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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.
