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FDA Authorizes Emergency Use for Novavax COVID Vaccine for Ages 12 to 17 + More
FDA Authorizes Emergency Use for Novavax COVID Vaccine for Ages 12 to 17
Biotechnology company Novavax announced on Friday that its COVID-19 vaccine has been authorized for emergency use by the U.S. Food and Drug Administration for adolescents between the ages of 12 and 17.
In July, Novavax’s two-dose COVID-19 vaccine for adults ages 18 and over got its emergency approval from the FDA.
Novavax was one of the original participants in the U.S. government’s race to develop a COVID vaccine in 2020, receiving $1.8 billion in taxpayer funding from Operation Warp Speed. However, the small Maryland biotech company struggled to quickly get manufacturing in place and its clinical trial data read out much later than rivals Pfizer or Moderna.
Dr. Peter Marks, a senior FDA official, has said that Novavax’s vaccine would potentially appeal to unvaccinated people who would prefer a shot that is not based on the messenger RNA technology used by Pfizer and Moderna.
Fauci Plans to Step Down in December After Half a Century in Government
Anthony S. Fauci, the nation’s preeminent infectious-disease expert who achieved unprecedented fame while enduring withering political attacks as the face of the coronavirus pandemic response under two presidents, plans to step down in December after more than a half-century of public service, he announced Monday.
Fauci, 81, has led the National Institute of Allergy and Infectious Diseases since 1984. He joined the parent agency, the National Institutes of Health, in 1968 as a 27-year-old doctor who had just finished medical residency and was quickly identified as a rising star. Most recently, Fauci has also served as President Biden’s chief medical adviser since the start of his administration.
While Fauci is one of the most cited researchers of all time and has been widely known in scientific circles for decades, it was the coronavirus pandemic that catapulted him to worldwide fame — and ignited criticism from some Republican politicians and threats from the public.
Pfizer Asks FDA to Authorize COVID Booster Shots That Target Omicron BA.5 for People Ages 12 and Older
Pfizer and its German partner BioNTech on Monday asked the Food and Drug Administration to authorize COVID booster shots that target the Omicron BA.4 and BA.5 subvariants for people ages 12 and older.
The updated vaccines would target the original strain of the virus that first emerged in Wuhan, China in 2019 as well as Omicron. Scientists and public health officials hope the new shots will provide broader and more durable protection against infection and mild illness.
Dr. Ashish Jha, the White House COVID response coordinator, has said the new shots will become available to the public by early to mid-September. Pfizer said it could ship the Omicron BA.4/BA.5 boosters as soon as the FDA authorizes them. The U.S. government has secured 105 million doses of Pfizer’s updated shots and 66 million doses of Moderna’s new vaccine.
New Virus Breakout Raises Question of Bioterrorism
Recently, the discovery of the “Langya virus” in the Shandong and Henan provinces of China has quickly attracted the attention of medical experts around the world. The virus is a type of zoonotic henipavirus and 35 people have been identified to be infected with this Langya virus since 2019 in these two provinces in China.
Notably, this virus is related to the Mojiang virus — found in the infamous Mojian Caves where the bat-borne coronavirus most similar to the SARS-CoV-2 was discovered.
The Wuhan Institute of Virology has become very interested in henipaviruses as of late, taking great pains to obtain and reconstruct the Nipah virus, which is not even a threat in China.
What does this all mean, and what is going on inside China’s military labs?
CDC Figures Show Just How Few Over-50s Have Had COVID Vaccine Boosters
Millions of eligible U.S. adults have not yet had a COVID booster vaccine, data from the Centers for Disease Control and Prevention (CDC) shows, as the U.S. heads into the winter.
The CDC recommended a COVID booster vaccine — an extra shot to boost immunity in people who had already been fully vaccinated against COVID — in some populations in September 2021. Access was further expanded to other populations before a recommendation for a second booster dose in March this year.
However, despite the rise of Omicron over the winter and the spread of the BA.5 variant, uptake of booster shots in the U.S. has been lackluster.
FDA Asks Pfizer to Test Second Paxlovid Course in Patients With COVID Rebound
The U.S. Food and Drug Administration (FDA) has asked Pfizer Inc. (PFE.N) to test the effects of an additional course of its antiviral Paxlovid among people who experience a rebound in COVID-19 after treatment, the regulator said on Friday.
The drugmaker must produce the initial results of a randomized controlled trial of a second course of the antiviral by Sep. 30 next year, the FDA told Pfizer in a letter dated Aug. 5.
The directive follows reports of recurrent viral infection or symptoms, or both, after the first course, including in President Joe Biden and National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci.
Omicron-Specific COVID Booster Shots Are Just Weeks Away. Here’s Who Will — and Won’t — Be Eligible
Newly updated COVID booster shots designed to target Omicron’s BA.5 subvariant should be available within the next three weeks. That begs an important question: Who’s going to be eligible to get them?
The short answer: Anyone ages 12 and up who has completed a primary vaccination series, a Centers for Disease Control and Prevention spokesperson tells CNBC Make It. It’s unlikely to matter whether you’ve received any other booster doses or not before, the spokesperson says — but if you’re unvaccinated, you won’t be eligible for the updated formula until you complete a primary series with the existing COVID vaccines.
The longer answer is somewhat more complex because it depends on which booster shots get approved and when.
LA Public Health Department Faces Backlash After Offering COVID Test to Animals, Including Seals
The Los Angeles Public Health Department is facing growing criticism over its decision to offer free COVID-19 testing for animals, despite there being no positive cases reported among animals in the area.
LA Public Health announced the initiative on Aug. 20 and said it has received funding from the Council of State and Territorial Epidemiologists and the Centers for Disease Control and Prevention (CDC) to monitor COVID-19 in animals in Los Angeles County.
Out of the 177 animals that have been tested in Los Angeles County so far, including dogs, cats, bats, raccoons, skunks, rats and sea lions, none have tested positive for COVID-19 as of Aug. 18.
U.K. COVID Inquiry Bill Already at £85m as Government Hires Top Law Firms
Bills for the COVID-19 public inquiry have already hit £85m despite hearings not starting until next year after the government hired top legal and public relations firms.
Departments making key decisions during the pandemic have hired leading law firms on multimillion-pound contracts alongside specialist firms tasked with sifting through millions of sensitive documents and emails for disclosure.
The early outlays of public funds suggest the U.K.-wide inquiry into the response to and impact of the pandemic will be one of the most expensive ever statutory public inquiries.
Amid COVID Surge, Iran Cut Corners to Approve yet-Unproven Vaccine
As Iranian regulators considered endorsing a locally developed coronavirus vaccine a year ago, a top health official issued a stern warning, saying the test results were insufficient and the vaccine’s approval could undermine efforts to contain the country’s raging epidemic.
But the vaccine had influential backers. It was the highly touted project of a company called Barkat, part of a sprawling corporate empire close to Iran’s supreme leader, Ayatollah Ali Khamenei.
Less than a week later, Health Minister Saeed Namaki announced that the vaccine had received emergency approval. At the time, Barkat had not even begun its Phase 3 clinical trial, meant to confirm the vaccine’s effectiveness and identify possible side effects, Iranian researchers later reported in a medical journal. That trial started two days later, the researchers said. The results are still not public.
Hundreds of Thousands of Expired U.S. Monkeypox Shots Still Viable, Tests Reveal
Four hundred thousand doses of the monkeypox vaccine that had expired and were destined to be destroyed have been tested from American stockpiles and found to still be viable, the chief executive of vaccine manufacturer Bavarian Nordic told POLITICO.
The Danish firm is carrying out tests, at the request of the United States, on some of the 28 million doses that expired around two years ago, Bavarian Nordic boss Paul Chaplin said in an exclusive interview. So far the news is good. The youngest batches of expired doses remain of a high quality with vaccine levels at sufficient concentrations. Tests are ongoing but up to 1 million doses could pass muster from the batches now being analyzed, Chaplin said.
There’s now “ongoing dialogue” with the U.S. Food and Drug Administration (FDA) on how to extend the shelf life of those batches to allow the Biden administration to distribute them, Chaplin said.
Fauci Urges Black Americans to Get COVID Booster Shots in Preparation for Fall Surge + More
Fauci Urges Black Americans to Get COVID Booster Shots in Preparation for Fall Surge
Dr. Anthony Fauci has an important message for Black Americans: get a booster shot.
In a recent interview with TheGrio, Fauci, who is director of the National Institute of Allergy and Infectious Diseases, urged the Black community to get a COVID booster shot in preparation for the fall surge when the COVID infection rates are expected to rise.
He said that the Food and Drug Administration will soon authorize an updated booster shot, known as the bivalent BA.5 vaccine, which is a closer match to the circulating Omicron variants of COVID.
He also noted that COVID infection rates continue to disproportionately affect Black Americans because of two key factors: their occupations and underlying health conditions.
Researchers Are Working on a New Rapid COVID Immunity Test
As SARS-CoV-2 continues to evolve, knowing your immunity status — both from vaccines and from infections — will become increasingly important.
COVID-19 antibodies are the best proxy for disease immunity. But they currently require a healthcare provider to order the test, which has to be performed at a pharmacy or doctor’s office. The sample is then sent to a lab to analyze — all of which takes time, making the process inconvenient and too burdensome for most people.
Researchers at Johns Hopkins have found a way to potentially make antibody testing much more accessible. They developed a method to use widely available and relatively inexpensive glucometers — small devices that read blood sugar levels from a finger prick — to detect SARS-CoV-2 antibodies.
Canada OKs Pfizer COVID Booster for Kids 5 to 11, Sees Monkeypox Cases Slow
Canada’s health ministry on Friday said it had authorized the use of Pfizer Inc.’s (PFE.N) and BioNTech’s (22UAy.DE) COVID-19 vaccine as a booster for children five to 11 years old at least six months after receiving their initial two doses.
Canada is witnessing a decrease in COVID-19 cases but citizens must prepare for the potential emergence of new variants of the virus in the months ahead, Dr. Theresa Tam, Canada’s chief public health officer, told a news conference.
Canada has reported 1,168 confirmed cases of monkeypox, including 30 hospitalizations, Tam said, adding there has “been a slowing trend in the increase in new cases reported in recent weeks.”
Has the Latest COVID Wave in the U.S. Peaked?
U.S. News & World Report reported:
The latest coronavirus wave in the U.S. appears to be receding after a relentless plateau that lasted most of the summer months.
The latest wave, which was fueled by several Omicron subvariants, including BA.2.12.1 and BA.5, brought a steady onslaught of new infections, including among President Joe Biden and first lady Jill Biden, as well as increasing reinfections.
While the wave looks to have crested, the numbers remain elevated with few mitigation measures in widespread use, begging the question: Is this the country’s “new normal?”
What Will the Next Generation of COVID Vaccines Look Like?
As the coronavirus continues to evolve into newer and more contagious variants — capable of evading immunity from infection or vaccination — public health experts are trying to develop the next generation of vaccines that can outsmart the novel virus.
New infections give the virus the opportunity to mutate, and thus, COVID-19 vaccines can wane in efficacy. That’s why during a White House summit last month, federal health officials, public health experts and vaccine manufacturers stressed the need to develop innovative new vaccines to help induce broad and durable protection against coronaviruses.
Here are some of the next-generation vaccines under development:
‘Most Have Thrown Their Hands up’: Has the U.S. Forgotten About COVID?
Have we simply forgotten about COVID-19? Data obtained earlier this month by the Centers for Disease Control and Prevention (CDC) reveals that the rate of new infections has been decreasing, with the country reporting an average of 107,000 new cases a day. This marks a 12% decrease compared to infection rates two weeks ago.
The majority of the recent infections come from BA.4 and BA.5, subvariants of Omicron whose original strain first emerged over eight months ago. According to the CDC, the two variants appear to represent over 80% of the U.S. cases.
With the virus continuing to mutate, breakthrough and rebound infections are becoming increasingly common, especially with the BA.5 variant. New data published in June by Harvard Medical School researchers reveal that the BA.4 and BA.5 appear to evade antibody responses from people who have been fully vaccinated and boosted and those who have previously gotten COVID-19.
More recently, reports have been emerging of another Omicron subvariant, BA.4.6, which is Omicron’s seventh major subvariant since the variant first appeared in Africa last November. According to health experts, BA.4.6 possesses a certain mutation that gives it an increased ability to avoid antibodies.
‘Paxlovid Mouth’: Internet Remedies to Fight Earwax and Dirty Pennies Taste
“Paxlovid mouth” has become a new topic of discussion on social media in recent days, as many people have complained about an unpleasant taste in their mouths after they’ve taken Pfizer‘s Paxlovid to treat COVID-19.
Twitter users have compared the taste left behind by the antiviral drug to earwax, “dirty pennies,” a “horrible rotted placenta” and “satan’s ashtray.” The U.S. Food and Drug Administration (FDA) has acknowledged that an “altered or impaired sense to taste” known as dysgeusia is a possible side effect of Paxlovid, while Pfizer‘s clinical trial of the drug conducted before it was granted emergency use authorization from the FDA said dysgeusia only showed up as a symptom in 5.6% of the people in a study.
‘Window of Opportunity’ to Stop Monkeypox Spread Could Be Closing as Vaccine Rollouts Stall
Concerns are mounting that the window of opportunity for containing the escalating monkeypox outbreak may be closing, with vaccine shortages leaving some at-risk groups waiting weeks to get jabbed.
Health professionals have warned that a failure to get the outbreak under control could see it spill over into other populations or species.
The U.K. Health Security Agency has said that it expects to run out of its initial batch of 50,000 vaccines within the next two weeks, and may not receive further doses until September. Meanwhile, other high-case countries are considering new inoculation methods amid dwindling supplies.
Wastewater Testing, Vital in COVID Tracking, Could Help Identify Monkeypox Spread
As wastewater testing continues to prove useful in estimating the spread of the coronavirus, scientists again are using sewage to track the latest public health emergency: monkeypox.
In late June — about a month after the first California case was confirmed — monkeypox DNA was detected in wastewater in San Francisco, according to the WastewaterSCAN coalition, a group of scientists who have been testing sewage for the coronavirus since 2020.
The group recently confirmed the presence of the monkeypox virus in Los Angeles County waste.
“It helps understand how widespread this is,” said Stanford civil and environmental engineering professor Alexandria Boehm, one of the lead researchers on the WastewaterSCAN team.
Lyme Disease Becomes Latest Infection for New Vaccine Trials
Pharmaceutical companies are trying to launch a new vaccine against Lyme disease after cases recently increased almost five-fold in 15 years.
Pfizer and Valneva announced in a statement last week that they are conducting later-stage studies into what could be the first vaccine to fight the disease in decades.
Current studies are meant to “investigate the efficacy, safety and immunogenicity of their investigational Lyme disease vaccine candidate, VLA15,” according to researchers.
Everyone Over 12 Expected to Be Eligible for New Boosters, White House Official Says + More
Everyone Over 12 Expected to Be Eligible for New Boosters, White House Official Says
White House COVID coordinator Dr. Ashish Jha said on Wednesday that the newly updated COVID boosters will be available to teens and adults “in a few short weeks.”
The new boosters target the Omicron subvariants BA.4 and BA.5, as well as the original strain of the virus. BA.5 accounts for nearly 90% of new COVID cases in the U.S., according to the Centers for Disease Control and Prevention.
The Food and Drug Administration will determine how well the updated shots protect against the virus, Jha said, adding that he expects that they should “work much better at preventing infection transmission and serious illness” than the current boosters.
New Book Challenges COVID Vaccine Narrative
As more research is published on people who have taken the COVID-19 vaccine, more data — at least the data that make it to publication — are revealing that many people have had harmful effects from the injections.
Of course, COVID-19 itself came with health consequences, and everyone understood that. The vaccine was supposed to be so safe and effective that it was acceptable to even coerce people into getting it. In fact, even those who caught COVID-19 and achieved natural immunity were compelled to get the vaccine.
In her latest book “Neither Safe Nor Effective: The Evidence Against the COVID Vaccines,” Dr. Colleen Huber shares some of the data that have been emerging.
The Arizona-based naturopathic medical doctor says the damage done so far from the mRNA vaccines is undeniable. She also highlights issues in the medical and media fields that have kept people from getting access to facts. This all comes as many people are still being pressured to take the vaccine or are suffering consequences.
COVID: ‘Very Rare’ Vaccine Complications Led to Alston Man’s Death
A former rock singer died due to “very rare and aggressive complications of the AstraZeneca COVID vaccine”, an inquest has ruled. Zion XXX, from Alston in Cumbria, developed an “excruciating” headache eight days after his jab in May 2021.
The 48-year-old was taken to hospital but died as a result of “vaccine-induced thrombotic thrombocytopenia.” His fiancée Vikki Spit was the first person to receive compensation for a COVID-19 vaccine death.
The inquest in Newcastle heard that Zion XXX was generally fit and well with no significant previous medical history. His death certificate confirmed he died due to complications from the vaccine, which had led to swelling and bleeding on the brain.
Up to July 27, 2022, the MHRA had received reports of 444 cases of major thromboembolic events (blood clots) with concurrent thrombocytopenia (low platelet counts) in the U.K. following vaccination with AstraZeneca.
HHS Says It Plans to Extend COVID Public Health Emergency
State and local public health officials — having not heard differently this week — are expecting the Biden administration to extend the COVID-19 public health emergency for another 90 days in mid-October.
An extension would ensure expanded Medicaid coverage, telehealth services, boosted payments to hospitals and other pandemic measures remain in place beyond the midterm elections even as public health experts and lawmakers debate the merits of a PHE that was first declared in January 2020.
The administration has not notified groups, including the Association of State and Territorial Health Officials, Federation of American Hospitals and the American Public Health Association, that the PHE would end, a courtesy HHS has said it would issue 60 days before the COVID-19 declaration is terminated. The 60-day notice would have been issued early this week under that pledge.
“Silence from the administration means that the public health emergency will almost certainly be extended into January 2023,” said Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation.
Why Do People Consent to Receiving SARS-CoV-2 Vaccinations? A Representative Survey in Germany
In Germany and elsewhere, public discourse about how to deal with the SARS-CoV-2 pandemic has been dominated from the beginning by the opinion that it is important to achieve a high number of COVID-19 vaccinations in the population.
Politicians and media presented these novel vaccinations as beneficial and receiving them as an act of solidarity and respect for others. In parallel, politicians and other stakeholders have talked about restricting access to public participation for those that are not vaccinated.
This increases implicit pressure on persons that have hitherto refused to be vaccinated to finally assent to being vaccinated. This also introduces novel motives that are no indication for vaccinations, as a medical indication for vaccination would be the prevention of severe or fatal disease.
Anywhere but Here
When Alice Hughes downloaded a preprint from the server Research Square in September 2021, she could hardly believe her eyes. The study described a massive effort to survey bat viruses in China, in search of clues to the origins of the COVID-19 pandemic. A team of 21 researchers from the country’s leading academic institutions had trapped more than 17,000 bats, from the subtropical south to the frigid northeast, and tested them for relatives of SARS-CoV-2. The number they found: zero.
The paper meshed with a growing political reality in China. From the start of the pandemic, the Chinese government — like many foreign researchers — has vigorously rejected the idea that SARS-CoV-2 somehow originated in the Wuhan Institute of Virology (WIV) and escaped.
But over the past 2 years, it has also started to push back against what many regard as the only plausible alternative scenario: The pandemic started in China with a virus that naturally jumped from bats to an “intermediate” species and then to humans — most likely at the Huanan Seafood Market in Wuhan.
Beijing was open to the idea at first. But today it points to myriad ways SARS-CoV-2 could have arrived in Wuhan from abroad, borne by contaminated frozen food or infected foreigners — perhaps at the Military World Games in Wuhan, in October 2019 — or released accidentally by a U.S. military lab located more than 12,000 kilometers from Wuhan.
COVID Can Impair Brain Function, Large Study Suggests
Patients recovering from coronavirus infection suffer from increased rates of neurological and psychological problems, according to a wide-ranging observational study published Thursday.
Researchers from Oxford University combed through more than a million patient files and discovered that two years after infection, patients who had recovered from COVID-19 were at a higher risk of psychosis, dementia and “brain fog” when compared with patients who recovered from other respiratory diseases.
For some symptoms, there was an initial uptick that leveled off. Anxiety and depression fell to rates in line with other respiratory diseases after two months.
But, in the case of brain fog, for example, adults aged between 18 and 64 who had recovered from COVID-19 suffered from it at a rate 16% higher than patients with other respiratory diseases. The difference was more marked in those aged over 65, where increased risk was also found for psychosis and dementia.
Biden Officials Accelerating Monkeypox Vaccine Effort, Including 1.8 Million Additional Doses
The Biden administration is planning to accelerate the delivery of its remaining supply of monkeypox vaccines and will make an additional 1.8 million doses available for ordering starting Monday, officials said Thursday.
Jurisdictions will only be able to access the additional doses if they adopt the intradermal administration of vaccine and have used 90% of their current supply of vaccine, officials said.
The Department of Health and Human Services is also launching a pilot program to provide additional vaccine allocations to state and local health departments in jurisdictions that are hosting large events that attract members of the LGBTQ community.
The latest federal data show more than 13,500 monkeypox cases have been reported so far in the United States.
Monkeypox Vaccine Maker Can’t Keep up With Demand as Case Numbers Swell
Danish biotech company Bavarian Nordic A/S, the only producer of an FDA-approved monkeypox vaccine, said it is struggling to meet the demand for its shots amid the rise in cases of the disease.
Increased demand may force the company to expand its limited manufacturing capacity by outsourcing some of its production, including to facilities in the U.S. Currently, the vaccine is only manufactured at Bavarian Nordic’s Danish facility.
The Danish company had previously said it would produce all of its vaccine doses in the local facility, and that transferring some of its technology to a third-party producer would be cumbersome and inefficient, Bloomberg reported.
But monkeypox case numbers are swelling worldwide, leading to a surge in demand for vaccines and treatments.
Illinois Health Department Urges Schools to Watch for Monkeypox; COVID Measures Pulled Back
Monitoring students and staff at Illinois schools for new and unexplained lesions is among the new monkeypox prevention guidance recommended this week by the state’s health department as officials pivot away from COVID-19 restrictions.
While the monkeypox virus in children is exceedingly rare, with just a handful of such cases across the U.S., a Tuesday webinar hosted by the Illinois Department of Public Health for school district administrators statewide conveyed strategies for preventing the spread of the infection in schools.
“Any persons with MPV should remain out of school until MPV symptoms have resolved, the rash has healed, all scabs have fallen off and a fresh layer of skin has formed per (CDC) recommendations,” officials said in a statement.
School districts were urged to “rapidly identify and assess people who might have been exposed to MPV, in collaboration with the local health department,” while noting that “rashes are not uncommon in children due to a variety of causes.”
CDC Director Orders Agency Overhaul, Admitting Flawed COVID Response + More
CDC Director Orders Agency Overhaul, Admitting Flawed COVID Response
The Centers for Disease Control and Prevention is launching an overhaul of its structure and operations in an attempt to modernize the agency and rehabilitate its reputation following intense criticism of its handling of the coronavirus pandemic and, more recently, the growing monkeypox outbreak.
On Wednesday, CDC Director Rochelle Walensky shared a series of changes with CDC leadership and staff designed to “transform” the organization and its work culture by improving how the agency shares information, develops public health guidance and communicates with the American public.
There is consensus within the CDC that it “needs to make some changes for how it communicates and how it operates — to be faster, to be nimbler, to use more plain-spoken language,” said a CDC official, who was granted anonymity to discuss the changes before they were announced.
Biden Administration Will Stop Buying COVID Vaccines, Treatments and Tests as Early as This Fall, Jha Says
The Biden administration has been planning for how to get past the crisis phase of the COVID-19 pandemic and will stop buying vaccines, treatments and tests as early as this fall, White House COVID-19 Response Coordinator Dr. Ashish Jha said on Tuesday.
“My hope is that in 2023, you’re going to see the commercialization of almost all of these products. Some of that is actually going to begin this fall, in the days and weeks ahead. You’re going to see the commercialization of some of these things,” he said.
Availability of those products would transition to the regular healthcare system, Jha said, so if you need a vaccine or an antiviral treatment, you’d get it from your doctor or from a hospital.
Jha said the transition to commercialization is complicated. It involves regulatory issues, market dynamic issues and equity issues, but the administration is working carefully and thoughtfully to get it right.
Scientists Have Re-Created the Deadly 1918 Flu Virus. Why?
With all the controversy about gain-of-function research and all the concerns about how dangerous it is, you might think that scientists have stopped doing that kind of work. Well, no.
In the latest news, a team of scientists in Canada and the U.S. report that they have re-created the 1918 influenza virus and used it to infect macaques. Let’s be clear here: the 1918 flu vanished from the Earth, long ago. It’s simply not a threat, or at least it wasn’t until someone figured out a way to bring it back.
Why do they do it? All of the papers give essentially the same reason: these experiments, they say, will help us develop animal models in which we can test vaccines. These same justifications have been used for decades, but flu vaccines haven’t improved one whit, as far as I can tell.
But hold on a minute! Even if you accept their argument that infecting macaques and other animals with the influenza virus will help develop better vaccines, why use the 1918 influenza virus at all?
They don’t answer that question, because there really is no good answer. The fact is that the experiments will be more relevant if they use currently circulating flu strains — because those are the strains that we need vaccines against.
Lab Rat Offspring Got Rib Malformations From COVID Vaccine: Moderna Trial Documents
Moderna documents regarding its COVID vaccine trial on animals, obtained via a Freedom of Information Act request by Judicial Watch, showed that some of the rats that were tested with the Moderna mRNA shot developed rib malformations.
The 700 pages contain a portion of the formal Biologics Licensing Application (BLA) package that a manufacturer is required to submit to the FDA for approval.
The documents have not yet been made public but were analyzed by former pharma executive Alexandra Latypova and reviewed by The Epoch Times. Included in the documents are test results that show that Moderna mRNA shots caused statistically significant skeletal malformations in the offspring of the rats that took the mRNA-1273 (Spikevax mRNA) doses.
Despite the abovementioned lab results, the FDA issued a statement on Jan. 30 saying that there were no adverse effects on postnatal developments.
COVID Public Health Emergency Appears to Be Headed for Extension
The Biden administration appears headed toward extending the COVID-19 public health emergency for another three months, allowing special powers and programs to continue past the midterm election.
HHS had extended the emergency declaration through Oct. 13 and pledged it would give states and health providers 60 days’ notice before it ends. Lifting the emergency would bring major policy shifts to insurance markets, drug approvals and telehealth.
After a long plateau, the number of new COVID cases has been falling and wastewater surveillance data has shown declines for three straight weeks, per Evercore ISI.
What You Need to Know About Moderna’s New ‘Bivalent’ COVID Vaccine
Moderna Inc. has just received approval from the U.K. for a COVID-19 booster shot that targets Omicron, the version of the virus that’s now the world’s most widespread. The snappily-named Spikevax Bivalent Original/Omicron has been given the green light for use in the U.K. and is expected to be rolled out in other countries soon.
The new shot targets two separate strains of COVID-19 — the original version of the virus that emerged in the central Chinese city of Wuhan along with the BA.1 subvariant, the earliest version of Omicron.
Other versions of Omicron, BA.4 and BA.5, are now more prevalent, but the virus is evolving faster than new vaccines can be formulated and tested, and this is the closest match available that has received clearance. Moderna has another shot available that targets the BA.4 and BA.5 subvariants, which has been ordered by the U.S., but not yet cleared.
Is Oxygen the Answer to Long COVID?
She was dead tired but couldn’t sleep, couldn’t think straight and could barely walk. The muscle pain in her arms and legs was so bad that she spent days in bed. When she did get up, she used a wheelchair. And she couldn’t focus on even the most trivial tasks, let alone work. But doctors couldn’t agree on what was wrong with 41-year-old Maya Doari.
The sac-like tissues surrounding her heart were inflamed, of that they were sure, so she was diagnosed with pericarditis. But when her left hand turned blue — on and off for months — her physicians told her “don’t try to understand,” because they no longer could.
Yet today, a year after her long COVID symptoms arrived, Doari says they are “98% gone,” a turnaround tied to new research that may have uncovered a promising long-COVID treatment.
It’s called hyperbaric oxygen therapy, and in July Israeli researchers published a study — in which Doari participated — that showed using this technique to deliver massive amounts of oxygen to the body appears to alleviate many of COVID’s cognitive and physical after-effects.
Merck Jumps Into a $3.7 Billion mRNA Collaboration
Merck has been a laggard among its peers in the COVID-era race to invest in messenger RNA technology, but on Tuesday it announced a deal worth as much as $3.7 billion with a private biotech to collaborate on mRNA-based vaccines and therapeutics.
Merck made the deal with year-old Cambridge-based biotech called Orna Therapeutics, which has a novel take on mRNA. The company calls the approach oRNA, and it involves modifying mRNA strands so that they form a circle rather than a line. The company says that will make them work better as medicines.
Doctor Warns of Suspicious Pattern Behind Monkeypox Outbreak
There has been much speculation that the novel coronavirus was a bioweapon developed in a Chinese Communist Party (CCP) lab. Now, an American doctor has a theory that the new monkeypox outbreak may also have similar nefarious origins.
Dr. Syed Haider told The Epoch Times that the development of the monkeypox outbreak seems identical to the way COVID-19 was introduced to the world.
“It’s an unusual variant,” Haider said. “We’ve never had a variant of monkeypox that primarily spreads between gay men.” Haider said there are other signs that lead him to believe the current strain of monkeypox was engineered.
He said the monkeypox virus mutates very slowly and that the last known precursor to this variant is so different that it could not have happened naturally, adding that there just wasn’t enough time for natural evolution to create the variant spreading right now.
WHO Says Monkeypox Vaccine ‘Not a Silver Bullet’ as Breakthrough Cases Reported
The World Health Organization said Wednesday that the monkeypox vaccine is not a “silver bullet,” with the health body beginning to receive reports of breakthrough cases after people have received the vaccine.
“The fact that we’re beginning to see some breakthrough cases is also really important information because it tells us that the vaccine is not 100% effective in any given circumstance, whether preventive or post-exposure,” said Rosamund Lewis, the WHO’s technical lead for monkeypox.
“We have known from the beginning that this vaccine would not be a silver bullet, that it would not meet all the expectations that are being put on it.”
The only approved vaccine for monkeypox is from developer Bavarian Nordic and is being used as both a preventative vaccine, as well as to protect people recently exposed to the virus. Monkeypox, which spreads through close physical contact, was declared last month by the WHO to be a public health emergency of international concern.
An HIV Vaccine May Be Closer Than Ever — Thanks, in Part, to COVID
Despite nearly forty years of research, there’s still no vaccine to combat HIV/AIDS. However, recent discussions at the 24th International AIDS Conference in Montreal provided some hope that that situation might change.
Roughly a year after the world first became aware of COVID-19, two vaccines that effectively reduce the risk of this disease were approved for use by the Food and Drug Administration. Lessons learned during the development of those vaccines may spur efforts to develop a vaccine against HIV/AIDS.
As I’ve described before, HIV/AIDS and COVID-19 differ in myriad ways. HIV and SARS-CoV-2 are different viruses that are transmitted in different ways and cause vastly different diseases. Additionally, structural and biological differences between these two viruses have impacted our ability to develop effective vaccines.
The search for an effective HIV vaccine has been a slow, arduous process. But the 40-year struggle has benefited the vaccine field in many ways. We understand the human immune system better because of the work done on HIV. Arguably, the COVID-19 vaccines were developed so rapidly in part because of lessons learned from HIV. Now, perhaps, lessons learned from COVID-19 will impact the development of an HIV vaccine.