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FDA approves 2nd COVID19 Vax- LA in crisis with 0% ICU beds available

Right now, the most important action for everyone to take to stop the surge is to stay home

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Screenshot CNN news coverage from December 17, 2020.

SILVER SPRING, Maryland – The U.S. Food & Drug Administration (FDA) has given its tentative approval for emergency authorisation of the coronavirus vaccine developed by Cambridge, Massachusetts- based biotechnology company Moderna Thursday night. Final FDA sign-off is expected Friday morning.

The FDA’s approval came after a panel of experts outside of the agency independently recommended that the agency sign off on immediate use of the vaccine.

UPDATE: On Friday the FDA authorised Moderna’s coronavirus vaccine for emergency use, offering a new source of hope in the nation’s fight against the pandemic

The Financial Times reported that Stephen Hahn, the head of the FDA, and Peter Marks, the head of the regulator’s vaccine division, issued a statement on Thursday night that said they had informed Moderna they would work towards the “finalisation and issuance” of an emergency approval. Officials close to the process said they had made the decision to authorise the vaccine, and were now working on the written information to doctors and patients to accompany it.

For healthcare providers FDA approval is welcome news, especially for smaller hospitals, community clinics, and regional medical facilities because Moderna’s vaccine can be stored in normal refrigeration units and does not require a super-cold transportation network.

The FDA gave its okay to clinical trials of Moderna’s vaccine last Spring on March 3, and the biotech company commenced its advanced stage clinical trials in July. Moderna’s vaccine the first government-funded Phase 3 clinical trial for a Covid-19 vaccine under the Trump Administration’s Operation Warp Speed. The company applied to the FDA for emergency use authorization for the vaccine on November 30.

According to the FDA advisory committee’s briefing document, Moderna’s vaccine had the same level of efficacy (94.1%) as Pfizer-BioNTech’s vaccine. The document also stated that the vaccine was effective across age groups, genders, racial and ethnic groups, and participants with medical comorbidities associated with high risk of severe Covid-19,. About 10% of study participants in the human trials were Black and 20% were of Hispanic or Latino.

Dr. Paul Offit, a member of the FDA’s vaccine advisory committee told CNN’s Anderson Cooper that both vaccines rely on mRNA, or messenger RNA, to work, although with slightly different structures and makeup. “They appear to be roughly equivalent,” said Offit.

The head of the Trump Administration’s Operation Warp Speed Dr. Moncef Slaoui, speaking with CNN, noted that the Pfizer vaccine needs to be stored at about minus-75 degrees Celsius, about 50 degrees colder than any vaccine currently used in the US. Moderna’s vaccine can be put into a standard refrigerator for up to fie days before it expires.

The other differences he noted were that in terms of dosage and timing; Moderna’s vaccine is administered as two 100-microgram doses given 28 days apart. Pfizer’s vaccine is administered as two 30-microgram doses given 21 days apart. The range of ages are slightly different as the Moderna vaccine would be used in people 18 and older, while the Pfizer vaccine was authorized for people 16 and older.

Screenshot Nightly News with Lester Holt, December 17, 2020

While news of a second weapon in the fight against the coronavirus is welcome news, in Southern California it comes as the healthcare system is in critical condition as the availability of intensive care unit (ICU) beds fell to 0.0% Thursday.

The Los Angeles County Department of Public Health confirmed 102 new deaths and 14,418 new cases of COVID-19 as hospitals in the region reported that they were resorting to emergency measures turning regular wards into makeshift ICU spaces.

As cases mount, Public Health reports that  the Pfizer COVID-19 vaccine has been received by all nine pre-designated sites in L.A County and this initial allocation is being used by acute care hospitals to vaccinate health care personnel. Healthcare workers are prioritized for vaccination based on their job duties and associated risks of exposure to COVID-19 as well as risks of severe disease.

A second allotment of Pfizer vaccine is anticipated to arrive next week and will be used to vaccinate additional healthcare workers at acute care hospitals.  If the Moderna vaccine receives EUA, doses of this vaccine should arrive in L.A. County next week as well.  These doses will be used to vaccinate residents and staff at skilled nursing facilities and frontline EMS responders.

Doctors and nurses caring for COVID-19 patients in the ICU and Emergency Department at LAC+USC Medical Center, suit up in PPE before their shift.
(Photo Credit: Los Angeles County)

A spokesperson for Public Health pleaded; “Right now, the most important action for everyone to take to stop the surge is to stay home as much as possible and not mingle with others not in your household.  Only go out for work, exercise or for essential services. When you must leave your home, always wear a face covering and stay at least 6 feet away from people you do not live with at all times. Individuals with underlying health conditions and those that are older should remain in their home and not be around others unless seeking routine or essential health and dental care.”

Officials also worry that as nearly 85 million Americans are expected to travel over the holiday break this next week, the healthcare systems already teetering on collapse may fail altogether even as vaccine delivery begins in greater numbers. Healthcare frontline workers are bearing the brunt of the pandemic’s assault.

 “There is an increasingly bright light at the end of this pandemic for us as a second vaccine gets closer to emergency use authorization. However, we are months away from having enough vaccine widely available in L.A. County.  Until then, we need to make choices in our daily lives to protect ourselves and others. The devastation we are experiencing now is in part because many people ignored warnings and made the decision to travel or visit with people from outside of their home over the Thanksgiving holidays,” said Dr. Barbara Ferrer, Director of L.A. County Public Health.

“We are now learning a very painful lesson that, despite how much we want things to go back to normal, this virus is relentless and will continue to spread, make people very ill, and tragically lead to people passing away. We can’t afford another holiday season surge that will further overwhelm our already strained hospitals and healthcare staff. We must all work together to prevent as much death as possible,” Ferrer urged.

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CDC: 85% of gay & lesbian adults in U.S. are vaccinated against COVID

Data on COVID-19 vaccination among LGBTQ persons limited because of the lack of routine SOGI data collection at the national & state levels

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Photo Credit: Centers for Disease Control and Prevention/GSA

ATLANTA – A new study report released Friday by the Centers for Disease Control and Prevention, (CDC), found that found 85.4% of gay and lesbian Americans above age 18 had received at least one vaccine dose as of October 2021.

The study, conducted from August 29 until October 30, 2021, also found that by comparison, only 76.3% of heterosexuals reported receiving at least an initial dose by the same date.

The report noted that Lesbian, gay, bisexual, and transgender (LGBT) populations have higher prevalence of health conditions associated with severe COVID-19 illness compared with non-LGBT populations.

The potential for low vaccine confidence and coverage among LGBT populations is of concern because these persons historically experience challenges accessing, trusting, and receiving health care services

Data on COVID-19 vaccination among LGBT persons are limited, in part because of the lack of routine data collection on sexual orientation and gender identity at the national and state levels.

In March of 2021, the Blade reported the coronavirus (COVID-19) pandemic has revealed deep-seated inequities in health care for communities of color and amplifies social and economic factors that have contributed to those communities being hit hardest, and Mega-vaccination centers set up by California health officials and the Federal Emergency Management Agency have been addressing and tracking the issue- the LGBTQ communities are still not being tracked.

This lack of data collection has frustrated and angered California State Senator Scott Wiener who authored a bill last year that passed through the legislature and signed by Governor Gavin Newsom last Fall that mandates gathering sexual orientation and gender identity data related to the COVID testing in California.

“We’re one year into the pandemic, and LGBTQ people continue to be erased in our public health response to COVID-19 — similar to our invisibility throughout history. No government is successfully tracking COVID-19 cases in the LGBTQ community, despite a law I wrote mandating that California do so,” Weiner told the Blade. “And, we now know that LGBTQ people are more vulnerable to COVID-19. We’ve also just learned that vaccination demographic data doesn’t include LGBTQ data. It simply shocking that in 2021, progressive health agencies continue to forget about our community,” he added.

The CDC also noted that gay and lesbian adults were more likely to be concerned about COVID-19 and to believe in the safety and efficacy of vaccines.

“We know that the prevalence of certain health conditions associated with severe COVID-19 illness, such as cancer, smoking, and obesity, are higher in LGBT populations, and access to health care continues to be an issue for some people in the LGBT community,” Dr. A.D. McNaghten, a member of the CDC’s COVID-19 Emergency Response Team and corresponding author of the study, told ABC News. “We wanted to see if vaccination coverage among LGBT persons was the same as non-LGBT persons.”

The CDC data recorded that bisexual and transgender adults had similar vaccination rates to heterosexual adults with 72.6% of bisexual adults fully vaccinated by the end of October, as were 71.4% of transgender adults. The numbers however for Black and Hispanic lesbian women had lower rates of vaccination at 57.9% and 72.6%, respectively, compared to Black and Hispanic heterosexual women at 75.6% and 80.5%, respectively.

Higher percentages of gay or lesbian adults and bisexual adults reported that they thought COVID-19 vaccine was very or somewhat important to protect oneself (90.8% and 86.8%, respectively) compared with heterosexual adults (80.4%), and higher percentages of adults who identified as transgender or nonbinary reported they thought COVID-19 vaccine was very or somewhat important to protect oneself (83.2%) compared with those who did not identify as transgender or nonbinary (80.7%).

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White House orders distribution of 400 million free N95 masks

Dr. Tom Inglesby, the administration’s Covid testing coordinator; “We know that these masks provide better protection than cloth masks”

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President Joe Biden (Blade file photo/screenshot)

WASHINGTON – As the latest surge of the highly contagious and easily transmissible Omicron variant of the coronavirus continues to cause a rise in hospitalizations, especially among unvaccinated adults and children, the White House announced Wednesday it is making 400 million N95 masks available for free at thousands of locations across the nation.

The plan an admkistartion official said, is to start shipping the nonsurgical masks to pharmacies and community health centers to distribute this week, which will come from the Strategic National Stockpile.

In an interview with NBC News, Dr. Tom Inglesby, the administration’s Covid testing coordinator, said, “We know that these masks provide better protection than cloth masks.”

The N95 masks will be made available to everybody, and recipients will not be prioritized based on vulnerability to Covid, income or other criteria. Inglesby said the administration was “confident that people who want to access them will be able to access them,” but it was not immediately clear how many masks a person could receive at one time.

On January 13, President Joe Biden had announced a plan to have the government distribute 1 billion rapid, at-home COVID-19 tests free to Americans, along with the N95 masks, as the administration works to fight the spiraling upward spike in coronavirus cases.

The White House website to order free at-home Covid tests went live Tuesday. The website says: “Every home in the U.S. is eligible to order 4 free at-home COVID-19 tests. The tests are completely free. Orders will usually ship in 7-12 days.”

A White House official said Wednesday that the distribution of 400 million masks would be the largest deployment of personal protective equipment in U.S. history.

Inglesby told NBC News that the administration was “absolutely preparing for the possibility of additional variants in the future” and that people could expect the government to make N95 masks “more and more available.”

Biden announces free masks, tests to fight omicron:

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Coronavirus

COVID-19 Cases increase by nearly 10 times in one month

While hospitalizations continue to climb, Public Health data shows that many positive cases are admitted for reasons other than COVID

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Graphic courtesy of UCLA/Centers for Disease Control & Prevention

LOS ANGELES – A total of 31,576 new COVID-19 cases were documented on Monday — up ten times the number of cases reported on Dec. 17, 2021, when there were 3,360 new cases recorded the Los Angeles County Department of Public Health reported Monday.

There are  4,564 people with COVID-19 currently hospitalized, nearly 6 times the number from one month ago when 772 people were hospitalized. The daily positivity rate is 16.5%, more than 8 times the 2% daily positivity rate on December 17th.

Just one week ago, the county surpassed 2 million total COVID-19 cases, with the figure reaching 2,289,045 cases as of Monday.

“On this national holiday where we celebrate the life and legacy of Dr. Martin Luther King, we remember his deep commitment to health equity.  As Reverend King memorably said, ‘Of all the forms of inequality, injustice in health is the most shocking and the most inhuman because it often results in physical death,’ ” said Dr. Barbara Ferrer, Director of Public Health.

“Tragically, we have seen this play out in real life and very clearly over the past two years with the disparate impacts of the COVID-19 pandemic on people of color. From the onset of the pandemic, communities of color have experienced the greatest devastation from COVID-19 in Los Angeles County and throughout the nation,” she added.

“The good news is that while hospitalizations continue to climb, Public Health data shows that many positive cases are admitted for reasons other than COVID but, are identified with COVID when tested for COVID upon hospital admission,” the health department said in a statement released last week.

As of Friday, more than 80% of all adult ICU beds in the county were occupied.

There are also 27 new deaths due to COVID-19 in Los Angeles County and 31,576 new positive cases.

The public health department also noted that while the number of children hospitalized with the virus remains low, the number of them admitted to L.A. County hospitals “significantly increased” over the past month, with the largest increase among children younger than 5 years old.

The increase mirrors trends seen nationwide for the age group — the only one not yet eligible for the vaccine.

The county also saw its highest coronavirus death rate in nearly 10 months over this past week, with an average of 40 COVID-19 deaths a day.

“From the onset of the pandemic, communities of color have experienced the greatest devastation from COVID-19 in Los Angeles County and throughout the nation. As we continue to implement strategies – enforcing worker protections through our Health Officer Orders, providing resources needed by many to survive the impact of the pandemic, funding community-based organizations in hard hit areas to serve as trusted public health messengers, and increasing vaccination access in under-sourced neighborhoods – we also need to come together to address the impact that racism, historical disinvestment, and social marginalization have on COVID-19 outcomes,” Ferrer said.

“While these conditions predate the pandemic, without deliberate collective actions to address the root causes of health inequities, we are unlikely to close the gaps we have documented for 2 long years,” she added.

California has recorded more than 7 million coronavirus cases after its fastest accumulation of reported infections in the history of the pandemic, the Los Angeles Times reported.

The unprecedented count, recorded in California’s databases late Monday, comes one week after the state tallied its 6 millionth coronavirus case.

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