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Rutgers Recruiting Participants for Pfizer COVID Pediatric Bivalent Vaccine Clinical Trial
Rutgers has been selected as a clinical trial site for the global Pfizer-BioNTech research study to evaluate the safety and efficacy of the bivalent COVID-19 vaccines in children under age 5.
Although the U.S. Food and Drug Administration and Centers for Disease Control and Prevention have given early-use authorization for the bivalent COVID-19 vaccine, children under 5 are still only eligible for the monovalent vaccine.
Partnering with Pfizer/BioNTech, the Pediatric Clinical Research Center at Rutgers Robert Wood Johnson Medical School will begin to study the bivalent vaccine in children less than 5 years old. The trial will include a substudy of children under 2 who have never received a COVID-19 vaccine and a substudy of children under 5 who have received doses of COVID vaccines.
This is the fourth time Rutgers has served as a COVID-19 vaccine clinical trial site for pharmaceutical companies. In 2021, it conducted trials for Moderna and Johnson & Johnson, and in 2022, it conducted pediatric vaccine trials for Pfizer/BioNTech.
Alcohol Deaths Spiked Among Middle-Aged Adults, Especially Women, During Pandemic
Excessive drinking is increasingly killing middle-aged adults — a trend that had been brewing for nearly two decades before it ramped up at an alarming pace when the coronavirus pandemic began.
Alcohol-related deaths rose by 26% from 2019 to 2020, a new report published Friday by the Centers for Disease Control and Prevention finds. The increase was even sharper among women ages 35 to 44, going up by 42% from 2019 to 2020.
When the pandemic hit, many people greatly increased their drinking. The new research “unmasks the fact that we have a vulnerable population that was also living through the COVID-19 pandemic,” said Dr. Kristopher Kast, the clinical director of the Addiction Consult Service at Vanderbilt University Medical Center in Nashville, Tennessee.
“With that increased rate” of drinking, Kast said, “we saw this increase in mortality.”
‘Giving People a Voice’: New Platform Hopes to Shed Light on Post-Vaccine Injuries
Rather than get bogged down in the never-ending debate on vaccine science, Matt Jordan set out to simply give people a voice when he launched Jab Injuries Global. The platform, which has garnered 113,000 followers on its Australian Instagram account in just 10 months, has big plans globally, with local accounts in the United States, United Kingdom, and New Zealand beginning to gain traction.
“We are offering a service. I’ve got a team of about 12 writers, and we sit on the phone with people for about one-and-a-half to two hours. We type out their whole story from beginning to end in as much detail as possible so that the community can go through and see what’s really happening,” Jordan told The Epoch Times.
“We’re not really sharing science, news, data or any of our own opinions. We’ve allowed the people to speak about their experiences and their stories. I think we’ve got 300 now,” he said.
The platform comes as debate continues on the efficacy of vaccines and processes that governed their worldwide rollout during the pandemic years. The Instagram pages include testimonials from individuals reporting side effects, including pericarditis and seizures.
‘That’s a Tactic!’: Megyn Kelly’s Podcast Gets Heated as She Questions Virologist Dodging COVID Lab-Leak Theory Questions
Megyn Kelly’s podcast got heated on Thursday as she questioned virologist Dr. Robert Garry about the Wuhan lab-leak theory, asking him several times to stop dodging her questions.
During Sirius XM’s “The Megyn Kelly Show” podcast, the host spoke with Garry, a Tulane virologist, about the “furin cleavage site” in the virus, and how he allegedly changed his mind in just 48 hours regarding its origin from that of a lab leak in Wuhan, China, to something that started in nature.
Kelly then noted that we know, thanks to uncovered emails, that Garry originally thought COVID was likely leaked from the Wuhan lab, stating that he said, “I just can’t figure out how this gets accomplished in nature.”
After his conversations with Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, as well as the then-Director of the National Institutes of Health Dr. Francis Collins, he changed his mind. Kelly said that Garry completely “reversed” himself, claiming just two days later that “it can’t possibly be lab leak, it is nature.”
U.S. Faces Pandemic Crossroads With COVID Deaths Still Too High and New Omicron Variants Emerging, Fauci Says
White House chief medical advisor Dr. Anthony Fauci on Thursday said the U.S. is at a crossroads in the COVID-19 pandemic as new Omicron subvariants are gaining ground across the country.
Fauci, in a radio interview Thursday, said the pandemic has clearly eased since last winter, but deaths, which average more than 2,600 per week, remain far too high. At the same time, the new Omicron variants are knocking out key tools used to protect the most vulnerable.
Natural infection from the BA.5 subvariant or vaccination with the new boosters should provide protection against these subvariants for healthy people, Fauci said. But U.S. health officials are concerned the subvariants will basically knock out antibody treatments such as Evusheld that play a key role in protecting people with severely compromised immune systems, he said.
The Omicron subvariants BQ.1 and BQ.1.1 are of greatest concern. They are resistant to Evusheld and are increasing in the U.S. every week. BQ.1 and BQ.1.1 represent 27% of infections combined while Omicron BA.5 has declined to 50%, according to the Centers for Disease Control and Prevention.
Pfizer/BioNTech Say Updated COVID Booster Generates ‘Substantially Higher’ Protection Against Omicron Subvariants Than Original Vaccine
Pfizer and BioNTech said Friday that the immune responses against Omicron BA.4/BA.5 subvariants were “substantially higher” in people who got its new bivalent booster compared with people who received the companies’ original COVID-19 vaccine.
The bivalent booster that targets the original coronavirus strain and the Omicron BA.4 and BA.5 subvariants became available in the U.S. in early September. Pfizer and BioNTech said in a news release that the bivalent booster generated about four times higher levels of neutralizing antibody against the Omicron BA.4/BA.5 variants in people older than 55, compared with the original vaccine. The data has not been peer-reviewed or published.
The companies’ new data comes after two small studies that measured immune responses about three to five weeks after the updated booster dose; both found that the updated COVID-19 booster shots appear to work about as well against the BA.4 and BA.5 Omicron subvariants as the original boosters they replaced. The studies were released as preprints and have not been peer-reviewed or published.
Scholz’s China Visit Secures BioNTech/Pfizer Vaccine Access for Expats
People in China will soon be offered the BioNTech/Pfizer COVID-19 vaccine — but only if they are not Chinese. German Chancellor Olaf Scholz announced the deal today during a visit to China accompanied by a cohort of business leaders from his country, including BioNTech chief Uğur Şahin.
Scholz agreed with Chinese President Xi Jinping and outgoing Prime Minister Li Keqiang that the countries will work more closely in the fight against the coronavirus, he said.
“This also includes an approval of the BioNTech vaccine for expats in China,” he said during a press conference in Beijing.
The chancellor did not specify if he was referring to German ex-pats only, or all expats in the country. But one influential financial news outlet, Caixin, reported that the BioNTech vaccine would only be available to “German ex-pats” in China.
Why You May Soon Have to Pay for That COVID Test
The federal government is poised to stop paying for COVID-19 vaccines, tests and treatments in the coming months, shifting the costs onto the public.
Experts say most Americans are not aware that this will happen and will be in for a major case of sticker shock. They warn without additional protections or funding, the transition to commercialized treatments and preventive services will lead to health barriers.
Instead of free access to tests and treatments like Paxlovid, insurance companies and manufacturers will set the price.
The days of free, easily accessible COVID-19 tests will also likely end. Private insurance may not cover over-the-counter tests anymore, and patients may need a prescription first for a PCR test.
