Tag Archives: Centers for Disease Control and Prevention

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EzriCare eye drops: CDC advises against use as it investigates dozens of infections and one death in 11 states

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CNN
 — 

The US Centers for Disease Control and Prevention is urging health care providers and consumers to stop using EzriCare Artificial Tears as it conducts an investigation into at least 50 infections in 11 states that have led to instances of permanent vision loss, hospitalization and one death.

Most of the people with these infections reported using artificial tears, and EzriCare was the most common brand, the agency says. These eye drops are preservative-free, meaning they don’t have ingredients to prevent bacterial growth.

Testing of open EzriCare bottles identified Pseudomonas aeruginosa bacteria that were resistant to carbapenem antibiotics as well as the antibiotics ceftazidime and cefepime. Testing of unopened bottles is ongoing, the CDC says.

“CDC recommends that clinicians and patients immediately discontinue the use of EzriCare Artificial Tears until the epidemiological investigation and laboratory analyses are complete,” the agency says.

New Jersey-based EzriCare says in a statement dated January 24 that it has not received any consumer complaints or adverse event reports.

“We have not been asked to conduct a recall. EzriCare does not manufacture the Lubricant Eye Drops,” the statement says.

“Nevertheless, and in an abundance of caution, EzriCare recommends that during this evolving situation you discontinue use of any portions of EzriCare Artificial Tears Lubricant Eye Drops you may have until we can discover more details about any potential safety concerns.”

Pseudomonas bacteria are common in the environment, such as in soil and water. Pseudomonas aeruginosa is usually spread in health care settings, the CDC says, and is increasingly difficult to treat because of antibiotic resistance. It caused more than 32,000 infections in hospitalized patients and about 2,700 deaths in the US in 2017.

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Information for Persons Who Are Immunocompromised Regarding Prevention and Treatment of SARS-CoV-2 Infection in the Context of Currently Circulating Omicron Sublineages — United States, January 2023

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BOX. Prevention measures against SARS-CoV-2 for persons who are immunocompromised, their household members, and close contacts in the context of currently circulating Omicron sublineages — United States, January 2023

Because Evusheld is not currently authorized for preexposure prophylaxis against SARS-CoV-2 infection in the United States, it is important that persons who are moderately to severely immunocompromised,* those who might have an inadequate immune response to COVID-19 vaccination, and those with contraindications to receipt of COVID-19 vaccines, exercise caution and recognize the need for additional preventive measures to protect themselves from SARS-CoV-2 infection. Persons with immunocompromise, their household members, and close contacts can use the following steps and precautions to help prevent SARS-CoV-2 infection and mitigate COVID-19 illness if they become infected.

COVID-19 vaccines, booster doses, and staying up to date*
  • COVID-19 vaccines remain the best way to protect against severe COVID-19. COVID-19 vaccines help the body develop protection against SARS-CoV-2 infection. Although vaccinated persons sometimes get infected with SARS-CoV-2, staying up to date with COVID-19 vaccines significantly lowers the risk for severe illness, hospitalization, or death from COVID-19.
  • CDC recommends that all persons who are eligible, especially those who are immunocompromised or have weakened immune systems,† get an updated (bivalent) booster dose and stay up to date with their COVID-19 vaccines.
Personal COVID-19 action plan§
  • Persons should consider how to protect themselves and others around them should they become ill with COVID-19 or if the community COVID-19 transmission level changes. The plan should include:
    • ways to protect oneself and others including considerations in case of illness, such as finding a room in which to isolate
    • actions to take in case of exposure or symptom onset
    • what to do in the event of receipt of a positive SARS-CoV-2 test result
  • Persons should share their COVID-19 plan with their family, friends, and health care providers so they can support prevention and preparation steps. CDC suggests that persons consider how others can help them if they get ill. It is important to adhere to treatment plans, keep routine health care appointments, and ensure that prescriptions are filled. Persons should make alternative plans for work, child care, and other responsibilities that might cause stress if they become ill.
Masks or respirators
  • Masks are made to contain droplets and particles that persons breathe, cough, or sneeze. A variety of masks are available. Some masks provide a higher level of protection than others. Wearing a mask with the best fit and comfort provides the best protection.**
  • Respirators (e.g., N95 and NIOSH-approved KN95) provide higher protection than masks.†† Respirators are made to protect persons by fitting closely on their face to filter out particles, including SARS-CoV-2. They can also block droplets and particles that a person breathes, coughs, or sneezes out to limit transmission to others. NIOSH approves many types of filtering facepiece respirators. The most widely available are N95 respirators, but other types (N99, N100, P95, P99, P100, R95, R99, and R100) offer the same or better protection as an N95 respirator.
Physical distancing
  • Small particles that persons breathe out can contain virus particles. The closer a person is to other persons, the higher the risk for exposure to SARS-CoV-2. Persons can minimize risk of exposure by avoiding indoor crowded areas or maintaining a ≥6 ft (1.8 m) distance from others. Such actions must be balanced against risks of avoiding such activities.
Ventilation§§
  • Opening windows and doors to bring as much fresh air into the home as possible (weather permitting) can improve ventilation.
  • Portable high-efficiency particulate air cleaners are useful if a home is not outfitted with an HVAC system.
  • Exhaust fans and other fans can improve air flow.
  • In homes where the HVAC fan operation can be controlled by a thermostat, the fan should be set to the “on” position instead of “auto” when others are visiting. This allows the fan to run continuously, even if heating or air conditioning is not on, to ensure the HVAC system provides continuous airflow and filtration.
Time outdoors
  • Spending time outdoors, when possible, instead of indoors, can also help reduce transmission. Viral particles spread between persons more readily indoors than outdoors.
Handwashing
  • Frequent handwashing with soap and water, preferably, or using a hand sanitizer that contains ≥60% alcohol can reduce risk for many illnesses, including COVID-19.
Testing for SARS-CoV-2¶¶
  • Persons should get tested if they have COVID-19 symptoms. Viral tests are used for SARS-CoV-2 detection. There are two types of viral tests: rapid tests and laboratory tests. These tests might use nasal, throat, or saliva samples. Persons can take actions to reduce further transmission if they are aware of their SARS-CoV-2 infection.
  • Free at-home tests*** are available. Persons should check with their health insurance, Medicaid, or Medicare plan to learn what tests are available.††† Persons with a disability can receive help from the Disability Information and Access Line§§§ to access a test or identify an accessible test location.
  • Persons should be aware of free or low-cost testing locations¶¶¶ that are near their homes.
COVID-19 Treatment****
  • Persons should contact their health care provider, health department, or community health center†††† to learn about treatment options. Treatment must be started within 5–7 days after symptoms develop to be effective.
  • Community Test to Treat locations§§§§ can be accessed if or when persons cannot reach their health care provider or do not have one. These sites offer testing and prescriptions from a health care provider (either onsite or by telehealth) and dispense medications.
  • Antiviral treatments are available for persons with mild to moderate COVID-19 symptoms who are at high risk for progression to severe disease, hospitalization, and death. Persons are at high risk of disease if they
    • are aged ≥50 years
    • have an underlying health condition,¶¶¶¶ especially moderate to severe immunosuppression
    • are unvaccinated
  • Persons who are immunocompromised should discuss a treatment plan with their doctor and identify which COVID-19 treatment would be best for them. Some persons with COVID-19 who are immunocompromised or receiving immunosuppressive treatment might benefit from a convalescent plasma treatment.*****
  • CDC recommends that immunocompromised persons with COVID-19 isolate for ≥10 days and check with their health care provider before ending isolation.†††††

Abbreviations: HVAC = heating, ventilation, and air conditioning; NIOSH = National Institute for Occupational Safety and Health.

* https://www.cdc.gov/coronavirus/2019-ncov/vaccines/stay-up-to-date.html

† https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html

§ https://www.cdc.gov/coronavirus/2019-ncov/downloads/needs-extra-precautions/FS_COVID_Plan_FINAL.pdf

https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/types-of-masks.html

** Persons who are deaf or hard of hearing may request a clear mask to assist with lipreading or seeing facial expressions. Persons with sensory disorders or intellectual and developmental disabilities might be unable to wear masks and should consider face shields.

†† Persons with severe respiratory impairment (e.g., shortness of breath with minimal exertion or supplemental oxygen use) should consult with a health care provider regarding N95 respirator usage. Some N95 respirators might contain latex. Persons with natural rubber latex allergies should consult the manufacturer’s website for information about the specific model.

§§ https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/Improving-Ventilation-Home.html; https://www.cdc.gov/coronavirus/2019-ncov/community/ventilation.html

¶¶ https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/testing.html

*** https://special.usps.com/testkits

††† https://www.cms.gov/how-to-get-your-at-home-OTC-COVID-19-test-for-free

§§§ https://acl.gov/DIAL

¶¶¶ https://www.hhs.gov/coronavirus/community-based-testing-sites/index.html

**** https://www.cdc.gov/coronavirus/2019-ncov/your-health/treatments-for-severe-illness.html

†††† https://data.hrsa.gov/data/reports/datagrid?gridName=FQHCs

§§§§ https://covid-19-test-to-treat-locator-dhhs.hub.arcgis.com/

¶¶¶¶ https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html

***** https://www.fda.gov/media/136798/download

††††† https://www.cdc.gov/coronavirus/2019-ncov/your-health/isolation.html

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FDA vaccine advisers vote to harmonize Covid-19 vaccines in the United States

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CNN
 — 

A panel of independent experts that advises the US Food and Drug Administration on its vaccine decisions voted unanimously Thursday to update all Covid-19 vaccines so they contain the same ingredients as the two-strain shots that are now used as booster doses.

The vote means young children and others who haven’t been vaccinated may soon be eligible to receive two-strain vaccines that more closely match the circulating viruses as their primary series.

The FDA must sign off on the committee’s recommendation, which it is likely to do, before it goes into effect.

Currently, the US offers two types of Covid-19 vaccines. The first shots people get – also called the primary series – contain a single set of instructions that teach the immune system to fight off the original version of the virus, which emerged in 2019.

This index strain is no longer circulating. It was overrun months ago by an ever-evolving parade of new variants.

Last year, in consultation with its advisers, the FDA decided that it was time to update the vaccines. These two-strain, or bivalent, shots contain two sets of instructions; one set reminds the immune system about the original version of the coronavirus, and the second set teaches the immune system to recognize and fight off Omicron’s BA.4 and BA.5 subvariants, which emerged in the US last year.

People who have had their primary series – nearly 70% of all Americans – were advised to get the new two-strain booster late last year in an effort to upgrade their protection against the latest variants.

The advisory committee heard testimony and data suggesting that the complexity of having two types of Covid-19 vaccines and schedules for different age groups may be one of the reasons for low vaccine uptake in the US.

Currently, only about two-thirds of Americans have had the full primary series of shots. Only 15% of the population has gotten an updated bivalent booster.

Data presented to the committee shows that Covid-19 hospitalizations have been rising for children under the age of 2 over the past year, as Omicron and its many subvariants have circulated. Only 5% of this age group, which is eligible for Covid-19 vaccination at 6 months of age, has been fully vaccinated. Ninety percent of children under the age of 4 are still unvaccinated.

“The most concerning data point that I saw this whole day was that extremely low vaccination coverage in 6 months to 2 years of age and also 2 years to 4 years of age,” said Dr. Amanda Cohn, director of the US Centers for Disease Control and Prevention’s Division of Birth Defects and Infant Disorders. “We have to do much, much better.”

Cohn says that having a single vaccine against Covid-19 in the US for both primary and booster doses would go a long way toward making the process less complicated and would help get more children vaccinated.

Others feel that convenience is important but also stressed that data supported the switch.

“This isn’t only a convenience thing, to increase the number of people who are vaccinated, which I agree with my colleagues is extremely important for all the evidence that was related, but I also think moving towards the strains that are circulating is very important, so I would also say the science supports this move,” said Dr. Hayley Gans, a pediatric infectious disease specialist at Stanford University.

Many others on the committee were similarly satisfied after seeing new data on the vaccine effectiveness of the bivalent boosters, which are cutting the risk of getting sick, being hospitalized or dying from a Covid-19 infection.

“I’m totally convinced that the bivalent vaccine is beneficial as a primary series and as a booster series. Furthermore, the updated vaccine safety data are really encouraging so far,” said Dr. David Kim, director of the the US Department of Health and Human Services’ National Vaccine Program, in public discussion after the vote.

Thursday’s vote is part of a larger plan by the FDA to simplify and improve the way Covid-19 vaccines are given in the US.

The agency has proposed a plan to convene its vaccine advisers – called the Vaccines and Related Biological Products Advisory Committee, or VRBPAC – each year in May or June to assess whether the instructions in the Covid-19 vaccines should be changed to more closely match circulating strains of the virus.

The time frame was chosen to give manufacturers about three months to redesign their shots and get new doses to pharmacies in time for fall.

“The object, of course – before anyone says anything – is not to chase variants. None of us think that’s realistic,” said Jerry Weir, director of the Division of Viral Products in the FDA’s Office of Vaccines Research and Review.

“But I think our experience so far, with the bivalent vaccines that we have, does indicate that we can continue to make improvements to the vaccine, and that would be the goal of these meetings,” Weir said.

In discussions after the vote, committee members were supportive of this plan but pointed out many of the things we still don’t understand about Covid-19 and vaccination that are likely to complicate the task of updating the vaccines.

For example, we now seem to have Covid-19 surges in the summer as well as the winter, noted Dr. Michael Nelson, an allergist and immunologist at the University of Virginia. Are the surges related? And if so, is fall the best time to being a vaccination campaign?

The CDC’s Dr. Jefferson Jones said that with only three years of experience with the virus, it’s really too early to understand its seasonality.

Other important questions related to the durability of the mRNA vaccines and whether other platforms might offer longer protection.

“We can’t keep doing what we’re doing,” said Dr. Bruce Gellin, chief of global public health strategy at the Rockefeller Foundation. “It’s been articulated in every one of these meetings despite how good these vaccines are. We need better vaccines.”

The committee also encouraged both government and industry scientists to provide a fuller picture of how vaccination and infection affect immunity.

One of the main ways researchers measure the effectiveness of the vaccines is by looking at how much they increase front-line defenders called neutralizing antibodies.

Neutralizing antibodies are like firefighters that rush to the scene of an infection to contain it and put it out. They’re great in a crisis, but they tend to diminish in numbers over time if they’re not needed. Other components of the immune system like B-cells and T-cells hang on to the memory of a virus and stand ready to respond if the body encounters it again.

Scientists don’t understand much about how well Covid-19 vaccination boosts these responses and how long that protection lasts.

Another puzzle will be how to pick the strains that are in the vaccines.

The process of selecting strains for influenza vaccines is a global effort that relies on surveillance data from other countries. This works because influenza strains tend to become dominant and sweep around the world. But Covid-19 strains haven’t worked in quite the same way. Some that have driven large waves in other countries have barely made it into the US variant mix.

“Going forward, it is still challenging. Variants don’t sweep across the world quite as uniform, like they seem to with influenza,” the FDA’s Weir said. “But our primary responsibility is what’s best for the US market, and that’s where our focus will be.”

Eventually, the FDA hopes that Americans would be able to get an updated Covid-19 shot once a year, the same way they do for the flu. People who are unlikely to have an adequate response to a single dose of the vaccine – such as the elderly or those with a weakened immune system – may need more doses, as would people who are getting Covid-19 vaccines for the first time.

At Thursday’s meeting, the advisory committee also heard more about a safety signal flagged by a government surveillance system called the Vaccine Safety Datalink.

The CDC and the FDA reported January 13 that this system, which relies on health records from a network of large hospital systems in the US, had detected a potential safety issue with Pfizer’s bivalent boosters.

In this database, people 65 and older who got a Pfizer bivalent booster were slightly more likely to have a stroke caused by a blood clot within three weeks of their vaccination than people who had gotten a bivalent booster but were 22 to 42 days after their shot.

After a thorough review of other vaccine safety data in the US and in other countries that use Pfizer bivalent boosters, the agencies concluded that the stroke risk was probably a statistical fluke and said no changes to vaccination schedules were recommended.

At Thursday’s meeting, Dr. Nicola Klein, a senior research scientist with Kaiser Permanente of Northern California, explained how they found the signal.

The researchers compared people who’d gotten a vaccine within the past three weeks against people who were 22 to 42 days away from their shots because this helps eliminate bias in the data.

When they looked to see how many people had strokes around the time of their vaccination, they found an imbalance in the data.

Of 550,000 people over 65 who’d received a Pfizer bivalent booster, 130 had a stroke caused by a blood clot within three weeks of vaccination, compared with 92 people in the group farther out from their shots.

The researchers spotted the signal the week of November 27, and it continued for about seven weeks. The signal has diminished over time, falling from an almost two-fold risk in November to a 47% risk in early January, Klein said. In the past few days, it hasn’t been showing up at all.

Klein said they didn’t see the signal in any of the other age groups or with the group that got Moderna boosters. They also didn’t see a difference when they compared Pfizer-boosted seniors with those who were eligible for a bivalent booster but hadn’t gotten one.

Further analyses have suggested that the signal might be happening not because people who are within three weeks of a Pfizer booster are having more strokes, but because people who are within 22 to 42 days of their Pfizer boosters are actually having fewer strokes.

Overall, Klein said, they were seeing fewer strokes than expected in this population over that period of time, suggesting a statistical fluke.

Another interesting thing that popped out of this data, however, was a possible association between strokes and high-dose flu vaccination. Seniors who got both shots on the same day and were within three weeks of those shots had twice the rate of stroke compared with those who were 22 to 42 days away from their shots.

What’s more, Klein said, the researchers didn’t see the same association between stroke and time since vaccination in people who didn’t get their flu vaccine on the same day.

The total number of strokes in the population of people who got flu shots and Covid-19 boosters on the same day is small, however, which makes the association a shaky one.

“I don’t think that the evidence are sufficient to conclude that there’s an association there,” said Dr. Tom Shimabukuro, director of the CDC’s Immunization Safety Office.

Nonetheless, Richard Forshee, deputy director of the FDA’s Office of Biostatistics and Pharmacovigilance, said the FDA is planning to look at these safety questions further using data collected by Medicare.

The FDA confirmed that the agency is taking a closer look.

“The purpose of the study is 1) to evaluate the preliminary ischemic stroke signal reported by CDC using an independent data set and more robust epidemiological methods; and 2) to evaluate whether there is an elevated risk of ischemic stroke with the COVID-19 bivalent vaccine if it is given on the same day as a high-dose or adjuvanted seasonal influenza vaccine,” a spokesperson said in a statement.

The FDA did not give a time frame for when these studies might have results.

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Flu, Covid-19 and RSV are all trending down for the first time in months

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CNN
 — 

A rough respiratory virus season in the US appears to be easing, as three major respiratory viruses that have battered the country for the past few months are finally all trending down at the same time.

A new dataset from the US Centers for Disease Control and Prevention shows that the number of emergency department visits for the three viruses combined – flu, Covid-19 and RSV – have dropped to the lowest they’ve been in three months. The decline is apparent across all age groups.

Measuring virus transmission levels can be challenging; health officials agree that Covid-19 cases are vastly undercounted, and surveillance systems used for flu and RSV capture a substantial, but incomplete picture.

But experts say that tracking emergency department visits can be a good indicator of how widespread – and severe – the respiratory virus season is.

“There’s the chief complaint. When you show up to the emergency room, you complain about something,” said Janet Hamilton, executive director at Council of State and Territorial Epidemiologists. “Being able to look at the proportion of individuals that seek care at an emergency department for these respiratory illness concerns is a really good measure of the respiratory disease season.”

In the week following Thanksgiving, emergency department visits for respiratory viruses topped 235,000 – matching rates from last January, according to the CDC data.

While the surge in emergency department visits early in the year was due almost entirely to Omicron, the most recent spike was much more varied. In the week ending December 3, about two-thirds of visits were for flu, about a quarter were for Covid-19 and about 10% were for RSV.

Grouping the impact of all respiratory viruses together in this way offers an important perspective.

“There’s a strong interest in thinking about respiratory diseases in a more holistic way,” Hamilton said. “Transmission is the same. And there are certain types of measures that are good protection against all respiratory diseases. So that could really help people understand that when we are in high circulation for respiratory diseases, there are steps that you can take – just in general.”

Now, Covid-19 again accounts for most emergency department visits but flu and RSV are still the reason behind about a third of visits – and they’re all trending down for the first time since the respiratory virus season started picking up in September.

More new data from the CDC shows that overall respiratory virus activity continues to decline across the country. Only four states, along with New York City and Washington, DC, had “high” levels of influenza-like illness. Nearly all states were in this category less than a month ago.

Whether that pattern will hold is still up in the air, as vaccination rates for flu and Covid-19 are lagging and respiratory viruses can be quite fickle. Also, while the level of respiratory virus activity is lower than it’s been, it’s still above baseline in most places and hospitals nationwide are still about 80% full.

RSV activity started to pick up in September, reaching a peak in mid-November when 5 out of every 100,000 people – and 13 times as many children younger than five – were hospitalized in a single week.

RSV particularly affects children, and sales for over-the-counter children’s pain- and fever-reducing medication were 65% higher in November than they were a year before, according to the Consumer Healthcare Products Association. While “the worst may be over,” demand is still elevated, CHPA spokesperson Logan Ramsey Tucker told CNN in an email – sales were up 30% year-over-year in December.

But this RSV season has been significantly more severe than recent years, according to CDC data. The weekly RSV hospitalization rate has dropped to about a fifth of what it was two months ago, but it is still higher than it’s been in previous seasons.

Flu activity ramped up earlier than typical, but seems to have already reached a peak. Flu hospitalizations – about 6,000 new admissions last week – have dropped to a quarter of what they were at their peak a month and a half ago, and CDC estimates for total illnesses, hospitalizations and deaths from flu so far this season have stayed within the bounds of what can be expected. It appears the US has avoided the post-holiday spike that some experts cautioned against, but the flu is notoriously unpredictable and it’s not uncommon to see a second bump later in season.

The Covid-19 spike has not been as pronounced as flu, but hospitalizations did surpass levels from the summer. However, the rise in hospitalizations that started in November has started to tick down in recent weeks and CDC data shows that the share of the population living in a county with a “high” Covid-19 community level has dropped from 22% to about 6% over the past two weeks.

Still, the XBB.1.5 variant – which has key mutations that experts believe may be helping it to be more infectious – continues to gain ground in the US, causing about half of all infections last week. Vaccination rates continue to lag, with just 15% of the eligible population getting their updated booster and nearly one in five people remain completely unvaccinated.

Ensemble forecasts published by the CDC are hazy, predicting a “stable or uncertain trend” in Covid-19 hospitalizations and deaths over the next month.

And three years after the first Covid-19 case was confirmed in the US, the virus has not settled into a predictable pattern, according to Dr. Maria Van Kerkhove, the World Health Organization’s technical lead for the Covid-19 response.

“We didn’t need to have this level of death and devastation, but we’re dealing with it, and we are doing our best to minimize the impact going forward,” Van Kerkhove told the Conversations on Healthcare podcast this week.

Van Kerkhove says she does believe 2023 could be the year in which Covid-19 would no longer be deemed a public health emergency in the US and across the world, but more work needs to be done in order to make that happen and transitioning to longer-term respiratory disease management of the outbreak will take more time.

“We’re just not utilizing [vaccines] most effectively around the world. I mean 30% of the world still has not received a single vaccine,” she said. “In every country in the world, including in the US, we’re missing key demographics.”

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U.S. investigating first cases of “concerning” new drug-resistant gonorrhea strain

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Health authorities in Massachusetts announced Thursday they have identified two cases of a new strain of gonorrhea that appears to have developed resistance to a broad swath of antibiotic treatments.

Both patients got better after getting injections of ceftriaxone, the main drug currently recommended to treat cases of the sexually transmitted infection. But state health officials warn the strain that infected them shows signs of at least some resistance to almost every drug to treat the bacteria, the first of its kind confirmed in the U.S. to date.

Investigators are now working with the Centers for Disease Control and Prevention to test other samples collected from gonorrhea cases in the state. Massachusetts is also conducting contact tracing to find out if the drug-resistant strain has spread to others.

“The discovery of this strain of gonorrhea is a serious public health concern which DPH, the CDC, and other health departments have been vigilant about detecting,” Margret Cooke, head of the Massachusetts Department of Public Health, said Thursday in a statement.

Gonorrhea is the second most common sexually transmitted infection reported to health authorities in the U.S., behind chlamydia, according to the CDC.

Many who are infected by the bacteria often have little to no symptoms. However, some can develop bleeding, discharge, and more serious complications that can lead to infertility and pain.

The initial case was identified in a patient who went to a primary care clinic with symptoms of urethritis, a kind of irritation that can make it difficult to urinate. Samples examined by the state’s health laboratory flagged a “concerning” pattern later verified by follow-up testing by the CDC.

A spokesperson for the state declined to clarify additional details about the two cases, beyond those identified in the department’s announcement and alert to providers. 

No direct connection has been identified between the two cases. One had no recent travel history, suggesting the strain could be spreading within the state.

“We urge all sexually active people to be regularly tested for sexually transmitted infections and to consider reducing the number of their sexual partners and increasing their use of condoms when having sex,” Cooke said.

Gonorrhea’s “alarming” drug resistance

For years, health authorities have been working to respond to the “alarming” ability that gonorrhea has to develop resistance against antibiotics that have been deployed to combat it. 

In 2013, the CDC named gonorrhea as one of the three most urgent threats posed by antibiotic-resistant bacteria. Both U.S. and world health authorities have launched campaigns to curb new cases of gonorrhea in hopes of controlling the bacteria until vaccines and new treatments are developed.

The Massachusetts cases are the first confirmed in the lab to have developed the ability to sidestep six of the seven drugs that health authorities track for potential resistance. It carries a change to the “penA60 allele” – a gene mutation – which has been linked to previous ceftriaxone-resistant cases in Nevada, the United Kingdom, and Asia.

“This case is a reminder that antimicrobial-resistant gonorrhea remains an urgent public health threat nationally and internationally; all providers in all clinical settings need to remain vigilant,” Dr. Laura Hinkle Bachmann, chief medical officer of the CDC Division of STD Prevention, said Thursday in a letter to providers.

Ceftriaxone injections, boosted with other oral antibiotics like azithromycin and doxycycline, have been the last recommended treatment for gonorrhea since 2012. At the time, laboratory data showed a related drug known as cefixime had been losing effectiveness and risked creating resistance to ceftriaxone too.

Only one drug tested against the Massachusetts strain by the CDC’s panel – gentamicin – showed no sign of reduced susceptibility. However, that drug is already generally considered a less effective treatment for gonorrhea.

Scientists have pursued new drugs for gonorrhea like zoliflodacin, which showed promising early results in a 2018 study backed by the National Institutes of Health. That drug is currently being studied in clinical trials and has not been approved by the Food and Drug Administration for gonorrhea.

“Timely identification and treatment, as well as rapid public health response, are essential to keeping patients safe and reducing the risk of community transmission. We must all remain alert for potential gonococcal treatment failures as we combat the growing threat of antimicrobial resistance,” Bachmann said.

Alexander Tin

CBS News reporter covering public health and the pandemic.

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CDC identifies possible safety issue with Pfizer’s updated Covid-19 vaccine but says people should still get boosted

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CNN
 — 

The US Centers for Disease Control and Prevention said Friday that there is a possible safety issue with the bivalent Covid-19 vaccine made by Pfizer and BioNTech but that it is unlikely to represent a true risk. The agency said it continues to recommend that people stay up-to-date with Covid-19 vaccines.

The CDC said one of its vaccine safety monitoring systems – a “near real-time surveillance system” called the Vaccine Safety Datalink – detected a possible increase in a certain kind of stroke in people 65 and older who recently got one of Pfizer’s updated booster shots.

A rapid response analysis of that signal revealed that seniors who got an bivalent booster might be more likely to have ischemic strokes within the first three weeks after their shots, compared with weeks four through six.

Ischemic strokes, the most common form, are blockages of blood to the brain. They’re usually caused by clots.

The Vaccine Safety Datalink, or VSD, is a network of large health systems across the nation that provides data about the safety and efficacy of vaccines through patients’ electronic health records. The CDC said it had identified possible confounding factors in the data coming from the VSD that may be biasing the data and need further investigation.

Of about 550,000 seniors who got Pfizer bivalent boosters and were tracked by the VSD, 130 had strokes in the three weeks after the shot, according to a CDC official who spoke to CNN on condition of anonymity because they weren’t authorized to share the data. None of the 130 people died.

The number of strokes detected is relatively small, said Dr. William Schaffner, an infectious disease expert at Vanderbilt University and a member of the CDC Advisory Committee on Immunization Practices’ Covid-19 Vaccine Work Group.

“These strokes are not a confirmed adverse event at the moment,” he said. “It’s like a radar system. You’re getting a blip on the radar, and you have to do further investigation to discover whether that airplane is friend or foe.”

The same safety signal has not been detected with the bivalent Moderna booster, the CDC said in its notice.

The agency noted that it has looked for and failed to find the same increase in strokes in other large collections of medical records, including those maintained by Medicare, the US Department of Veterans Affairs, as well as its Vaccine Adverse Event Reporting System, known as VAERS.

Neither Pfizer nor other countries that are using the vaccine have seen any increase in this kind of stroke, the agency said, and the signal was not detected in any other databases.

The CDC says that it does not recommend any change to vaccination practices at this time and that the risks of Covid-19 for older adults continue to outweigh any possible safety issues with the vaccine.

“Although the totality of the data currently suggests that it is very unlikely that the signal in VSD represents a true clinical risk, we believe it is important to share this information with the public, as we have in the past, when one of our safety monitoring systems detects a signal,” the notice says.

“CDC and FDA will continue to evaluate additional data from these and other vaccine safety systems. These data and additional analyses will be discussed at the upcoming January 26 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.”

Pfizer said in a statement Friday, “Neither Pfizer and BioNTech nor the CDC or the U.S. Food and Drug Administration (FDA) have observed similar findings across numerous other monitoring systems in the U.S. and globally and there is no evidence to conclude that ischemic stroke is associated with the use of the companies’ COVID-19 vaccines.

“Compared to published incidence rates of ischemic stroke in this older population, the companies to date have observed a lower number of reported ischemic strokes following the vaccination with the Omicron BA.4/BA.5-adapted bivalent vaccine.”

The bivalent boosters from Pfizer/BioNTech and Moderna protect against the original strain of the coronavirus as well as the Omicron BA.4 and BA.5 subvariants. Only about 50 million Americans ages 5 and up have gotten them since they were authorized last fall, according to CDC data.

Schaffner said he was part of a briefing Thursday with members of the Covid-19 Vaccine Work Group. He couldn’t share specific details about the briefing but said the safety signal was discussed.

His biggest takeaway was that the safety surveillance system is working.

It’s very likely that this is a false signal, he said, but it’s being investigated, which is important.

“You want a surveillance system that occasionally sends up false signals. If you don’t get any signals, you’re worried that you’re missing stuff.”

Schaffner said he would absolutely tell people to get their Covid-19 booster if they haven’t done so yet – even those 65 and older.

“Undoubtedly, the risk of a whole series of adverse events, including hospitalization, is much, much greater with Covid-19 than it is from the vaccine,” he said.

He also said the signal – if real – may be more a factor of numbers than an indication that one manufacturer’s vaccine is riskier than the other.

Nearly two-thirds of the people in the US who’ve gotten an updated booster – 32 million – have gotten Pfizer, compared with about 18 million Moderna shots.

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Flu activity peaked without post-holiday spike in cases, but respiratory virus season is still in full swing

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CNN
 — 

Flu continues to be very prevalent in the US, but the first wave of the season – which swept through the country weeks earlier than usual – appears to have peaked.

The weeks after the year-end holidays brought sustained high levels of transmission and hospitalization, but flu activity doesn’t seem to have spiked as many public health experts cautioned.

Still, even after weeks of improvement, data published Friday by the US Centers for Disease Control and Prevention shows that more than 12,400 people were admitted to the hospital for flu in the first week of the new year, and nearly 9% of lab tests were positive for flu.

About 4% of everyone who visited a health care provider last week had respiratory virus symptoms, including fever plus a cough or sore throat, which is nearly twice as high as the national baseline.

Flu is notoriously unpredictable, and a season can bring multiple peaks of activity.

“It’s pretty clear that there was a peak of activity, but that doesn’t mean we won’t have another one,” Lynnette Brammer, lead of the CDC’s domestic influenza surveillance team, said last week. “Things could turn around and go back up.”

Flu vaccination rates remain far below ideal levels, and hospitals remain very full, leaving the US vulnerable as respiratory virus season drags on.

“It’s certainly something we’re gonna watch really carefully. We’re just going to have to keep an eye on all the data, see what viruses are circulating and who’s getting sick, and what sort of impact that’s having,” Brammer said.

“And I want to remind people that if they haven’t yet gotten vaccinated, please do so. It’s not too late.”

As of December 31, about 171 million doses of flu vaccine have been distributed in the US – enough to cover only about half of the population. Just 40% of adults had gotten their shot by the end of November, and just 48% of children had gotten their shot by the end of December, according to CDC data.

Through January 7, the CDC estimates that there have been 24 million illnesses, 260,000 hospitalizations and 16,000 deaths from flu this season.

Although this season did hit earlier than usual, outcomes are within an expected range – at least so far.

“It’s not an unusually high influenza season. It’s sort of falling in with the mid- to higher range, but it’s within the limits of what we normally expect to see during a regular flu season, unfortunately,” Brammer said. “So basically, this is looking like a typical flu season, except in terms of the timing. It was just a little bit earlier than normal.”

Overall, flu and other respiratory virus activity remains “high” or “very high” in about half of states, according to the new CDC data, and the US continues to contend with multiple respiratory viruses that are circulating at high levels.

RSV activity has also peaked in the US, reaching a season high in mid-November. But even after a sharp decrease in trends over the past month and a half, weekly hospitalization rates for RSV remain higher than the peaks for most recent seasons.

RSV is particularly dangerous for children, and at least 13 out of every 100,000 children younger than 5 were hospitalized for RSV in the last week of the year, bringing the cumulative hospitalization rate this season up to 5 out of every 1,000 children in this age group.

Meanwhile, Covid-19 activity has been trending up for the past few months.

Hospitalizations have been on the rise since November and have surpassed the most recent peak from this summer, before the updated booster shot was available, federal data shows.

Case reporting has become more irregular over the course of the pandemic, but wastewater monitoring data from Biobot Analytics suggests that Covid-19 activity is higher than it was during the Delta surge, too.

The rapidly growing Omicron subvariant XBB.1.5 now accounts for an estimated 43% of new Covid-19 cases in the US, according to the CDC, making it the strain that is causing the most new infections in the US.

Notably, it is the only variant that is gaining ground in the U.S.

XBB.1.5 was first detected in New York in October. It grew quickly throughout the Northeast, and the CDC estimates that it accounts for more than 80% of new cases in that region.

From there, XBB.1.5 seems to be picking up steam along the Eastern Seaboard. It now accounts for about half of Covid-19 cases in the mid-Atlantic states and nearly one-third of cases in the Southeast. It is less prevalent in other US regions.

The rise of XBB.1.5 has coincided with an increase in Covid-19 hospitalizations, especially among seniors.

XBB.1.5 has a key mutation that helps it bind more tightly to cells. Experts believe that may be helping it be more infectious.

Still, just 16% of the US population has received their updated Covid-19 booster shot. Data from October shows that people ages 5 and up who had received an updated booster had 19 times lower risk of dying from Covid-19 compared with those who were unvaccinated. Chances of testing positive were three times lower for those who had their updated booster.

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250,000 kindergartners are vulnerable due to drop in vaccination rate

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Nearly a quarter of a million kindergartners are vulnerable to measles due to a dip in vaccination coverage during the pandemic, according to the Centers for Disease Control and Prevention.

The CDC, in a report published Thursday, found that 93% of kindergartners were up to date with state-required vaccines during the 2021-22 school year, a decline of 2% from 2019-20.

“While this might not sound significant, it means nearly 250,000 kindergartners are potentially not protected against measles,” Dr. Georgina Peacock, head of the CDC’s immunization services division, said during a call with reporters Thursday.

“And we know that measles, mumps and rubella vaccination coverage for kindergartners is the lowest it has been in over a decade,” Peacock said.

Kindergartners are required to be vaccinated against measles, mumps and rubella; chickenpox; polio; and diphtheria, tetanus and pertussis. The vaccination rate for measles, mumps and rubella was 93.5% during the 2021-22 school year, below the target coverage of 95% to prevent outbreaks.

An ongoing measles outbreak in Columbus, Ohio, has spread to 83 children, 33 of whom were hospitalized. None of the children have died. The overwhelming majority of the kids, 78, were not vaccinated.

“These outbreaks harm children and cause significant disruptions in their opportunities to learn and grow and thrive,” said Dr. Sean O’Leary, who heads the American Academy of Pediatrics committee on infectious disease. “This is alarming and it should be a call to action for all of us.”

The CDC report looked at whether the kindergartners had received the second dose of their measles, mumps and rubella vaccine. Two doses are 97% effective at preventing disease and one dose is about 93% effective, according to the CDC.

Measles is a highly contagious virus that spreads when someone coughs or sneezes and contaminates the air, where the virus can linger for up to two hours. It can also spread when a person touches a contaminated surface and then touches their eyes, nose or mouth.

The virus is so contagious that a single person can spread the virus to 90% of people close to them who do not have immunity through vaccination or a previous infection, according to the CDC.

Measles can be dangerous for children younger than 5, adults older than 20, pregnant women, and people with compromised immune systems.

About 1 in 5 unvaccinated people who catch it are hospitalized. About 1 in 20 kids get pneumonia, and one in 1,000 have brain swelling that can cause disabilities. Symptoms begin with a high fever, cough, runny nose and red eyes. White spots appear in the mouth two to three days later, and a rash breaks out on the body.

CDC officials said disruptions to schools and the health-care system during the Covid pandemic are largely responsible for the decline in vaccination rates.

“We know that the pandemic really had a disruption to health-care systems,” Peacock said. “Part of it is that well-child visits maybe were missed and people are still trying to catch up on those well-child visits.”

“We know that the schools had a lot of things to focus on and in some cases maybe they were not able to gather all that documentation on the vaccinations,” Peacock said. “Or because children were at home for a lot of the pandemic, that may have not been the emphasis while they were focused on testing and doing all those other things related to the pandemic.”

In a separate report published Thursday, the CDC found that coverage for what’s known as the combined seven-vaccine series actually increased slightly among children born in 2018-19 by the time they turned two, compared with kids born in 2016-17.

This seven-vaccine series includes shots against measles, chickenpox, polio, hepatitis B, streptococcus pneumoniae, haemophilus influenzae or Hib, and diphtheria, tetanus and pertussis.

However, the CDC found that there were major income and racial disparities. Vaccination coverage declined by up to 5% during the pandemic for those living below the poverty level or in rural areas. Black and Hispanic children had lower vaccination rates than white children.

O’Leary said that while misinformation about vaccines is a problem, the vast majority of parents are still getting their kids vaccinated. He said inequality is the bigger issue.

“The things we really need to focus on are addressing access and child poverty,” O’Leary said.

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Updated childhood obesity treatment guidelines include medications, surgery for some young people

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CNN
 — 

Updated American Academy of Pediatrics guidelines for treatment of obesity urge prompt use of behavior therapy and lifestyle changes, and say surgery and medications should be used for some young people.

The guidelines, published Monday in the journal Pediatrics, are the first comprehensive update to the academy’s obesity treatment guidelines in 15 years. They provide guidance for treatment of children as young as 2 and through the teen years.

The guidelines acknowledge that obesity is complex, and tied to access to nutritious foods and health care, among other factors.

Treatment for younger children should focus on behavior and lifestyle treatment for the entire family, including nutrition support and increased physical activity. For children 12 and older, use of weight loss medications is appropriate, in addition to health behavior therapy and lifestyle treatment, AAP says. Teens 13 and older with severe obesity should be evaluated for surgery, according to the guidelines.

“There is no evidence that ‘watchful waiting’ or delayed treatment is appropriate for children with obesity,” Dr. Sandra Hassink, an author of the guideline and vice chair of AAP’s Clinical Practice Guideline Subcommittee on Obesity, said in a statement. “The goal is to help patients make changes in lifestyle, behaviors or environment in a way that is sustainable and involves families in decision-making at every step of the way.”

For children and teens, overweight is defined as a body mass index at or above the 85th percentile and below the 95th percentile; obesity is defined as a BMI at or above the 95th percentile.

Myles Faith, a psychologist at the State University of New York at Buffalo who studies childhood eating behaviors and obesity, praised the new report both for acknowledging that the causes of childhood obesity are complex and that its treatments must be a team effort.

“It’s not one cause for all kids,” he says. “There’s not been this kind of report to say that there are more options and that we shouldn’t automatically discount the possibility of medication, that we shouldn’t discount the role of surgery. For some families, it might be something to consider,” said Faith, who was not involved in the creation of the guidelines.

The new guidelines do not discuss obesity prevention; it will be addressed in another AAP policy statement to come, it says.

“These are the most comprehensive, patient-centered guidelines we have had that address overweight and obesity within childhood,” Dr. Rebecca Carter, pediatrician at the University of Maryland Children’s Hospital and assistant professor at the University of Maryland School of Medicine, said in an email Monday.

“New to these recommendations are several new medication management strategies that have proven very successful in the treatment of obesity as a chronic disease for adults, and are now being recommended for use in children and adolescents,” Carter said. “This is a major step in allowing overweight and obesity to be considered as the chronic diseases that they are.”

She added that the recommendations also are a “major step forward” in helping both parents and medical teams “take ownership” over a child’s long-term health risks related to overweight and obesity.

“They give a variety of tools to help families feel empowered that there are ways to treat these medical conditions, and that there are nuanced causes for these conditions that go beyond easy solutions and certainly take our focus away from outdated or unhealthy dieting strategies,” Carter said.

The new guidelines are designed for health care providers, but Carter said parents should talk with their children’s doctor if there are concerns about weight, and discuss strategies to optimize health and monitor changes.

“It is also appropriate to do this in a child-focused manner, taking care not to stigmatize them or make them feel bad about their body, while empowering the child to feel they have the tools needed to keep their body healthy over time.”

The new guidelines are a “much-needed advancement” to align holistic care with current science, Dr. Jennifer Woo Baidal, assistant professor of pediatrics and director of the Pediatric Obesity Initiative at Columbia University in New York City, said in a separate email Monday.

“Uptake of the new guidelines will help reverse the epidemic of childhood obesity,” she said. “More work at policy levels will be needed to mitigate policies and practices that propagate racial, ethnic, and socioeconomic disparities in obesity starting in early life. Although the guidelines support advocacy efforts of pediatricians, we as a society need to voice our support for healthful environments for the nation’s children.”

AAP says more than 14.4 million children and teens live with obesity. Children with overweight or obesity are at higher risk for asthma, sleep apnea, bone and joint problems, type 2 diabetes and heart disease, according to the US Centers for Disease Control and Prevention.

Separate research, published last month in the American Diabetes Association journal Diabetes Care, suggests that the number of young people under age 20 with type 2 diabetes in the United States may increase nearly 675% by 2060 if current trends continue.

Last month, the CDC released updated growth charts that can be used to track children and teens with severe obesity.

Growth charts are standardized tools used by health care providers to track growth from infancy through adolescence. But as obesity and severe obesity became more prevalent in the last 40 years – more than 4.5 million children and teens had severe obesity in 2017-2018, the agency says – the charts hadn’t kept up.

The growth chart in use since 2000 is based on data from 1963 to 1980 and did not extend beyond the 97th percentile, the agency said. The newly extended percentiles incorporate more recent data and provide a way to monitor and visualize very high body mass index values.

The existing growth charts for children and adolescents without obesity will not change, the CDC said, while the extended growth chart will be useful for health care providers treating patients with severe childhood obesity.

“Prior to today’s release, the growth charts did not extend high enough to plot BMI for the increasing number of children with severe obesity. The new growth charts coupled with high-quality treatment can help optimize care for children with severe obesity,” Dr. Karen Hacker, director CDC’s National Center for Chronic Disease Prevention and Health Promotion, said in a statement. “Providers can work with families on a comprehensive care plan to address childhood obesity.

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Health

CDC Monitoring Reported Increase In Strep A Cases In Children

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The Centers for Disease Control and Prevention on Thursday issued a health advisory over reports of a rise in invasive strep A infections in children.

While cases of strep A are currently “relatively low” and still rare in children, the CDC will continue investigating.

Group A Streptococcus is a category of bacteria that can cause illnesses ranging from pharyngitis to more dangerous diseases with high mortality rates like sepsis and streptococcal toxic shock syndrome.

In the U.S., strep A infections usually follow a seasonal pattern, with cases typically peaking in December through April. Cases also typically rise with high influenza activity, the CDC said.

The increase was first recorded in children at a Colorado hospital, with more states recordings cases since then, the agency said.

Last week, Colorado’s Department of Public Health and Environment said it had recorded 11 cases of invasive group A strep in children since Nov. 1 in the Denver metro area. Children ranging from 6 months to 10 years old make up most recent cases.

A possible reason behind the increase in infections could be the absence of mixing among children in the past few years due to the COVID-19 pandemic, according to health experts in the U.K., where at least 15 children have died since September from a strep A outbreak.

CDC spokesperson Kate Grusich told CNN it’s not clear whether the number of infections is adjusting to pre-pandemic levels or rising beyond that.

“The recent increases in respiratory viruses, particularly influenza, may also be contributing to a possible increase in iGAS infections,” Grusich said.

The best way to guard against step A is practicing good hygiene, like frequently washing your hands, the CDC said.

“There is no vaccine for group A strep, but keeping up to date on vaccines for COVID-19, flu and chickenpox can help protect your child from developing complications from a group A strep infection,” said Dr. Rachel Herlihy, a state epidemiologist for Colorado.

Herlihy also urged parents to contact a doctor if they observe new symptoms.

Symptoms may include fever, chills and rashes, among other things.

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