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Officials Wrestle With Whether to Allow New Monkeypox Vaccination Strategy

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WASHINGTON — It sounded like a simple solution to the shortage of monkeypox vaccine: Merely by changing the way doses are injected, the federal government could vaccinate five times as many people with the supply it has in hand.

But the approach — injecting one-fifth of the current dose into the skin instead of a full dose into underlying fat — is not actually all that simple, experts say. And some federal officials are concerned about changing the method without more research, even though Dr. Robert M. Califf, the head of the Food and Drug Administration, described the proposal on Thursday as promising.

Some outside experts, too, are urging caution. “From a basic science perspective, this should work,” said Dr. Jay K. Varma, the director of the Cornell Center for Pandemic Prevention and Response. “But, of course, there are lots of things in life, in science, that we think should work, and then when we actually do them, they don’t.”

Stretching out doses of the vaccine, Jynneos, could help the federal government resolve a predicament partly of its own making. Even though it invested more than $1 billion developing the two-dose vaccine to use against both monkeypox and smallpox, the government only has 1.1 million shots on hand, partly because it was slow to order bulk vaccine stocks to be processed into vials.

That supply is enough to cover 550,000 people, but about three times as many doses are needed to cover the 1.6 million to 1.7 million Americans who, according to the Centers for Disease Control and Prevention, are at high risk of monkeypox. For now, the virus has been spreading primarily through skin-to-skin contact during sex among gay and bisexual men, the C.D.C. has said.

Some federal officials are hoping that by injecting a smaller dose of the vaccine between skin layers, called an intradermal shot, the Biden administration could tamp down the outbreak before it spreads more widely.

But some experts argue that this approach has not been sufficiently studied. They also warn that some vaccinators will need training to properly deliver the shots, which could slow vaccination efforts. Otherwise, the government could end up wasting doses, not saving them.

Intradermal injection involves carefully guiding a needle into skin layers, a thin space with immune cells. If a vaccinator goes too deep and inserts the dose into fat, the patient might not receive enough vaccine, experts say. But if the needle is not inserted far enough, some of the vaccine could leak back out.

“If you’re giving a lower dose and you don’t inject it properly into the skin — you might inject it into the wrong place — you may not be giving a protective vaccine,” said Dr. Phil Krause, who retired as a senior F.D.A. vaccine regulator last year and worked on the agency’s licensing of Jynneos. “If you ask this to be done nationwide in millions of doses, it’s a lot easier for there to be mistakes made in the administration of the vaccine.”

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On the other hand, the method has a track record. It has been used in polio vaccination campaigns when doses have been limited, as well as for rabies and for tuberculosis skin tests.

“It’s not a brand-new concept,” said Dr. Anthony S. Fauci, President Biden’s chief medical adviser. “We were thinking about this as a strategy in the event of a paucity of vaccines years ago.”

Vaccinators have used special bifurcated needles in smallpox inoculation campaigns that have allowed them to perform intradermal injections more uniformly and cheaply.

Dr. John Beigel, an associate director of clinical research at the National Institutes of Health, said a government-sponsored study of Jynneos published in 2015 compared the intradermal approach with the standard injection method and found that it triggered a comparable level of neutralizing antibodies, a measure of the strength of the immune response. The intradermal method caused more redness, swelling and itching, but the standard injection was more painful.

Dr. Beigel said that switching to the intradermal method was a better option for preserving vaccine than administering just a single shot, as some jurisdictions are now doing, because research has shown that one shot does not prompt nearly as strong of an immune response.

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“One dose is not likely to be effective,” he said, adding that the intradermal method “is an acceptable way to go.”

Although the 2015 trial involved hundreds of participants, some experts note that it was a single study that was limited in what it measured. Researchers at the N.I.H. had been planning to test the intradermal strategy for Jynneos in a trial that was set to begin in a few weeks. But results were not expected until the late fall or early winter, and that plan is up in the air for now.

Dr. H. Clifford Lane, the clinical director of Dr. Fauci’s National Institute of Allergy and Infectious Diseases at the N.I.H., said that while researchers could glean insight by following people who get vaccinated, a traditional clinical trial would provide a clearer picture.

“I can understand doing it as long as it’s very clear why it’s being done,” he said of the intradermal strategy. “The question is: How can we stretch the current supplies without significantly compromising efficacy?”

Another question is how well the vaccine will actually work: It was licensed in 2019 for use against both monkeypox and smallpox after studies showed it provoked a stronger immune response than an earlier vaccine. That drug itself was approved because it compared favorably to an even earlier vaccine, federal officials said.

Monkeypox is rarely fatal and no deaths have been reported in the United States. Symptoms typically resolve within two to four weeks. But with the outbreak spiraling from eight reported cases in late May to 7,510 now, the administration is scrambling to try to improve the vaccination rate and the availability of tests and treatments.

As of now, the outbreak is almost entirely limited to men who have sex with men, with those who have multiple partners considered at particular risk. But five cases involving children have been reported so far On Friday, the Illinois Department of Public Health announced that an adult working at a day care center had tested positive for monkeypox and that children and other staff members there were being screened.

Thursday’s declaration of a public health emergency allowed the federal government to speed up investigations of monkeypox and approve grants, but did not invoke the F.D.A.’s emergency powers. Changing the injection mode would require a second kind of emergency declaration, giving the Food and Drug Administration more leeway to issue emergency use authorizations.

Federal regulators can issue emergency authorizations of products when they believe the potential benefits outweigh potential risks. Early in the coronavirus pandemic, the Trump administration issued the same type of emergency declaration, allowing the F.D.A. to make Covid-19 vaccines available to Americans many months before regulators issued full approvals.

Dr. Califf, the F.D.A. commissioner, said on Thursday that regulators would continue to ensure the vaccine was delivered in a safe and effective manner. He said regulators would probably decide in the next few days whether to go with the intradermal strategy, but that it was “looking good right now” — a comment that some outside experts said seemed to get ahead of deliberations by career regulators.

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Emily Cochrane and Tracey Tully contributed reporting.

Read the full article here

A journalist since 1994, he also founded DMGlobal Marketing & Public Relations. Glover has an extensive list of clients including corporations, non-profits, government agencies, politics, business owners, PR firms, and attorneys.

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Democratic Governors’ Strategies For Winning Their First Election

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(WASHINGTON, D.C. – November 7, 2022) –

“I like the noise of democracy.” – James Buchanan

In America, the Democratic party has had tremendous success in recent years when it comes to campaigning to win elections at the Governors’ level. In this post, we will examine five strategies for Democrats seeking the Governor office in a U.S. State. If you are looking to win your first election as a Democratic governor, then you should definitely read this article and learn from these examples.

1. Knock on doors

A vital strategy for Democratic governors is to knock on doors and talk to voters face-to-face. Canvassing allows politicians to get to know their constituents and understand their concerns towards building a connection with the voters, which can be very important in a close election. Knocking on doors can also increase a voters’ confidence in a candidate when it comes to raising campaign funds. PRO TIP: It’s important to have enough money to reach more voters to get your message out. As well, canvassing also assists with building a grassroots campaign. A grassroots campaign is important for politicians as it allows them to connect with voters on a personal level. It’s a good way to garner immediate feedback from voters regarding local concerns.

2. Use social media

Various social media platforms such Facebook, Twitter, Instagram and YouTube are a great way to reach out to voters and communicate your message effectively, as well as directly. Democratic governors use these platforms to share photos and videos of themselves meeting with voters and talking about important issues. This helps connect them with voters showing that they are accessible and interested in hearing what the people have to say. Additionally, Democratic governors campaign on their record of service and accomplishments. They talk about the progress they can make in their respective state and how they plan to keep moving forward if elected. This helps voters see that the Democratic governor is someone who gets things done and is looking out for the best interests of the people.

3. Spread your message through ads

A third strategy includes targeting specific groups of voters with advertising. Political ads can be a very effective way to reach out to voters and convince them to support the campaign. Democratic governors use targeted advertising to reach specific groups of voters who are likely to support them. Democratic governors also often have a strong grassroots campaign that helps them connect with voters on a personal level, built on the fabric of this targeted advertising campaign.

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4. Hold events

Events are a great way to engage with voters and show them what you stand for. Democratic governors often hold town hall meetings, rallies and fundraisers to connect with voters and raise money for their campaigns. These events give you a chance to show voters what you stand for and what you would do if elected. Make sure to have a good turnout at your events and be sure to spread the word to as many people as possible. Democratic governors also reach out to key constituencies like labor unions and minority groups. They make sure they have a strong support base early on in the campaign so they can win come election day.

5. Get endorsements from key figures

Endorsements from influential people can be very helpful in a gubernatorial election. Democratic governors often seek endorsements from party leaders, celebrities and other high-profile figures. Democratic governors running for their first term in office typically seek endorsements from Democratic Party leaders and high-profile celebrities to booster their visibility and chances of winning. Obtaining the endorsement of a popular figure can help attract media attention and votes.

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Pasadena Black Pages: Kennedy Memorial, Women for Racial Justice, & more!

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Pasadena Black Pages 

KENNEDY’S CONNECTION TO THE COMMUNITY WAS HIGHLIGHTED AT MEMORIAL

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The day after Justin Jones was sworn in to replace John Jackson Kennedy as a member of the Pasadena City Council, a memorial service was held at the steps of city hall in honor of the leader who is gone but will never be forgotten.

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JUSTIN JONES CHOSEN TO REPLACE JOHN KENNEDY ON THE CITY COUNCIL

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On Thursday evening, the Pasadena City Council, along with Mayor Victor Gordo chose Justin Jones to replace the deceased John Kennedy as a city council member until December, when they will choose the successor for the next two years.

Jones was selected over Brandon Lamar, whom many believe should have won, and Pastor Lucious Smith who didn’t stand a good chance against the two young men regarding policy and views on community growth and development.

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FINALISTS SELECTED FOR THE 2023 TOURNAMENT OF ROSES® PARADE

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PASADENA, Calif. (September 27, 2022) – Before the final round of interviews, the 28 finalists for the 2023 Royal Court presented by Citizens Business Bank took a group photo on the front steps of Tournament House. Applicants from 33 Pasadena area schools participated in the interview process and seven of the finalists will be named to the 2023 Royal Court on October 3, 2022. The announcement will be live-streamed on the Tournament of Roses YouTube channel beginning at 9 a.m. PST.

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CHRIS HOLDEN TO SPEAK AT AAPC’s VIRTUAL MEETING, POLICY IS POWER!

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The African American Parent Coalition is a model coalition of collaborative parents, students, and communities. The AAPC respects and embraces the diverse cultures of our communities facilitate educational equity and improvements in academic outcomes, values varied forms of parent involvement to foster the healthy development of all students, and provides the tools and skills necessary for families to access information to purposefully participate in a rapidly changing world.

MEASURE PCC, PROVIDING AFFORDABLE EDUCATION TO THE SGV

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Pasadena City College (PCC) has provided high-quality, affordable college education and career training to local students in the San Gabriel Valley for almost 100 years. Offering a wide range of undergraduate degrees, university-transfer courses, certificate programs, career and technical education, PCC provides affordable access to the education and job training students need to succeed and the skilled workers needed to fuel our local economy.

RACIAL JUSTICE ACT FOR All PASSES CALIFORNIA LEGISLATOR

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AB 256, the Racial Justice Act for All, passed its final hurdle in the Legislature and will be sent to Governor Newsom. AB 256 is a follow-up measure to the original Racial Justice Act, AB 2542 (Kalra, Chapter 317, Statutes of 2020), which prohibits the state from seeking or obtaining a criminal conviction, or from imposing a sentence, based upon race, ethnicity, or national origin. In a phased-in approach, AB 256 would allow persons with convictions or judgments prior to January 1, 2021 to petition the court and seek relief if a racial bias violation was proven to be present in their case.

©2022 Pasadena Black Pages | Pasadena, Ca

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Harvard University Affordable Housing Seminar

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Mr. Suleiman Alli

CAMBRIDGE, MASS. –

Harvard University is hosting an Affordable Housing seminar titled, ‘Affordable Housing:  Principles for Changing Domestic and Global Markets’. The two-day seminar takes place at the Graduate School of Design. Individuals in the fields of development, lending, investment and policymaking, will learn the skills to navigate the affordable housing industry.

One of the attendees will be Mr. Suleiman Alli. Sule, as close associates call him, works in conjunction with a design and construction company, FABHAUS USA INC. Sule’s role is in the Marketing, Sales and Business Development department, for the African market.

The course is led by instructors in the Affordable Housing industry: David Smith, Davina Wood and Sanjana Sidhra. Sule, a Nigerian, with American permanent residency, believes that the information and collaborations obtained via this course will assist him in supporting FABHAUS. FABHAUS’ mission is to design and construct pre-fabricated homes, globally.

For nearly a decade, Sule has been investing time and money into journeying throughout Nigeria in attempts to persuade decision makers, in the African nation, to utilize natural resources to build homes for the growing population. His association with a Nigerian organization, FEDUP, led him to find that much of the problem surrounding housing affordability in the country, was political.

Sule’s vision aligns with the mission of the Harvard University course, in that the course is built for entrepreneurs. Affordable Housing is not only a Warri problem, a Lagos problem or a third world problem; Affordable Housing is a global problem and if it were a disease, it could possibly be likened to a pandemic.

Affordable Housing is a burgeoning industry that will continue to grow. This industry is interdisciplinary, encompassing political science, sociology, economics, government, architecture, engineering, etc.

BlackUSA.News will follow up on this seminar and its’ benefits, upon its completion.

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