Target $16
Friday, September 24, 2021
CDC director urges COVID booster for younger at-risk workers, defying advisors
U.S. Centers for Disease Control and Prevention Director Dr. Rochelle Walensky late Thursday endorsed the Pfizer coronavirus vaccine booster shot for younger at-risk workers, which is seen as a rare break from the agency's Advisory Committee on Immunization Practices panel.
The panel had recommended the booster for Americans 65 and older and for those over 50 with underlying medical conditions, but voted against the younger at-risk worker recommendation.
Walensky put it back in, saying it aligns with a U.S. Food and Drug Administration booster authorization from earlier this week.
"As CDC Director, it is my job to recognize where our actions can have the greatest impact," Walensky said in a statement. "At CDC, we are tasked with analyzing complex, often imperfect data to make concrete recommendations that optimize health. In a pandemic, even with uncertainty, we must take actions that we anticipate will do the greatest good."
The younger at-risk group includes teachers and front-line medical workers.
CDC directors rarely reverse panel decisions and in doing so can risk undermining the process, The New York Times reported. The lateness of the CDC statement showed the complex nature of deciding who needs the booster most.
But Walensky aligned herself with the FDA and the White House, which recommended giving boosters to more Americans.
"I am surprised that Dr. Walensky overturned one of the four ACIP votes today, and I believe others will be as well," Dr. Yvonne Maldonado, an infectious disease expert on the committee, told The Times. But she agreed the vote was close and didn't begrudge Walensky's decision.
An email was sent out to the panelists minutes before the CDC statement was released, advising them Walenksy was reversing the decision.
"I am hoping to share this news with you before you see it in the press," Dr. Amanda Cohn, who oversaw the panel, wrote, according to The Times.
The panel had offered the option of a booster for those ages 18 to 49 who have chronic health problems and want one. But the advisers refused to go further and open boosters to otherwise healthy front-line health care workers who aren't at risk of severe illness but want to avoid even a mild infection.
Walensky opened Thursday's meeting by stressing that vaccinating the unvaccinated remains the top goal "here in America and around the world." Around 55% of Americans are fully vaccinated.
Thursday, September 23, 2021
Apple Wallet getting verifiable Covid-19 vaccination cards
There’s a real chance you’ll need proof of a COVID-19 vaccination to enter certain venues, and Apple is hoping it can save you the hassle of digging up an email or carrying a physical card in your pocket. The company is bringing verifiable COVID-19 vaccination cards to Wallet as part of a future iPhone software update. The feature will take advantage of the international SMART Health Cards standard (already in use in several states) to produce proof of vaccination, sign it with a private key and create a public key to verify your info.
The just-released iOS 15 already lets you store verifiable vaccination and test results in the Health app using the same standard. You’ll receive your records through QR codes, downloadable files or healthcare providers who use Health Records on iPhone.
Apple is promising strict privacy for all your data. The company won’t have access to your imported or shared records, and all info must be encrypted and securely stored when transferred elsewhere. The tech giant also can’t see your vaccination card or how you’ve used it. You can share information with “approved” third-party apps, but only on a one-time basis.
Apple didn’t say when it might release the card update. This won’t thrill you if you’re anxious about the very concept of sharing your vaccination status with a concert venue or restaurant. However, it should at least streamline the process — important when you’re already running late for a show.
https://techcrunch.com/2021/09/21/apple-wallet-is-getting-verifiable-covid-19-vaccination-cards/
I Got Moderna. Can I Boost With Pfizer?
With FDA authorizing boosters for Pfizer's COVID-19 vaccine (Comirnaty) for certain groups, recipients of the Moderna vaccine are wondering if they can crossover to Pfizer for a third dose.
Experts are quick to point out that there are no data to guide that decision -- and that no federal health agency explicitly recommends doing so.
In addition, Moderna's booster application is in the FDA's hands, so an authorization may not be far away.
Nonetheless, people already have been taking matters into their own hands, said John Moore, PhD, a virologist and professor at Weill Cornell Medical College in New York City.
"It's anarchy," Moore told MedPage Today. "People are getting a third dose on the grounds that they can, not that they need to. They're just wandering into Walgreens and wandering out with an armful of vaccine."
"What do we have an FDA for?" he added.
Moore said there's no clear data from the medical literature for mixing and matching Pfizer and Moderna mRNA shots. Thus, if a Moderna booster is authorized, there still won't be any scientific guidance on mixing and matching.
What if a Pfizer recipient wants a Moderna boost because they've been hearing Moderna is the superior product? What if a Moderna recipient wants Pfizer in the hopes that its lower dose will lead to fewer side effects (and will still be lower than Moderna's 50-mcg booster)?
The dynamics of [government-run] vaccine rollout sites is they're not allowed to do anything that's not CDC or FDA approved," Moore said. "But CVS and Walgreens, sometimes they can do funky things. Sometimes they won't because of liability. And a lot of people just lie. There's all sorts of anarchy going on."
Yet during Wednesday's meeting of CDC's Advisory Committee on Immunization Practices (ACIP), many panelists seemed to be in favor of "heterologous boosting." Panelist Wilbur Chen, MD, of the University of Maryland in Baltimore, said booster recommendations should be "agnostic of the primary series."
ACIP chair Grace Lee, MD, of Stanford University in California, said COVID vaccine recommendations eventually should be handled like flu -- generalized to a population rather than made for a particular product. That would "make sense from a public health perspective," she said.
Indeed, in its guidelines for vaccination of immunocompromised patients, CDC states that a third dose of the same vaccine should be used, but if the product for the first two doses is unknown or unavailable, "either mRNA COVID-19 vaccine product may be administered." The agency's interim clinical considerations for vaccination similarly acknowledge that mixing mRNA products can happen "in exceptional situations."
During the ACIP meeting, it was noted that NIAID will have a full booster dataset for all three vaccines available in the U.S. later this fall. The NIH is also conducting a specific mix-and-match trial, which started in June and plans to enroll 150 people for testing mixed boosting regimens.
Thus, more definitive, data-based answers may be coming in the not-too-distant future.
What About Boosters for J&J Recipients?
The debate is somewhat different for the 15 million Americans who got the Johnson & Johnson/Janssen (J&J) vaccine, who are now asking whether they'll be in line for a second dose of that shot (the company recently issued a press release showing good efficacy for a two-dose regimen) or if they should "boost" with an mRNA vaccine -- or Pfizer, specifically, now that it has an EUA.
Leana Wen, MD, of George Washington University in Washington, D.C., has long advocated for mRNA boosters for all J&J recipients, regardless of whether they're immunocompromised.
There is a surplus of vaccines in the United States, with millions of doses soon to expire," Wen wrote in a Washington Post op-ed last month. "In addition, while the Pfizer and Moderna vaccines provide at least 90% protection against symptomatic disease, the J&J provides about 66%."
While there are, again, no data on mixing and matching J&J with Moderna or Pfizer vaccines, there's some literature on mixing AstraZeneca with mRNA vaccines. Both J&J and AstraZeneca vaccines rely on the same mechanism, an adenovirus vector, to induce immunity to SARS-CoV-2.
Two trials from across the pond -- one in Spain (CombiVacs) and one in England (Com-COV) -- as well as smaller health system-based cohort studies, "consistently show that you get a stronger antibody response when you give AstraZeneca followed by one of the mRNA vaccines," Moore said.
"Two AstraZeneca shots are weaker than anything containing mRNA," he said. "It's weaker than one AstraZeneca plus an mRNA or two mRNA shots."
Moore noted that these results are based on antibody response and not on prevention of infection, hospitalization, or death.
In addition, mixing and matching became something of a necessity in Europe, as vaccine hesitancy with AstraZeneca ran high there following reports of unusual blood clotting incidents, which ultimately came to be known as thrombosis with thrombocytopenia. Many European countries moved ahead with mixing and matching AstraZeneca with mRNA vaccines; German Chancellor Angela Merkel famously received Moderna after her first AstraZeneca dose.
But Wen, who received the J&J shot during its phase III study, noted that mixing and matching adenoviral vector vaccines with mRNA vaccines appears to be safe and effective based on the European experience, and that women who received J&J especially may want to weigh their options.
"As the FDA considers a second J&J booster, I hope that federal health officials will permit J&J recipients to receive not only J&J as a second shot, but also the mRNA vaccines," she tweeted. "Patients at high risk should be allowed to decide, with doctors, about their best option."
https://www.medpagetoday.com/special-reports/exclusives/94678
Witnesses Clash Over Masking Kids in Schools During House Hearing
Expert witnesses offered conflicting perspectives on whether masking children in schools prevents transmission of the SARS-CoV-2 virus during a hearing of the House Committee on Energy & Commerce's Subcommittee on Oversight and Investigations on Wednesday.
Several Republican committee members said that protecting children from the virus has had unintended consequences for their overall well-being.
Cathy McMorris Rodgers (R-Wash.), ranking member of the full committee, argued that the policies that emerged as a consequence of the "fearmongering" around COVID-19 have harmed children's mental health more than the virus itself.
"I know the Delta variant is scary. It's more infectious, but from what we've seen so far, it is not more severe," she said.
If a child 9 years old or younger is infected with COVID-19, that child's chance of being hospitalized is about 0.1%, and the risk of hospitalization for a person ages 11 to 19 is about 0.2%, McMorris Rodgers noted, citing data from a preprint published on medRxiv.
"Rather than accept this reality, too many of our leaders and people like President Biden want us to continue to live in fear" and are forcing "cruel restrictions" on children, she added.
"Where is the consideration of other aspects of health, children's overall well-being and mental health?" she asked.
She noted that mental health-related emergency room visits increased by 24% for children ages 5 to 11 and by 31% for those ages 12 to 17. Visits related to suicidal ideation, suicide attempts, and self-harm more than doubled.
"Mask wearing and social isolation has taken a toll, shutdowns and isolation contributed to children and teens gaining weight, at an alarming rate," McMorris Rodgers pointed out. These policies have made children "more unhealthy, and more at risk to COVID-19. How is that following the science?"
Risk of COVID in Children
Tracy Beth Høeg, MD, PhD, an epidemiologist and physical medicine and rehabilitation research associate at the University of California Davis, echoed McMorris Rodgers's concerns, stating that children's risk of infection was lower than most people initially thought.
According to the same seroprevalence data cited by McMorris Rodgers, death rates are approximately "five to six per million in children," Høeg noted.
Unvaccinated children have nearly the same risk for hospitalization as fully vaccinated adults ages 40 to 50, she added.
SARS-CoV-2 is generally "not as severe in children as adults," said Lee Beers, MD, president of the American Academy of Pediatrics (AAP), but countered that "lower risk does not mean no risk."
"To date, more than 5.5 million children have been infected by the virus [and] since the start of the pandemic. Over 21,000 children have been hospitalized and 480 children have died as a result of COVID-19," she said, citing data collected by the AAP and the Children's Hospital Association.
Beers noted that in many instances these deaths could have been prevented "through safe and simple measures."
For most of the pandemic, Margaret Rush, MD, of Monroe Carell Jr. Children's Hospital at Vanderbilt in Nashville, said that her hospital "averaged a daily census of two to four patients." During the Delta surge, the hospital saw a maximum number of 27 pediatric patients and needed to open a second COVID unit.
A quarter of these patients were in intensive care, and half of those in ICUs were "on alert for cardio bypass technology that would support their organs that were failing," she added.
But Rush also pointed out that behavioral health concerns are just as much of a concern for pediatricians.
"I have consistently had equally, if not more, numbers of children admitted to my hospital in the last 6 weeks with a behavioral health primary diagnosis, as I have COVID," she said.
Rep. Annie McLane Kuster (D-N.H.) praised the ranking member of the subcommittee, Morgan Griffith (R-Va.), for underscoring the importance of getting vaccinated in his opening statement. She then addressed McMorris Rodgers, noting that she wished "the ranking member of the full committee would focus on that as well ... I think your effort to diminish the risk [of COVID-19] rings hollow. I'm a parent. I also have 12 great-nieces and great-nephews; I want to do everything I can to keep them safe."
With regard to mental health, Kuster said that no one is recommending that those concerns not be recognized and addressed. The pandemic has indeed added to children's stress, she said, but that's an even stronger argument for supporting vaccination and "put[ting] this pandemic behind us."
Arthur Evans Jr., PhD, CEO of the American Psychological Association, also called on lawmakers and others to "avoid perpetuating a false choice between [protecting] children's education and mental well-being, and their physical health and safety ... we can and should be doing everything possible to reopen schools safely, adhering to proven public health measures, [and] providing virtual options if they become necessary."
The Science Behind Masking Kids
On the specific issue of masking children, Høeg argued that Europe has been better about prioritizing children's education, and experts there tend to admit "that we actually don't really have solid data showing that ... masking children in schools particularly has had any impact on preventing the spread of disease."
Høeg, who conducted her postdoctoral research in Denmark and maintains ties there, noted that the country recently "dropped all mitigation" related to children.
She pointed out that there isn't "robust science or randomized control trials" on masking; an observational study based on the COVID-19 School Response Dashboard in Florida found no impact of cloth mask mandates for children and teachers. She also pointed to a CDC study conducted in Georgia that demonstrated no significant reduction in disease spread in schools that mandated cloth masks for kids.
She did highlight one randomized study from Bangladesh, which found that wearing surgical masks was protective against COVID-19 in adults over 50 when increased distancing was also practiced; however, cloth masks "did not have any detectable impact in terms of SARS-CoV-2 rates," she said.
Beers countered that the AAP "reviewed hundreds of studies to develop its interim guidance for children in schools" and found that "the science is robust."
"And we are seeing ... this in action... where schools who have implemented strong mitigation policies have much lower rates of COVID than schools who have not implemented universal masking," she noted.
She pointed to recent examples from Florida in the Morbidity and Mortality Weekly Report, as well as another group in North Carolina "that saw the same thing. So, it really is strong, robust evidence."
Rep. Kim Schrier, MD, (D-Wash.), a pediatrician, asked about the quarantine protocols for children who test positive for COVID in schools.
Beers noted that the rules vary depending on whether children are vaccinated or masked. If children are unvaccinated and "not consistently masking," they may be required to stay home from school for 7 to 14 days, she said.
Schrier also asked Beers for her take on a new protocol being implemented in some Los Angeles schools in which if one person tests positive, the whole classroom can be tested daily while continuing to wear masks and follow other safety precautions instead of quarantining the whole class at home for 2 weeks, which is known as the "test to stay" model.
Beers agreed that this could be "a really effective strategy" for keeping kids in school.
"Again, it has to be in the context of other important strategies, including vaccination and, at least for right now, masking," she said.
Høeg also supported the model and urged the CDC to "highly recommend" its implementation.
https://www.medpagetoday.com/infectiousdisease/covid19/94680
CDC Panel: Thumbs Down on Pfizer Booster for Healthcare Workers
The CDC's Advisory Committee on Immunization Practices (ACIP) voted Thursday to unanimously recommend a booster dose of Pfizer's COVID-19 vaccine (Comirnaty) for adults ages 65 and up and those in long-term care facilities, as well as for adults ages 50 to 64 with high-risk medical conditions (by a vote of 13-2), but that was where their agreement ended.
ACIP voted 9-6 that adults ages 18 to 49 with high-risk medical conditions should receive a booster dose of the COVID-19 vaccine based on their individual benefit and risk (which was formerly known as a "permissive" recommendation).
However, the committee voted 6-9 not to adopt an interim recommendation for adults ages 18 to 64 who were at high risk of occupational or institutional exposure to COVID-19, based on their individual benefit and risk.
Those who voted "no" argued that there was no scientific evidence to support the fact that people were at higher risk of severe COVID-19 based on their profession. Public health officials were also vehemently opposed, given the programmatic challenges involved in implementing a recommendation where people would judge their individual benefit and risk that was not based on any clinical factors.
"I just think it's so open-ended in the way that it's stated," said Sarah Long, MD, of Drexel University College of Medicine in Philadelphia, who voted no. "It's an extremely slippery slope that's extremely difficult to interpret. I think it's unusual for us to do, letting individuals decide vaccine policy."
Long also said that the ACIP would be expanding on the FDA "approval," as the point of booster doses would be to prevent severe disease, and the occupational exposure group was not one that was at increased risk of severe COVID.
Pablo Sanchez, MD, of Nationwide Children's Hospital, who also voted no, added that an effective vaccine exists and to recommend boosters for such a broad group of people would be "like saying [the vaccine] is not working when it's working."
"We might as well say just give it to everybody 18 and older," he said.
Wilbur Chen, MD, of the University of Maryland, also brought up that this could exacerbate the equity issue, that "basically people with great health literacy will get boosters" when that might not be who needs it most.
Liaison member, Jason Goldman, MD, of the American College of Physicians, said that boosters in this group were "a solution looking for a problem" and that they would "create more confusion on the provider implementation level."
ACIP chair Grace Lee, MD, of Stanford University, who voted yes, shared a personal anecdote about caring for children who died from COVID, when they got it from a family member who was asymptomatic.
"I do worry that by inhibiting access to this, some individuals and families may suffer," she said.
Helen Keipp Talbot, MD, of Vanderbilt University, who also voted yes, emphasized that vaccinating healthcare workers, who are being exposed in the community, would help to maintain staffing levels at already overwhelmed hospitals.
"There are caveats and groups that might not be the best fit for this recommendation, but I think healthcare workers are critical," she said.
The rest of the votes were relatively straightforward, with the "no" votes to the third question (18 to 49 with high-risk medical condition) mainly centered on the lack of data for individuals with underlying conditions in the younger age groups, where boosters were estimated to avert fewer hospitalizations and severe cases compared to older adults.
Matthew Daley, MD, of Kaiser Permanente Colorado, who voted no, emphasized that there was a lot more "uncertainty" in the younger age groups, as well, and "the primary [vaccine] series is providing good effectiveness."
Ultimately, the 13-2 vote for adults ages 50 to 64 was driven in part by the committee recognizing that different races and ethnicities age differently. Oliver Brooks, MD, of Watts Healthcare Corporation in Los Angeles, pointed out that African Americans were at higher risk for severe COVID beginning at age 50, not 65, although "likely a lot of that is related to underlying medical conditions," he said.
The vote on adults ages 65 and up and those in long-term care facilities was also straightforward, as the data showed that this group derived the most benefit from boosters in terms of preventing hospitalization and death.
Mixing and matching vaccine doses also provoked discussion, with committee members upset that this booster recommendation would only apply to those who received the Pfizer vaccine as their primary series.
Peter Marks, MD, PhD, director of FDA's Center for Biologics Evaluation and Research, said that they understood the urgency of trying to have a solution for anyone who's been vaccinated with an authorized or approved vaccines.
"We will proceed with all due urgency to try to get there as quickly as possible ... to make a science-based decision so we have something that is based on evidence to bring forward," he said.
CDC staff noted that while these were the decisions of the ACIP today, they could be revisited as new data come in.
https://www.medpagetoday.com/infectiousdisease/covid19vaccine/94681
Lawsuit challenges Montana ban on employer vaccine mandates
A lawsuit brought on by the Montana Medical Association is challenging the state's ban on employer vaccine mandates.
The association, along with other hospitals and patient groups, filed a lawsuit Wednesday against sate Attorney General Austin Knudsen and Commissioner of Labor and Industry Laurie Esau over House Bill 702, which banned employers from requiring the COVID-19 vaccine.
The lawsuit, which was filed in federal court, alleges the bill violates the Americans with Disabilities Act, Occupational Safety and Heath Act regulations, a right to a safe work environment and equal protection laws.
It “directly prohibits physician offices from following long-held evidence-based practices that create the safest environment possible for our patients and employees. This includes the ability to take reasonable mitigation steps if an employee has not been,” the Montana Medical Association said in a statement Thursday.
“To be clear, HB 702, while passed in the context of COVID-19, has wide-ranging impacts outside of the current pandemic,” it added.
Employer vaccine mandates have been implemented around the country since the delta variant has caused cases to rise — and since the Pfizer vaccine received full approval from the Food and Drug Administration.
However, some Republican states have gone after such mandates, saying an employer should not be allowed to require an individual to get a vaccine.
“Attorney General Knudsen ... is committed to protecting Montanan’s right to privacy and their ability to make their own health care decisions," Knudsen's spokesperson Emilee Cantrell said in a statement Thursday.
A spokesperson for Republican Gov. Greg Gianfore said the governor's office “generally doesn’t comment on ongoing or pending litigation, but ultimately what this comes down to is that no Montanan should be discriminated against based on his or her vaccination status.” “While we will not mandate vaccination in Montana, the governor will continue encouraging Montanans to talk with their doctor or pharmacist and get vaccinated, because vaccines are safe, they work, and they can save lives,” the spokesperson added.
The lawsuit wants a permanent injunction on the law the governor signed and have it be declared invalid.
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