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Former FDA Head Says CDC Guidance Hurt Pandemic Response

September 19, 2021 Admin

The Centers for Disease Control and Prevention’s guidance ultimately hindered the U.S. response to the pandemic, former FDA Commissioner Scott Gottlieb wrote in his upcoming book “Uncontrolled Spread,” set to be released Sept. 21.

Gottlieb said in the book that U.S. intelligence agencies need to play a more active role in preparing for a pandemic, as opposed to leaving plans solely to health agencies like the CDC.

“We need to have human assets in the medical community so we understand when an outbreak emerges,” Gottlieb said, Axios reported. “We need to have the capability of monitoring typical streams of intelligence, like signals intelligence and maybe even satellite intelligence, looking for things that could be trip wires for an outbreak of disease.”

Report: Top Health Officials Tell White House to Pause Vaccine Booster Plan

September 6, 2021September 5, 2021 Florida Capital Star Staff

Top U.S. health officials told the White House pandemic coordinator on Thursday to scale back the Biden administration’s plan to administer the coronavirus booster shots to individuals in September, The New York Times reported.

Dr. Janet Woodcock, the acting commissioner of the Food and Drug Administration (FDA), and Dr. Rochelle P. Walensky, the director of the Centers for Disease Control and Prevention (CDC), told White House Coronavirus Response Coordinator Jeffrey D. Zients that they need more time to collect and analyze the necessary data relating to the booster shots, The New York Times reported.

The doctors told Zients that their agencies might be able to determine whether to recommend boosters for recipients of the Pfizer-BioNTech vaccine in the coming weeks, according to the Times.

The two doctors presented their argument to Zients at a meeting on Thursday. It is unclear how Zients responded to the news.

Commentary: The Clear Case for Joe Biden’s Impeachment

September 1, 2021August 31, 2021 Florida Capital Star Staff

Alan Dershowitz says calls for the impeachment of Joe Biden are “wrong.” He claims in his most recent op-ed at the D.C. establishment’s favorite Republican rag, The Hill: “Whatever one may think of what Biden did or failed to do, it does not constitute an impeachable offense under the text of the Constitution.” With all due respect, Dershowitz is full of crap.

“The Framers,” Dershowitz writes, “insisted that a president could not be impeached unless he committed criminal-type conduct akin to treason and bribery.” If this is true, then why did President Thomas Jefferson call for the impeachment of a federal district judge on the grounds that he was “a man of loose morals and intemperate habits?” Jefferson was a prominent founder, who greatly influenced the framers of the Constitution.

‘Require It’: Biden Tells Private Companies to Mandate COVID-19 Vaccinations

August 25, 2021August 24, 2021 Florida Capital Star Staff

President Joe Biden encouraged private sector companies Monday to “step up” vaccine requirements for employees following the Food and Drug Administration’s approval of the Pfizer COVID-19 vaccine.

“If you’re a business leader, a non-profit leader, a state or local leader, who has been waiting for full FDA approval to require vaccinations, I call on you now to do that. Require it,” Biden said. “Do what I did last month. Require your employees to get vaccinated or face strict requirements.”

Lawyer Suing Indiana University for COVID Vaccine Mandate Expanding Effort to ‘Four or Five States’

August 19, 2021August 18, 2021 Florida Capital Star Staff

The lawyer representing students challenging Indiana University’s COVID vaccine mandate has been “retained by students in other states to bring similar claims,” he said in an interview Tuesday.

Veteran litigator James Bopp told the John Solomon Reports podcast that he expects to file suit in another “four or five states in the next couple of weeks.”

United Airlines to Become First Major Airline Requiring Staff be Vaccinated

August 8, 2021August 7, 2021 Florida Capital Star Staff

United Airlines announced Friday that it will require all employees to be vaccinated against COVID-19 starting this fall, making it the first major airline to do so.

“We know some of you will disagree with this decision to require the vaccine for all United employees,” United CEO Scott Kirby and President Brett Hart announced in a memo. “But, we have no greater responsibility to you and your colleagues than to ensure your safety when you’re at work, and the facts are crystal clear: everyone is safer when everyone is vaccinated.”

The order requiring proof of vaccination will go into effect five weeks after the Federal Drug Administration officially gives full approval of the COVID-19 vaccines, or by Oct. 25, whichever comes first, The Hill newspaper reports. The FDA is expects to start giving full approval as early as next month.

FDA Asks for Internal Review of Approval Process for Alzheimer’s Drug

July 13, 2021July 12, 2021 Florida Capital Star Staff

The U.S. Food and Drug Administration is asking for an internal review of its own approval process that gave a greenlight to a drug to treat Alzhiemer’s, a move that could shed more light on the controversial chain of decision-making that led to the drug’s being okayed for use.

The FDA last month approved drug company BioGen’s product Aduhelm, the first medicine greenlit in the U.S. to slow the cognitive decline of those living with Alzhiemer’s.

Yet that decision was shrouded in controversy: The approval went against the advice of an outside panel of FDA experts and even led to the resignation of several of those experts in protest.

Fully Vaccinated Do Not Need Booster for Delta Variant, CDC and FDA Say

July 12, 2021July 11, 2021 Florida Capital Star Staff

Fully vaccinated Americans do not need to receive a booster shot to protect against the Delta variant, the Centers for Disease Control and Prevention and Food and Drug Administration said in a press release.

“People who are fully vaccinated are protected from severe disease and death, including from the variants currently circulating in the country such as Delta,” a joint statement said on Thursday.

U.S. Government Allocates $3.2 Billion for COVID-19 Antiviral Pills

June 20, 2021June 19, 2021 Florida Capital Star Staff

The Department of Health and Human Services will invest $3.2 billion to develop and manufacture COVID-19 antiviral medicines, it announced Thursday.

The initiative, funded as part of the American Rescue Plan, is designed to accelerate research into antivirals as well as build platforms for urgent response to future viral threats, the Department of Health and Human Services (HHS) said in a statement Thursday. Specifically, the plan expands antiviral clinical trials, forms partnerships between health agencies and pharmaceutical companies, and funds “drug discovery groups” tasked with innovating new antiviral medicines.

“New antivirals that prevent serious COVID-19 illness and death, especially oral drugs that could be taken at home early in the course of disease, would be powerful tools for battling the pandemic and saving lives,” said chief medical adviser Dr. Anthony Fauci in the statement.

Study Finds Novavax COVID-19 Vaccine 90 Percent Effective

June 15, 2021June 14, 2021 Florida Capital Star Staff

Novavax announced on Monday that its two-dose COVID-19 vaccine is 90% effective, according to a press release on Novavax’s website.

The phase-3 trial enrolled 29,960 participants ages 18 and older in the U.S. and Mexico. The study found that 77 of the participants tested positive for COVID-19, with 63 testing positive in the placebo group and 14 in the vaccine group, according to the press release.

“Today, Novavax is one step closer to addressing the critical and persistent global public health need for additional COVID-19 vaccines. These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe COVID-19 infection,” Stanley C. Erck, President, and CEO of Novavax said in the press release.

Pro-Life Groups Accuse FDA of ‘Ignoring the Science’ on at-Home Abortion Drugs

April 15, 2021April 20, 2021 Florida Capital Star Staff

Pro-life groups are accusing the Food and Drug Administration of “ignoring the science” by removing restrictions that prevented abortion drugs from being delivered by mail.

The national pro-life Susan B. Anthony List (SBA List) and its research and education arm, the Charlotte Lozier Institute (CLI), said Tuesday that the FDA’s decision to remove restrictions on abortion drugs “ignores the risk of increased mortality and morbidity for women taking the abortion pill,” according to an SBA List press release.

Arizona House Passes Bill Banning Abortions Based on Genetic Abnormality

April 3, 2021April 2, 2021 Florida Capital Star Staff

Susan B. Anthony List State Policy Director Sue Liebel

The Arizona House passed a bill Thursday that bans abortions based on diagnosis of genetic abnormality, such as Down syndrome.

S.B. 1457 states that the rights of “an unborn child at every stage of development” must be acknowledged and prohibits abortions based on the sex, race, or genetic abnormality of the child. The bill makes exceptions for medical emergencies.

“A person who knowingly” performs such an abortion “is guilty of a class 3 felony,” according to the legislation.

Factory Mixup Ruins 15 Million Johnson & Johnson Coronavirus Vaccines

April 2, 2021April 1, 2021 Florida Capital Star Staff

Workers at a Baltimore plant responsible for producing two separate coronavirus vaccines mistakenly mixed up their respective ingredients, ruining approximately 15 million doses of Johnson & Johnson’s vaccine and pausing all production at the plant, the company confirmed Wednesday.

The facility, run by Emergent BioSolutions, had partnered with both Johnson & Johnson and AstraZeneca to produce vaccines. Federal officials said that the mistake was a result of human error, according to The New York Times, which first reported the mix up that reportedly occurred several weeks ago.

A quality control review “identified one batch of drug substance that did not meet quality standards at Emergent BioSolutions, a site not yet authorized to manufacture drug substance for our COVID-19 vaccine,” Johnson & Johnson said in a statement. “This batch was never advanced to the filling and finishing stages of our manufacturing process.”

FDA Panel Votes to Recommend Johnson & Johnson’s Coronavirus Vaccine for Emergency Authorization

February 28, 2021February 27, 2021 Florida Capital Star Staff

The Food and Drug Administration’s vaccine advisory panel voted Friday evening to recommend Johnson & Johnson’s coronavirus vaccine for emergency approval, clearing the way for its authorization, distribution and administration nationwide.

The vote followed hours of the panel live-streaming its process of scouring over data from the pharmaceutical company in order to reaffirm that the vaccine was safe for the millions of Americans who will receive it. The FDA also released the vaccine’s clinical trial data on Wednesday showing that the vaccine was effective in fighting the virus itself.