Chicago battles measles with calls for vaccination—in contrast with Florida

A brightly colored transmission microscope image of measles viruses.
Enlarge / A brightly colored transmission microscope image of measles viruses.

A team of health experts from the Centers for Disease Control and Prevention arrived in Chicago on Tuesday as officials identified three new measles cases amid a flare-up of cases at a migrant shelter in the city’s Pilsen neighborhood.

So far, there have been seven cases identified at the Halsted Street shelter. In addition to the three cases identified today, there were two young children, one recovered and one hospitalized in good condition as of March 10, and according to an announcement on Monday, March 11, two adults who were reported in good condition.

The seven cases come just days after the city’s health department announced a measles case in a Chicago resident with no recent travel outside of the city and no reported connection with the shelter. The case, announced on March 7, was the first measles case identified in the city since 2019, officials noted. It remains unclear how that resident contracted the highly infectious virus, though the health department noted that the person had been in contact with domestic and international travelers. The person was said to be recovering well at home, and their infectious period ended on March 6.

The measles cases at the shelter have led to a massive response—and strong encouragement from health officials for vaccination. The city’s health department on Monday reported that, along with help from other area health officials and health care providers, it had “successfully vaccinated more than 900 shelter residents with the measles-mumps-rubella (MMR) vaccine.” Those newly vaccinated shelter residents are to stay at the shelter for 21 days until their immunity from the vaccination reaches full effectiveness. Meanwhile, more than 700 shelter residents, who had been assessed and found to already have immunity to measles from either prior vaccination or infection, were allowed to move freely in and out.

In a statement Monday, the city’s health commissioner Olusimbo “Simbo” Ige called the response a “massive operation.” She thanked health partners and shelter residents for “understanding the need to get vaccinated and quarantine. … Vaccination remains by far the most effective way to prevent the spread of measles. New arrivals and all Chicagoans should get the MMR vaccine if they haven’t already.”

Contrast with Florida

Chicago’s proactive response, full-throated calls for vaccination, and collaboration with the CDC are in contrast to the approach Florida’s health department took in a recent measles outbreak. That outbreak began last month in a Broward County elementary school with a vaccination rate reported to be below the target of 95 percent. To date, Broward has reported nine measles cases, all in children. However, the health department has not released data on if or how all nine cases are connected to the school, nor has it reported the vaccination status of those cases.

During the initial response, Florida’s health department went against CDC guidance and did not have unvaccinated children stay home during their potential infectious period after exposure to the highly infectious virus. In a February 20 letter sent to parents of the elementary school’s students, Florida Surgeon General Joseph Ladapo—who is known for spreading anti-vaccine rhetoric and vaccine misinformation—told parents that the health department would leave it up to parents to decide if their children should attend school.

https://arstechnica.com/?p=2009758




CDC ditches 5-day COVID isolation, argues COVID is becoming flu-like

A view of the Centers for Disease Control and Prevention headquarters in Atlanta.
Enlarge / A view of the Centers for Disease Control and Prevention headquarters in Atlanta.

COVID-19 is becoming more like the flu and, as such, no longer requires its own virus-specific health rules, the Centers for Disease Control and Prevention said Friday alongside the release of a unified “respiratory virus guide.”

In a lengthy background document, the agency laid out its rationale for consolidating COVID-19 guidance into general guidance for respiratory viruses—including influenza, RSV, adenoviruses, rhinoviruses, enteroviruses, and others, though specifically not measles. The agency also noted the guidance does not apply to health care settings and outbreak scenarios.

“COVID-19 remains an important public health threat, but it is no longer the emergency that it once was, and its health impacts increasingly resemble those of other respiratory viral illnesses, including influenza and RSV,” the agency wrote.

The most notable change in the new guidance is the previously reported decision to no longer recommend a minimum five-day isolation period for those infected with the pandemic coronavirus, SARS-CoV-2. Instead, the new isolation guidance is based on symptoms, which matches long-standing isolation guidance for other respiratory viruses, including influenza.

“The updated Respiratory Virus Guidance recommends people with respiratory virus symptoms that are not better explained by another cause stay home and away from others until at least 24 hours after both resolution of fever AND overall symptom are getting better,” the document states. “This recommendation addresses the period of greatest infectiousness and highest viral load for most people, which is typically in the first few days of illness and when symptoms, including fever, are worst.”

“Residual risk”

The CDC acknowledged that the eased isolation guidance will create “residual risk of SARS-CoV-2 transmission,” and that most people are no longer infectious only after 8 to 10 days. As such, the agency urged people to follow additional interventions—including masking, testing, distancing, hygiene, and improving air quality—for five additional days after their isolation period.

“Today’s announcement reflects the progress we have made in protecting against severe illness from COVID-19,” CDC Director Dr. Mandy Cohen said in a statement. “However, we still must use the commonsense solutions we know work to protect ourselves and others from serious illness from respiratory viruses—this includes vaccination, treatment, and staying home when we get sick.”

Overall, the agency argued that a shorter isolation period would be inconsequential. Other countries and states that have similarly abandoned fixed isolation times did not see jumps in COVID-19 emergency department visits or hospitalizations, the CDC pointed out. And most people who have COVID-19 don’t know they have it anyway, making COVID-19-specific guidance moot, the agency argued. In a recent CDC survey, less than half of people said they would test for SARS-CoV-2 if they had a cough or cold symptoms, and less than 10 percent said they would go to a pharmacy or health care provider to get tested. Meanwhile, “The overall sensitivity of COVID-19 antigen tests is relatively low and even lower in individuals with only mild symptoms,” the agency said.

The CDC also raised practical concerns for isolation, including a lack of paid sick leave for many, social isolation, and “societal costs.”

The points are likely to land poorly with critics.

“The CDC is again prioritizing short-term business interests over our health by caving to employer pressure on COVID guidelines. This is a pattern we’ve seen throughout the pandemic,” Lara Jirmanus, Clinical Instructor of Medicine at Harvard Medical School, said in a press release last month after the news first broke of the CDC’s planned isolation update. Jirmanus is a member of the People’s CDC, a group that advocates for more aggressive COVID-19 policies, which put out the press release.

Another member of the group, Sam Friedman, a professor of population health at NYU Grossman School of Medicine, also blasted the CDC’s stance last month. The guidance will “make workplaces and public spaces even more unsafe for everyone, particularly for people who are high-risk for COVID complications,” he said.

COVID and flu

But, the CDC argues that the threat of COVID-19 is fading. Hospitalizations, deaths, prevalence of long COVID, and COVID-19 complications in children (MIS-C) are all down. COVID-19 vaccines are safe and effective at preventing severe disease, death, and to some extent, long COVID—we just need more people to get them. Over 95 percent of adults hospitalized with COVID-19 in the 2023–2024 respiratory season had no record of receiving the seasonal booster dose, the agency noted. Only 22 percent of adults got the latest shot, including only 42 percent of people ages 65 and older. In contrast, 48 percent of adults got the latest flu shot, including 73 percent of people ages 65 and older.

But even with the crummy vaccination rates for COVID-19, a mix of past infection and shots have led to a substantial protection in the overall population. The CDC even went as far as arguing that COVID-19 deaths have fallen to a level that is similar to what’s seen with flu.

“Reported deaths involving COVID-19 are several-fold greater than those reported to involve influenza and RSV. However, influenza and likely RSV are often underreported as causes of death,” the CDC said. In the 2022–2023 respiratory virus season, there were nearly 90,000 reported COVID-19 deaths. For flu, there were 9,559 reported deaths, but the CDC estimates the true number to be between 18,000 and 97,000. In the current season, there have been 32,949 reported COVID-19 deaths to date and 5,854 reported flu deaths, but the agency estimates the real flu deaths are between 17,000 and 50,000.

“Total COVID-19 deaths, accounting for underreporting, are likely to be higher than, but of the same order of magnitude as, total influenza deaths,” the agency concluded.

In all, the CDC was ready to fold SARS-CoV-2 into the gang of common seasonal respiratory viruses, with most cases mild and undiagnosed. “Viruses cause most acute respiratory illnesses, but it is rarely possible to determine the type of virus without testing, and oftentimes testing does not change clinical management,” the agency wrote.

https://arstechnica.com/?p=2007434




Protective vaccination rates falling out of reach in US; exemptions hit record

A small person looks at the band-aid being applied to their arm.
Enlarge / A child getting a vaccination on February 19, 2021, in Bonn, Germany.

For the third consecutive year, kindergartners across the US have fallen short of reaching the protective threshold of 95 percent vaccination coverage, and vaccine exemptions have reached an all-time high of 3 percent, according to a new study led by researchers at the Centers for Disease Control and Prevention.

In the 10 years prior to the COVID-19 pandemic, vaccination coverage among US kindergartners hovered around the target of 95 percent. But amid the health crises, vaccination rates slipped to 94 percent in the 2020–2021 school year, then to 93 percent in the 2021–2022 school year. For the 2022–2023 school year, overall coverage remained around 93 percent, but exemptions rose to 3 percent, up from 2.6 percent in the previous year. The current exemption rate is the highest ever recorded for the country.

The study, published in the CDC’s Morbidity and Mortality Weekly Report, included reported data from 49 states and the District of Columbia. Montana did not report vaccination data to the CDC.

Among the exemptions reported, more than 90 percent are nonmedical, meaning children were exempted from lifesaving, routine vaccinations for religious or personal reasons and not medical needs. Nonmedical exemptions accounted for roughly 100 percent of the rise in exemptions over last year.

Most troubling, perhaps, is that the rise in exemptions is occurring nationwide—40 states reported percentage-point increases in exemptions between the 2021–2022 and 2022–2023 school years. In all, 10 states now have exemption rates above 5 percent, meaning that even if they are able to vaccinate all other non-exempt kindergartners in the state, they will not be able to achieve the 95 percent threshold to protect from the spread of dangerous, vaccine-preventable infectious diseases. In the previous school year, only four states had exemption rates above 5 percent, and in the year before that, there were only two states.

The current vaccination coverage and exemption rates mean that around 250,000 kindergartners in the US are at risk of measles and other severe infections.

States of disease

Some states saw dramatic increases in exemptions just in the previous year. Hawaii topped the list with a year-over-year increase in exemptions of 3 percentage points, bringing the number of kindergartners in the state with vaccine exemptions to 6.4 percent. Idaho came in second with a 2.3 percentage-point increase, bringing its exemption rate to a startling 12.1 percent.

Other states reporting high exemption rates include Arizona (7.4 percent), Oregon (8.2 percent), Utah (8.1 percent), and Wisconsin (7.2 percent).

For specific vaccines, coverage of two doses of MMR vaccine (measles, mumps, and rubella) across the US spanned a low of 81.3 percent in Idaho to a high of at least 98.4 in Mississippi. For Polio, vaccination coverage across the US spanned a low of 81.8 percent in Idaho to at least 98.4 percent in Mississippi. Both measles and polio have popped up in the US in recent years, threatening outbreaks in under-vaccinated communities. For both MMR and Polio coverage, 13 states reached 95 percent or higher, but 12 states and DC were below 90 percent.

Overall, Idaho had the lowest state-wide vaccination rates, hovering around 81 percent with its 12.1 percent exemption rate. Mississippi had the highest rates, with 98.4 percent or above and an exemption rate of just 0.2 percent.

The study’s authors highlighted the troubling increase in exemptions nationwide but acknowledged not knowing why more parents are choosing exemptions. “It is not clear whether this reflects a true increase in opposition to vaccination, or if parents are opting for nonmedical exemptions because of barriers to vaccination or out of convenience,” they wrote. But, whatever the driver, it appears the COVID-19 pandemic was a catalyst for the decline in routine childhood vaccination rates.

While a better understanding of what’s driving exemptions could help improve vaccination rates in the future, the authors point to evidence-backed strategies to use in the meantime. These include enforcement of school vaccination requirements, school-based vaccination clinics, reminder and recall systems, and follow-up with under-vaccinated students.

https://arstechnica.com/?p=1983182




FDA approves and authorizes updated COVID boosters for everyone 6 months and up

Words and symbols adorn a large outdoor sign.
Enlarge / The Food and Drug Administration headquarters in White Oak, Maryland.

The Food and Drug Administration greenlit two updated COVID-19 vaccine booster shots Monday—a day before advisors for the Centers for Disease Control and Prevention are scheduled to meet and vote on recommendations for use of the updated vaccines.

The two shots are the 2023-2024 formulations of mRNA vaccines from Moderna and Pfizer-BioNTech, both of which target the recent omicron subvariant XBB.1.5. The FDA granted full approval of both Pfizer-BioNTech’s updated vaccine (Comirnaty) and Moderna’s updated vaccine (Spikevax) for use in those ages 12 years and up. The agency issued emergency use authorizations for both updated vaccines for use in children ages 6 months to 11 years.

If CDC and its advisors sign off on use of the vaccines Tuesday—which is likely—the shots could become fully available at local pharmacies and doctor’s offices in the coming days. While the FDA timed today’s actions to boost the population ahead of an anticipated winter wave of infection, the regulatory clearance come amid a mild increase of COVID-19 transmission that began in late summer.

“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” Peter Marks, the FDA’s top vaccine regulator, said in a press announcement. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”

In its announcement, the FDA said it determined that preliminary data on the shots found they can spur neutralizing antibody responses against currently circulating variants—including EG.5 and the highly mutated BA.2.86—that are “of a similar magnitude” to the neutralizing antibody responses seen in prior COVID-19 formulas targeting prior variants. Safety data also continues to be favorable. Thus, “the benefit-risk profile is favorable” for everyone ages 6 months and up to get the updated vaccine, the FDA said.

In a statement Monday, Moderna CEO Stéphane Bancel thanked the FDA for its timely review and called updated vaccines “critical to protecting the population” as the virus evolves. Pfizer’s CEO Albert Bourla, meanwhile, highlighted that COVID-19 cases are already climbing.

“We expect this season’s vaccine to be available in the coming days, pending recommendation from public health authorities, so people can ask their doctor about receiving their COVID-19 vaccine during the same appointment as their annual flu shot, saving time now and helping to prevent severe disease later when respiratory viruses are at their peak,” Bourla said in a statement.

Booster price

In the early years of the pandemic, the FDA moved to establish this annual update of COVID-19 vaccines, with boosters rolling out in the fall alongside flu shots ahead of anticipated winter waves. This was despite many experts expressing concern that COVID-19 has not necessarily established seasonality. Nevertheless, the FDA has charged forward with the plan, and this will be the third fall booster rollout. But, it will be the first in which the government is not paying for the shots.

This year, COVID-19 vaccines moved from government distribution to the commercial market, and Pfizer and Moderna hiked the prices of their vaccines significantly—raising them by around 400 percent. In recent vaccination rounds, the government spent around $26 to $30 for doses of the mRNA vaccines. But on the commercial market, the vaccines cost $110 to $130. The hikes have drawn intense criticism for price gouging, especially against Moderna, which developed its vaccine in partnership with federal scientists and with the help of $1.7 billion in federal grant money.

Assuming the CDC recommends the updated vaccines, most insured Americans will continue to have the vaccine available with no out-of-pocket costs. The federal government has also provided a “Bridge Access Program” to provide the vaccine freely to uninsured people through December 2024.

Still, the widely panned price hikes are not likely to help improve vaccination coverage. To date, only 17 percent of the US population (and 43 percent of the people age 65 and older) have gotten the updated booster released in the fall of 2022.

Who should get boosted

There’s also room for debate about who should receive this year’s booster dose. Experts generally agree that the elderly and people with compromised immune systems should have access to the boosters. But some experts say it’s less clear—or at least less critical—whether younger, healthy people should get the shot. The vaccines primarily provide strong protection against severe disease and death, for which young, healthy people generally have lower risk. Protection against infection and mild disease, meanwhile, is weaker and short-lived, on the order of weeks to a few months.

Thus, the benefits of vaccination for the young, healthy crowd are lower. But, some experts argue that boosters for all can help reduce transmission to the most vulnerable. Although young, healthy people have lower risks than other groups, they are not wholly immune from severe disease and complications like long COVID. Boosting can help protect against those outcomes, even if they’re less likely.

Tomorrow’s meeting

Discussion of who should get the vaccine will likely come up in tomorrow’s advisory meeting—a meeting of the CDC’s Advisory Committee on Immunization Practices (ACIP)—which is the committee that sets such things as age recommendations for immunizations.

The ACIP will also discuss a vaccine left out of today’s FDA’s actions: Novavax, a non-mRNA, protein-based COVID-19 vaccine. Novavax also developed an XBB.1.5-targeting updated vaccine for ages 12 and up. The company said in an announcement Monday that it is ready to roll out its updated shot, pending FDA authorization and CDC sign-off, but that it is “currently responding to the FDA’s requests to facilitate final review, and timing is ultimately at the discretion of the FDA.”

https://arstechnica.com/?p=1967187




BA.2.86 fears fizzle as other variants drive up hospitalizations, deaths

BA.2.86 fears fizzle as other variants drive up hospitalizations, deaths

Concern over the highly evolved omicron subvariant BA.2.86 is easing as the first batch of preliminary studies on the virus suggests it may not be as immune evasive or dangerous as its numerous mutations suggest.

But the good news is tempered by the latest COVID-19 data, which shows increasing rates of hospitalizations, emergency department visits, and deaths—all driven by the current gang of circulating omicron subvariants, led in the US by EG.5, FL.1.5.1 and XBB.1.16.6. No single variant is dominant globally, though EG.5 is on the rise.

In the US, hospitalizations are up nearly 16 percent since last week, and deaths have risen almost 18 percent in that time. Test positivity is also on a steep incline, according to the latest Centers for Disease Control and Prevention data.

Although the COVID-19 numbers are still low relative to other waves of infection, surveillance systems and testing have plummeted to worrying levels, meaning the true burden of the disease is likely underestimated. And the current wave is hitting ahead of fall booster availability, raising concern for those most vulnerable to the virus.

“One of [the World Health Organization’s] biggest concerns is the low level of at-risk people who have received a dose of COVID-19 vaccine recently,” WHO Director-General Tedros Adhanom Ghebreyesus said in a press briefing Wednesday. “Our message is not to wait to get an additional dose if it is recommended for you.”

According to reporting by NBC News, the US Food and Drug Administration could sign off on fall booster doses as early as this Friday, though the timeline could slide into early next week. The CDC is expected to sign off on the shots quickly after that.

Data so far suggests that those fall boosters—designed to target XBB.1.5—are effective against the current leading variants, namely EG.5 and FL.1.5.1. In a press release Wednesday, Moderna said that its booster is also effective against BA.2.86. According to preliminary clinical trial data, the vaccine generated an 8.7-fold increase in neutralizing antibodies against BA.2.86.

Experts are still unsure of how BA.2.86 will play out—whether it will take over, fizzle out, or further evolve into a nightmare variant. The remarkably large number of mutations it has now and its seemingly abrupt international spread raised alarm last month. But in the weeks since, the mutated omicron subvariant remains a rare find. As of the time of publishing, researchers from only 12 countries had reported just 64 BA.2.86 genome sequences out of the thousands of SARS-CoV-2 sequences submitted from around the globe each week. Meanwhile, about 30 percent of the sequences submitted recently are EG.5, Maria Van Kerkhove, WHO’s COVID-19 technical lead, said Wednesday.

BA.2.86 “is not outcompeting any of the variants of interest right now or other variants that are in circulation, and this is what we’re looking out for,” Van Kerkhove said.

The latest data

Three new studies out in the last few days—all pre-prints that have not been peer-reviewed—may help explain why the subvariant has stayed mostly on the sidelines. Collectively, the studies suggest BA.2.86 may not be as good at infecting human cells as the other currently circulating subvariants, and its mutations are not enough to overcome the high levels of immunity built up from past infections and vaccinations. While the preliminary data is heartening, researchers caution that BA.2.86 can continue to evolve, and—with our severely diminished COVID monitoring systems—we may have dodged a bullet.

One of the pre-print studies, from researchers in China, found that BA.2.86 was not as efficient at infecting cells in the lab compared with other circulating omicron subvariants, namely XBB.1.5 and EG.5. “In sum, it appears that BA.2.86 has traded its infectivity for higher immune evasion during long-term host-viral evolution,” the researchers concluded. But, they cautioned: “Close attention should be paid to monitoring additional mutations that could improve BA.2.86’s infectivity.”

A pre-print study from researchers in Sweden, meanwhile, looked at how well serum from blood donors could neutralize BA.2.86 compared with XBB.1.5 and BA.2, the omicron subvariant from which BA.2.86 descended. Though they saw dips in neutralizing levels against BA.2.86 compared to the other variants, they weren’t as severe as originally feared. In one analysis looking at the most recent serum samples—taken while XBB variants were circulating—neutralizing antibody levels against BA.2.86 were slightly lower but still pretty strong compared with levels seen against XBB.1.5. The modest drops against BA.2.86 paled in comparison to the extreme immune evasion seen when the original omicron subvariant arose in the background of the delta subvariant, leading to a massive wave of infection at the start of 2022.

The third preprint study, led by researchers in Boston, came to a similar conclusion as the Swedish study. The US-based group looked at neutralizing antibody responses from 66 people (44 who got a bivalent booster last year and 22 people who hadn’t gotten boosted.) Across the board, neutralizing antibody levels against BA.2.86 were significantly lower than those to BA.2, but “were comparable or slightly higher” than those seen against a slew of other circulating omicron subvariants, namely XBB.1.5, XBB.1.16, EG.5, EG.5.1, and FL.1.5.1.

In a post on X, Ben Murrell, senior author of the Swedish study and a researcher at the Karolinska Institute, concluded from their data that “[O]ur antibodies do not appear to be completely powerless against [BA.2.86].” But, he offered a word of caution moving forward: “The fact, however, that another Omicron-like emergence event has occurred, with that long unobserved branch [of evolution] and subsequent spread, should warn us against giving up our genomic surveillance infrastructure.”

https://arstechnica.com/?p=1966041




New malaria vaccine works well in infants, offers adults layered protection

An African girl holding a sign with

Even after 140 years of its discovery, malaria remains one of the deadliest infections humans have ever encountered. It affected 247 million individuals and was responsible for over 600,000 deaths in 2022, according to the World Health Organization. What’s more shocking is that 95 percent of malaria cases and deaths are reported in Africa alone, and 80 percent of the people who die in various African countries due to malaria are children under 5.

Currently, there exists only one malaria vaccine called RTS,S, and it only offers partial protection in children. However, a newly developed vaccine elicits a much stronger immune response in children, and it could offer layered protection to everyone by targeting a different stage of the malarial parasite’s life cycle.

The RH5 vaccine

A team of researchers from the University of Oxford recently tested a new malaria vaccine on 63 participants ranging in age from 6 months to 35 years in Bagamoyo, a town in Tanzania. The vaccine is technically ChAd63-MVA RH5, but generally called the RH5 vaccine. It exclusively targets RH5, a protein that Plasmodium falciparum (malaria parasite) employs to penetrate human red blood cells.

“RH5 is essential for the parasite to invade red blood cells and survive. Without it, the parasite will die. An RH5 vaccine stimulates the body to produce antibodies against the RH5 protein. These antibodies will bind to RH5 and if there are enough antibodies that bind, they will prevent the parasite from invading the red blood cells and causing the disease,” Dr. Angela Minassian, chief research investigator and a clinician scientist at Oxford, told Ars Technica.

Before testing the vaccine, the participants were divided into different groups based on their age (infants, teenagers, and adults). The researchers then conducted a double-blind trial in which neither the participants nor the health care workers who administered the doses didn’t know who received the malaria vaccine and who received a rabies vaccine that acted as the control.

Those who were administered the malaria vaccine developed antibodies targeting RH5. When these antibodies were tested against P. falciparum in lab settings, they prevented the growth of the pathogen, limiting it to levels that should protect against the disease.

Apart from mild fever and injection pain, none of the participants experienced any side effects from the vaccine during or after the trial period. The people who ran the trial note, “There were no serious adverse events (SAEs), adverse events (AEs) of special interest (AESIs), or unexpected reactions and no safety concerns during the course of the trial.”

In contrast to the RTS,S vaccine, RH5 triggered the most robust immune response in the group comprising infants 11 months old or younger. The next best malaria immunity was observed in 1- to 6-year-old children. The study authors said, “Higher anti-RH5 serum immunoglobulin (Ig) G responses were observed post-boost in young children and infants compared to adults.” They added, “Why the infants and young children vaccinated with ChAd63-MVA RH5 induced such high levels of antibody remains to be fully understood.”

Layered protection?

In the last two years, the RTS,S vaccine, which is currently being used in Malawi, Ghana, and Kenya, has prevented thousands of malaria deaths. The UN recently announced that nine more African countries will soon receive their first batch of RTS,S, and it plans to allocate 18 million RTS,S vaccine doses this year. WHO is reviewing another vaccine called R21 that showed 80 percent efficacy during its initial trials.

Both RTS,S and R21 are anti-sporozoite vaccines, which means they can prevent the malaria parasite’s spores from infesting the liver (plasmodium first enters the liver, then invades the blood, and from there, the infection spreads throughout the body). If somehow the pathogen makes it to the bloodstream despite these vaccines, they won’t offer any protection.

The RH5 protein, in contrast, is essential for the spread of the parasite to the blood. So the new vaccine should provide blood-stage protection that can work as a “second line of defense” against malaria. Even if some P. falciparum spores evade the RTS,S response, the antibodies produced by the new vaccine will still limit the parasite’s ability to enter red blood cells.

Med, 2023. DOI: http://dx.doi.org/10.1016/j.medj.2023.07.003 (About DOIs)

Rupendra Brahambhatt is an experienced journalist and filmmaker. He covers science and culture news, and for the last five years, he has been actively working with some of the most innovative news agencies, magazines, and media brands operating in different parts of the globe.

https://arstechnica.com/?p=1961792




New SARS-CoV-2 variant gains dominance in US amid mild summer COVID wave

New SARS-CoV-2 variant gains dominance in US amid mild summer COVID wave

For a fourth consecutive summer, COVID-19 is on the rise, though this year’s warm-weather wave appears milder than those in the emergency period of the pandemic.

COVID-19 indicators of hospital admissions, emergency department visits, test positivity, and wastewater levels have all been increasing in the past month, with a peak not yet clearly in sight, according to data-tracking by the Centers for Disease Control and Prevention. From June 10 to July 29, test positivity rose from 4.1 percent to 8.9 percent. For reference, the most recent winter wave had a peak test positivity of 10.6 percent on December 31, 2022.

On the brighter side, however, weekly COVID-19 hospital admissions and deaths continue to be at their lowest points since the start of the pandemic. For now, deaths do not appear to be rising, though there are lags in data reporting. Weekly new hospital admissions are ticking up only slightly—with admissions rising to about 8,000 in the week of July 22, up from around 6,300 the week of June 24.

Death counts for the most recent weeks with complete data show tallies of 500 to 400. And excess deaths—the number of deaths above expected baseline levels—are no longer being observed in CDC data. That is, the weekly number of deaths in the US from all causes is currently tracking with the pre-pandemic number of expected deaths.

The seemingly milder wave is likely due to a combination of factors, including immunity from vaccines and past infections and the fact that many people vulnerable to the virus died in previous waves. The cumulative US death toll of the COVID-19 pandemic stands at over 1.1 million.

Still, the virus is surging again this summer, raising questions of whether summer waves will be a fixed seasonal cycle for this virus. Many health experts see SARS-CoV-2 as predominately a cold-weather virus, much like other respiratory germs, such as the common cold and flu viruses that thrive and surge in the fall and winter. The Food and Drug Administration, for instance, has modeled its COVID-19 vaccine booster plans around those used for annual flu shots.

But SARS-CoV-2’s seasonality is still unclear, and researchers don’t know exactly what’s driving the summer waves, which often start in the southern part of the country. A leading hypothesis is that the upticks coincide with summer vacations, travel, and get-togethers.

Another potential factor for waves is newly emerging variants. Currently, a new omicron subvariant—EG.5, which is related to XBB.1.9.2—is gaining dominance in the US over the previously reigning variants, XBB.1.5 and XBB.1.16. However, monitoring for SARS-CoV-2 variants has declined so steeply that the CDC only has enough data to estimate variant prevalence for three of the country’s 10 health regions (the areas around California, New York, and the Southeast).

Based on an FDA advisory committee meeting in June, vaccine manufacturers will likely roll out updated COVID-19 booster shots this fall aimed at an XBB subvariant lineage, possibly XBB.1.5.

https://arstechnica.com/?p=1959483




mRNA technology for vaccines and more: An Ars Frontiers recap

Ars' John Timmer (left) with Karin Bok (center) and Nathaniel Wang (right).
Enlarge / On May 22, John Timmer (left) moderated a panel featuring Karin Bok (center) and Nathaniel Wang (right) for the Ars Frontiers 2023 session titled, “Beyond COVID: What Does mRNA Technology Mean for Disease Treatment?”
Ars Technica

The world of biomedicine has developed a lot of technology that seems a small step removed from science fiction, but the public isn’t aware of much of it. mRNA-based vaccines, though, were a big exception as a lot of the public tracked the technology’s development as a key step toward emerging from the worst of the pandemic and then received the vaccines in droves.

mRNA technology has a lot of potential applications beyond COVID, and we talked a bit about those during the “Beyond COVID: What Does mRNA Technology Mean for Disease Treatment?” panel at last week’s Ars Frontiers event. We’ve archived the panel on YouTube; if you want to focus on the discussion about mRNA therapies, you can start at the 1-hour, 55-minute mark.

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mRNA is a nucleic acid molecule that instructs the cell to make specific proteins. When used as vaccines, the instructions call for a protein produced by a pathogen, such as a virus. “It helps put up a wanted poster for the immune system,” was how Nathaniel Wang, co-founder and CEO of Replicate Bioscience put it.

The production of a wanted poster is no different from other vaccines. “mRNAs is just the vessel, it’s the delivery vehicle,” said Karin Bok of the National Institutes of Health. “So let’s say you have your sandwich for lunch—mRNA is the bread that you choose to deliver that sandwich.” Where RNA differs is in how easy it is to work with. Bok said that since the mRNA is synthetic, it avoids many of the potential safety precautions that need to be taken when the vaccine is produced in cells. (Bok is the director of Pandemic Preparedness and Emergency Response at NIH’s Vaccine Research Center.) This means that we can get a vaccine into safety tests quickly and potentially test alternate vaccines in parallel.

That ease of use affects manufacturing, as well. “You don’t need to recreate a manufacturing process for flu versus COVID-19 versus Epstein-Barr virus,” Wang said. “You just change the sequence that’s in the RNA itself, but the way you manufacture and purify that material is the same, and that’s why it’s so much faster.”

Beyond speed

Speed of development has some additional benefits. Bok named seasonal vaccines, such as the flu (and potentially COVID in the future), as a big beneficiary. Because the testing and manufacturing process go faster, we can wait a few extra months to gather additional data before committing to a specific formulation for the year’s vaccine. Beyond that, Bok suggested we’ll use mRNAs for additional diseases, but which ones will depend on an analysis of the specific disease and whether mRNA can provide what’s needed to generate lasting immunity.

Wang, for his part, is excited by technologies that are in development (he termed them “mRNA 2.0”) that could produce more protein from each RNA molecule and include signals that stimulate the immune response. This, he suggested, could lower the required vaccine dose by as much as 1,000-fold, making manufacturing even easier.

That could be good news for uses beyond vaccines. Therapies such as those for autoimmune disorders and diabetes may be based on protein injections, often done daily. But with mRNAs, we can get our cells to produce the therapies themselves. Wang said there is work toward developing mRNA-like molecules that can drive expression for weeks or even months, potentially eliminating the need for daily injections.

Further into the future, Wang said people are working on so-called “cancer vaccines,” where proteins are used to restore the immune response to cancerous cells. mRNA, he suggested, was an obvious candidate for use in this work.

All of these uses, however, depend on the public being comfortable with the continued use of mRNA, which caused a lot of suspicion in some circles after the COVID vaccine rollout. Bok partially attributed that to the speed aspect of Project Warp Speed, though she emphasized that “we only bet money; we didn’t bet safety.” But she also acknowledged that there has been long-term mistrust of vaccines in many societies.

“I think our R&D excitement needs to come hand-in-hand with how do we instill trust in vaccines, but also in mRNA vaccines, which is a fantastic new technology that we can use for many, many infectious diseases that we don’t have vaccines for,” Bok said. She and Wang emphasized that transparency and authenticity will be key to instilling trust.

Still, the fact that we need to restore trust is a sign of just how successful this technology has been compared to where it was before COVID. “I think it’s hard to remember anything before the pandemic sometimes, but people were ready to take RNA technologies behind the shed and shoot it,” Wang said. “There were real questions on whether it could ever scale, whether it was ever going to be commercially deployable, whether there were going to be fundamental safety questions, and I think what the past few years have done is really answer all of those questions with a resounding yes, it is a scalable technology, it can be manufactured, it can be safe and deployable.”

https://arstechnica.com/?p=1943062




Moderna rakes in surprise profits ahead of 400% vaccine price hike

Moderna CEO Stephane Bancel during a Bloomberg Television interview on the closing day of the World Economic Forum in Davos, Switzerland, on May 26, 2022.
Enlarge / Moderna CEO Stephane Bancel during a Bloomberg Television interview on the closing day of the World Economic Forum in Davos, Switzerland, on May 26, 2022.

Things are looking rosy for Moderna, as it reported unexpected first-quarter profits Thursday. But the company is not wavering in its plans to dramatically hike the price of its COVID-19 vaccines.

While financial analysts expected the company to post revenue of $1.18 billion and a loss of $1.77 per share in the first quarter, the company reported $1.86 billion in revenue with a small profit of 19 cents per share.

The company forecasts $5 billion in COVID vaccine sales for this year.

The plump profits haven’t changed the company’s plans for its COVID-19 vaccines. In an earnings call Thursday, Moderna Chief Commercial Officer Arpa Garay confirmed that the company is still proceeding with the 400 percent increase as the vaccines move from federal distribution to the commercial market later this year.

“In terms of pricing across the US market, we do anticipate our list price—when we have our updated vaccines—to be in the range of $110 to $130,” Garay said.

In March, Moderna CEO Stéphane Bancel unabashedly defended the price hike to lawmakers in the face of biting criticism. Senators in the Congressional hearing emphasized that Moderna developed the vaccine in collaboration with government scientists at the National Institutes of Health, and the federal government spent roughly $10 billion to support clinical development and speed production of the shots in the early days of the pandemic.

“This vaccine would not exist without NIH’s partnership and expertise and the substantial investment of the taxpayers of this country,” Sen. Bernie Sanders (I-Vt.), who led the hearing, said. “And here is the thank you that the taxpayers of this country received from Moderna for that huge investment: They are thanking the taxpayers of the United States by proposing to quadruple the price of the COVID vaccine.”

According to a report from The Washington Post last week, Bancel has profited handsomely from the pandemic, which made him a billionaire. Last year, Moderna increased Bancel’s salary by 50 percent to $1.5 million and increased his target cash bonus. He also exercised stock options worth nearly $393 million.

Moderna’s pay and governance, in general, has raised eyebrows among financial analysts, the Post notes. Moderna board members’ pay ranks in the top 25 percent of directors at America’s top 500 largest publicly traded companies, with a member’s average pay last year set at $475,000. That’s well above rival pharmaceutical giants, including Pfizer, Bristol-Myers Squibb, and Merck.

https://arstechnica.com/?p=1937072




Healthy adults don’t need annual COVID boosters, WHO advisors say

A vial containing Moderna COVID-19 booster vaccine at a vaccination center.
Enlarge / A vial containing Moderna COVID-19 booster vaccine at a vaccination center.

A vaccine advisory group for the World Health Organization said Tuesday that, at this point, it does not recommend additional, let alone annual COVID-19 booster shots for people at low to medium risk of severe disease. It advised countries to focus on boosting those at high risk—including older people, pregnant people, and those with underlying medical conditions—every six to 12 months for the near- to mid-term.

The new advice contrasts with proposed plans by US Food and Drug Administration, which has suggested treating COVID-19 boosters like annual flu shots for the foreseeable future. That is, agency officials have floated the idea of offering updated formulations each fall, possibly to everyone, including the young and healthy.

In a viewpoint published last May in JAMA, the FDA’s top vaccine regulator, Peter Marks, along with FDA Commissioner Robert Califf and Principal Deputy Commissioner Janet Woodcock, argued that annual COVID booster campaigns in the fall, ahead of winter waves of respiratory infections—such as flu, COVID-19, and RSV—would protect health care systems from becoming overwhelmed. And they specifically addressed the possibility of vaccinating those at low risk.

“The benefit of giving additional COVID-19 booster vaccines to otherwise healthy individuals 18 to 50 years of age who have already received primary vaccination and a first booster dose is not likely to have as marked an effect on hospitalization or death as in the other populations at higher risk,” the FDA officials wrote. “However, booster vaccinations could be associated with a reduction in health care utilization (e.g., emergency department or urgent care center visits).”

In a press briefing Tuesday, WHO advisors called the benefit of boosting those at low or even medium risk “actually quite marginal” and suggested that countries could roll back offering primary COVID-19 vaccination series to low-risk healthy children and teens based on country-specific conditions and resources.

Context and limits

These updated recommendations “reflect that much of the population is either vaccinated or previously infected with COVID-19, or both,” said Hanna Nohynek, chair of the WHO’s advisory groups, called SAGE for the Strategic Advisory Group of Experts on Immunization. But the advisor’s updated guidance “reemphasizes the importance of vaccinating those still at risk of severe disease, mostly older adults and those with underlying conditions, including with additional boosters,” she added.

Specifically, the WHO’s SAGE considered high-risk groups: older adults; younger adults with significant comorbidities, such as diabetes and heart disease; people 6 months and older with immunocompromising conditions, such as people living with HIV and transplant recipients; pregnant people; and frontline health workers.

For these high-risk groups, SAGE recommended an additional booster six to 12 months after their last, given the current epidemiological conditions. The advisors noted that the advice is “time-limited” for the current situation, not one for annual or biannual shots to be offered in perpetuity. The scenario and overall recommendations could change depending on new, more virulent variants or future declines in COVID-19 spread, for instance.

Already, the United Kingdom and Canada have offered spring COVID-19 boosters to high-risk groups, including older people and those who have immunocompromising conditions. So far, the FDA has not indicated that it will do the same.

https://arstechnica.com/?p=1927482