Covid News Watch
Pfizer and BioNTech Get FDA Fast-Track Designation for Single-Dose COVID and Flu Vaccine Candidate + More
Pfizer and BioNTech Get FDA Fast-Track Designation for Single-Dose COVID and Flu Vaccine Candidate
Pfizer Inc. PFE, 0.32%, and German partner BioNTech SE BNTX, -0.77% said Friday they have received fast-track designation from the U.S. Food and Drug Administration for a single-dose-mRNA-based vaccine candidate targeting both COVID and flu.
The companies already announced that they are in early-stage trials to review the safety and immunogenicity of their combined vaccine among healthy adults.
The vaccine will target the BA.4 and BA.5 Omicron sublineages, which have become dominant globally, as well as four different flu strains, as recommended for use in the Northern Hemisphere by the World Health Organization. If approved, the vaccine would be the first to target COVID and flu. Both stocks were slightly lower premarket.
U.S. CDC Expands Use of Bivalent COVID Vaccines for Kids as Young as 6 Months
The U.S. Centers for Disease Control and Prevention (CDC) on Friday expanded the use of COVID-19 vaccines that target both the original coronavirus and Omicron sub-variants to include children aged 6 months through 5 years.
The development comes a day after the U.S. Food and Drug Administration authorized the updated shots from Moderna (MRNA.O) as well as Pfizer (PFE.N) and its partner BioNTech (22UAy.DE) for use in children as young as 6 months.
Children aged 6 months through 5 years will now be eligible to get a Moderna bivalent booster 2 months after their final primary vaccination dose for COVID-19.
Pfizer/BioNTech’s updated vaccine for children aged 6 months through 4 years can be given only as the third dose for those who are yet to complete their primary COVID-19 vaccinations.
New COVID Booster Authorization Will Sway Parents to Get Young Kids Vaccinated, FDA Vaccine Chief Hopes
Dr. Peter Marks, the Food and Drug Administration‘s vaccine chief, said he is well aware that COVID-19 booster uptake might be low for the latest shot, authorized by the government on Thursday morning for young children over 6 months old, but he told ABC News that he’s hopeful increased access may also lead to some kids getting greater protection against the virus ahead of the winter when infections can be more likely.
The updated bivalent booster which targets multiple newer strains of the virus will likely be available early next week for the youngest children, Marks said in an interview. That age group is the last to become eligible for the new booster.
So far, according to the Centers for Disease Control and Prevention, less than 10% of kids under 5 have gotten their initial COVID-19 vaccines — which means there’s a very small pool of children who are even eligible for boosters. But Marks hopes that those vaccinated children will soon get their boosters, and unvaccinated children will be encouraged to get their first series.
On a larger scale, vaccine uptake for the youngest age group has traditionally been far lower than for other groups throughout the pandemic. And even for older age groups, booster uptake has been very low over the three months that bivalent shots have been on the market.
Canada Authorizes First Bivalent Booster Shot for 5 to 11 Year-Olds
Canada on Friday authorized Pfizer-Biontech’s (PFE.N), (22UAy.DE) bivalent COVID-19 vaccine booster for children 5 to 11 years of age, according to a statement from Health Canada.
Pfizer-BioNTech’s shots are designed to target the BA.4/BA.5 variants of Omicron as well as the original coronavirus variant, and is the first bivalent booster authorized in Canada for 5 to 11 years age group, Health Canada said.
COVID Isn’t a Pandemic of the Unvaccinated Anymore
Americans received their first COVID-19 vaccine doses in December 2020, which means we are now approaching the beginning of the third year of the pandemic’s vaccine phase. And yet hundreds of Americans are still dying each day. Who are they? The data offers a straightforward answer: older adults.
Though it’s sometimes uncomfortable to say it, the risk of mortality from COVID has been dramatically skewed by age throughout the pandemic. The earliest reports of COVID deaths from China sketched a pattern quickly confirmed everywhere in the world: In an immunologically naïve population, the oldest were several thousand times more at risk of dying from infection than the youngest.
But the skew is actually more dramatic now — even amid mass vaccinations and reinfections — than it was at any previous point over the last three years. Since the beginning of the pandemic, people 65 and older accounted for 75% of all American COVID deaths. That dropped below 60% as recently as September 2021. But today Americans 65 and over account for 90% of new COVID deaths, an especially large share given that 94% of American seniors are vaccinated.
Yet these facts seem to contradict stories we’ve told about what drives vulnerability to COVID-19. In January, Joe Biden warned that the illness and death threatened by the Omicron variant represented “a pandemic of the unvaccinated.” But that month, in which nearly 85,000 Americans died, the unvaccinated accounted for 59% of those deaths, down from 77% the previous September, according to an analysis by the Kaiser Family Foundation. The share of deaths among older adults that January was nearly 74%.
Omicron Subvariants Are Now Dominant in the U.S. As COVID Cases Tick up and New York City Becomes a Hot Spot
Omicron subvariants continued to account for more new cases of COVID-19 in the U.S. in the latest week than did BA.5, according to the latest data from the Centers for Disease Control and Prevention.
BQ.1 and BQ.1.1, which are sublineages of BA.5, accounted for 67.9% of cases in the week through Dec. 10, while BA.5 accounted for 11.5%, the data show.
New York City is again emerging as a hot spot for COVID, according to a New York Times tracker, which shows cases up about 60% in recent weeks and hospitalizations at their highest level since February.
Hospital Financial Decisions Play a Role in the Critical Shortage of Pediatric Beds for RSV Patients
The dire shortage of pediatric hospital beds plaguing the nation this fall is a byproduct of financial decisions made by hospitals over the past decade, as they shuttered children’s wards, which often operate in the red, and expanded the number of beds available for more profitable endeavors like joint replacements and cancer care.
A major factor in the bed shortage is a years-long trend among hospitals of eliminating pediatric units, which tend to be less profitable than adult units, said Mark Wietecha, CEO of the Children’s Hospital Association. Hospitals optimize revenue by striving to keep their beds 100% full — and filled with patients whose conditions command generous insurance reimbursements.
In addition, the relentless pace of the pandemic has spurred more than 230,000 healthcare providers — including doctors, nurses and physician assistants — to quit. Before the pandemic, about 10% of nurses left their jobs every year; the rate has risen to about 20%, Wietecha said. He estimates that pediatric hospitals are unable to maintain as many as 10% of their beds because of staffing shortages.
CDC Director Calls for Overhaul of Public Health Data Collection
The emergence of COVID-19 exposed the limitations of the American public health system — particularly its ability to collect and share data quickly. As daily cases rose to hundreds of thousands nationwide, information about who was being hit hardest — and later, who was getting vaccinated — was scattered across local health systems, causing confusion and hampering efforts for a swift, equitable national response.
Mounting frustration over delayed reporting of infections and deaths has, over the years, prompted calls for a better, more centralized data collection system, in real-time — and an overhaul of the Centers for Disease Control and Prevention.
CDC Director Rochelle Walensky defended the federal agency’s efforts to analyze and disseminate information, saying that its abilities are largely limited by how efficiently local governments share their data. She also said — twice — that the CDC “does not have direct authority to require data reporting,” and noted that it relies on data from 50 states and more than 3,000 local jurisdictions and territories.
Long COVID Is Distorting the Labor Market — and That’s Bad for the U.S. Economy
For about a year, Charlotte Hultquist was among those long-COVID patients sidelined from the workforce. She would fall constantly, tripping just by stepping over a toy or small object on the floor. She eventually learned that the balance issues and ear pain resulted from a damaged vestibular nerve, a known effect of long COVID. After rigorous testing, a physical therapist told Hultquist she had the “balance of a 1-year-old learning to walk.”
There remain many unknowns about long COVID, including causes, cures and even how to define it. But this much is clear: The illness is disabling thousands, perhaps millions, of workers to such an extent that they must throttle back hours or leave the workforce altogether.
In other words, at a time when job openings are near an all-time high, long COVID is reducing the supply of people able to fill those positions. The dynamic may have large and adverse effects on the U.S. economy.
The Crisis of Student Mental Health Is Much Vaster Than We Realize
Nationally, adolescent depression and anxiety — already at crisis levels before the pandemic — have surged amid the isolation, disruption and hardship of COVID-19. Even as federal coronavirus relief money has helped schools step up their efforts to aid students, they also have come up short. It’s unclear how much money is going to mental health, how long such efforts will last or if they truly reach those who struggle most.
“The need is real, the need is dire,” said Alberto Carvalho, superintendent of the Los Angeles Unified School District, who recalled hearing just that day from the district’s mental health partners that calls about suicidal thoughts had quadrupled. “We’re living through historically unprecedented times,” he said.
More than 75% of schools surveyed in spring said their teachers and staff have voiced concerns about student depression, anxiety and trauma, according to federal data. Nearly as many schools cited a jump in the number of students seeking mental health services.
But mental health is not the only pandemic priority. Schools are spending vast sums of their coronavirus relief money on ventilation upgrades, expanded summer learning, after-school programs, tutors and academic specialists.
FDA Authorizes COVID Omicron Vaccines for Children as Young as 6 Months Old + More
FDA Authorizes COVID Omicron Vaccines for Children as Young as 6 Months Old
The Food and Drug Administration on Thursday authorized updated COVID shots that target the Omicron variant for children as young as 6 months old.
The eligibility rules vary depending on whether children received Moderna’s or Pfizer’s original vaccines as their primary series. Children 6 months through 5 years old who received Moderna’s two-dose primary series are now eligible for an Omicron booster two months after their second shot.
Kids ages 6 months through 4 years old who have not yet received the third dose of Pfizer’s primary series will now receive the Omicron shot as their third dose. But kids in the same age group who have already completed Pfizer’s three-dose primary series cannot get the Omicron shot as a booster, or fourth dose, at this time.
The FDA, in a statement, said it did not authorize Omicron shots for those children who already received three doses of Pfizer’s vaccine because the agency is still waiting on supporting data for the booster dose. That data is expected in January and the FDA will review it as quickly as possible, the agency said.
4 Takeaways From Sen. Johnson’s Panel on COVID Vaccines
Sen. Ron Johnson (R-Wis.) held a panel on COVID-19 vaccines in Washington on Dec. 7, featuring experts including Dr. Robert Malone and Dr. Peter McCullough. Experts discussed vaccine development, vaccine composition, data from insurance and adverse event systems and other topics. Here are four takeaways from the panel.
Edward Dowd, a former BlackRock analyst now with the Humanity Project, showed data from the Society of Actuaries 2021 Group Life Insurance survey that showed a jump in excess mortality among young and middle-aged adults starting around the time the vaccines began being administered.
Several vaccines have been linked to side effects such as myocarditis, a form of heart inflammation that can turn deadly. Doctors testifying during the panel said they’ve seen an increase in patients with the inflammation. Dr. Kirk Milhoan, a pediatrician based in Hawaii, said he’s seen more cases. The studies show that the spike protein, which the vaccines cause the body to make, is “cardiotoxic and cause the heart to be inflamed,” Milhoan said. “Let that sink in, the current public health plan is asking our own body to make a cardiotoxin.”
Dr. Harvey Risch, a professor emeritus of epidemiology at the Yale School of Public Health, presented data from the CDC that show young people face little risk from COVID-19.
McCullough, chief scientific officer of The Wellness Company, said that no randomized, double-blind, placebo-controlled trial has shown the vaccines reduce hospitalization or death. Such trials, known as RCTs, are generally considered the highest form of evidence for a drug.
French Health Authority Advises Against Use of Valneva’s COVID Vaccine
France’s Haute Autorite de Sante public health body advised the government not to use Valneva’s (VLS.PA) VLA2001 COVID-19 vaccine as part of its wider vaccination strategy, although two rival products should be included as booster shots. The snub caused Valneva’s shares to fall, with Valneva down by around 1% during the late morning trading session in Paris.
The HAS body recommended Sanofi (SASY.PA) and GSK’s (GSK.L) VidPrevtyn Beta and Novavax‘s (NVAX.O) Nuvaxovid shots to boost the vaccination of people who can not be given bivalent mRNA vaccines which shall remain the first choice, it said. “However, the HAS does not include the use of Valneva’s VLA2001 vaccine in the current primary vaccination strategy”, it added.
“There are no clinical efficacy or immunological data about the current variants. Therefore, it has not been retained for the time being,” Elisabeth Bouvet, president of the HAS’ vaccination department, told a news conference.
Experimental Decoy Drug Tricks Coronavirus, Then Destroys It
The coronavirus has been a shifty foe, with new variants and subvariants rapidly evolving to evade vaccines and treatments. Researchers at Boston’s Dana-Farber Cancer Institute are working on an experimental drug that takes one of the virus’ most dangerous traits — its talent for mutation — and turns it back on itself.
When the coronavirus binds to a specific type of receptor on the surface of a cell, it drives its spike protein in like a switchblade and initiates an infection.
The drug is designed to mimic that receptor, working like an assassin in an attractive disguise. When the coronavirus attempts to bind to it instead of to the real thing, it destroys the structure of the spike protein, permanently disabling the mechanism that would make that switchblade, according to a report published Wednesday in the journal Science Advances.
This approach backs the coronavirus into a corner: If it adopts a mutation that makes it bind less effectively with the decoy drug, it will also bind less effectively to the human cell.
DeSantis Pledges to Hold Vaccine Manufacturers ‘Accountable’
A comment made by Gov. Ron DeSantis during a private Republican Party of Florida event at the Florida Governor’s Mansion has activists across the state abuzz with hope for the change they’ve been requesting for more than a year.
“We are going to work to hold these manufacturers accountable for this mRNA because they said there was no side effect. And we know that there have been. A lot,” DeSantis said at the Dec. 3 event in Tallahassee.
“And so we did a study in Florida and we saw an 86% increase in [problems in] cardiac-related activity from people 18 to 39 from mRNA shots. And so we’re going to be doing some stuff to bring accountability there.”
Under the Public Readiness and Emergency Preparedness Act of the federal Emergency Use Authorization, the U.S. Health and Human Services (HHS) Secretary issued several declarations that provide liability immunity for activities related to medical countermeasures against COVID-19, as long as they did not commit fraud.
Walgreens Launches Free Paxlovid Delivery Service With DoorDash and Uber
Walgreens has launched a new delivery service for the COVID-19 oral antiviral therapy Paxlovid in partnership with DoorDash and Uber to get the treatment “directly to the doorsteps of those who need it.”
Walgreens on Thursday said it has more than 8,000 locations offering same-day delivery services, available to anyone who lives within 15 miles of participating stores. Walgreens said that means real access to a lot of Americans — offering it to roughly 92% of the population.
Paxlovid, from Pfizer, is one of the few treatments still expected to hold up against currently circulating subvariants and comes as coronavirus hospitalizations are trending upward in the elderly.
To use Walgreens’ new delivery service, eligible patients must have a Paxlovid prescription from a healthcare provider.
Wisconsin Youth Health Survey Shows Stress up Since COVID
More than half of Wisconsin high school seniors surveyed in the fall of 2021 reported having significant problems with feeling very anxious, nervous, tense, scared or like something bad was going to happen, according to a health risk survey.
Rising numbers of students also reported symptoms of depression, self-harm and thoughts of suicide, according to the CDC’s Youth Risk Behavior Survey released Tuesday.
The results are the first picture of Wisconsin students’ mental health since the onset of the pandemic, the Milwaukee Journal Sentinel reported. The results were publicized by the Wisconsin Department of Public Instruction, which called for “drastic action.”
The Youth Risk Behavior Survey goes out every two years to a sample of schools across the country selected to inform county, state and national reports, including 43 Wisconsin high schools. The national results have not yet been shared for 2021.
FDA Gives Priority Review to Pfizer RSV Vaccine for Older Adults
The Food and Drug Administration (FDA) accepted Pfizer’s application for an RSV vaccine for older adults and is expected to make an approval decision by the spring.
Pfizer in a statement on Wednesday said the FDA is going to review its application under the priority review program, which reduces the approval timeline by four months. The end of the review period is expected to be May 2023, Pfizer said.
In healthy adults and older children, RSV typically causes mild, cold-like symptoms that go away with moderate rest and self-care. But it can result in severe illness in infants and older adults.
There is no vaccine for RSV in either adults or children. If approved, Pfizer’s candidate would become the first RSV vaccine for older adults.
WHO: COVID Disruption Resulted in 63,000 More Malaria Deaths
The coronavirus pandemic interrupted efforts to control malaria, resulting in 63,000 additional deaths and 13 million more infections globally over two years, according to a report from the World Health Organization published Thursday.
Cases of the parasitic disease went up in 2020 and continued to climb in 2021, though at a slower pace, the U.N. health agency said Thursday. About 95% of the world’s 247 million malaria infections and 619,000 deaths last year were in Africa.
“We were off track before the pandemic and the pandemic has now made things worse,” said Abdisalan Noor, a senior official in WHO’s malaria department.
Noor said he expected the wider rollout of the world’s first authorized malaria vaccine next year to have a “considerable impact” on reducing the number of severe illnesses and deaths if enough children get immunized, adding that more than 20 countries have applied to vaccines alliance Gavi for help in securing the shot. Still, the vaccine is only about 30% effective and requires four doses.
Uganda Receives 1,200 Doses of Ebola Vaccine Candidates for Trials
A shipment of Ebola vaccine candidates set to be used in a clinical trial has arrived in Uganda, where an outbreak has infected 142 people and killed at least 56, health authorities said on Thursday.
Last week Uganda said it had discharged its last Ebola patient from the hospital, raising hopes for the end of an outbreak of the deadly hemorrhagic fever declared on Sept. 20.
The WHO had said it would send three vaccine candidates to Uganda to be used in a trial, one by the University of Oxford and Serum Institute of India, another by the Sabin Vaccine Institute and a third by Merck & Co Inc. (MRK.N).
At a ceremony to receive the vaccines in Entebbe, about 45 km (28 miles) south of the capital Kampala, Health Minister Jane Ruth Aceng said the 1,200 doses that had arrived were from the Sabin Vaccine Institute.
Omicron Boosters Weaker Against BQ.1.1 Subvariant That Is Rising in U.S., Study Finds + More
Omicron Boosters Are Weaker Against BQ.1.1 Subvariant That Is Rising in U.S., Study Finds
COVID shots designed to protect against the Omicron variant trigger a weaker immune response against the rapidly emerging BQ.1.1 subvariant than the previously dominant strain, according to a new lab study. Scientists at the University of Texas Medical Branch, in a study published online Tuesday in Nature Medicine, found that the booster shots performed well against the BA.5 subvariant they were designed to target.
But the boosters did not trigger a robust response when faced with BQ.1.1, the scientists found. Antibodies were about four times lower against BQ.1.1 compared with BA.5. These neutralizing antibodies prevent the virus that causes COVID-19 from invading human cells.
People with a prior history of infection who received an Omicron booster, however, had a stronger response to BQ.1.1. Antibodies that neutralize BQ.1.1 were nearly four times higher in this group compared with individuals with no history of infection who faced the subvariant, the scientists found.
Omicron BQ.1.1 subvariant appears on track to become the dominant variant in the U.S. It currently makes up about 32% of infections in the U.S., according to CDC surveillance data. Omicron BA.5, on the other hand, now represents about 14% of new infections.
Paxlovid Has Been Free So Far. Next Year, Sticker Shock Awaits.
Nearly 6 million Americans have taken Paxlovid for free, courtesy of the federal government. The Pfizer pill has helped prevent many people infected with COVID-19 from being hospitalized or dying, and it may even reduce the risk of developing long COVID. But the government plans to stop footing the bill within months, and millions of people who are at the highest risk of severe illness and are least able to afford the drug — the uninsured and seniors — may have to pay the full price.
Soon the Department of Health and Human Services will stop supplying COVID treatments, and pharmacies will purchase and bill for them the same way they do for antibiotic pills or asthma inhalers. Paxlovid is expected to hit the private market in mid-2023, according to HHS plans shared in an October meeting with state health officials and clinicians. Merck’s Lagevrio, a less-effective COVID treatment pill, and AstraZeneca’s Evusheld, a preventive therapy for the immunocompromised, are on track to be commercialized sooner, sometime in the winter.
The U.S. government has so far purchased 20 million courses of Paxlovid, priced at about $530 each, a discount for buying in bulk that Pfizer CEO Albert Bourla called “really very attractive” to the federal government in a July earnings call. The drug will cost far more on the private market, although in a statement to KHN, Pfizer declined to share the planned price. The government will also stop paying for the company’s COVID vaccine next year — those shots will quadruple in price, from the discount rate the government pays of $30 to about $120.
Bourla told investors in November that he expects the move will make Paxlovid and its COVID vaccine “a multibillion-dollar franchise.”
FDA ‘Turned a Blind Eye’ to ‘Submission of Fraudulent Data’ on COVID Vaccine, Says Former Criminal Investigator
On Nov. 2, 2021, The BMJ broke the story of Brook Jackson, the regional director who blew the whistle on data integrity issues in Pfizer’s pivotal COVID-19 vaccine trial. Weeks later, documents were leaked supporting Jackson’s complaint about “falsified data.”
Among the leaked documents was an email, authored by a former federal agent in the FDA’s Office of Criminal Investigations (OCI), claiming Pfizer knowingly submitted fraudulent data to the FDA, and the agency responded by turning a blind eye.
OCI is the FDA’s criminal law enforcement arm. Much like a police force, it conducts criminal investigations of illegal activities involving FDA-regulated products and brings them before the Department of Justice for prosecution.
“Having worked at FDA, I see it as surprising, for many reasons, that the agency turned a blind eye to a company’s knowing submission of fraudulent data,” wrote the OCI officer, whose identity is suppressed after signing a non-disclosure agreement.
Pfizer Partners With Clear Creek Bio to Develop Oral COVID Drug
Pfizer Inc. (PFE.N) and Clear Creek Bio Inc. on Tuesday announced a collaboration to identify a potential drug candidate and develop a new class of oral treatment against COVID-19, as Pfizer seeks to expand its anti-infective pipeline.
Charlotte Allerton, Pfizer’s chief scientific officer, said COVID-19 has “the potential to remain a global health concern for years to come.” Pfizer already has a COVID antiviral pill Paxlovid, which the drugmaker expects to generate about $22 billion in revenue this year.
Pfizer has been making various deals to boost its portfolio. This year, it has announced acquisitions of Biohaven Pharmaceutical Holding Co (BHVN.N) and Global Blood Therapeutics for $11.6 billion and $5.4 billion, respectively, and also launched a company with Roivant Sciences (ROIV.O) focused on an experimental bowel disease treatment.
Under the agreement with Clear Creek Bio, the pharmaceutical giant will pay an undisclosed amount upfront as well as make additional milestone payments along with royalties on future product sales.
Rep. Louie Gohmert Urges HHS to Establish Vaccine Injury Table
As he prepares to depart Congress, Rep. Louie Gohmert (R-Texas) urges Health and Human Services (HHS) to establish a Vaccine Injury Table, as required by law.
In a statement issued exclusively to The Epoch Times, Gohmert said: “It is asinine that despite the fact that our government and pharmaceutical companies fast-tracked the production of an experimental vaccine and forced millions of Americans to take it or risk losing their jobs or freedom, that a vaccine injury table disclosing known side effects of the vaccine as required by law has yet to be developed for the COVID-19 shot.”
According to U.S. Code 247d-6e (5)(A): “The Secretary shall by regulation establish a table identifying covered injuries that shall be presumed to be directly caused by the administration or use of a covered countermeasure and the time period in which the first symptom or manifestation of onset of each such adverse effect must manifest in order for such presumption to apply.”
Even when someone suffers a side effect known to be caused by the vaccine, Gohmert said “the government is making it as difficult as possible to be compensated for the damages.”
Some COVID Clinical Trials Lacked Diversity, Female Representation
Women were underrepresented in pandemic trials of antiviral treatments, and sponsors didn’t recruit enough Black and Asian participants for human studies on COVID vaccines, a new JAMA analysis of more than 100 trials found.
Why it matters: Treatment regimens that are found to be effective in clinical trials can’t be confidently applied to all populations when certain groups are not adequately represented, researchers said.
What they found: The researchers analyzed 122 clinical trial studies that included more than 176,000 participants conducted during the pandemic from October 2019 to February 2022.
FDA Expected to Decide on Pfizer RSV Vaccine for Older Adults by May 2023
The Food and Drug Administration is expected to decide by spring whether to approve Pfizer’s vaccine to prevent respiratory syncytial virus or RSV, in adults ages 60 and older.
Pfizer, in a statement Wednesday, said the FDA has accepted its RSV vaccine candidate for review under an expedited process that reduces the approval process by four months. The FDA is expected to make a final decision on whether to approve the vaccine by May 2023.
The U.S. is facing an unusually tough RSV season this year. RSV transmission was very low during the COVID pandemic due to masking and social distancing measures. Many people did not get infected as a consequence, so population immunity is lower right now.
Pfizer is also developing a maternal vaccine to protect newborns who are too young for vaccination.
Novavax to Make COVID Vaccine Shots in Canada
Novavax Inc. (NVAX.O) said on Wednesday it will manufacture its COVID-19 vaccine in Canada after the country’s health regulator allowed its use in children aged between 12 and 17 years as a primary series of shots. Production of test batches of the protein-based vaccine, Nuvaxovid, will begin at the Montreal manufacturing center by early 2023, the company said.
The agency’s approval was based on a late-stage study that showed the vaccine was effective against COVID-19 in children aged between 12 and 17 years.
Hurt by a global supply glut in COVID-19 vaccine and waning demand, Novavax cut its full-year revenue forecast last month to a range of $2 billion and $2.3 billion. Shots from rivals Pfizer/BioNtech and Moderna were approved last year for the initial vaccination of adolescents in Canada, hurting the vaccine maker further.
Millions of Unused COVID Vaccines Will Expire at End of Year: Auditor General
Tens of millions of doses of COVID-19 vaccines are likely about to expire and go to waste because of a failure to manage an oversupply, Canada’s auditor general reported Tuesday — a failure with an estimated price tag of about $1 billion.
The government knew that by signing advanced purchase agreements with a number of pharmaceutical companies there was a risk of buying up more COVID-19 vaccines than Canadians needed.
Scientists Finally Know Why People Get More Colds and Flu in Winter
A chill is in the air, and you all know what that means — it’s time for cold and flu season, when it seems everyone you know is suddenly sneezing, sniffling or worse. It’s almost as if those pesky cold and flu germs whirl in with the first blast of winter weather.
Yet germs are present year-round — just think back to your last summer cold. So why do people get more colds, flu and now COVID-19 when it’s chilly outside?
In what researchers are calling a scientific breakthrough, scientists behind a new study may have found the biological reason we get more respiratory illnesses in winter. It turns out that the cold air itself damages the immune response occurring in the nose.
In fact, reducing the temperature inside the nose by as little as 9 degrees Fahrenheit (5 degrees Celsius) kills nearly 50% of the billions of virus and bacteria-fighting cells in the nostrils, according to the study published Tuesday in The Journal of Allergy and Clinical Immunology.
China Medical Expert Says COVID Has Mutated, Should Be Renamed — State Media
China should change its official name for COVID-19 to reflect the virus’ mutation, and patients with light symptoms should be allowed to quarantine at home, a leading authority on traditional Chinese medicine was quoted as saying on Wednesday.
Gu Xiaohong told the state-run Beijing Daily newspaper that the coronavirus’ Chinese name, which identifies it as a pneumonia-causing disease, should be changed to call it simply an infectious virus.
China’s approach to COVID — which has emphasized widespread testing and the quarantining of positive cases in specialized facilities — should change from “passive detection” to “active prevention”, with recuperation at home for light cases.
Gu said the China Association of Chinese Medicine’s infectious disease arm, which she heads, had reached a consensus to change how they describe the virus.
Pfizer, BioNTech Countersue Moderna Over COVID Vaccine Patents + More
Pfizer, BioNTech Countersue Moderna Over COVID Vaccine Patents
Pfizer Inc. (PFE.N) and its German partner, BioNTech SE (22UAy.DE), fired back at Moderna Inc. (MRNA.O) on Monday in a patent lawsuit over their rival COVID-19 vaccines, seeking dismissal of the lawsuit in Boston federal court and an order that Moderna’s patents are invalid and not infringed.
Moderna first sued Pfizer in August, accusing the company of violating its rights in three patents related to innovations that Cambridge, Massachusetts-based Moderna said it pioneered before the COVID-19 pandemic.
Moderna has also filed a related lawsuit against Pfizer and BioNTech in Germany. All three companies are also embroiled in U.S. patent disputes with other companies over the vaccines.
A Pfizer spokesperson said the company and BioNTech are confident in their intellectual property and will “vigorously defend” against Moderna’s claims.
‘Vaguely Familiar?’: Here’s the Fauci Fib That Stood out Most in the Doc’s Dishonest Deposition
Dr. Anthony Fauci would wear a mask for the rest of his life just to hide his face if he weren’t vaccinated and triple-boosted for shame.
The octogenarian immunologist who once claimed to be the human embodiment of science put on a clinic of mendacity in a November 23 deposition for a lawsuit brought by the attorneys general for Louisiana and Missouri. Over the course of seven hours, Fauci praised the monstrous regime in China for its COVID response, admonished a court reporter for not wearing a useless mask and invoked some variation of “I don’t recall” nearly 200 times.
But here’s the whopper that scored a John Blutarsky-level 0.0 on the laugh test: “I’m vaguely familiar with the fact that EcoHealth Alliance has been doing research on trying to understand the bat coronavirus emergence,” he told lawyers alleging the feds colluded with social media to chill debate about COVID policies.
That the man who inspired “In Fauci, We Trust” yard signs and St. Fauci votive candles could make that statement with a straight face is a testament to his pathological aversion to the truth. EcoHealth Alliance is the federal grant-grubbing “nonprofit” run by Fauci’s longtime pal, Peter Daszak. Fauci’s National Institute for Allergy and Infectious Diseases gave EcoHealth Alliance a $600,000 grant that wound up funding illegal gain-of-function experiments with bat coronaviruses at a lab in Wuhan, China.
Britain’s Health Regulator Backs COVID Vaccine for Infants From Six Months
Britain’s health regulator on Tuesday authorized a COVID-19 vaccine for infants as young as six months, opening the door for vaccinating the country’s youngest children once the U.K.’s Joint Committee on Vaccination and Immunization (JCVI) agrees.
The Medicines and Healthcare products Regulatory Agency (MHRA) authorized the vaccine — made by Pfizer (PFE.N) and BioNTech (22UAy.DE) — for children aged six months to four years old after it was deemed safe and effective based on an ongoing clinical trial involving 4,526 participants.
Whether the vaccine is eventually deployed in this age group depends on a recommendation from the JCVI, which advises U.K. health departments on which shots should be used as part of the national vaccination program.
The vaccine is tailored for use in this age group — it is a lower dose version than the one used in children aged five to 11 years. It is given as three injections in the upper arm, with the first two doses given three weeks apart, followed by a third dose administered at least two months after the second dose.
Axios-Ipsos Poll: Few COVID Worries for the Holidays
Americans are entering the holidays for the first time in two years with COVID firmly in the back of their minds, according to the latest installment of the Axios/Ipsos Coronavirus Index.
The big picture: Public behavior on masking, social distancing and other precautions hasn’t changed significantly since September, and 7 in 10 believe strongly or somewhat that we’re moving to a point where the virus won’t disrupt our daily lives.
Between the lines: Large segments of the public remain distrustful of the government’s pandemic response, including the role of top infectious-disease expert Anthony Fauci.
Forty-five percent strongly or somewhat agreed with the statement that public health officials lied about how effective COVID-19 vaccines and masks are at preventing the virus’ spread, 39% strongly or somewhat think Fauci should be investigated for his role in the response; and 63% said they trust the Centers for Disease Control a great deal or a fair amount to provide accurate information about COVID, compared to 51% for Fauci and 43% for President Biden.
COVID Boosters Provided Little Added Protection for People With Natural Immunity: Study
COVID-19 vaccine boosters provided small boosts for people who have recovered from COVID-19, according to a new study. Measuring the effectiveness of the Moderna and Pfizer boosters against the BA.1 Omicron subvariant, researchers found that a booster upped protection against infection by just 6.1% for those who had a documented prior infection, or natural immunity.
The effectiveness of a primary series 14 to 149 days after a second dose was pegged as 41% for the group. A booster brought the protection to 47.1%. Excluding people with a documented prior infection, the booster increased infection more.
“While booster vaccination was associated with additional protection against Omicron BA.1 infection in people without a documented prior infection, it was not found to be associated with additional protection among people with a documented prior infection,” researchers said.
A number of studies have analyzed the protection people enjoy after recovering from COVID-19 and found that the protection is higher than that conferred by vaccines. Both forms of protection have waned against infection and to a smaller degree against severe illness, but natural immunity has held up better against both infection and severe disease.
Pfizer Announces $750 Million Expansion of Western Michigan Plant
Pfizer announced a $750 million project Monday toward expanding capacity at the western Michigan pharmaceutical plant where the company first mass-produced its COVID-19 vaccine.
Company officials said the project will boost the plant’s manufacturing of sterile injectable medications and could lead to 300 new jobs at the Portage plant near Kalamazoo which now has about 3,000 workers.
Pfizer executive David Breen said the project will help ensure an uninterrupted supply of medicines and vaccines, including those based on mRNA technology used in its COVID-19 vaccine.
The plant first started shipping the COVID-19 vaccines in December 2020 and President Joe Biden toured the plant two months later to highlight the national vaccination campaign.
Myocarditis After COVID Vaccine Low Among Teens and Young Adults, Large Study Finds
The incidence of myocarditis and pericarditis after COVID vaccination is low and most patients make a full recovery, a large international study from Nationwide Children’s Hospital found. Most of the cases occurred in male teens and young adults and usually after the second dose of a primary series of either the Pfizer-BioNTech or Moderna vaccine, according to the study published Monday in JAMA Pediatrics.
Although a majority of the people recovered quickly, 93% of the cases required hospitalization and 23% of the cases were serious enough to require admission to the intensive care unit. No deaths were observed.
While the study’s findings are “reassuring,” the vaccine-associated heart problems “should not be viewed as always mild,” said Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston. He was not involved in the research.
Most patients recovered with rest and medication. However, 87% had abnormalities on their cardiac MRI, raising the question of whether there may be long-term consequences to the condition, Barouch said.
Ex-FDA Vaccine Inspectors Call for Better Training
Training in the Food and Drug Administration’s office that oversees licensed vaccines has decreased dramatically in recent years, raising concerns that the team is not equipped to identify quality control issues in manufacturing, according to three former inspectors.
An agency-wide reorganization and an influx of inexperienced inspectors led to an increased workload, particularly during the pandemic, they said. In the last several years, multiple inspectors have left the team, citing internal frustrations over the lack of training and concern that supervisors had little knowledge of the complexities associated with the inspections they oversee.
All three former inspectors worked in one of the FDA’s most critical offices, Team Biologics, which is responsible for inspecting licensed vaccine products, as well as cord blood, allergenic, gene and cell-therapy products.
The former inspectors said they do not know of any instances in which Team Biologics accidentally missed contamination of a vaccine or failed to report a manufacturing issue. However, they said they are concerned about inspectors misidentifying a problem or overlooking a serious issue if more rigorous training is not reinstated and experienced inspectors are not brought on to the team.
NYC’s Pandemic Response Lab to Close as COVID Testing Plummets
New York City’s Pandemic Response Lab, a much-vaunted effort to increase COVID-19 testing capacity at the height of the pandemic, will close at the end of the month and eliminate all 185 jobs.
ReOpen Diagnostics, the subsidiary of the laboratory automation company Opentrons Labworks Inc. that runs the Queens lab, said Monday it was winding down operations because of a “rapidly changing external environment.”
The elimination of testing capacity follows a global decline in demand for COVID tests, a trend that could limit the ability of public health officials to track new variants and outbreaks, the World Health Organization has warned.
Fewer than 1 million COVID tests were performed by laboratories in New York City last month, according to state data, down from 4.6 million in January.
The Year Without Germs Changed Kids
In the spring of 2021, Brett Finlay, a microbiologist at the University of British Columbia, offered the world a bold and worrying prediction. “My guess is that five years from now we are going to see a bolus of kids with asthma and obesity,” he told Wired. Those children, he said, would be “the COVID kids”: those born just before or during the height of the crisis, when the coronavirus was everywhere, and we cleaned everything because we didn’t want it to be.
Finlay’s forecast isn’t unfounded. As James Hamblin wrote in The Atlantic last year, our health relies on a constant discourse with trillions of microbes that live on or inside our bodies. The members of the so-called microbiome are crucial for digesting our food, training the immune system and even greasing the wheels of cognitive function; there does not seem to be a bodily system that these tiny tenants do not in some way affect.
These microbe-human dialogues begin in infancy, and the first three or so years of life are absolutely pivotal: Bacteria must colonize babies, then the two parties need to get into physiological sync. Major disruptions during this time “can throw the system out of whack,” says Katherine Amato, a biological anthropologist at Northwestern University, and raise a kid’s risk of developing allergies, asthma, obesity and other chronic conditions later in life.
The earlier, more intense, and more prolonged the interruptions, the worse. Infants who receive heavy courses of antibiotics — which can nuke microbial diversity — are at greater risk of developing such problems; the same is roughly true for babies who are born by C-section, who formula feed or who grow up in nature-poor environments. If pandemic-era mitigations re-create even an echo of those effects, that could spell trouble for a whole lot of little kids who may have lost out on beneficial microbes in the ongoing effort to keep nasty ones at bay.
