The Food and Drug Administration on Thursday issued an emergency use authorization for what it said is the first device that can detect COVID-19 in breath samples.
The InspectIR COVID-19 Breathalyzer is about the size of a piece of carry-on luggage, the FDA said, and can be used in doctor’s offices, hospitals and mobile testing sites. The test, which can provide results in less than three minutes, must be carried out under the supervision of a licensed health care provider.
Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, called the device “yet another example of the rapid innovation occurring with diagnostic tests for COVID-19.”
The FDA said the device was 91.2% accurate at identifying positive test samples and 99.3% accurate at identifying negative test samples.
“InspectIR expects to be able to produce approximately 100 instruments per week, which can each be used to evaluate approximately 160 samples per day,” the agency said. “At this level of production, testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by approximately 64,000 samples per month.”
California is delaying a coronavirus vaccine mandate for schoolchildren until at least the summer of 2023.
Gov. Gavin Newsom’s administration announced the change on Thursday.
California was the first state to announce it would require all schoolchildren to receive the coronavirus vaccine. But the mandate will not take effect until federal regulators give final approval to the vaccine for children. That hasn’t happened yet.
California Health and Human Services Secretary Dr. Mark Ghaly said school districts would need more time to implement the mandate once federal approval happens. State officials say the mandate will not happen before July 1, 2023.
THIS IS A BREAKING NEWS UPDATE. AP’s earlier story follows below.
California parents should have an easier time getting their school-aged children excused from the state’s upcoming coronavirus vaccine mandate after a state lawmaker announced Thursday he would stop trying to block personal belief exemptions from the new rules.
Gov. Gavin Newsom has said the state will eventually require all California schoolchildren to be vaccinated against the coronavirus. He hasn’t done it yet because while federal regulators have authorized the vaccine for use on children in an emergency, they have not yet given it final approval. Once that happens, Newsom says the state’s vaccine mandate will likely take effect the following semester.
State law would allow two exceptions to the coronavirus vaccine: Medical reasons and personal beliefs. A medical reason often requires proof from a doctor. But a personal belief exemption is easier to obtain, requiring a letter from the student or parent stating their objections.
State Sen. Richard Pan, a Democrat from Sacramento who is also a pediatrician, authored a bill in the Legislature earlier this year that would have blocked students from using the personal belief exemption to avoid the coronavirus vaccine.
Thursday, Pan announced he was holding the bill — meaning it will not become law this year. While nearly 75% of California’s population has been vaccinated, rates for children 17 and under are much lower. Just under 34% of children between the ages of 5-11 have received the vaccine, while just over 66.4% of children ages 12-17 have gotten it, according to state data.
“Until children’s access to COVID vaccination is greatly improved, I believe that a state-wide policy to require COVID vaccination in schools is not the immediate priority, although it is an appropriate safety policy for many school districts in communities with good vaccine access,” Pan said in a news release.
Pan did not say he pulled the bill because of a lack of support. A poll by the Institute of Governmental Studies at the University of California, Berkeley, found 64% of registered voters support coronavirus vaccine requirements for schools — including 55% of voters who are the parents of school-aged children. The poll was published in February based on a sampling of 8,937 California registered voters, with a margin of error of plus or minus 2 percentage points.
This is the second vaccine-related bill to fail in the California Legislature this year before it even got to a vote. Last month, Democratic Assemblymember Buffy Wicks withdrew a bill that would have forced all California businesses to require coronavirus vaccines for their employees — a decision she attributed to “a new and welcome chapter in this pandemic, with the virus receding for the moment.”
Coronavirus cases and hospitalizations have declined significantly following a winter surge of the omicron variant. State officials have removed most virus restrictions, no longer requiring masks in schools or other public places.
“Definitely a lot of parents are excited that Sen. Pan is pulling this bill. It’s one less thing that they have to worry about,” said Jonathan Zachreson, the parent of three high-school children who founded the advocacy group Reopen California Schools. “The fact is kids ages 5-11 have had access to vaccines for quite some time and their low vaccination rates, I think, is evident of how parents feel about the vaccine.”
Other vaccine-related bills are still alive in the California Legislature, including one that would let schoolchildren 12 and older receive the coronavirus vaccine without their parents’ permission. Currently, California requires parental permission for vaccines unless they are specifically to prevent a sexually transmitted disease.
Total Doses Distributed = 714,749,345. Total Doses Administered = 567,818,086. Number of People Receiving 1 or More Doses = 256,590,734. Number of People Fully Vaccinated = 218,707,476.
The coronavirus pandemic ushered in what may be the most rapid rise in homeschooling the U.S. has ever seen. Two years later, even after schools reopened and vaccines became widely available, many parents have chosen to continue directing their children’s educations themselves.
Homeschooling numbers this year dipped from last year’s all-time high, but are still significantly above pre-pandemic levels, according to data obtained and analyzed by The Associated Press.
Families that may have turned to homeschooling as an alternative to hastily assembled remote learning plans have stuck with it — reasons include health concerns, disagreement with school policies and a desire to keep what has worked for their children.
In 18 states that shared data through the current school year, the number of homeschooling students increased by 63% in the 2020-2021 school year, then fell by only 17% in the 2021-2022 school year.
Around 3% of U.S. students were homeschooled before the pandemic-induced surge, according to the U.S. Census Bureau. The rising numbers have cut into public school enrollment in ways that affect future funding and renewed debates over how closely homeschooling should be regulated. What remains unknown is whether this year’s small decrease signals a step toward pre-pandemic levels — or a sign that homeschooling is becoming more mainstream.
Linda McCarthy, a suburban Buffalo mother of two, says her children are never going back to traditional school.
Unimpressed with the lessons offered remotely when schools abruptly closed their doors in spring 2020, she began homeschooling her then fifth- and seventh-grade children that fall. McCarthy, who had been working as a teacher’s aide, said she knew she could do better herself. She said her children have thrived with lessons tailored to their interests, learning styles and schedules.
“There’s no more homework ’til the wee hours of the morning, no more tears because we couldn’t get things done,” McCarthy said.
Once a relatively rare practice chosen most often for reasons related to instruction on religion, homeschooling grew rapidly in popularity following the turn of the century before leveled off at around 3.3%, or about 2 million students, in the years before the pandemic, according to the Census. Surveys have indicated factors including dissatisfaction with neighborhood schools, concerns about school environment and the appeal of customizing an education.
In the absence of federal guidelines, there is little uniformity in reporting requirements. Some states, including Connecticut and Nevada, require little or no information from parents, while New York, Massachusetts and some others require parents to submit instruction plans and comply with assessment rules.
The new surge in homeschooling numbers has led state legislatures around the country to consider measures either to ease regulations on homeschool families or impose new ones — debates have gone on for years. Proponents of more oversight point to the potential for undetected cases of child abuse and neglect while others argue for less in the name of parental rights.
All of the 28 state education departments that provided homeschooling data to the AP reported that homeschooling spiked in 2020-21, when fears of infection kept many school buildings closed. Of the 18 states whose enrollment data included the current school year, all but one state said homeschooling declined from the previous year but remained well above pre-pandemic levels. (The exception, South Dakota, recently changed the way it collects data).
Minnesota, for example, reported that 27,801 students are being homeschooled now, compared to 30,955 during the last school year. Before the pandemic, homeschool figures were around 20,000 or less.
Black families make up many of the homeschool converts. The proportion of Black families homeschooling their children increased by five times, from 3.3% to 16.1%, from spring 2020 to the fall, while the proportion about doubled across other groups, according to U.S. Census surveys.
Raleigh, North Carolina, mother Laine Bradley said the school system’s shortcomings became more evident to families like hers when remote learning began.
“I think a lot of Black families realized that when we had to go to remote learning, they realized exactly what was being taught. And a lot of that doesn’t involve us,” said Bradley, who decided to homeschool her 7-, 10- and 11-year-old children. “My kids have a lot of questions about different things. I’m like, ‘Didn’t you learn that in school?’ They’re like, ‘No.’”
Bradley, who works in financial services, converted her dining room into a classroom and rearranged her work schedule to take over her children’s education, adding lessons on financial literacy, Black history and Caribbean history important to her heritage.
“I can incorporate things that I feel like they should know,” she said. Her husband, Vince, who retired from the Air Force last year, steps in at times. The couple also have a 14-month-old. They plan to continue homeschooling for as long as their children want it. Her social media posts about her experience have drawn so much interest that Bradley recently created an online community called Black Moms Do Homeschool to share resources and experiences.
Boston University researcher Andrew Bacher-Hicks said data showed that while homeschool rates rose across the board during the last school year, the increase was greater in school districts that reverted to in-person learning, perhaps before some parents were ready to send their children back.
He said the same health concerns that drove those increases are likely behind the continued elevated rates, despite additional upheaval in schools as parents and policy-makers debate issues surrounding race and gender and which books should be in libraries.
“It’s really hard to disentangle those two things because all of this is kind of happening at the same time,” he said. “But my my guess would be that a large part of the decisions to exit from the system do have to do with COVID-related issues as opposed to political issues, because those things come up frequently and we’ve never seen an increase in homeschooling rates like this before.”
He said parents also may be concerned about the quality of education delivered by schools that have had to rely heavily on substitute teachers amid pandemic-caused staffing shortages.
McCarthy, the mom from suburban Buffalo, said it was a combination of everything, with the pandemic compounding the misgivings she had already held about the public school system, including her philosophical differences over the need for vaccine and mask mandates and academic priorities.
The pandemic, she said, “was kind of — they say the straw that broke the camel’s back — but the camel’s back was probably already broken.”
“There are kids that don’t know basic English structure but they want to push other things on children, and it can be blatant but it can be, and mostly is, very subtle, very, very subtle,” McCarthy said. “So we were ready to pull them and will never send them back to traditional school. It’s just not a fit for us.”
“It’s just a whole new world that is a much better world for us,” she said.
Pfizer said Thursday it wants to expand its COVID-19 booster shots to healthy elementary-age kids.
U.S. health authorities already urge everyone 12 and older to get one booster dose for the best protection against the newest variants — and recently gave the option of a second booster to those 50 and older.
Now Pfizer says new data shows healthy 5- to 11-year-olds could benefit from another kid-sized shot.
In a small study, 140 youngsters who’d already gotten two shots were given a booster six months later, and researchers found the extra shot generally revved up their immune response. But a closer look at 30 of the children found a 36-fold increase in virus-fighting antibodies, levels high enough to fight the super-contagious omicron variant, Pfizer and its partner BioNTech said in a press release.
The data has not been published or vetted by independent experts.
Pfizer tested the kid booster while omicron was surging this winter. While COVID-19 cases now are at much lower levels in the U.S., in recent weeks an even more contagious version of omicron, called BA.2, has become the dominant type locally and around the world.
In the coming days, the companies plan to ask the U.S. Food and Drug Administration to authorize a booster for healthy 5- to 11-year-olds. They also plan to share the data with European and other regulators.
Vaccinations are generally less effective against the omicron variant than earlier versions of the coronavirus — but they do still offer strong protection against severe disease. While COVID-19 is a bigger threat to adults, youngsters can get seriously ill. But regulators will have to decide if healthy elementary-age kids really need a booster, and if so, when.
The Pfizer shots are the only vaccine available to U.S. children. Those ages 5 to 11 receive one-third of the dose given to everyone 12 and older. Just over a quarter in the younger age group have gotten two doses since vaccination opened to them in November, shortly before omicron struck.
The U.S. hasn’t yet allowed vaccinations for children under 5. But certain 5- to 11-year-olds — those with severely weakened immune systems — already are supposed to get three doses, to give that high-risk group a better chance of responding.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
British authorities have authorized a coronavirus vaccine for adults made by French drugmaker Valneva, despite the government’s decision last year to cancel an order for at least 100 million doses.
The U.K. is the first country to authorize Valneva’s vaccine, which is also under review by the European Medicines Agency. Britain’s medicines regulator said Thursday that the two-dose vaccine is intended for adults ages 18 to 50, with the second dose given about a month after the first.
The Valneva vaccine is made with the decades-old technology used to manufacture shots for flu and polio. It is the sixth COVID-19 vaccine the U.K. has cleared and the only one that utilizes a “killed” virus; scientists grow the coronavirus in a lab and then inactivate the virus so it cannot replicate or infect cells.
The U.K. government scrapped an agreement with Valneva in September to purchase at least 100 million doses, saying at the time that British regulators probably would not cleared the shot. Valneva said Britain canceled the deal because of supply concerns.
Health Secretary Sajid Javid said in September that he couldn’t go into details because of commercial issues but that the deal was spiked because “it was also clear to us that the vaccine in question that the company was developing would not get approval.”
Britain was an early backer of the Valneva vaccine, agreeing to invest millions of pounds in a production facility in Scotland. As part of the contract, the U.K. had agreed to buy 100 million doses with options for another 90 million.
Even without the Valneva vaccine, the government has acquired more than enough doses to fully vaccinate everyone in the country twice. To date, nearly 60% of the British population has received three doses.
