Covid News Watch
Pfizer and Moderna to Investigate Their Own Vaccines for Myocarditis Risks + More
Pfizer and Moderna to Investigate Their Own Vaccines for Myocarditis Risks
Why is Big Pharma investigating their own COVID vaccines for myocarditis side effects if the vaccines were already supposedly tested and proven safe and effective? Both Pfizer and Moderna have announced that they will be undertaking studies to determine the longer-term risks of myocarditis (an inflammatory condition of the heart which can lead to death) for people who have been injected with the mRNA-based COVID vaccines.
The decision comes after the release of multiple medical studies which show a correlation and causation between the vaccines and an exponential increase in heart problems, specifically among men 40 years old and younger. Only a year ago the link between COVID vaccinations and myocarditis was widely denied.
Studies also show that myocarditis risk increases with the number of boosters a person has taken.
Before the year 2020, the average vaccine was tested and re-tested by pharmaceutical companies and the FDA for 10 to 15 years before it could be released to the public. This was done not only because testing is a complex process with a lot of red tape involved, but also because it is the only way to discover any long-term side effects that might be associated with a particular immunization product. If you read any medical journal or scientific outline on vaccine development published before 2020, they all agree that long-term testing is necessary for public safety.
How the Speed of the COVID Vaccine Breakthrough Is Changing the Way Pfizer Thinks About the Future
The mRNA technology underlying COVID vaccines was being perfected in the lab for decades ahead of its biggest real-world test during the pandemic, but the actual breakneck pace at which COVID vaccines and antiviral drugs like Paxlovid came through clinical trials and to the market was unprecedented. That’s an experience and speed of discovery that Pfizer hopes to replicate as it looks to the future of vaccine and drug development.
Aamir Malik, who joined Pfizer in August 2021 as chief business innovation officer, said far from any letdown after the huge success of the COVID vaccine, he came into a company where “there was almost an even renewed energy” within the organization after the vaccine success.
“Let’s do that again, and let’s figure out what are all the other problems that we can bring this kind of mindset, our resources, our capabilities, to try and solve,” Malik said at the recent CNBC Work Summit. Tapping into that energy, Malik said, means understanding and learning from the “importance of speed” in the COVID vaccine success story.
“It was very evident in the pandemic because it needed to be solved with urgency, and we’ve taken this concept of speed now and applied it to everything we do,” he told CNBC’s Bertha Coombs. “If we can find a way to take three years out of the timeline of developing a drug which can last orders of magnitude longer, that’s three years faster we can bring medicine to a patient. And in order to make a change like that requires tremendous ingenuity, but there’s a belief it can be done.”
High Court Injunction Sought Over Use of COVID Vaccines on Children
Two individuals have asked the High Court to make orders preventing the State from administering COVID-19 vaccines or booster shots to children aged between five and 11 years of age until full information about any alleged risks has been given to the public. The action has been brought by Limerick housewife Sharon Browne and data analyst David Egan.
They are seeking to injunct Taoiseach Micheál Martin, Minister for Health Stephen Donnelly, the Health Service Executive (HSE) and the former chief medical officer, Dr. Tony Holohan. The pair, who were not legally represented, claim they are seeking an injunction to protect the rights of children. They claim that alleged harm is being caused by the vaccines, which breaches the Constitutional right to bodily integrity.
The action is opposed by the State and the HSE, which is represented by David Leahy SC. They deny all the adverse claims about the vaccine’s safety.
If granted, the applicants claim, the order would allow parents and guardians to be fully informed about what the applicants allege are the risks, deaths, injuries, illnesses and disabilities caused by the vaccines. This information, it is claimed, would allow parents to give informed consent regarding vaccination.
Australia Recommends Against Fifth Vaccine Dose as Fresh COVID Wave Builds
Australian health authorities have recommended against getting a fifth COVID-19 vaccine shot, even as they urged those eligible to sign up for their remaining booster doses as the country’s latest COVID wave grows rapidly.
Health Minister Mark Butler said the Australian Technical Advisory Group on Immunizations (ATAGI) had recommended against a fifth dose, or third booster, after evidence from Singapore’s recent wave showed that severe illness and death were rare among the vaccinated and that a fifth shot had minimal impact on virus transmission.
Butler also accepted ATAGI recommendations that Pfizer‘s (PFE.N) Omicron-specific vaccine be approved as a booster dose for adults; 4.7 million doses will arrive ahead of a rollout due to begin on Dec. 12. The company’s vaccine for children aged six months to five years will also be approved for use on the severely immunocompromised.
Biden Administration to Renew Fight for More COVID Funding With $10 Billion Request
The White House will return for another round of the fight for COVID-19 funding. After multiple failed attempts this past winter and spring to secure more money to address the pandemic, the White House plans on requesting $10 billion during the lame-duck session of Congress before newly elected lawmakers begin in January, sources familiar with the discussions confirmed to ABC News.
It could potentially be one of the last chances for Democrats to receive additional COVID funding if there is a divided government next year, but it also comes at one of the lowest points of public concern over the entire pandemic. In a recent poll from Quinnipiac University that asked voters about the most urgent issues ahead of the midterms, only 1% said the pandemic.
People familiar with the budget discussions told ABC News that that $10 billion request would go toward the “research and development of next-generation vaccines and therapeutics” — which has been a major priority for the administration — as well as research into long COVID and global efforts to combat the virus. There would also be some money set aside for combating other infectious diseases, these people said.
Sick With a New Omicron Variant? Be Prepared for This Symptom, New Study Says
If you’ve come down with one of the newer COVID variants related to “stealth Omicron” BA.2, you might want some fever-reducer at the ready. Among more than 200 patients in India who were infected with several BA.2 strains, the vast majority — 82% — experienced a fever, according to an article published last week in Cureus Journal of Medical Science.
Just under half had a cough, researchers found, and more than a third had cold symptoms. Other symptoms included fatigue (27%), headache (21%), and muscle pain (20%).
Most patients recovered with minimal treatment. Only 5% percent required hospitalization, a little over 4% required oxygen, and three died, researchers noted. About a quarter of patients provided vaccination information, and virtually all had received at least one dose of a COVID vaccine.
Fauci’s Pandemic Leadership Needs to be Investigated: Dr. Scott Atlas
Former White House COVID-19 adviser Dr. Scott Atlas sees multiple reasons for an investigation into Dr. Anthony Fauci, the outgoing director of the National Institute of Allergy and Infectious Diseases (NIAID).
Such a probe has been in the talks as Republicans inch closer to a House majority that would grant them subpoena powers. Some GOP lawmakers have accused Fauci of playing a role in misleading the public about the origins of COVID-19 and supporting pandemic mandates they describe as draconian.
While Atlas, a vocal critic of the NIAID head, is “very skeptical” that an investigation like this could get away from politics or the perception of it being political, he thinks it’s warranted. Fauci’s changing stance on certain COVID-19 policies needs to be put under the spotlight, Atlas recently said on the EpochTV’s Newsmakers program.
He further questioned if there had been any “cover-up” of funding from the National Institutes of Health (NIH) in Fauci’s division, citing the awards to the Wuhan Institute of Virology through the New York nonprofit EcoHealth Alliance as an example.
What Is BN.1? Meet the Newest Omicron Spawn Being Tracked by the CDC
The U.S. Centers for Disease Control and Prevention on Friday added a 16th variant to the list of those it’s tracking — BN.1.
The newly singled-out strain was estimated to comprise just over 4% of U.S. infections through Saturday, making it the sixth most common variant in the country. It came in just above BA.4.6, a descendant of Omicron spawn BA.4, which was prominent globally this summer.
Just what do we know about one of the newer additions to COVID’s autumn “alphabet soup”? BN.1, also a strain of Omicron, is a shorter name for B.1.1.529.2.75.5.5.1, according to cov-lineages.org, a collection of COVID data run by contributors at universities in the U.K. and Australia. The new variant is also a descendant of “stealth Omicron” BA.2, which became famous for producing confusing results on lab-based COVID tests when it was prominent this spring and summer.
So far, the largest concentrations of BN.1, first identified in late July, have been found in the U.S., the U.K., Austria, Australia and India, according to cov-lineages.org. Each country is home to about 15% of the nearly 4,000 identified cases throughout the world.
Pandemic Still Affecting U.K. Students’ Mental Health, Says Helpline
The pandemic is still taking its toll on U.K. university students’ mental health, experts are warning, as figures show that growing numbers are seeking help from peer-run helplines for anxiety, depression and suicidal thoughts.
Nightline, which is staffed by anonymous student volunteers, said it had recorded a 51.4% increase in calls in 2020-21, and that this has grown since, with early data suggesting numbers for 2021-22 were 30% higher, and up a further 23% since the new academic year began.
The helpline, which has been running for more than 50 years, said there had been a significant increase in callers discussing stress and anxiety, reaching 10.9%. This has risen to 17% since September, including a rise in calls from students worried about their finances.
Despite a small reduction in calls from students attempting suicide, Nightline recorded an increase in the number expressing suicidal thoughts, which has risen even higher this year, reaching 7.4% of calls.
U.S. COVID Public Health Emergency to Stay in Place + More
U.S. COVID Public Health Emergency to Stay in Place
The United States will keep in place the public health emergency status of the COVID-19 pandemic, allowing millions of Americans to still receive free tests, vaccines and treatments, two Biden administration officials said on Friday.
The possibility of a winter surge in COVID cases and the need for more time to transition out of the public health emergency to a private market were two factors that contributed to the decision not to end the emergency status in January, one of the officials said.
The public health emergency was initially declared in January 2020, when the coronavirus pandemic began, and has been renewed each quarter for 90 days. But the government in August began signaling it planned to let it expire in January.
The U.S. Department of Health and Human Services (HHS) has promised to give states 60 days’ notice before letting the emergency expire, which would have been on Friday if it did not plan on renewing it again in January. The agency did not provide such notice, the second official said.
Myocarditis After COVID Vaccination: Research on Possible Long-Term Risks Underway
In October 2021, Da’Vion Miller was found unconscious in the bathroom of his home in Detroit a week after receiving his first dose of Pfizer‘s COVID vaccine. He had known something was wrong: Then 22, he had started experiencing chest pain two days after getting vaccinated, followed by fatigue, shortness of breath and dizziness.
Miller was rushed to Henry Ford West Bloomfield Hospital, where he was diagnosed with myocarditis, an inflammation of the heart muscle, and pericarditis, an inflammation of the outer lining of the heart. His doctor advised him not to receive a second dose of either the Pfizer or the Moderna vaccines.
Now, the first research in the U.S. is underway, tracking adverse health effects — if any — that may appear in the years following a diagnosis of vaccine-associated heart problems. Moderna has already launched two trials, the most recent in September. Pfizer confirmed that at least one of its trials, which will include up to 500 teens and young adults under age 21, is slated to begin in the next couple of months.
The Food and Drug Administration has required that the drugmakers conduct several studies assessing the potential long-term impacts of myocarditis, as part of its approval of the mRNA COVID vaccines in the U.S. Early findings from the research could be published as early as next year, sources told NBC News.
Some of the trials will follow those who developed the condition for as long as five years, according to the FDA’s approval letters. The trials will be monitoring for myocarditis and subclinical myocarditis, which doesn’t cause symptoms.
The Search for COVID’s Origins Is as Important as Ever
The possibility that the COVID pandemic started with a lab accident isn’t a conspiracy theory. Nor has science conclusively proven that it started in a Wuhan wet market. We simply don’t know — because China has set up numerous roadblocks to impede scientists’ ability to understand the origin of a pandemic that’s killed millions and shows no sign of ending.
Americans, however, have been channeling our outrage not at China’s evasiveness, but at each other for disagreeing on what conclusions to draw from the sparse and indirect data that China has made available. Even if there isn’t enough evidence to paint a definitive picture of COVID’s origin, though, there’s something to be learned by stepping away from the fray and looking at whatever clues we have.
Identifying COVID’s origin didn’t have to become so fraught. After two previous coronavirus outbreaks — SARS1 and MERS — definitive data on their origins were available to scientists, said Laura Kahn, a physician who had studied biological threats at Princeton’s program on science and global security before co-founding the One Health initiative, aimed at pandemic prevention.
China stalled for four months after the SARS outbreak, she said, but scientists there collected critical data and eventually allowed international teams in to investigate. The Middle Eastern countries where MERS was spreading allowed similar data collection.
That’s very different from China’s behavior when SARS-CoV-2 broke out. Officials quickly cleared out the Wuhan market where early cases were found before any suspect animals could be tested. Taking blood samples from lab workers and market workers early on could have led to antibody tests that would have given hard evidence one way or another. (If such samples were taken in Wuhan, they were never disclosed to the outside world.)
Moderna Says Its Updated Booster Raises Antibodies Against Omicron Subvariants
Moderna’s updated COVID booster appears to increase the immune response to Omicron subvariants BA.4 and BA.5, as well as another subvariant, called BQ.1.1, that’s gaining ground in the United States, the company said in a release Monday.
The results are based on blood samples taken from 511 adults who got the updated booster, which targets BA.4 and BA.5, along with the original coronavirus strain, in a single shot. In people who got the updated booster, neutralizing antibodies against BA.4 and BA.5 were about fivefold higher in those with a previous COVID infection and sixfold higher in those without a documented infection, the company said.
Moderna’s results, announced in a news release, have not been published in a peer-reviewed journal or reviewed by outside scientists.
The data still doesn’t answer key questions: “Do these vaccines bring back durable protection against infection and onward transmission of SARS-CoV-2, and if so, for how long?” said Dr. Isaac Bogoch, an infectious disease specialist at the University of Toronto.
Study Finds ‘Huge’ Increase in Children Going to the Emergency Room With Suicidal Thoughts
There has been a steady increase in the number of children who are seen in emergency rooms for suicidal thoughts, according to a new study — and the increase started even before the COVID-19 pandemic, which brought record high demand for psychological services for children.
The pandemic’s effects drew renewed attention to suicide in teens and young children. In June, the Biden administration called the recent rise in rates of depression, anxiety and suicidal thoughts among kids an “unprecedented mental health crisis.”
The study, published Monday in the journal Pediatrics, used data from hospitals in Illinois. The researchers looked at the number of children ages 5 to 19 who sought help for suicide in emergency departments between January 2016 and June 2021.
In that period, there were 81,051 emergency department visits by young people that were coded for suicidal ideation. About a quarter of those visits turned into hospital stays. The study found that visits to the ER with suicidal thoughts increased 59% from 2016-17 to 2019-21. There was a corresponding increase in cases in which suicidal ideation was the principal diagnosis, which rose from 34.6% to 44.3%.
Hospitalizations for suicidal thoughts increased by 57% between the fall of 2019 and fall of 2020.
Dr. Anthony Fauci Talks Family, Career and What’s Next
Dr. Anthony Fauci may be stepping down from his role as chief medical advisor to the president in December, but the immunologist says he’s “not even close” to completely retiring.
Fauci has served under seven different presidents, covering health crises from Ebola to the AIDS epidemic. Over the course of his five-decade career, the physician has faced both criticism and accolades from officials and the public.
He reflected on the work of his career, and what the nation has learned over the years, noting that the response to AIDS informed the country on the COVID-19 vaccine development.
“We made major investments in science for decades prior to COVID, and within 11 months [to] have a vaccine that went through massive clinical trials, that is beyond unprecedented,” he said. “We will never be able to prevent the emergence of a new infection. What you can do is prevent that emergence from becoming a pandemic.”
COVID Variants BQ.1/BQ.1.1 Make up 44% of U.S. Cases — CDC
The U.S. national public health agency said on Friday that Omicron subvariants BQ.1 and BQ.1.1 were estimated to account for about 44.2% of COVID-19 cases in the country for the week ending Nov. 12, compared with 32.6% in the previous week.
The two variants, which are closely related to Omicron’s BA.5 sub-variant that drove COVID-19 cases in the United States earlier in the year, made up less than 10% of total cases in the country last month, but currently have surpassed Omicron’s BA.5, according to the U.S. Centers for Disease Control and Prevention.
While there is no evidence linked to the increased severity of the new variants compared to BA.4 and BA.5, they have shown an increasing presence in Europe, Singapore and Canada, among other places.
Omicron BQ Variants Resistant to Antibody Treatments Are Quickly Becoming Dominant in U.S.
Omicron subvariants resistant to key antibody treatments will soon make up a majority of new COVID infections in the U.S., according to the Centers for Disease Control and Prevention. Omicron subvariants BQ.1 and BQ.1.1 now make up 44% of new COVID cases compared to 32% last week, according to CDC data. These subvariants will likely become dominant in the next week.
BQ.1 and BQ.1.1 pose a special threat to people who have severely compromised immune systems, such as organ transplant patients and people on cancer chemotherapy. Many people with moderate or severely compromised immune systems take an antibody cocktail called Evusheld to protect them from severe disease. It is administered as two injections every six months.
But BQ.1 and BQ.1.1 are likely resistant to Evusheld, according to the National Institutes of Health. This leaves people with compromised immune systems increasingly vulnerable as these subvariants become dominant.
BQ.1 and BQ.1.1 are also likely resistant to bebtelovimab, a monoclonal antibody people with compromised immune systems can take to prevent severe disease from COVID after an infection.
Cruise Ship With 800 COVID-Positive Passengers Docks in Sydney
A cruise ship with hundreds of COVID-positive passengers docked in Sydney, Australia, after being hit by a wave of infections. The Majestic Princess cruise ship was about halfway through a 12-day voyage when an outbreak of cases was noticed, Carnival Australia president Marguerite Fitzgerald told reporters in a media briefing on Saturday.
Cruise operators separately escorted those infected off the ship and advised them to complete a five-day isolation period, CNN affiliate Nine News reported. Those who tested negative were permitted to leave the ship, a New South Wales Health statement read.
Fitzgerald said the company has been implementing “the most rigorous and strict measures which go well above current guidelines,” including requiring 95% of guests over the age of 12 to be vaccinated and testing staff and passengers for COVID before they board.
The Majestic Princess isn’t the first Carnival cruise to be hit by a COVID outbreak. At least three other ships within the company’s Princess fleet — the Ruby Princess, Diamond Princess and Grand Princess — experienced outbreaks earlier in the pandemic.
Thousands of Experts Hired to Aid Public Health Departments Are Losing Their Jobs
As COVID-19 raged, roughly 4,000 highly skilled epidemiologists, communication specialists and public health nurses were hired by a nonprofit tied to the Centers for Disease Control and Prevention to plug the holes at battered public health departments on the front lines.
But over the past few months, the majority of the CDC Foundation’s contracts for those public health workers at local and state departments have ended as the group has spent nearly all of its almost $289 million in COVID relief funding. The CDC Foundation, an independent nonprofit that supports the CDC’s work, anticipates that no more than about 800 of its 4,000 hires will ultimately staff those jurisdictions, spokesperson Pierce Nelson said.
That has left many local and state health departments facing staffing shortages as the nation eyes a possible winter uptick in COVID cases and grapples with the ongoing threat of monkeypox, exploding caseloads of sexually transmitted infections and other public health issues.
European Regulator Recommends Pfizer’s Omicron Booster for Children + More
European Regulator Recommends Pfizer’s Omicron Booster for Children
Pfizer Inc. (PFE.N) and its partner BioNTech said on Thursday the EU health regulator has recommended authorizing the use of their bivalent COVID-19 shot as a booster in children aged 5 through 11.
The Omicron-tailored vaccine is already authorized by the European Commission for individuals aged 12 years and above. The updated bivalent booster shot targets the original coronavirus strain as well as the BA.4 and BA.5 sub-variants of Omicron.
In October, European Medical Agency backed authorization of Moderna Inc.’s (MRNA.O) COVID-19 tailored booster shots for 12 and above to further vaccination campaigns in the region.
‘We’re Not Permitted to Make the Connection’: Social Worker Shares Aftermath of COVID Vaccine Injury
As a social worker known for her expertise when handling high-stress conflict management cases, Angela Loerzel Swafford figured she’d navigate her own concerns when it came to addressing her employers’ vaccination mandate last fall. And she definitely had concerns.
Like many hospitals and health systems across the nation during that time, the hospital where the 46-year-old was and is still employed required their health workers to get the jab. But Swafford suffers from a venous malformation, a condition where veins in the body develop in an unusual way. Because the abnormality can increase the risk of developing blood clots and deep vein thrombosis, she was hesitant about getting the COVID jab.
After being one of the last of her cohort of colleagues to receive the first Pfizer shot, what transpired next for Swafford was nothing short of horrifying. Four hours later she started noticing pain in her upper body and difficulty charting her patients. Driving home that night, she lost orientation as to where she was.
Once home, the strange sensations were followed by a repeated jerking of her whole body, what she said resembled Tonic-Clonic seizures. She also experienced blurred vision and terrible headaches. Ultimately, Swafford was diagnosed with a severe adverse reaction to the mRNA vaccine. “We kept running into providers in every system saying, ‘We’re not permitted to make the connection’ or ‘It doesn’t mean anything until studies support it’ or ‘It doesn’t exist until the scientific community writes about it,” recounted Swafford.
AstraZeneca No Longer Pursuing U.S. Approval for COVID Vaccine
AstraZeneca (AZN.L) is no longer pursuing U.S. approval of its COVID-19 vaccine, Chief Executive Pascal Soriot said in a media call on Thursday.
Demand for vaccines in the country is declining and the market is well served by the mRNA shots, he said.
Who Killed the COVID Vaccine Waiver?
“Is that a direct threat? I don’t know.” The adviser to the Belgian prime minister spoke calmly as they recounted a lobbying phone call from 2021, but the contents of the conversation are extraordinary.
The call was from a spokesperson for Janssen, the Belgian-founded pharmaceutical arm of Johnson & Johnson (J&J) that developed the company’s single-shot COVID-19 vaccine. According to the adviser, the spokesperson warned them that if Belgium supported a radical proposal made by India and South Africa at the World Trade Organization, then Janssen might rethink its vast billion-dollar research and development investments in Belgium.
The proposal that provoked this fear, known as the TRIPS waiver, would have allowed some intellectual property (IP) rights for COVID-19 products to be waived during the pandemic. The ambition was to give companies wanting to produce vaccines and treatments the “complete freedom to operate,” explained one official from a country that co-sponsored the proposal.
Big Pharma used its vast lobbying and influencing efforts to try to kill a proposal that threatened the very tenets of the industry. Top industry executives enjoyed direct access to senior officials within the EU, which was opposed to the proposal from the very start and encouraged potentially rogue member countries, including Italy and France, to fall into line.
And the U.S., after a dramatic late intervention in favor of a waiver for vaccines, eight months after the proposal had been tabled, failed to follow through as the Biden administration came under pressure from industry and Congress, as reported by the Intercept.
Keeping Your Blood Pressure Below This Number Reduces Risk of Severe COVID, Study Finds
High blood pressure is a known risk factor for a bout of COVID-19 severe enough to raise the specter of hospitalization and death. In fact, research has shown having high blood pressure doubles the risk of having a severe case of COVID, even if you are fully vaccinated and boosted.
But what is considered a high enough blood pressure reading to trigger that risk? To date, scientists haven’t been sure. Now, a new study out of England published Wednesday in the journal PLOS One has answered that question.
“We found that in those with diagnosed hypertension, the risk of COVID-19 significantly increased once the high number exceeded 150 mmHg or the low number exceeded 90 mmHg compared to a target blood pressure (120-129/80-89 mmHg),” said lead author Holly Pavey, a doctoral student at the University of Cambridge in the United Kingdom who is funded by the British Heart Foundation, via email.
The research found people with this level of uncontrolled high blood pressure are more likely to be admitted to the hospital and die from a COVID infection, regardless of other known risk factors such as age, ethnicity or obesity.
Sanofi, GSK Score Late Win With EU COVID Booster Approval
Sanofi (SASY.PA) said on Thursday it won European Union approval for its COVID-19 vaccine booster, jointly made with British partner GSK (GSK.L), after a drawn-out development effort that saw the pair fall behind now-dominant vaccine suppliers.
The shot with the brand name VidPrevtyn Beta can be given to people who have already had a primary course of vaccination from other approved shots, the French drugmaker and the European Medicines Agency said in separate statements.
Shipments are ready to be distributed to European countries under advance purchase agreements, Sanofi said. The company said last year that the European Union and Britain had ordered a combined 75 million doses of the shot, contingent on approval.
The shot is based on lab-made viral proteins provided by Sanofi and an adjuvant ingredient from GSK that increases the immune response. By contrast, approved mRNA shots instruct human cells to produce viral proteins that alarm the immune system.
Repeat COVID Is Riskier Than First Infection, Study Finds
The risk of death, hospitalization and serious health issues from COVID-19 jumps significantly with reinfection compared with a first bout with the virus, regardless of vaccination status, according to a study published on Thursday.
“Reinfection with COVID-19 increases the risk of both acute outcomes and long COVID,” said Dr. Ziyad Al-Aly of Washington University School of Medicine in St. Louis. “This was evident in unvaccinated, vaccinated and boosted people.”
The findings were drawn from U.S. Department of Veterans Affairs data collected from March 1, 2020, through April 6, 2022, on 443,588 patients with one SARS-CoV-2 infection, 40,947 with two or more infections, and 5.3 million noninfected individuals. Most of the study subjects were male.
New Yale Study Finds Promising Results With Nasal COVID Vaccine
A nasal booster vaccine could be key for preventing COVID-19 transmissions, according to a new study published by Yale researchers.
The research team — led by Benjamin Goldman-Israelow, a YSM assistant professor, and Tianyang Mao, a YSM graduate student — hopes to prevent the COVID-19 vaccine’s efficacy from waning over time with their nasal vaccine, called “Prime and Spike.” Immunity from the intranasal vaccine would build off of the initial vaccination to help produce mucosal immunity — immunity specifically located in the nose, respiratory tract and lungs.
The nasal vaccine — which would be administered as a booster shot after an initial intramuscular vaccination — is a subunit vaccine, meaning it delivers a part of a COVID-19 spike protein to prime the body for infection.
This is where the name “Prime and Spike” comes from — the “prime” refers to the intramuscular vaccine “priming” the body for the “spike” protein delivered through the nasal vaccine.
U.S. FDA Panel Votes Against Veru’s COVID Pill
A panel of outside advisers to the U.S. health regulator on Wednesday voted against authorizing Veru Inc’s (VERU.O) drug for treating high-risk patients hospitalized with COVID-19, citing multiple concerns over efficacy and safety data being based on a small trial.
The panel voted 8-5 against the oral drug sabizabulin’s usage and hinted that Veru gather additional data, preferably from a larger sample, regarding the drug’s ability to treat COVID-19.
The unfavorable vote is a setback for Veru in its effort to develop a COVID-19 treatment. The company was originally testing sabizabulin, which prevents tumor cells from multiplying, as a treatment for prostate cancer.
During the meeting, other issues with sabizabulin’s data were also discussed, such as the lack of clarity over a relevant patient population and the high rate of deaths in a placebo group, which the reviewers had previously flagged.
FDA Authorizes IL-1 Drug for Hospitalized COVID Patients — Anakinra Indicated for Patients With Pneumonia Who Are at Risk of Severe Respiratory Failure
The FDA has issued an emergency use authorization (EUA) for anakinra (Kineret) injection for the treatment of COVID-19 in certain hospitalized adults.
These patients include those with pneumonia who require supplemental oxygen (low- or high-flow) and are at risk of progressing to severe respiratory failure and are likely to have an elevated plasma soluble urokinase plasminogen activator receptor.
Anakinra is an interleukin-1 (IL-1) receptor antagonist that is currently FDA-approved for the treatment of rheumatoid arthritis, cryopyrin-associated periodic syndromes and deficiency of IL-1 receptor antagonists.
Paul Offit on Science, Truth and Why He’s Not a Fan of Latest COVID Boosters + More
Paul Offit, Philly’s Most Vocal Vaccine Advocate, on Science, Truth and Why He’s Not a Fan of the Latest COVID Boosters
The Philadelphia Inquirer reported:
Philadelphia’s most prominent immunization expert isn’t planning to get the latest COVID-19 booster shot and doesn’t think most others need to either. Paul Offit, who is among the Food and Drug Administration’s advisers on which vaccines the public should receive, disagrees with the current recommendations of the White House, FDA and Centers for Disease Control and Prevention that everyone over the age of 5 should get the new vaccine.
“This product was grossly oversold,” said Offit, who was in the minority on the FDA’s panel of independent experts who voted 19-2 in June to recommend that the COVID vaccines used for boosters should be updated to the bivalent vaccine now being offered across the nation.
The government’s handling of this new COVID-19 vaccine frustrates Offit. He believes the average healthy person who has been fully vaccinated and boosted gets increasingly minuscule benefits from additional shots and probably doesn’t need the bivalent booster.
What concerns Offit more is the federal government making a decision that isn’t backed by robust science. Evidence of the bivalent vaccines’ effectiveness, which included human trials, but with a bivalent vaccine designed for a COVID strain different than those now circulating, and tests with mice, was “underwhelming,” Offit said.
The Latest COVID Variants Can Evade Vaccine Protection, According to New Data
New lab data suggest that vaccines and prior infections may not offer enough protection against several new COVID-19 variants cropping up in the U.S. and around the world. Dr. David Ho, director of Columbia University’s Aaron Diamond AIDS Research Center, and his team reported the results from a set of studies published in the journal Nature. They showed how well some of the latest variants — BQ.1, BQ.1.1, XBB and XBB.1, which were all derived from Omicron — are evading both vaccine-derived and infection-derived immunity.
These new variants all have mutations in the region that binds to cells and infects them, which means that they’re highly transmissible, as prior Omicron variants were. BQ.1 is growing steadily in France, according to the public database of SARS-CoV-2 variants GISAID. By mid-November, European health officials expect the variant to account for 50% of cases in Europe, and to become the dominant strain in that region by early 2023.
XBB is growing quickly in Singapore and India. Both variants have spawned new strains that have each picked up an additional mutation to create BQ.1.1 and XBB.1. As of early November, BQ.1 and BQ.1.1, combined, now make up about 35% of new cases in the U.S.
Other studies have found similar drops in antibody protection against BQ.1 among vaccinated people. But Ho’s group conducted what is likely the most comprehensive look to date at BQ.1, BQ.1.1, XBB and XBB.1, and how existing immunity — from the original mRNA vaccines, the new Omicron boosters and natural infections — stands up to them.
WHO Reports 90% Drop in World COVID Deaths Since February
The World Health Organization chief on Wednesday said a nearly 90% drop in recent COVID-19 deaths globally compared to nine months ago provides “cause for optimism,” but still urged vigilance against the pandemic as variants continue to crop up.
Director-General Tedros Adhanom Ghebreyesus said that last week just over 9,400 deaths linked to the coronavirus were reported to the WHO. In February of this year, he said, weekly deaths had topped 75,000 globally.
“We have come a long way, and this is definitely a cause for optimism. But we continue to call on all governments, communities and individuals to remain vigilant,” he said at a virtual news conference from the WHO’s Geneva headquarters.
Novavax BA.1 Booster Data Support COVID Vaccine Strain Switch, but Bivalent Fails to Bring Benefits
Novavax has generated phase 3 data to support a switch to its BA.1 variant COVID-19 vaccine. But with the original shot holding its own, and a bivalent version failing to bring benefits, the biotech is pushing the message that its existing adjuvanted recombinant protein vaccine remains viable.
As mRNA vaccines from Moderna and Pfizer have come to dominate the COVID-19 landscape, Novavax has tried to carve out a distinct space for its shot and make the case that its modality has benefits over the incumbent technology. Specifically, the biotech has touted the “very broad responses” in recipients of its vaccine against the ancestral strain at a time when its rivals are launching variant-specific updates.
Even so, Novavax, while continuing to tout the effectiveness of its original “prototype” vaccine, has run a phase 3 clinical trial of monovalent and bivalent shots adapted to the BA.1 Omicron subvariant. Gregory Glenn, M.D., president of R&D, framed the data as an affirmation of the original vaccine.
Novavax Cuts Full-Year Revenue Forecast Again Amid Weak Demand
Novavax Inc. (NVAX.O) cut its full-year revenue forecast on Tuesday for the second time in three months, hurt by a global supply glut in COVID-19 vaccine and waning demand.
The company now expects annual revenue to be near the low end of its prior forecast range of between $2 billion and $2.3 billion.
The company is now “pushing forward” on developing a vaccine targeting Omicron subvariants BQ.1 and BQ.1.1 which they would also formulate as a bivalent vaccine with another coronavirus strain, Filip Dubovsky, Novavax’s chief medical officer, said on a conference call with investors.
Novavax plans to have that ready in the second quarter of next year, in time for a potential surge of cases in the southern hemisphere, Dubovsky added.
People With Long COVID Face Barriers to Government Disability Benefits
When Josephine Cabrera Taveras was infected with COVID-19 in the spring of 2020, she didn’t anticipate that the virus would knock her out of work for two years and put her family at risk for eviction.
Like many others with long COVID, Taveras has fallen through the cracks of a system that was time-consuming and difficult to navigate even before the COVID pandemic.
People are facing years-long wait times, insufficient legal support and a lack of clear guidance on how to prove they are disabled — compounded by the challenges of a medical system that does not have a uniform process for diagnosing long COVID, according to health experts and disability attorneys.
The Biden administration promised support to people with long COVID, but patient advocates say many are struggling to get government help.
COVID: Evusheld Protects the Most Vulnerable Patients, Analysis Shows
The antibody drug Evusheld is effective for protecting clinically extremely vulnerable people from COVID-19, including its Omicron variants, a preprint study has reported.
The prophylactic treatment, manufactured by AstraZeneca, is a combination of two long-acting antibodies (tixagevimab and cilgavimab). It is given as two separate, sequential intramuscular injections in the same session and can be administered in the community.
A research team, led by the University of Birmingham alongside academics from King’s College London and the U.K. Health Security Agency, carried out a systematic review and meta-analysis to examine its effectiveness in immunocompromised patients.
Overall, it reported that the treatment was 86% (95% confidence interval 6.2% to 99.7%; P=0.04) effective for preventing COVID-specific death, 88% (47.1% to 98.7%; P<0.001) effective in preventing intensive care admission, 69% (50.8% to 81.6%; P<0.001) effective in preventing hospital admission and 40% (29.8% to 49.7%; P<0.001) effective in preventing SARS-CoV-2 infection.
Telemedicine Has Improved Healthcare Access. Let’s Keep It That Way
Telemedicine has emerged as one of the several crucial innovations coming out of the coronavirus pandemic, making it easier for many people to access healthcare. But as the crisis phase of the pandemic comes to an end, these gains could be rolled back. Policymakers should try to preserve them.
Before the pandemic, virtual medical visits were somewhat of a novelty. Telemedicine was mainly envisioned as a service for patients living in remote areas who couldn’t travel to see a specialist physician.
The ability to continue virtual visits is tied to the federal government’s public health emergency for the pandemic. While there are bipartisan efforts to continue telehealth flexibilities once the emergency ends, policy analysts have expressed concern that reimbursing providers the same amount for virtual as in-person visits could make healthcare spending harder to rein in.
U.K. Approves Pfizer-BioNTech’s COVID Booster Targeting Omicron BA.4/5
Britain’s health regulator on Wednesday approved the country’s first two-pronged COVID-19 booster targeting the Omicron BA.4 and BA.5 sub-variants and the original coronavirus strain.
The Medicines and Healthcare products Regulatory Agency (MHRA) said the vaccine from Pfizer (PFE.N) and partner BioNTech (22UAy.DE) was approved for use as a booster in people 12 years and older after it was found to meet safety, quality and effectiveness standards.
Britain had already approved so-called bivalent vaccines targeting the Omicron BA.1 sub-variant from Pfizer-BioNTech and rival Moderna (MRNA.O) but now has added a first against BA.4/5 in its arsenal with the latest authorization.
The regulator on Wednesday also approved Novavax‘s (NVAX.O) COVID-19 shot as a booster for adults.
CanSino’s Inhalable COVID Vaccines to Be Available in Tianjin From Nov. 10
Chinese pharmaceutical company CanSino Biologics (6185.HK) said on Wednesday its inhalable COVID-19 vaccines will be available in China’s northern city of Tianjin from Nov. 10, a statement on its WeChat account said.
Last week, the Tianjin-based company said it did not expect its inhaled COVID vaccine to significantly boost financial results, based on the current immunity strategy and domestic booster vaccination rates.
China’s financial hub Shanghai and 13 cities in eastern Jiangsu province have already introduced CanSino’s inhalable vaccines as a booster for their citizens, CanSino said.
