February 8, 2022: Johns Hopkins Report

COVID-19 Situation Report

Editor: Alyson Browett, MPH

Contributors: Clint Haines, MS; Natasha Kaushal, MSPH; Amanda Kobokovich, MPH; Christina Potter, MSPH; Matthew Shearer, MPH; Marc Trotochaud, MSPH; and, Rachel A. Vahey, MHS.

WASTEWATER SURVEILLANCE The US CDC has added wastewater surveillance of SARS-CoV-2 RNA to its COVID Data Tracker, as virus levels in sewage water may be capable of providing an early warning signal for transmission surges. The tool comprises data from more than 400 testing sites in 37 states, with more than 34,000 samples representing 53 million US residents collected so far. Hundreds of additional testing sites are expected to begin submitting data to the system in coming weeks. The CDC initiated the National Wastewater Surveillance System (NEWS) in September 2020, and it has become a critical tool for public health officials since it can show where viral loads are changing, which communities are at risk of a surge in cases, and where medical supplies should be deployed.

An additional benefit of the COVID wastewater tracking system is the identification of novel and “cryptic” variants of SARS-CoV-2. Cryptic variants are lineages of SARS-CoV-2 that contain mutations never before observed in humans. A number of cryptic lineages have been detected in the New York City sewer system. The origin of these out-of-the-ordinary lineages, which also have been detected in Missouri and California, has not yet been determined, but the most popular hypothesis is the mutations arose simultaneously in similar animal hosts, such as rodents that live in the sewer systems. Whatever the source, the new surveillance system could be critical in identifying and tracking the next major variant of concern.

US CDC ACIP MEETING The US CDC's Advisory Committee on Immunization Practices (ACIP) met on February 4 to provide updates to clinical considerations for utilization of COVID-19 vaccines. Topics of discussion included the FDA-approved Spikevax SARS-CoV-2 vaccine from Moderna, vaccination recommendations specific to immunocompromised individuals, and lengthening the gap between the first two doses of mRNA COVID-19 vaccines.

ACIP voted unanimously to recommend the use of a 2-dose primary series of Spikevax among US adults aged 18 years and older, and CDC Director Dr. Rochelle Walensky endorsed the recommendation later that day. ACIP members also discussed concerns regarding the risk of myocarditis following vaccination. Results of investigations into 13 deaths from myocarditis following mRNA vaccination found that the myocarditis was not caused by vaccination, and most other myocarditis cases among mRNA vaccine recipients were resolved within 90 days with no reported impact on quality of life. Additional discussions centered on potentially widening the time interval between initial mRNA vaccine doses from the current 21-28 days to 8 weeks apart. The change might reduce the risk of myocarditis among some recipients and increase vaccine effectiveness. However, no official vote was taken on the suggestion.

Officials also presented anticipated changes to vaccine guidance for certain immunocompromised individuals. The proposed revised guidance notes that people who are moderately or severely immunocompromised should receive a booster dose at least 3 months—instead of the current 5 months—after the last dose of a 3-dose primary series of mRNA SARS-CoV-2 vaccine. For immunocompromised individuals who received the single-dose J&J-Janssen vaccine, the guidance likely will change from the current recommendation—a primary dose followed by a booster 2 months later—to a 3-dose schedule of an additional mRNA dose at least 28 days after the initial dose and then an mRNA booster dose 2 months after the second dose. The guidance was expected to be updated on February 7 but the new recommendations are not yet published on the CDC’s website.

OMICRON-ONLY VACCINES As noted in previous briefings, both Moderna and Pfizer are pursuing the development and testing of Omicron variant-specific vaccines. Some health officials, such as those from the European Medicines Agency, support the efforts. However, research from the US National Institutes of Allergy and Infectious Diseases' (NIAID) Vaccine Research Center posted on February 3 to the preprint server bioRxiv suggests that an Omicron variant-specific booster developed by Moderna might not provide additional or greater protection beyond the company’s already authorized mRNA vaccine booster dose. The research, which is not yet peer-reviewed, tested the boosters in primates. These findings mirror the results of other small animal studies testing vaccines targeting other individual variants. But predicting the future emergence or dominance of SARS-CoV-2 variants is difficult, with scientists uncertain if a new dominant variant might evolve from Omicron, a past variant, or have mutations very different from either Omicron or other past variants. This concern has led some scientists and health officials to advocate publicly for broad protection in future vaccines—to multiple variants, all betacoronaviruses, or even all coronaviruses. Several NIAID researchers recently published a commentary in the New England Journal of Medicine (NEJM) calling for a universal coronavirus vaccine to help mitigate the impacts of any future coronavirus pandemic.

LONG COVID/PASC Long COVID, or post-acute sequelae of COVID-19 (PASC), are both terms that represent a broad range of symptoms that individuals with SARS-CoV-2 infection can develop days to months after initial infection. Some public health experts are warning that the most recent surge in Omicron cases could lead to a different type of public health crisis, with extended burdens on patients and the healthcare system long after the pandemic ends. Some studies suggest that convalescent COVID-19 patients, especially those who had more severe disease or certain symptoms during acute infection, could be at higher risk of long-term cardiovascular complications or abnormal brain changes. Many patients experiencing long COVID already are waiting months for care, as physicians and clinics try to determine the best way to treat the huge constellation of symptoms that characterize the condition. Research continuously suggests that vaccination could blunt the development of long-term symptoms.

A new cohort study published February 4 in JAMA Network Open sought to better understand certain new symptoms and their prevalence among individuals who test positive and negative for SARS-CoV-2 infection, stratified by age and disease severity. New-onset shortness of breath, heart rhythm abnormalities, and type 2 diabetes were more common 31 to 150 days after testing positive than among those with negative results. Among positive individuals over 20 years old, fatigue, shortness of breath, and sleep disorders were the most common new symptoms, whereas change in bowel habits, fatigue, and shortness of breath were the most common new symptoms for positive individuals under 20. The researchers also found that new symptoms—such as anxiety, depression, neuromuscular disorders, peripheral nerve disorders, and uncoordinated movements—were more common among hospitalized and ventilated patients. They called for healthcare providers to be aware of symptoms that might develop among patients after SARS-CoV-2 infection, particularly those who required hospitalization.

ANTIBODY DURABILITY Researchers are continuing to gain insight into SARS-CoV-2 immune responses—and the durability of antibody production—following infection. A study published February 3 in JAMA Network Open suggests that antibodies targeting the receptor-binding domain (RBD) of the spike protein can persist for up to 20 months in unvaccinated individuals who reported test-confirmed COVID-19. While the data are encouraging, it remains unclear how the antibody levels correlate to protection against future infections, especially with new variants. Another study, published February 7 in Nature Microbiology, had similar results, with researchers finding the magnitude of persistent antibody responses were correlated with COVID-19 severity in unvaccinated individuals. They note that while the neutralizing antibody (nAb) response seen in most individuals in the study would be sufficient to provide protection against reinfection and severe infection at 480 days from disease onset, people who had asymptomatic or mild infections likely would need to be vaccinated to maintain antibody-mediated protection against future SARS-CoV-2 infection. With more people becoming infected with SARS-CoV-2 and recovering from COVID-19, the future of the pandemic may see surges of infections due to new variants, but hopefully those cases will result in fewer hospitalizations and deaths. Vaccination remains the most reliable way to help prevent infection, severe disease, and death.

NOVAVAX Novavax on January 7 said it has received expanded US government funding to support late-stage clinical trials for its 2-dose SARS-CoV-2 vaccine among adolescents aged 12 to 17, including a booster component. The company has filed with the US FDA for Emergency Use Authorization (EUA) of its vaccine among adults, and the vaccine has received clearances for use in adults in Great Britain and Germany, as well as endorsement in New Zealand. Israel recently signed a deal to purchase 5 million doses of the protein-based vaccine, and Australia this week received its first shipment of a total order of 51 million doses. Some experts hope that Novavax’s use of protein-based technology will help win over individuals who are reluctant to be vaccinated with shots using newer mRNA technology.

SOUTH AFRICAN VACCINE REPLICATION Scientists at South Africa’s Afrigen Biologics and Vaccines announced last week that they have used publicly available information to produce a close copy of Moderna’s SARS-CoV-2 mRNA vaccine, without the company’s support. The effort—which is backed by the WHO-supported mRNA technology transfer hub launched in June 2021—represents the first mRNA vaccine designed, developed, and produced in an African lab. Scientists are using Moderna-patented technology because the company has vowed to not enforce its COVID-19-related patents against those making vaccines intended to combat the pandemic. However, without the involvement of an mRNA vaccine producer, the process to bring the new vaccine to market could take up to 3 years, instead of about 1 year with support from an outside company, according to the WHO’s Initiative for Vaccine Research. Human clinical trials using the Moderna mimic are expected to begin in the fourth quarter of this year after production is scaled up. Though the long timeline for vaccine production and testing does not address Africa’s urgent need for vaccines, many scientists are enthusiastic that the effort will lay the groundwork for the future development and production of mRNA vaccines on the continent.

OTTAWA STATE OF EMERGENCY The mayor of Canada’s capital declared a state of emergency this week to help police and city staff obtain the resources they need to address a 12 day-long demonstration involving a convoy of truck drivers and other protestors who are blocking the streets of Ottawa, running their large vehicle engines, honking horns, and bringing the city to a standstill. The initial purpose of the “Freedom Convoy,” which arrived in the city on January 29, was to protest vaccine mandates for cross-border truckers, but it has since evolved into a broader demonstration against general COVID-19-related public health measures and now involves others with ties to far-right groups. Over the weekend, police began ticketing and arresting people who were caught bringing fuel, food, or other “material aid” to protestors and cautioned that demonstrators “exhibited extremely disruptive and unlawful behavior” that presents risks to public safety. Some residents reported being harassed for wearing masks.

Additionally, the crowdfunding platform GoFundMe is facing allegations of fraud from the Florida Governor and Texas State Attorney General after the fundraising platform froze nearly US$10 million in donations to the Freedom Convoy’s fundraiser and said it would redistribute the money to a different charity. After threats of investigations, GoFundMe said it instead will automatically issue refunds to donors, based on police determinations that what began as a peaceful protest has became an occupation. Donors are now using a Christian crowdfunding site called GiveSendGo, which has raised more than US$6 million as of today. The Ottawa demonstrations have become a rallying cry for far-right and anti-vaccine groups worldwide. In Australia today, hundreds of anti-vaccine demonstrators blocked the streets of the capital Canberra, as politicians and their staff return to the city for a week of parliamentary proceedings.

WHITE-TAILED DEER White-tailed deer infected with SARS-CoV-2 have been identified in at least 15 US states—Arkansas, Illinois, Iowa, Kansas, Maine, Massachusetts, Minnesota, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Tennessee, and Virginia—adding to concerns that the wild animals could become a potential source of new variants. Researchers looking at deer in Iowa found 1,200 of 2,000 lymph node samples collected from deer that were killed by hunters or car strikes tested positive for the virus. Additionally, white-tailed deer on Staten Island, New York, have been found to be carrying the Omicron variant, the first time the variant has been detected in wild animals. Researchers say it is likely deer are being infected through human contact, then spreading the virus to other deer, and so far there is no evidence that the animals have transmitted the virus back to humans. But more widespread infection among the estimated 30 million deer in the US raises the risk that the animals could become a viral reservoir, which could lead to spillover into humans or other animal species.

The truth about Ivermectin?

Why do Americans keep taking ivermectin for COVID despite FDA warnings? Hundreds of doctors continue to prescribe it.

Adrianna Rodriguez, USA TODAY

Wed, February 2, 2022, 11:51 AM

Contrary to scientific evidence and warnings from health agencies, hundreds of doctors nationwide continue to prescribe ivermectin – encouraged by a little-known national group of physicians – to prevent and treat COVID-19.

During the omicron wave they've been busier than ever, writing tens of thousands of prescriptions.

Many of the doctors follow treatment guidelines set by an organization called the Front Line COVID-19 Critical Care Alliance, which promotes the controversial drug along with other unproven therapies.

The alliance has been gaining momentum, appearing in conservative media outlets and serving as an inspiration for proposed legislation in various states to force acceptance of the anti-parasitic as a legitimate COVID-19 treatment.

The group's protocol is a laundry list of ivermectin and other prescription drugs, over-the-counter medications, vitamin supplements and herbs, none of which have been scientifically proven to work against COVID-19.

Dr. Paul Marik, a pulmonary and critical care specialist who co-founded and now chairs the FLCCC, said the group was created at the start of the pandemic when little was known about treating COVID-19 and early intervention was needed.

“We developed a protocol for the early treatment of COVID-19,” he said. “Why wait until the patients have severe pulmonary disease? They can’t breathe. They’re dying to be treated. This is stupidity.”

But two years into the pandemic, health experts say science has yielded proven therapies and effective vaccines that prevent hospitalizations and death.

“There’s a group of physicians who will abandon the science in order to satisfy the unscientific demands of patients,” said Dr. Gregory Poland, professor of medicine and infectious diseases and director of the Mayo Clinic's Vaccine Research Group. “It’s disinformation. You’re failing to use proven therapies in favor of disproven therapies, and that’s wrong.”

Dr. Miriam Merad, director of the Precision Immunology Institute at Mount Sinai’s Icahn School of Medicine, called the drug cocktail "terrifying" and "frankly, dangerous."

Although ivermectin for humans is not dangerous when used as directed, health experts say the danger lies in choosing it over COVID-19 vaccination or verified treatments.

“It's a bunch of lies,” Merad said, "and it’s embarrassing for our profession.”

What is ivermectin?

The American Medical Association and the American Academy of Allergy, Asthma and Immunology declined to comment on the FLCCC Alliance and the actions of associated doctors. The American College of Physicians, the American Board of Allergy and Immunology and the American Academy of Family Physicians did not respond to USA TODAY’s request for comment.

Professional organizations may not want to engage in discussions about ivermectin, health experts say.

“Most of us have really repudiated its use for COVID-19. It’s frustrating that people continue to prescribe it and direct people away from proven therapies. ... I don’t know what more we can do,” said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security.

"The fact is this has become more of a political crusade now rather than a scientific one,” he said. “It’s out of the realm of scientific discussion.”

Ivermectin is approved by the Food and Drug Administration in tablet form for people to treat some parasitic infections. The drug also comes in a paste or can be injected to treat or prevent parasites in animals.

The drug wasn’t frequently used in Americans before the pandemic because ivermectin is prescribed to treat specific parasites not common in the U.S, said Laurel Bristow, infectious disease clinical researcher at Emory University. But fueled by desperation and disinformation, it caught on as an alternative COVID-19 treatment, particularly among those who refused to be vaccinated.

By summer, poison control centers saw a fivefold increase in calls related to ivermectin compared with pre-pandemic levels, according to the Centers for Disease Control and Prevention. Data from the American Association of Poison Control Centers shows ivermectin poison cases increased 212% from Jan. 1, 2021, to Sept. 21.

In some cases, people were self-medicating with ivermectin intended for livestock and required emergency care. “You are not a horse. You are not a cow,” the FDA said in an advisory in August. “Seriously, y’all. Stop it.”

US COVID-19 map: Tracking cases and deaths

Yet doctors continued to prescribe it, and insurance companies continued to pay for it. A study published in JAMA Network this month estimated private and Medicare plans may have paid nearly $2.5 million for ivermectin prescriptions in the week of Aug. 13 alone.

“Spending on inexpensive drugs like ivermectin can add up pretty quickly,” said lead author Dr. Kao-Ping Chua, assistant professor of pediatrics at the University of Michigan Medical School. “Insurers may be aware that this may be happening, but they may simply be reluctant to do anything about it for public relations purposes.”

Because ivermectin prescriptions have tracked with case counts, he suspects more are being dispensed now than in August.

In response to questions about why it covered ivermectin prescriptions, the Centers for Medicare & Medicaid Services told USA TODAY it sent out a memo in December warning of potential fraud associated with the drug. It's unclear why it took so long for CMS to sound the alarm or what other action was taken.

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Despite the government warnings, FLCCC Alliance members continued to push ivermectin for COVID-19, appearing on conservative media outlets, talk shows and podcasts. Last week, U.S. Sen. Ron Johnson, R-Wis., invited FLCCC founders to a roundtable in Washington, D.C., to promote ivermectin. The five-hour discussion was hosted on Rumble, a YouTube alternative popular among conservatives that doesn't censor content.

In an email sent Monday to members of the FDA, Dr. Hooman Noorchashm, a physician, immunologist and public health advocate, pleaded for the Biden administration to take action.

"It is critically important for the United States government to urgently determine the legal legitimacy of the 'non-profits' involved with marketing these, at best controversial 'early treatment' wares," he wrote. "I do believe that this all amounts to a very severe national public health security threat."

The FDA told USA TODAY it does not discuss ongoing investigations as a general policy but said the "safety and efficacy of ivermectin for the prevention or treatment of COVID-19 has not been established."

How the FLCCC Alliance helped keep ivermectin alive

Dr. James P. Johnston, a concierge doctor who runs a telemedicine platform for COVID-19 patients, told USA TODAY that with COVID-19 cases on the rise, he has been prescribing ivermectin to about 40 people a day.

“It’s been a huge, huge boost to my practice,” he said.

Dr. Benjamin Marble, a former ER doctor and founder of another COVID-19 telemedicine platform, says he and about 20 other doctors working for his site have written more than 100,000 ivermectin prescriptions for COVID-19. The consultation is free, but after the prescriptions are sent, the site asks patients for a $125 donation.

Before prescribing any medications, many of the doctors listed on the FLCCC's website charge patients a consultation fee of $50 to $300.

"We’re trying to help as many people as we can," said Marble, who is based in Florida.

Both doctors say they look to the FLCCC protocol for guidance and "science-based recommendations." The Public Readiness and Emergency Preparedness Act, amended during the pandemic, allows physicians to prescribe, dispense or administer COVID-19 therapeutics across state lines no matter where they are licensed.

When Larry Hetu, 38, of Gulf Breeze, Florida, contracted COVID-19 in July, he reached out to Marble, a friend he met through the Republican Party. Hetu said he was unvaccinated because he mistrusted the government and wanted to avoid the hospital at all costs. He paid about $300 for his entire treatment, which included ivermectin and other medications included in the FLCCC protocol.

"I heard about it but I’m not too much into medicine, so I didn’t understand exactly what it was," Hetu said. "So, I relied on (Marble's) judgement."

Across the country, conservative lawmakers are pushing for ivermectin to become an accepted COVID-19 treatment.

In Indiana, Republican Rep. Curt Nisly has filed a bill that would allow doctors and registered nurses to write a standing order for the drug and prohibit pharmacies that fill it from providing information discouraging its use for COVID-19.

Nisly cited FLCCC Alliance co-founder Dr. Pierre Kory, who said a treatment that includes ivermectin could reduce COVID-19 deaths by about 75%. There is no evidence to support the claim, health experts say.

Vaccinated and test positive?: What to know about omicron, COVID for this holiday season.

In Kansas, a group of legislators is pushing a bill that would make it easier for doctors to prescribe ivermectin for off-label use. Pharmacists would be required to fill such prescriptions even if they believe the drug would be dangerous to patients. Physicians and pharmacists would be immune from civil liability.

The Federation of State Medical Boards said it strongly opposes efforts to limit medical board authority and investigate harm to patients.

"If passed, these bills would ultimately endanger patients and their ability to seek recourse if harmed by a physician," said federation spokesperson Joe Knickrehm.

Steve Stites, chief medical officer at The University of Kansas Health System, called the situation "messy."

"This is politics, unfortunately, and not health care," he said in a media briefing last week. "And when politics gets involved in health care, it kind of gets a little messy."

What does the science say?

On Monday, Japanese trading and pharmaceutical company Kowa Co. Ltd said ivermectin showed an “antiviral effect" against omicron and other coronavirus variants in nonclinical research, Reuters reported, but it has not been approved by the Japanese government to treat COVID-19.

Doctors who prescribe ivermectin insist the practice is supported by such findings.

Members of the alliance frequently cite a study from Brazil – co-written by one of its founding members – that showed ivermectin significantly reduced COVID-19 hospitalization and death, and another from Mexico that they say found ivermectin can improve recovery and lessen severe disease.

Health experts say these observational studies were poorly designed, relied on subjective measures for success and left room for bias. They also appeared in lesser-known journals that lack rigorous peer-review.

Many more randomized, controlled trials – the gold-standard for clinical research – have shown ivermectin is not effective at preventing or treating COVID-19. A meta-analysis of 23 trials controlling for bias found it had no effect on survival, hospitalization, the risk of mechanical ventilation or recovery.

Merck, the manufacturer of ivermectin, said last year that the drug has “no meaningful evidence of clinical activity or clinical efficacy in patients with COVID-19” and that there’s “a concerning lack of safety data in the majority of studies.”

In medicine, drugs are frequently used "off-label" to treat other conditions when there is evidence they work.

“We should be evaluating whether existing drugs can be repurposed for COVID treatment,” Chua said. “It’s just that the efficacy (for ivermectin) has not been established by these trials to date.”

In June, the National Institutes of Health launched a randomized, controlled trial to see whether ivermectin, along with two other drugs, can be repurposed to reduce COVID-19 symptoms. Bristow, who is involved in the large study, urged Americans who are interested in the drug to enroll in the trial to ensure safe use, get compensated and "contribute to the library of scientific knowledge." Final results are expected in March 2023.

The FLCCC does not plan any clinical trials on the group's medication protocol in part because it changes based on the "fluid nature of treating COVID-19," Marik said.

After numerous rigorous studies, the FDA has authorized or approved several therapies proven to treat or prevent the worst effects of COVID-19, including two antiviral pills authorized by the FDA in December. There is also one monoclonal antibody, sotrovimab, that remains effective against omicron.

The supply of these regulated therapeutics is limited for now, but health experts say the most powerful tool against severe illness and death from COVID-19 is safe, free and widely available: the authorized vaccines.

“There’s enough data out there to show if the vaccines are not working," Merad said. "So I wonder, who has the bias here?”

Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

This article originally appeared on USA TODAY: Ivermectin for COVID: US doctors continue to prescribe unproven drug

Experts question unusual authorization plan for Covid vaccine for kids under 5

This is the source document for Johns Hopkins comment in their February 3, 2022 COVID-19 Report which is posted below  and available at:  http://boonecountywatchdog.blogspot.com/2022/02/february-3-2022-johns-hopkins-covid.html

HEALTH

Experts question unusual authorization plan for Covid vaccine for kids under 5

• 

By Helen Branswell Feb. 2, 2022

A health care worker prepares to administer a Pfizer-BioNTech Covid-19 vaccine dose at a drive-thru site in Miami.JOE RAEDLE/GETTY IMAGES

The Food and Drug Administration’s willingness to consider authorizing a Covid-19 vaccine developed by Pfizer and BioNTech for children under the age of 5 — without evidence yet that it would be protective — is raising concerns among some vaccine experts who fear the plan could backfire and undermine vaccine uptake in this group.

Pfizer and BioNTech confirmed Tuesday that they had been asked by the FDA to submit an application for the use of a two-dose vaccine in children 6 months to 4 years old. Data on a third shot would be submitted to regulators once they became available in the spring — ostensibly clearing the way for the agency to authorize a three-shot regimen for the youngest children who can get vaccinated.

If the two-dose series is authorized by the FDA and the Centers for Disease Control and Prevention, potentially sometime this month, parents who want to vaccinate children under 5 could begin to do so before Pfizer has proven that the vaccine is protective for this entire age group — something that doesn’t normally happen.

“It’s certainly a creative approach to trying to address the urgency that FDA and the White House is hearing from parents … for making these vaccines available for this younger age group,” said Jason Schwartz, an assistant professor of health policy at the Yale School of Public Health.

“But … the stakes are high and they’re never higher than for vaccines in this youngest age group, both for their effects on this vaccine and the effects on childhood vaccination and vaccine confidence generally.”

Pfizer announced before Christmas that in a clinical trial of children aged 2 to 4 years old, two doses of vaccine failed to generate antibody levels on par with those seen in people aged 16 to 25 after two shots. Paradoxically, two doses given to infants aged 6 months to 23 months did generate antibody levels similar to those seen in the 16- to 25-year-olds, levels that are deemed to equate with protection.

In both groups of little kids, the vaccines appeared to be safe and the side effect profile was tolerable. Side effects included fever and chills, which are not uncommon reactions to vaccines in early childhood.

The companies decided to test whether adding a third dose would raise antibody levels to required levels. But the data from the modified trial aren’t expected until late March and the FDA appears to be unwilling to wait until then. The agency’s independent vaccine expert panel, the Vaccines and Related Biological Products Advisory Committee, will meet Feb. 15 to review the data Pfizer is submitting with this application.

In emailed comments, the FDA said that given the recent increase in infections among children, it felt holding a public discussion about the risks and benefits of vaccination of this critical age group was important.

“The surge of the Omicron variant has rapidly facilitated the collection of important additional clinical data impacting the potential benefit-risk profile of a vaccine for the youngest children,” spokeswoman Abby Capobianco wrote. “In light of these new data and the rise in illnesses and hospitalization in this youngest age group, FDA believed that it was prudent to request that Pfizer submit the data it had available, including the data that it has recently collected during the Omicron surge.”

The idea of authorizing use of the first two doses while the third-dose data are pending is being framed as a way to allow parents eager to vaccinate children 4 and under to get a head start on the process, with a third dose to follow after review of the results of that part of the study.

None of the experts STAT spoke to for this article could recall a precedent for this approach. And several worried going down this path could erode willingness on the part of parents of young children to get them vaccinated. To date only about 20% of children aged 5 to 11 have received two doses of vaccine, according to CDC data.

“I don’t think authorizing two doses in children ages 2 to 4 years of age where effectiveness in this age group hasn’t been confirmed is going to convince the majority of parents to vaccinate their children,” said Norman Baylor, president and CEO of Biologics Consulting and a former head of the FDA’s Office of Vaccines. “If the vaccine in this age cohort is a three-dose vaccine, FDA should review the data from the three-dose series before authorizing the vaccine.”

In a poll released Monday by the Kaiser Family Foundation, 31% of parents of young children said they intend to have them vaccinated as soon as they are able. But 26% said they would not vaccinate children under the age of 5. A further 12% said they would only vaccinate their children if they were required to and 29% said they would take a “wait and see” approach.

Baylor said those results suggest following normal procedures would make more sense here. “The question is, where’s the fire?” he asked. “I think we can take a little time. If that third dose data is available in March, that’s not that long now.”

Schwartz has a vaccinated 8-year-old and a 2-year-old who was home from day care on Tuesday because a teacher tested positive for Covid. He suggested expediting the process for children 4 and younger will be welcomed by some parents, but won’t lead to a flood of vaccinated kids.

“To the extent that this is moving the clock ahead just by a few months, I think we should recognize that it will be a pretty limited number of families who will jump at this opportunity in the way that I have and in the way I probably would, depending on what the data look like,” he said.

Saad Omer, director of Yale University’s Institute for Global Health, said he understands concerns about what pursuing this plan could do to vaccine hesitancy among parents who aren’t convinced of the need to vaccinate children against Covid or the safety of the vaccines. But at this point, his expectations for vaccine uptake rates in children are not high.

“Childhood immunization coverage [for Covid] isn’t stellar anyway,” Omer said. “I don’t think this will particularly dent it.”

Likewise, he wasn’t too concerned that this approach will provide ammunition to the burgeoning anti-vaccination movement. “The bottom line is contrarians will do what they do. That’s their schtick,” Omer said. “And anti-vaccine people will do what they always do.”

Malia Jones, an epidemiologist who teaches at the University of Wisconsin-Madison and who specializes in vaccine hesitancy, said it has been clear for a while that getting children vaccinated against Covid is going to be an uphill battle. She worries that the low level of confidence in Covid vaccines for children will erode parental support for other vaccines. “This is the thing that keeps me up at night,” she said.

“I think already it’s kind of a disaster for vaccine uptake in kids,” Jones said of the prospects for persuading parents to vaccinate their children against Covid and whether the FDA’s approach here will influence them. “Is it throwing gasoline on a dumpster fire? Maybe. But it was already a dumpster fire.”

This article has been updated with comment from the Food and Drug Administration.

Above is from:  https://www.statnews.com/2022/02/02/worry-vaccinating-under-5-could-backfire/

February 3, 2022: Johns Hopkins COVID Report

COVID-19 Situation Report

Editor: Alyson Browett, MPH

Contributors: Clint Haines, MS; Natasha Kaushal, MSPH; Amanda Kobokovich, MPH; Christina Potter, MSPH; Matthew Shearer, MPH; Marc Trotochaud, MSPH; and, Rachel A. Vahey, MHS.

EPI UPDATE The WHO COVID-19 Dashboard reports 380 million cumulative cases and 5.68 million deaths worldwide as of February 2. The global weekly incidence increased for the 15th consecutive week, up to 23.2 million new cases (+1.4% compared to the previous week)—once again, setting a new record. The trend appears to be tapering off, which could indicate that the Omicron surge is peaking on the global level. The Eastern Mediterranean, European, and Western Pacific regions continue to report record high weekly totals, but the other regions appear to be past their respective Omicron peaks. Notably, South-East Asia’s peak appears to be only its second highest since the onset of the pandemic, while all of the other regions recently set new weekly incidence records. Global weekly mortality increased for the fourth consecutive week, up 13.9% from the previous week. The weekly total of 63,298 deaths is the highest since the week of August 30, 2021. Based on trends observed over the course of the COVID-19 pandemic, we expect the weekly mortality to continue increasing over the next several weeks before it peaks.

Global Vaccination

The cumulative global SARS-CoV-2 vaccine doses administered surpassed 10 billion. The WHO reported 10.04 billion cumulative doses administered globally as of February 2. A total of 4.79 billion individuals have received at least 1 dose, and 4.13 billion are fully vaccinated. Analysis from Our World in Data indicates that the overall trend in global daily vaccinations continues to decline steadily from the most recent high of 38 million doses per day in early January 2022 to 20.7 million.* Our World in Data estimates that there are 4.82 billion vaccinated individuals worldwide (1+ dose; 61.2% of the global population) and 4.18 billion who are fully vaccinated (53.1% of the global population).

*The average daily doses administered may exhibit a sharp decrease for the most recent data, particularly over the weekend, which indicates effects of reporting delays. In an effort to reflect the longer-term trends, the numbers reported here may not correspond to the most recent data.

UNITED STATES

The US CDC is currently reporting 75.3 million cumulative cases of COVID-19 and 888,784 deaths. The US is averaging 415,552 new cases and 2,369 deaths per day.* Sufficient time has elapsed since the Martin Luther King Jr. Day holiday to assess the longer-term US trends, and it appears that the US has passed the peak of its Omicron surge at the national level—although this varies at regional and state levels. The surge began in earnest in mid-December 2021, and daily incidence peaked at a record high of 805,904 new cases per day on January 15, 2022. The trend has decreased rapidly since then, falling by nearly half over the second half of January. Daily mortality continues to increase, surpassing the spring 2020 peak—2,297 on April 21, 2020—which makes the Omicron surge the second highest peak daily mortality to date. Based on trends observed over the course of the pandemic, we expect daily mortality to peak sometime in the next week or so, lagging the trend in daily incidence by 3-4 weeks.

*Changes in state-level reporting may affect the accuracy of recently reported data, particularly over weekends. In an effort to reflect the longer-term trends, the numbers reported here may not correspond to the most recent dates.

US Vaccination

The US surpassed 250 million individuals who have received at least 1 vaccine dose, which corresponds to more than 75% of the entire US population. The US has administered 668 million cumulative doses of SARS-CoV-2 vaccines. Daily vaccinations continue to decline, down from the most recent peak of 1.77 million doses per day on December 6 to 644,000 on January 28.* Among adults, 87.0% have received at least 1 dose, as well as 25.6 million children under the age of 18. A total of 212 million individuals are fully vaccinated**, which corresponds to 63.9% of the total population. Approximately 74.2% of adults are fully vaccinated, as well as 20.5 million children under the age of 18. Since August 13, 88.6 million individuals have received an additional or booster dose. This corresponds to 41.8% of fully vaccinated individuals, including 64.5% of fully vaccinated adults aged 65 years or older.

*Due to delays in reporting, estimates for the average daily doses administered are less accurate for the most recent 5 days. The most current average provided here corresponds to 5 days ago.

**Full original course of the vaccine, not including additional or booster doses.

VACCINE FOR <5 CHILDREN At the request of the US FDA over concerns about an increase in COVID-19 cases and hospitalizations among children, Pfizer and BioNTech announced they have initiated a “rolling submission” that seeks an amendment to the Emergency Use Authorization (EUA) for the companies’ SARS-CoV-2 vaccine that would expand eligibility to children as young as 6 months. The companies expect to complete the application in “the coming days,” and it will cover the first 2 doses of an expected 3-dose primary series using a 3 µg dosage for this age group. Data on the third dose, which is administered at least 8 weeks after the second dose, is expected to be available in the coming months, and a subsequent determination on further expanding the EUA to a full 3-dose series would need to be addressed at that time. Pfizer Chairman and CEO Albert Bourla indicated that Pfizer expects 3 doses to be necessary to provide adequate protection, but the initial EUA for 2 doses will enable children to begin that series while awaiting the final determination on the third dose. Review by the FDA and US CDC could potentially be completed this month. The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will discuss the issue at its meeting scheduled for February 15.

The unusual and aggressive plan is raising concerns among some vaccine experts who argue that the FDA’s willingness to consider an EUA for a vaccine that has yet to demonstrate efficacy could risk increasing vaccine hesitancy and anti-vaccine sentiment and negatively affect vaccine uptake among young children. There are 2 principal concerns. First, the FDA is evaluating data from only 2 doses of a possible 3-dose series, without any data available yet for that third dose. And second, the small-scale trials may not be sufficient to capture adverse events that would emerge in larger trials.

Early clinical trial data published in December 2021 showed that a 2-dose series failed to elicit sufficient antibody responses in children aged 2-4 years, although children aged 6-23 months produced antibodies similar to older individuals. Notably, the Phase 2b/3 clinical trials were designed only to determine if the vaccine stimulated an immune response similar to older individuals—since previous trials demonstrated efficacy corresponding to that degree of antibody response—so traditional efficacy estimates are not available for young children. The early clinical trial data showed minimal adverse events, but there is concern that additional adverse events could be missed without larger trials. To date, only about 20% of children aged 5-11 years are fully vaccinated. A recent poll found that only 31% of parents of children under 5 years plan to vaccinate their child as soon as a vaccine is available, and some experts argue that speeding the EUA process is unlikely to make a substantial impact on vaccination coverage.

BOOSTER EFFECTIVENESS An early release published in the US CDC’s Morbidity and Mortality Weekly Report examining infection and hospitalization rates in Los Angeles County, California, depicts stark differences among vaccinated and unvaccinated individuals from November 7 to January 8, a period spanning the end of Delta variant predominance and the beginning of Omicron’s predominance. Data were further stratified among vaccinated individuals to include those with and without a booster to show booster effectiveness. For the 14-day period ending December 11, also the last week of Delta predominance, incidence and hospitalization rates among unvaccinated individuals were 12.3 and 83.0 times, respectively, those of boosted fully vaccinated individuals, and 3.8 and 12.9 times, respectively, those of fully vaccinated individuals without a booster. During the period ending January 8, when Omicron gained predominance, the rate ratios dropped, but vaccinated persons remained better protected. Unvaccinated individuals had infection and hospitalization rates 3.6 and 23.0 times, respectively, those of fully vaccinated persons with a booster and 2.0 and 5.3 times, respectively, those of fully vaccinated persons without a booster. According to Los Angeles County Department of Public Health data, 71% of county residents were fully vaccinated as of January 8.

During a White House briefing on February 2, US CDC Director Dr. Rochelle Walensky shared data from 25 US jurisdictions showing unvaccinated individuals were 14 times more likely to die of COVID-19 than fully vaccinated individuals and unvaccinated individuals were 97 times more likely to die than people who were fully vaccinated and boosted. According to an analysis of Omicron’s impact conducted by the Financial Times, nearly half of US COVID-19-related hospitalizations this winter could have been prevented if the nation had vaccination coverage similar to leading European countries. About 64% of the total US population is fully vaccinated, and only 42% of eligible individuals have received a booster dose.

PANDEMIC PREPAREDNESS An analysis of pandemic preparedness across 177 countries and territories published this week in The Lancet suggests that trust—both in the government and among people—could be a driving factor behind why COVID-19 hit some countries harder than others. Trust in government and fellow citizens was strongly associated with higher vaccination rates and decreased mobility, an indicator of social distancing. Notably, no associations were found between COVID-19 outcomes and democracy, populism, government effectiveness, universal healthcare, pandemic preparedness metrics, economic inequality, or trust in science. The researchers estimated that if every country had the same level of government or interpersonal trust as Denmark, which ranks in the 75th percentile for these indicators, global infections between January 1, 2020, and September 30, 2021, might have been reduced by 12.9% for government trust and 40.3% for interpersonal trust. Other factors that explained the most variation in COVID-19 infection-fatality rate (IFR) included a country’s age profile, GDP per capita, and national mean body mass index (BMI). The researchers suggest that countries prepare for the next pandemic by investing in risk communication and community engagement to improve trust in public health guidance, as well as improving health promotion to reduce risks, such as BMI, associated with fatality.

Meanwhile in the US, a bipartisan duo of US Senate lawmakers is expected to introduce a new bill aimed at strengthening the government’s response to a future pandemic. The draft bill includes measures that would establish a 9/11-style bipartisan commission to formally investigate the US pandemic response and require Senate confirmation for the director of the US CDC. The effort—being led by Senators Patty Murray, a Democrat from Washington, and Richard Burr, a Republican from North Carolina—includes several other proposals outlining CDC oversight and tasks, better defining the role of the Assistant Secretary for Preparedness and Response (ASPR), requiring collaboration between the US NIH and other agencies, and ensuring manufacturing capabilities for pandemic tools such as vaccines and therapeutics. Additionally, senior administration officials, public health experts, and US lawmakers are taking stock of the US global COVID-19 strategy, urging more investment in global vaccination coverage and warning that leaving unfilled gaps risks the emergence of new variants. A group of Democrats in the US House is calling for an additional US$17 billion in federal funding for global vaccination delivery and infrastructure. Others are expressing concern over US President Joe Biden’s structuring of authority overseeing the US global COVID-19 strategy. The White House recently published a fact sheet on the Biden administration’s commitment to global health, and NIH issued a press release outlining the National Institute of Allergy and Infectious Diseases’ (NIAID) Pandemic Preparedness Plan.

COVID-19 IN US PRISONS Deaths among incarcerated populations in the US increased 46% from 2019 to 2020, as well as increased 32% among people on parole and 6% among people on probation, according to new data from the Bureau of Justice Statistics (BJS) analyzed by the Prison Policy Initiative. While researchers cannot yet say specifically that the increase is due to COVID-19, they do attribute many of the deaths to the pandemic in some way: directly from infections, a lack of access to regular health care, increases in overdoses and suicides, or a general burden on the correctional system. Since the start of the pandemic, nearly 3,000 incarcerated people have died of COVID-19, including about 300 in federal custody. Notably, imprisoned people are about 3 times more likely to die of COVID-19 than the general population, when data are adjusted for the population’s younger age. Since the emergence of Omicron, prisons across the US are witnessing an alarming increase in COVID-19 cases. In mid- to late-January, at least 7 federal prisons had triple-digit increases in new COVID-19 cases.

US President Joe Biden’s National Strategy for the COVID-19 Response, released in January 2021, included 2 pledges specifically addressing COVID-19 in prisons. One called for the distribution of SARS-CoV-2 vaccines to facility staff and incarcerated individuals in jails, prisons, and detention centers. Today, nearly 70% of the federal prison population is fully vaccinated, but the US Bureau of Prisons (BOP) has not conducted the educational efforts needed to address people with questions regarding medical concerns or distrust of the system, according to advocates. A second pledge promised an executive order to require the BOP and the US Immigration and Customs Enforcement (ICE) to evaluate their COVID-19 protocols, release data on cases, and use federal grant funding for state and local facilities to also follow public health guidance, but the order never came. Advocates say there has been some progress, including on accessibility to SARS-CoV-2 PCR testing and allowing people who were released to home confinement to remain so instead of returning to prison. However, the deteriorating situation in several prison systems since the emergence of the Omicron variant suggests that the response inside of federal, state, local, and private prisons remains inadequate 2 years into the pandemic.

HUMAN CHALLENGE TRIAL The first COVID-19 human challenge clinical trial was found to be safe in healthy young adults, according to the latest not-yet-peer-reviewed data. The Human Challenge Programme—run by Open Orphan, Imperial College London, and other partners—exposed 36 healthy adult volunteers aged 18 to 29 with no immunity to SARS-CoV-2 to the original strain of the virus and monitored them in a quarantine setting, where no serious adverse events occurred. The trial produced several clinical outcomes that could inform public health policy, including that symptoms in infected persons began to develop an average of 2 days following exposure—earlier than the widely accepted 5 days—and that infectious virus peaks around 5 days, when the virus is more concentrated in the nose versus the throat. The researchers plan to monitor participants for 12 months following discharge. Imperial College said it plans to use the trial model with the Delta variant and share the framework to allow similar research around the world, aiming to provide an accelerated route for testing new vaccines, antivirals, and diagnostics.

HEALTHCARE WASTE The COVID-19 pandemic response has generated tens of thousands of metric tons of extra medical waste, straining healthcare waste management systems, threatening human health and the environment, and highlighting an urgent need to improve waste management protocols, according to a WHO report released this week. The analysis only takes into account the amount of potential waste generated through shipments from a joint UN emergency initiative and does not account for COVID-19-related commodities procured outside of the initiative or waste generated by the public. The report estimates that 87,000 metric tons of personal protective equipment (PPE); 2,600 metric tons of non-infectious mainly plastic waste, such as test kits; 144,000 metric tons of vaccine-related waste including syringes, needles, and safety boxes; and 731,000 liters of chemical waste were produced solely through the UN initiative. Overall, the WHO estimates the pandemic has increased healthcare waste loads up to 10 times, potentially exposing workers to needle-stick injuries, burns, and infections, and local communities to poorly managed landfills and carcinogens from improperly incinerated waste. The report encourages countries to see this as an opportunity to revamp waste streams, recommending healthcare facilities and the public responsibly use and dispose of waste and calling for investment into innovative waste treatment technologies and the use of more reusable, recyclable, or biodegradable materials.

TONGA The South Pacific archipelago nation of Tonga went into lockdown on February 2 after at least 5 people were diagnosed with COVID-19. Two port workers in the capital city Nuku’alofa contracted the virus and then transmitted it to 3 family members, marking the first time the country has recorded community transmission. Concerns were high that an influx of international ships and planes delivering needed food, water, and supplies following a devastating volcanic eruption and tsunami would bring SARS-CoV-2 to Tonga, which previously had only 1 recorded COVID-19 case in a visitor. It is unclear how the workers contracted the virus. All foreign aid deliveries have been conveyed using contactless protocols, but the workers dealt with commercial ships at a different wharf. Under the lockdown, domestic flights are grounded, boats are disallowed from traveling between islands, schools are closed, most people are required to remain at home, and masking is encouraged in all public spaces. The lockdown will be reviewed every 48 hours, according to officials.