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Pfizer to Seek FDA EUA for COVID-19 Vaccine for 5- to 11-Year-Olds in Coming Weeks
Children as young as five years old may soon get the COVID-19 vaccine. Friday, Pfizer announced that it would submit its clinical trials for their 5 to 11-year-olds to the Food and Drug Administration (FDA) in the coming weeks.
This March, Pfizer began testing 4,500 children in a three-age group trial for their COVID-19 vaccine. The groups include school-age children from five to eleven, preschool age children from two to five, and infants from six months to two years old.
Parents Seek COVID-19 Vaccine Trials for Their Children Ahead of Official Authorization
The shots haven’t been proven to work safely for youngsters, and child volunteers in later-stage trials may get a placebo, rather than the vaccine. Yet parents said they were willing to take the chance and submit their children to the trials’ blood draws, COVID-19 tests and appointments to safeguard them, as well as their family and classmates.
Babies Could Be Given Pfizer’s COVID Vaccine in the U.S. This Winter
In a move likely to cause international controversy, the company intends to apply for authorisation to immunise American infants within the next two months.
America Has Its Own Virus Secrets
Questions about the origin of the COVID-19 pandemic are being asked more insistently in Washington. President Biden has directed US intelligence agencies to tell him by the end of August whether the cause was an infected animal or a laboratory leak. He said he had “specific questions for China” and urged Chinese leaders “to participate in a full, transparent, evidence-based international investigation.” Secretary of State Antony Blinken accused China of “failure to meet its basic responsibilities in terms of sharing information and providing access.”
For more than a year, China resolutely ignored the pressure to allow neutral inspectors into its biological laboratory in the provincial capital of Wuhan, where the virus was first detected. Now it is adopting a different public posture. The new Chinese gambit might be called “I’ll show you mine if you show me yours.”
Myocarditis VAERS Analysis Sparks Social Media Uproar
Researchers are getting pushback over a medRxiv preprint that relied heavily on Vaccine Adverse Event Reporting System (VAERS) data to characterize myocarditis risk with the COVID-19 vaccine in adolescents, particularly young boys.
The report by Tracy Høeg, MD, PhD, of the University of California Davis, and colleagues found that rates of “cardiac adverse events” after the second dose were higher than previous CDC estimates, at 162 per million among boys ages 12 to 15 and 94 per million among boys ages 16 to 17. (Rates were much lower for girls, at about 13 per million for each age group.)
Mu Variant, Which May Be Vaccine-Resistant, in All 50 States After Nebraska Case
The COVID-19 Mu variant was confirmed to be in all 50 U.S. states after the mutation was detected in Nebraska.
According to Outbreak.Info, which uses data from the GISAID virus reporting network, 5,659 Mu variant sequences have been detected worldwide, as of September 4. Of those, 2,436 were detected in the U.S.
Louisiana Nurses Refusing to Get the COVID Vaccine
Louisiana’s largest hospital systems are requiring their employees to be fully vaccinated, but a minority of nursing staff say they are still considering leaving their jobs instead of getting the jab, citing concerns over personal liberty, lack of long-term studies, and discredited conspiracy theories …
“I will not take it and if I get fired, so be it,” said Pam, an LPN employed at an Oschner family medicine clinic in Hammond, Louisiana. “I’m completely against it. If they can take this freedom away from us, what else can they take away from us?
Doctor Argues for More Research Into Effects of COVID-19 Vaccines on Menstruation
Clinical trials for coronavirus vaccines should include examination of any possible effects on women’s menstrual cycles — if only because so many women are worried about possible problems, a British expert argued Wednesday.
But there’s also evidence the immune response prompted by both vaccines and viral infections can temporarily affect menstrual cycles, so studying these effects is important, Dr. Victoria Male, a reproductive specialist at Imperial College London, wrote in the BMJ.
FDA Authorizes Additional Batch of Johnson & Johnson Vaccine From Troubled Baltimore Plant
The U.S. Food and Drug Administration has authorized an additional batch of COVID-19 vaccine produced by Johnson & Johnson at an East Baltimore plant where regulators previously determined several million doses of vaccine were unusable.
It is not clear how many doses the new batch contains, but regulators said in a Wednesday letter that they meet the agency’s standards for safety and effectiveness.
FDA Strikes Cautious, Neutral Tone Ahead of Friday Vaccine Booster Meeting
Influential government advisers will debate Friday if there’s enough proof that a booster dose of Pfizer’s COVID-19 vaccine is safe and effective — the first step toward deciding which Americans need one and when.
The Food and Drug Administration on Wednesday posted much of the evidence its advisory panel will consider. The agency struck a decidedly neutral tone on the rationale for boosters — an unusual and careful approach that’s all the more striking after President Joe Biden and his top health advisers trumpeted a booster campaign they hoped to begin next week.