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FDA approves first injectable drug to prevent HIV

FDA approves HIV prevention drugA new injectable treatment for HIV pre-exposure prevention, or PrEP, has been approved by the Federal Drug Administration.

The drug, Apretude, is approved for at-risk adults and adolescents who weigh at least 77 pounds to reduce the risk of sexually acquired HIV, the FDA announced Monday.

“Today’s approval adds an important tool in the effort to end the HIV epidemic by providing the first option to prevent HIV that does not involve taking a daily pill,” Debra Birnkrant, director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research, said in the announcement.

After the initial two injections, Apretude is administered one month apart, then every two months after that. The hope is that high-risk individuals, like men who have sex with men, will have better adherence to taking the PrEP injectable option every two months versus taking a pill everyday.

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Harvard announces January move to remote learning, work as COVID-19 case numbers rise

Harvard goes remoteHarvard University announced on Saturday that it would be transitioning to remote learning for several weeks in January amid an increase of new cases in the area and around the country.

In a letter to the school’s community, Harvard officials said that for the first three weeks of January, “we will take steps to reduce density on campus by moving much of our learning and work remotely."

The letter noted that students who had received approval from their specific school or previous authorization would be the only students allowed to remain on or return to campus during the three-week period.

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Eight heart inflammation cases among young kids who got COVID-19 shot - U.S. CDC

Eight heart inflammation casesThe U.S. Centers for Disease Control and Prevention said on Thursday it had received reports of eight cases of myocarditis, a type of heart inflammation, in children aged 5-11 years who received Pfizer (PFE.N) and BioNTech's COVID-19 vaccine.

The CDC had previously said that reporting rates of myocarditis for boys aged 16 to 17 could be more than 69 cases per million second doses administered and around 40 cases per million second doses in boys aged 12-15 years old.

The CDC did not say whether it believes there is a link between the myocarditis cases and the vaccine, or disclose the rate of myocarditis in the age group without vaccination.

The agency said there had been over 7 million vaccine doses in the 5-11 age group at the time it examined the data, with 5.1 million first doses and 2 million second doses. The cases had a mild clinical course, the CDC said.

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U.S. CDC advisers to weigh limits on J&J vaccine due to blood clot issues

CDC advisers to weigh limits on J&J vaccines- A U.S. Centers for Disease Control and Prevention advisory panel will meet on Thursday to consider possible limits on the use of the Johnson & Johnson (JNJ.N) COVID-19 vaccine because of continued blood clot issues, the Washington Post reported on Wednesday.

The CDC's Advisory Committee on Immunization Practices will be presented new data that appears to show the rate of clots in people who received the Johnson & Johnson vaccine has increased since April, the Post reported, citing clinicians familiar with the agenda.

Use of the vaccine in the United States was paused for 10 days in April to investigate extremely rare but potentially deadly clots, mostly in young and middle-aged women. r

There have been about nine deaths related to the issue, the Post said, citing an unnamed federal official.

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How Trump’s ‘America First’ edict delayed the global Covid fight

Trump's america First edict delayed fight against Covid

Decisions by top officials responding to President Donald Trump’s edict to protect “America first” contributed to a global delay in Covid-19 vaccine donations and a lack of effort to assist low- and middle-income countries, according to five current and former U.S. officials who worked under Trump on the federal pandemic response.

The failure to view the Covid threat in global terms left some nations — including those where the Omicron variant emerged in recent weeks — lacking inoculation and much more vulnerable to mutations, the officials said.

They described a White House and its health agencies fixated on one goal: obtaining enough drugs and protective gear to shield the American people from Covid-19. But that strategy, pushed directly by Trump and his senior aides, neglected to seriously consider the threat of variants and spread of infections if lower-income countries were left unprotected, the officials said.

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After Licensing Board Threatens Disciplinary Action, Maine Physician Asks Board to Define COVID ‘Misinformation’

Physicians face  losing licences; ask for definitionThe Maine Board of Licensure in Medicine this month issued a position statement in which it said: “Physicians who generate and spread COVID-19 vaccine misinformation or disinformation are risking disciplinary action by state medical boards, including the suspension or revocation of their medical license.”

In the letter below, Dr. Meryl Nass, a practicing physician in Maine and member of the Children’s Health Defense scientific advisory board, asked the board to define what it means by “misinformation” and “disinformation,” and to clarify what statutory authority the board has to discipline physicians on the basis of undefined transgressions. The letter, which includes the Nov. 16 testimony Nass gave to the New Hampshire state legislature, has been edited slightly for clarity.

November 22, 2021

To the Maine Board of Licensure in Medicine:

I am a physician, licensed in Maine for the past 24 years. I am concerned about the use of the terms “misinformation” and “disinformation” and the new threat to physicians’ licenses issued by the board today for undefined behaviors.

I require clarification regarding the board’s definition of misinformation and disinformation and would like to know what statutory authority the board has to discipline physicians on the basis of undefined transgressions.

Please tell me what law or regulation authorizes such threats for speech outside the clinic.

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TVNL Comment: Please read the letter to its conclusion.  It is VERY important.

US appeals court lets Texas resume ban on most abortions

Texaas appeal court lets abortion ban stayA federal appeals court Friday night quickly allowed Texas to resume banning most abortions, just one day after clinics across the state began rushing to serve patients again for the first time since early September.

Abortion providers in Texas had been bracing for the 5th U.S. Court of Appeals to act fast, even as they booked new appointments and reopened their doors during a brief reprieve from the law known as Senate Bill 8, which bans abortions once cardiac activity is detected, usually around six weeks.

On Wednesday, U.S. District Judge Robert Pitman, an appointee of President Barack Obama, suspended the Texas law that he called an “offensive deprivation” of the constitutional right to an abortion. But in a one-page order, the New Orleans-based appeals court temporarily set aside Pitman’s ruling for now while it considers the state’s appeal.

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