect on Monday and also will reduce the state’s cap on public gatherings from 25 people to 10. Northam is expanding the state's longstanding mask requirements to include outdoor areas where social distancing isn’t possible and all indoor areas shared with others, except for households. The current mask mandate requires only that masks be worn in indoor public settings.


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