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FDA Flags J&J’s COVID Vaccine for Myocarditis, Pericarditis Risk
Becker’s Hospital Review reported:
The FDA updated its fact sheet for healthcare providers about Johnson & Johnson‘s COVID-19 vaccine to include warnings of myocarditis and pericarditis.
Myocarditis is inflammation of the heart and pericarditis is inflammation of the lining outside the heart. Both are listed as potential risks of the vaccine, and the FDA said symptoms typically happen within eight days of inoculation. The risk is very low, the agency said.
The agency made the revision on March 13, about 10 months after the FDA limited the shot’s use after worries about a blood clot risk. The shot makes up a small share of all COVID-19 vaccinations: Nearly 19 million J&J shots have been administered, while 475 million of Pfizer‘s and Moderna‘s vaccines have been used, according to the CDC.
FDA Authorizes Pfizer’s COVID Omicron Booster as Fourth Shot for Kids Under 5
The U.S. Food and Drug Administration on Tuesday authorized Pfizer’s Omicron booster shot for kids under five years old who were previously vaccinated with three doses of the company’s original vaccine.
Children six months through four years old who completed their three-dose primary series with Pfizer and BioNTech’s original monovalent shots more than two months ago are now eligible to receive a single booster dose of the updated shot. The new shot is bivalent, meaning it targets the original COVID strain as well as Omicron BA.4 and BA.5.
Pfizer’s primary series for young children consists of three doses, while rival drugmaker Moderna’s primary series for that same age group is only two.
The Public Want Answers on the Origins of COVID
The public deserves to know the whole truth: How did the coronavirus pandemic begin? What happened in Wuhan in 2019? Was it from a lab leak? Why did the first cases of the virus pass by undetected? And why is it, more than three years later, that we still know so little about the origins of the virus that changed the world?
Research for Newsweek by Redfield & Wilton Strategies shows an overwhelming 70% of Americans say it matters to them a significant or fair amount whether the coronavirus pandemic originated from a lab leak or from nature. Notably, this figure includes virtually identical proportions of those who voted for Joe Biden in 2020 (72%) and for Donald Trump (75%). This broad bipartisanship has resulted in Congress voting unanimously for all government intelligence on the origins of the virus to be declassified. President Joe Biden, however, has yet to decide whether to sign or veto this bill.
Biden’s decision to sign the bill cannot wait. Trust in science urgently needs to be restored. Forty-three percent of Americans, a plurality, say they trust the scientists and public health officials less as a result of their pandemic experience. This is bad news for democracy and society at large. Without urgent and honest answers to restore their trust, it could have a detrimental effect on public health for many decades to come.
3 Years After COVID, It’s Past Time Taxpayers Stop Funding This Corrupt Organization
It seems that the long-repressed truth about COVID is finally allowed to trickle out. The Wall Street Journal broke the story that the Department of Energy’s intelligence now indicates that the COVID-19 virus “likely arose from a laboratory leak.” FBI Director Chris Wray is now saying the same in public. Despite the FBI’s opaqueness with the American people while “assessing the origins,” for “quite some time,” most people — not religiously devoted to the government/media/Big Pharma-approved narrative — could see the writing on the wall years ago.
Still, vindication of the truth alone is not enough. Justice demands accountability for all those who withheld and helped obscure information on the origins of this pandemic — especially the World Health Organization (WHO), which no longer deserves a scintilla of America’s trust, another penny of her tax dollars, or another second of her membership.
WHO Director Tedros Adhanom Ghebreyesus recently lashed out at people asking questions about COVID origins for supposedly turning “what should be a purely scientific process into a political football.” Such obvious defensive deflection makes sense; after all, while China was doing its best to cover up the virus’ origins, the WHO was the regime’s loudest cheerleader on the international stage, despite all indications of wrongdoing.
The Biden administration is now supporting the creation of a new international agreement that will fork over even more power and legitimacy to globalist WHO bureaucrats in Geneva. Officially tabbed as the “WHO Convention, Agreement, or Other International Instrument on Pandemic Prevention, Preparedness, and Response” or “WHO CA+” this “zero draft” of the proposed agreement, set for final consideration in 2024, would further empower the WHO by granting it more power to craft worldwide “public health” policy.
One of the Coronaviruses Causing Common Colds Boosts Immune Response to COVID in Children, Study Finds
During the pandemic, medical doctors and researchers noticed that children and adolescents infected with COVID-19 became less ill than adults. A possible explanation for this is that children already had a prior level of immunity to COVID-19 provided by memory T cells generated by common colds.
After studying unique blood samples from children taken before the pandemic, researchers from Karolinska Institutet in Sweden have now identified memory T cells that react to cells infected with SARS-CoV-2, the virus that causes COVID-19.
A possible explanation for this immunity in children is that they already had colds caused by one of the four coronaviruses causing seasonal common cold symptoms. This could stimulate an immune response with T cells able to also react to cells infected with SARS-CoV-2.
This new study reinforces this hypothesis and shows that T cells previously activated by the OC43 virus can cross-react against SARS-CoV-2.
Judge Rejects Request From Moderna, Moving Key COVID Vaccine Case to Discovery
A key COVID-19 vaccine case is moving to the discovery phase after a U.S. judge rejected a bid by Moderna to dismiss some of the patent infringement claims against it.
Moderna and the U.S. government, which backed the company, failed to prove that claims involving the company’s COVID-19 vaccine contract with the government should be dismissed, U.S. District Judge Mitchell Goldberg ruled on March 10.
Goldberg in late 2022 rejected a similar effort but Moderna revived its bid after the government filed a statement asserting it, not the company, should face the claims relating to the contract.
The parties, though, have failed to prove that the government’s interpretation “trumps a court’s analysis of this issue,” Goldberg said.
Pfizer Adjusts EU Vaccine Deal but Still Wants Payment for Undelivered Doses: FT
Pfizer and European Commission officials have waded through months of pushback over a large, controversial COVID-19 vaccine supply deal in Europe. They’ve now reportedly hashed out a new supply agreement — but there’s a catch.
Under the terms of a revised deal, Pfizer agreed to extend the European supply contract from 2023 out to 2026, the Financial Times reports based on two people with knowledge of the talks. Given the drop in vaccine use, Pfizer also agreed to cut the total number of doses to be supplied by 40%, but the company is also pushing for payment for the doses that will never be manufactured, according to the publication.
Pfizer and the European Commission (EC) inked their large vaccine supply deal in May 2021. The agreement covered 900 million vaccine doses for delivery split between 2022 and 2023, with the option for the EC to order another 900 million doses in the future. In December 2021, European officials exercised part of the option and agreed to buy another 200 million doses.
Since then, many European countries found they had too many doses as the pandemic eased. Officials have spent many months deliberating on how best to tackle the vaccine glut.
CDC Urges Bivalent Booster in New Push. Will People Listen?
The Atlanta Journal-Constitution reported:
Three years into the pandemic, COVID-19 vaccines are an increasingly hard sell — especially in Georgia. According to the Centers for Disease Control and Prevention. Only about 10% of residents in the state have gotten an updated bivalent booster, which targets the original strain and Omicron subvariants circulating now.
People are either unaware or simply not interested in the latest booster. And they likely aren’t getting the nudge from their doctor. A recent CDC study showed that nearly 60% of people surveyed had not received the bivalent booster because it had not been recommended by their healthcare provider.
The CDC is hoping to change that and move the needle. The agency is launching a nationwide initiative to talk to physicians about encouraging this latest booster, starting here in Georgia.
After 3 Years of the Pandemic, Loneliness May Be Ebbing for America’s Older Adults
U.S. News & World Report reported:
On the third anniversary of the pandemic, a new poll shows fewer older adults are experiencing loneliness and isolation though the numbers are still high.
About one-third of adults aged 50 to 80 still sometimes or often experience isolation and loneliness, according to the University of Michigan researchers. They may go a week or longer without social contact from someone outside the home.
Still, that’s fewer than half of older adults who reported this in June 2020.
“Three years into the COVID-19 pandemic, we see reason for hope, but also a real cause for concern,” said Dr. Preeti Malani, senior advisor and former director of the University of Michigan (U-M) National Poll on Healthy Aging. “If anything, the pandemic has shown us just how important social interaction is for overall mental and physical health, and how much more attention we need to pay to this from a clinical, policy and personal perspective.”
Long COVID Has Some Weird Symptoms. Face Blindness May Be One of Them.
Early in the pandemic, a 28-year-old customer service representative and portrait painter caught COVID-19. She had a high fever for a few days and trouble breathing. Her sense of smell and taste disappeared. But by mid-April 2020, she had recovered enough to start working from home.
It wasn’t until June, when she saw her family for the first time since her illness, that she realized she’d lost something else. She could no longer recognize her own father or distinguish him from her uncle.
It’s not clear how many people have developed face blindness after having COVID-19. But the woman, whom researchers identified only as “Annie” to protect her privacy, was one of more than 50 long COVID patients who reported to Dartmouth College researchers in a new study they were having trouble identifying faces after their infection.
Some people are born with face blindness, called prosopagnosia, while others lose the ability to identify faces from brain damage, typically caused by a stroke or brain injury.
Pfizer’s COVID Drug Data Supports Use in High-Risk Patients — FDA Staff
The U.S. health regulator’s staff reviewers said on Tuesday data from Pfizer Inc.’s (PFE.N) COVID-19 drug trials support its use in adults at high risk of progressing to severe disease, bringing the pill closer to full approval.
The Food and Drug Administration made its assessment in briefing documents ahead of a meeting of the agency’s external advisers on Thursday to discuss full approval to use Pfizer’s oral pill for high-risk COVID-19 patients exhibiting mild to moderate symptoms.
The FDA’s advisers will vote on whether the benefits related to Paxlovid outweigh its risks. The agency typically follows the advice of its expert advisers but is not mandated to do so.
Paxlovid has been authorized for emergency use since late 2021, and full approval is likely to allow Pfizer to expand its advertising campaign for the drug.
Veru to Proceed With Late-Stage Study of COVID Pill Despite FDA Snub
Drug developer Veru Inc (VERU.O) on Tuesday said it plans to proceed with a late-stage trial of its COVID-19 pill, weeks after the U.S. health regulator declined to authorize the oral drug to treat high-risk patients hospitalized with COVID-19.
It will, however, stop the development of the drug as a potential treatment for prostate cancer as part of its strategy to cut costs.
Veru plans to continue the development of the oral drug, sabizabulin, in late-stage studies with high-risk hospitalized influenza patients and COVID-19 patients. It expects to report interim data from the COVID-19 trial next year.