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FDA considering second COVID-19 booster in coming months

Food and Drug Administration (FDA) officials are “very carefully” considering second booster doses of the mRNA COVID-19 vaccines, according to The Wall Street Journal.

FDA spokesperson Alison Hunt confirmed to CNN that the FDA “is indeed continually looking at the emerging data on the pandemic and variants in the United States and overseas in order to evaluate the potential utility and composition of booster doses.”

Hunt also said that there is still much uncertainty, but the FDA is evaluating whether another booster dose will be needed when the country moves into the fall of 2022, which would coincide with the typical administration of annual flu shots, CNN noted.

“As more data become available about the safety and effectiveness of COVID-19 vaccines, including the use of a booster dose, we will continue to evaluate the rapidly changing science and keep the public informed,” Hunt wrote to CNN. “Any determination that additional booster doses are needed will be based on data available to the agency.”

If the FDA approves another booster dose, it would then face approval by the Centers for Disease Control and Prevention (CDC). 

Anthony FauciAnthony FauciFDA considering second COVID-19 booster in coming months GOP senator faces challenge on Trump credentials Britt in new ad tells ‘boys in Washington’ to ‘man up’ MORE, the head of the National Institute of Allergy and Infectious Diseases (NIAID), said the “potential future requirement” for an additional booster is being “very carefully monitored in real time, and recommendations, if needed, will be updated according to the data as it evolves.”

Fauci also said that he believes the timing of when the second booster would be administered is critical and that it “doesn’t make much sense” to administer the fourth dose now as omicron begins to fade.

Fauci suggested that it would be best to administer a second booster, if needed, in the fall or winter, when a new variant is more likely to emerge, CNN reports.

Both Pfizer-BioNTech and Moderna are currently developing omicron-specific vaccines, and both companies believe a fourth dose will eventually be necessary to keep protection levels high.

However, the CEO of BioNTech said Thursday that stalls in data evaluation have lead to a weeks-long delay in the development, as it still unclear whether or not these altered vaccines will be needed. It is also unclear whether or not a potential fourth dose approved by the FDA would be tailored to a new variant use the same formulation as previous doses. 

Israel was the first country to approve a second booster shot for certain citizens in December, while Sweden approved another booster for residents over the age of 80 on Monday.

Immunocompromised people in the U.S. have been eligible for a second booster shot since October, according to CDC guidelines.



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FDA considering second COVID-19 booster in coming months

Food and Drug Administration (FDA) officials are “very carefully” considering second booster doses of the mRNA COVID-19 vaccines, according to The Wall Street Journal.

FDA spokesperson Alison Hunt confirmed to CNN that the FDA “is indeed continually looking at the emerging data on the pandemic and variants in the United States and overseas in order to evaluate the potential utility and composition of booster doses.”

Hunt also said that there is still much uncertainty, but the FDA is evaluating whether another booster dose will be needed when the country moves into the fall of 2022, which would coincide with the typical administration of annual flu shots, CNN noted.

“As more data become available about the safety and effectiveness of COVID-19 vaccines, including the use of a booster dose, we will continue to evaluate the rapidly changing science and keep the public informed,” Hunt wrote to CNN. “Any determination that additional booster doses are needed will be based on data available to the agency.”

If the FDA approves another booster dose, it would then face approval by the Centers for Disease Control and Prevention (CDC). 

Anthony FauciAnthony FauciFDA considering second COVID-19 booster in coming months GOP senator faces challenge on Trump credentials Britt in new ad tells ‘boys in Washington’ to ‘man up’ MORE, the head of the National Institute of Allergy and Infectious Diseases (NIAID), said the “potential future requirement” for an additional booster is being “very carefully monitored in real time, and recommendations, if needed, will be updated according to the data as it evolves.”

Fauci also said that he believes the timing of when the second booster would be administered is critical and that it “doesn’t make much sense” to administer the fourth dose now as omicron begins to fade.

Fauci suggested that it would be best to administer a second booster, if needed, in the fall or winter, when a new variant is more likely to emerge, CNN reports.

Both Pfizer-BioNTech and Moderna are currently developing omicron-specific vaccines, and both companies believe a fourth dose will eventually be necessary to keep protection levels high.

However, the CEO of BioNTech said Thursday that stalls in data evaluation have lead to a weeks-long delay in the development, as it still unclear whether or not these altered vaccines will be needed. It is also unclear whether or not a potential fourth dose approved by the FDA would be tailored to a new variant use the same formulation as previous doses. 

Israel was the first country to approve a second booster shot for certain citizens in December, while Sweden approved another booster for residents over the age of 80 on Monday.

Immunocompromised people in the U.S. have been eligible for a second booster shot since October, according to CDC guidelines.



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COVID Omicron Updates: CDC releases new guidance for some Americans to get additional vaccine booster shot

NEW YORK (WABC) — The CDC has shortened the amount of time people who are moderately or severely immunocompromised need to wait before getting a fourth COVID vaccine booster dose.

They now recommend that the severely immunocompromised can get an additional Pfizer or Moderna shot three months after their third dose instead of five months.

The CDC also encourages people with weakened immune systems who originally got a Johnson & Johnson vaccine to take two additional doses, instead of just one.

RELATED: What are the symptoms of the COVID omicron variant?

Here are more of today’s COVID-19 headlines:

US death toll hits 900,000, sped by omicron
Propelled in part by the wildly contagious omicron variant, the U.S. death toll from COVID-19 hit 900,000 on Friday, less than two months after eclipsing 800,000. The two-year total, as compiled by Johns Hopkins University, is greater than the population of Indianapolis, San Francisco, or Charlotte, North Carolina. The milestone comes more than 13 months into a vaccination drive that has been beset by misinformation and political and legal strife, though the shots have proved safe and highly effective at preventing serious illness and death.

Scientists study why some never catch coronavirus
Scientists are trying to unlock the mystery of why some people seem never to catch COVID. While there is no clear-cut answer, one factor may lie in our DNA, giving people with certain genetic traits more pre-existing protection. Researchers in London have also found that people with higher levels of T-cells generated from other previous coronavirus infections like a common cold were less likely to get COVID. “If there are overlapping sequences that are shared between the common cold coronaviruses and the sarscov2, that T-cell can react very quickly to mount a defense against sarscov2,” said Dr. Akiko Iwasaki, professor of immunology, Yale University.

More vaccinations will lead to lifting mask rules: Hochul
Records show 80% of 12-to 17-year-olds in New York State have gotten their first dose of the COVID vaccine, and Gov. Kathy Hochul says more vaccinations will lead to the lifting of mask mandates in schools. “The more children we have vaccinated, the safer they will be in school,” she said, explaining vaccination rate will be a factor in decisions on mask rules. “And they wont need a mask anymore,” Hochul promised. “But we are just not there yet. It is all based on data.” Data shows 40% of 5-to 11-year-olds have gotten their first dose.

COVID falling in 49 of 50 states as deaths near 900,000
With omicron easing, new cases of COVID-19 in the U.S. are falling in 49 of the 50 states, even as the nation’s death toll closes in on another bleak round number: 900,000. The number of lives lost to the pandemic in the U.S. stood at about 899,000 as of Friday afternoon, with deaths running at an average of more than 2,400 a day, back up to where they were last winter, when the vaccine drive was still getting started. But new cases per day have tanked by almost a half-million nationwide since mid-January, the curve trending downward in every state but Maine.

CT crosses grim milestone
Connecticut reported an additional 175 COVID deaths since last week, bringing the state’s total across the 10,000 threshold to 10,083. The state’s positivity rate is currently 6.57%, with 869 current hospitalizations.

Palin resumes court battle with NY Times after COVID illness

Sarah Palin’s libel suit against The New York Times went to trial Thursday in a case over the former Alaska governor’s claims the newspaper damaged her reputation with an editorial linking her campaign rhetoric to a mass shooting. The trial is a rare example of a jury deciding the validity of a persistent refrain from Palin and other Republicans: That a biased news media is willing to bend the truth to make conservatives look bad. Palin, a one-time Republican vice presidential nominee, told journalists as she arrived at the courthouse that she was looking for “Justice for people who expect truth in the media.” Opening statements to the jury were initially scheduled for last week, but were postponed when Palin tested positive for COVID-19.
“We come to this case with our eyes wide open and keenly aware of the fact we’re fighting an uphill battle,” Palin attorney Shane Vogt said. “Give us a fair shot. We’re not here trying to win your votes for Governor Palin or any of her policies.”

Medicare opens up access to free at-home COVID-19 tests
The Biden administration says people with Medicare will be able to get up to eight free over-the-counter COVID-19 tests per month, starting in early spring. It’s seeking to fill a frustrating gap in coverage for coronavirus tests. Last month, the administration directed private insurers to cover rapid COVID-19 tests for people on their plans. But until now officials were trying to figure out what to do about Medicare, which covers older people particularly vulnerable to severe illness from COVID-19. Laws and regulations that govern the program stood in the way. Free tests will be available through participating pharmacies and other locations. AARP has praised Medicare’s decision.

Russia mulls loosening restrictions amid record virus surge
The Russian president says his government is considering loosening some coronavirus restrictions, even as the country is facing a record-breaking surge of infections because of the highly contagious omicron variant. Vladimir Putin on Thursday insisted that authorities are not planning any lockdowns or other additional restrictions because of the surge. Moreover, the government is considering lifting restrictions for those who come into contact with COVID-19 patients, “to give people the opportunity to continue working in peace.” Existing regulations mandate that people who come in contact with someone with COVID-19 must self-isolate for seven days. On Thursday, the country’s state coronavirus task force reported 155,768 new infections, a daily tally 10 times higher than a month ago.

How many times can I reuse my N95 mask?
How many times can I reuse my N95 mask? It depends, but you should be able to use N95s and KN95s a few times. The U.S. Centers of Disease Control and Prevention says health care workers can wear an N95 mask up to five times. But experts say how often the average person can safely wear one will vary depending on how it’s used. Using the same mask to run to the grocery store, for example, is very different than wearing it all day at work.
When am I contagious if infected with omicron?

When am I contagious if infected with omicron? It’s not yet clear, but some early data suggests people might become contagious sooner than with earlier variants – possibly within a day after infection. The U.S. Centers for Disease Control and Prevention says people with the coronavirus are most infectious in the few days before and after symptoms develop. But that window of time might happen earlier with omicron, according to some outside experts. That’s because omicron appears to cause symptoms faster than previous variants – about three days after infection, on average, according to preliminary studies. Based on previous data, that means people with omicron could start becoming contagious as soon as a day after infection.

MORE CORONAVIRUS COVID-19 COVERAGE

Omicron variant symptoms: what to know even if you are vaccinated
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Centers for Disease Control and Prevention on coronavirus

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COVID Omicron Updates: Variant may be headed for a rapid drop in US

NEW YORK (WABC) — Scientists are seeing signals that COVID-19’s alarming omicron wave may have peaked in Britain and is about to do the same in the U.S., at which point cases may start dropping off dramatically.

The reason: The variant has proved so wildly contagious that it may already be running out of people to infect, just a month and a half after it was first detected in South Africa.

“It’s going to come down as fast as it went up,” said Ali Mokdad, a professor of health metrics sciences at the University of Washington in Seattle.

At the same time, experts warn that much is still uncertain about how the next phase of the pandemic might unfold. The plateauing or ebbing in the two countries is not happening everywhere at the same time or at the same pace. And weeks or months of misery still lie ahead for patients and overwhelmed hospitals even if the drop-off comes to pass.

Take a look at cases and hospitalizations in New York City:

RELATED: What are the symptoms of the COVID omicron variant?

Here are more of today’s COVID-19 headlines:

No change to schools’ mask mandate after Nassau County executive order
One week after Nassau County Executive Bruce Blakeman signed an executive order allowing school boards to decide whether students wear masks in schools, not one school district has changed their mask policies.

Blakeman said school board members have told him privately that they feel threatened by Governor Kathy Hochul and state officials.

When am I contagious if infected with omicron?
When am I contagious if infected with omicron? It’s not yet clear, but some early data suggests people might become contagious sooner than with earlier variants – possibly within a day after infection. The U.S. Centers for Disease Control and Prevention says people with the coronavirus are most infectious in the few days before and after symptoms develop. But that window of time might happen earlier with omicron, according to some outside experts. That’s because omicron appears to cause symptoms faster than previous variants – about three days after infection, on average, according to preliminary studies. Based on previous data, that means people with omicron could start becoming contagious as soon as a day after infection.

3,000 United Airlines employees test positive for COVID
United Airlines said it is reducing its flight schedule in hopes of stemming COVID-related staffing shortages that have caused thousands of flight cancellations across the industry. In a new company-wide memo, CEO Scott Kirby said the airline is “reducing our near-term schedules to make sure we have the staffing and resources to take care of customers.” Kirby did not specify by how much the airline is drawing down flights. But the memo added that “the omicron surge has put a strain on our operation, resulting in customer disruptions during a busy holiday season.” He went on to thank employees for their professionalism in handling the delays.

CDC says it will update mask ‘information’
The CDC says it plans to update its mask information to “best reflect the multiple options available to people and the different levels of protection they provide.” The CDC did not say when its guidance will be updated. In the meantime, the CDC said in a statement, “any mask is better than no mask, and we encourage Americans to wear a well-fitting mask to prevent the spread of COVID-19.” Since the arrival of omicron, health experts have urged Americans to upgrade their cloth masks to an N95 or KN95 because the new variant is so highly transmissible. But these higher-grade masks are costly and hard to find.

Multiple states issue emergency declarations
Governors in multiple states are issuing emergency declarations as the omicron variant depletes vital health care resources. The CDC says the variant now makes up 98% of all new cases, and new numbers, accounting for the weekend backlog, show the U.S. tallied a record 1.4 million cases in a single day. The CDC has determined the unvaccinated are 17 times more likely to be hospitalized than vaccinated Americans.

Virginia issued a 30-day state of emergency to help health care facilities increase bed space and staff, while New Jersey and Washington, DC, are also under emergency orders. Maryland, Maine, and Massachusetts are all leaning on the National Guard as a record number of COVID patients flood hospitals.

Police: Nurse in Italy caught faking shots, ditching vaccine
Police in Italy have arrested a nurse on charges he faked giving coronavirus vaccinations to at least 45 people so they could get a health pass without actually getting the shot. The nurse ditched the vaccines in a bin and even put bandages on his “patients” so the scam would not be detected. Police in Ancona, on Italy’s eastern coast, also placed four alleged accomplices under house arrest, accusing them of finding anti-vaccine customers who were willing to pay for a health pass rather than get the shots. Forty-five people who allegedly received the fabricated passes are under investigation.

Stay home or work sick? Omicron poses a conundrum for workers without paid sick days
As the raging omicron variant of COVID-19 infects workers across the nation, millions of those whose jobs don’t provide paid sick days are having to choose between their health and their paycheck. While many companies instituted more robust sick leave policies at the beginning of the pandemic, some of those have since been scaled back with the rollout of the vaccines, even though omicron has managed to evade the shots. Meanwhile, the current labor shortage is adding to the pressure of workers having to decide whether to show up to their job sick if they can’t afford to stay home.

“It’s a vicious cycle,” said Daniel Schneider, professor of public policy at the Harvard Kennedy School of Government. “As staffing gets depleted because people are out sick, that means that those that are on the job have more to do and are even more reluctant to call in sick when they in turn get sick.”

Federal officials issue warnings about fake COVID-19 testing kits
COVID-19 cases continue to rise dramatically, leading to brutally long lines at testing sites and empty shelves at stores where at-home rapid test kits were once in stock. Now, an additional problem has emerged: The Federal Trade Commission is warning about fraudulent testing kits being sold online to desperate customers.

Note: A previous version of this article incorrectly stated the CDC determined the unvaccinated are 17% more likely to be hospitalized. This article has been updated to say 17 times more likely.

MORE CORONAVIRUS COVID-19 COVERAGE

Omicron variant symptoms: what to know even if you are vaccinated
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Centers for Disease Control and Prevention on coronavirus

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Coronavirus Updates: Restrictions to be lifted on fully-vaccinated, non-American travelers Monday

NEW YORK (WABC) — The U.S. is lifting restrictions on foreign travelers who are fully vaccinated against COVID, starting Monday.

The Biden administration is expecting long lines and delays at airports with travelers possibly pouring into the states.

When the announcement was made, online searches for international flights jumped 338%.

Delta Airlines saw bookings shoot up by 450%, and United Airlines says it will be bringing 30,000 travelers into the U.S. on Monday alone.

Here are more of today’s COVID-19 headlines:

Novavax says its vaccine could win over skeptics

The biotechnology company Novavax plans to submit complete data to the US Food and Drug Administration soon for possible emergency use authorization of its coronavirus vaccine, CEO Stanley Erck told CNN in a phone interview Friday. Novavax’s vaccine, called NVX-CoV2373, is made using somewhat more conventional methods than the vaccines already authorized for use in the US.

US cancels vaccine maker’s multimillion dollar deal
The federal government has canceled a multimillion dollar deal with Emergent BioSolutions, a Maryland-based vaccine manufacturer with facilities in Baltimore that were found to have produced millions of contaminated Johnson & Johnson vaccine doses this spring, the Washington Post reported. Emergent disclosed the development Thursday in a conference call discussing its latest financial results, the Post reported. Emergent said it will forgo about $180 million due to the contract’s termination, according to the Post. Emergent BioSolutions played a role in the Trump administration’s effort to speed up vaccine development and distribution. But after winning a contract from the previous administration, Emergent quickly ran into production problems. In March, ingredients intended for use in producing the Oxford-AstraZeneca vaccine shots contaminated 15 million doses of the Johnson & Johnson vaccine. The problems with the vaccines caused a monthslong delay in production. After that, the Biden administration put Johnson & Johnson in direct control of vaccine production there.

15 unions reach COVID vaccine mandate deal with NYC, talks continue with outliers
New York City employees who don’t want to get vaccinated have until Friday to file for a religious or medical exemption if they have any hope of staying on the payroll, this as the city announces more deals with unions representing municipal workers. Mayor Bill de Blasio said Friday that 15 unions, including city’s largest, DC 37, have signed onto the deal. The unions represent more than 100,000 city workers covered by this most recent mandate that took effect last week, but the police and fire unions are not included and are still trying to hash out their own deals. Around 92% of city workers under the mandate are vaccinated, including 90% of EMS, 79% of firefighters, 85% of sanitation workers, and 85% of NYPD employees.

COVID vaccine refusal 10th highest reason for job cuts in 2021, report says
While experts say we’re still in the so-called “Great Resignation,” a recent Jobs Cut Report uncovered vaccine refusal as the 10th highest reason for job cuts this year. Numbers released by Chicago-based outplacement and business and executive coaching firm Challenger, Gray & Christmas, Inc. came on on the same day President Biden announced new federal guidance and deadline for tens of millions of workers to get vaccinated.
“Roughly 5,000 people that lost their jobs in the last month due to COVID vaccine refusal made up actually 22% of the total number of people that we tracked being let go across the country,” the firm’s Senior VP Andy Challenger told our sister station KGO-TV.

Pfizer’s COVID-19 pill reduces risk of being hospitalized or dying by 89%, company says

A course of pills developed by Pfizer can slash the risk of being hospitalized or dying from COVID-19 by 89% if taken within three days of developing symptoms, according to results released Friday by the pharmaceutical company. In a study of more than 1,200 COVID-19 patients with a higher risk of developing serious illness, people who took Pfizer’s pills were far less likely to end up in the hospital compared to people who got placebo pills. None of the people who got the real pills died, but 10 people who got placebo pills died, according to results summarized in a Pfizer press release.
SantaCon returns
After taking a year off due to the pandemic, SantaCon is returning to New York City. The event requires a $13 donation for all-inclusive Santa Badge access to the official SantaCon venues. The location of a Yuletide kickoff party won’t be disclosed until closer to the December 11 SantaCon date.

Turkey Day troubles? Smaller birds, popular Thanksgiving sides could be harder to find in 2021
Consumers may have to trim their list of trimmings for their highly anticipated Thanksgiving meal this year. Top turkey seller Butterball said it doesn’t expect an overall gobbler shortage, but that those in search of a smaller size bird could have a hard time.
“Typically a 10- to 12-pound (turkey) up to 14 pounds is going to be more difficult,” Butterball CEO Jay Jandrain told “Good Morning America” on Friday. “Anything over 16 pounds, they’ll certainly be more readily available.”

Q&A: What to know about COVID-19 vaccines for kids aged 5-11
Vaccinations finally are available to U.S. children as young as 5, to the relief of some parents even as others have questions or fears. Late Tuesday, the Centers for Disease Control and Prevention gave the final OK for youngsters age 5 to 11 to get kid-size doses of the vaccine made by Pfizer and its partner BioNTech. Pediatricians and other doctors’ groups praised the move and are gearing up to help families decide whether to vaccinate their children. The shots could be available as soon as Wednesday and will be offered at pediatricians offices, clinics and pharmacies. Like COVID-19 vaccines for adults, they are free. Here’s everything you need to know.

Will the supply chain issues impact holiday shopping? Here’s what the experts say

With the holiday shopping suddenly upon us, it appears that getting that perfect gift or preparing that perfect meal will be far more challenging than in years past due to supply chain issues. Shoppers are noticing that it’s difficult to find a variety of items, and virtually everything from food to Christmas trees are more expensive. The price increase is being caused by gridlock at major seaports and a truck driver shortage across the country. Analysts say the forecast for the holiday season is not looking better.

MORE CORONAVIRUS COVID-19 COVERAGE

New York City COVID-19 Vaccine Tracker
New Jersey COVID-19 Vaccine Tracker
Centers for Disease Control and Prevention on coronavirus

Submit a News Tip or Question

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