Thursday, July 14, 2022

Outbreak Alert: Monkeypox

Outbreak Alerts

Monkeypox

Editor: Alyson Browett, MPH

Contributors: Christina Potter, MSPH, Eric Toner, MD, Rachel Vahey, MHS, and Lane Warmbrod, MS, MPH

If you received this email from a colleague and would like to receive these updates to your inbox, please sign up here.

Additional Monkeypox Resources

UPCOMING WEBINAR The country’s response to the COVID-19 pandemic led to new public-private partnerships (PPPs) that drove the development of new medical countermeasures and bolstered domestic manufacturing capacity for medical products. It is critical to sustain PPPs and build a domestic bioindustrial base beyond the current pandemic. Join us for a webinar, Strengthening Private Public Partnerships in Pandemic Preparedness for National Security and Economic Competitiveness, on Wednesday, July 20, at 12pm ET. Register here: https://jh.zoom.us/webinar/register/WN_fiapVqnbToKHkgwPcaDtIA

Recent Outbreaks Update as of July 12, 2022 at 2pm EDT

As of 5pm EDT on July 12, there were 10,611 cumulative confirmed cases of monkeypox in 65 countries, territories, and areas, according to the US CDC.* A majority of the confirmed cases continue to be reported in European countries, with Spain (2,447), the UK (1,735), and Germany (1,636) making up the top 3. The US remains in 4th position this week, reporting 928 confirmed cases. No deaths have been reported in countries not historically reporting monkeypox, while 3 deaths from confirmed or suspected cases have been reported in other countries.

Based on data from Global.health,** Our World In Data shows a cumulative total of 10,527 confirmed monkeypox cases and a 7-day average of 484 daily confirmed cases as of July 12. The 7-day rolling average of daily confirmed cases has increased about 35% from 1 week ago.

*The CDC updated its global monkeypox map to include countries historically reporting monkeypox cases and delineate between those and countries not historically reporting monkeypox cases. The CDC map only includes cases confirmed as monkeypox virus or orthopoxvirus through laboratory testing.

**Global.health data only include countries that have not historically reported monkeypox cases.

GLOBAL SITUATION The WHO this week confirmed that the Emergency Committee will reconvene next week to discuss the ongoing monkeypox outbreaks, although it was not specified which day or days the meetings will take place. Following 2 days of deliberation in June, the Emergency Committee stopped short of declaring a Public Health Emergency of International Concern (PHEIC). The PHEIC designation is the WHO’s highest level of alert, showing an event constitutes an extraordinary public health risk to other countries through international spread and requires a coordinated international response.

With the virus now spreading in dozens of countries, efforts to control its spread and stop it from establishing itself in the human population become more challenging. Some experts say the warning signs of a potential global outbreak have been present for decades but were largely ignored until the virus began circulating in higher-income countries. Others caution that the true scale of the current monkeypox outbreak is not yet fully understood, as global testing capacity, surveillance, and contact tracing continue to ramp up.

EUROPEAN REGION SITUATION The European Centre for Disease Prevention and Control (ECDC) on July 8 published its first risk assessment update on the multi-country monkeypox outbreak, saying that the likelihood of further monkeypox spread within networks of people with multiple sexual partners in Europe is considered high and the likelihood of spread among the broader population is very low. The report notes that prioritizing pre-exposure vaccination of high-risk groups, including men who have sex with men (MSM) and healthcare workers, should be considered in developing prevention strategies. Two studies published in Eurosurveillance—one examining local viral transmission in Madrid, Spain, and the other in Berlin, Germany—call for increased efforts to work with at-risk groups to reduce stigma, target information, and provide recommendations.

The UK Health Security Agency (UKHSA) on July 12 released an epidemiological update on the monkeypox outbreak in England, noting that, for cases with available data, 75% are in London, 99% are among males, and the median age is 36 years. Notably, in a technical briefing released last week, the agency said incidence continues to grow, with modeling implying positive growth between 3.8% to 6.7% per day, corresponding to a doubling time of 15 days (90% CI: 10 days, 18 days). On July 10, the UK Advisory Committee on Dangerous Pathogens (ACDP) recommended that the West African clade of monkeypox currently responsible for community transmission within the UK no longer be classified as a high consequence infectious disease (HCID) but that future importations of the West African clade or Congo Basin clade should be designated as HCIDs.

US RESPONSE US health authorities are applying lessons learned during the COVID-19 pandemic to the monkeypox outbreak, but efforts to close gaps in testing, vaccination, and surveillance continue to falter. Some experts blame systemic challenges within the nation’s public health response structure, including a lack of funding and authority, that have existed for decades.

Monkeypox vaccine remains in short supply, with appointment slots filling as soon as they are released in New York City and other metropolitan areas that have received supplies of the 2-dose Jynneos vaccine from the federal government. The US CDC and its Laboratory Response Network (LRN) continue to expand monkeypox testing capacity, with a goal of supporting 5 commercial laboratories to establish testing capacity of 10,000 tests per week per lab. Within the past week, Labcorp, Mayo Clinic Labs, and Quest Diagnostics have launched monkeypox tests to increase access and availability.

Saturday, July 9, 2022

BA.4 and BA.5 COVID Symptoms: What to Watch For as Infections Climb

NBC Chicago

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BA.4 and BA.5 COVID Symptoms: What to Watch For as Infections Climb

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The fastest-spreading COVID-19 subvariants yet, the two latest versions of omicron appear to evade protection from vaccines and previous infections more easily than any others before.

BA.4 and BA.5 COVID Symptoms: What to Watch For as Infections Climb

© Provided by NBC ChicagoBA.4 and BA.5 COVID Symptoms: What to Watch For as Infections Climb

As of July 2, the subvariant BA.5 was responsible for nearly 54% of COVID cases in the U.S. BA.4, a similar subvariant, accounted for nearly 17% more, according to the latest data from the Centers for Disease Control and Prevention.

David Montefiori, a professor at the Human Vaccine Institute at Duke University Medical Center, told NBC News that BA.4 and BA.5 are about three times less sensitive to neutralizing antibodies from existing COVID vaccines than the original version of the omicron variant, BA.1. Additional research suggests that BA.4 and BA.5 are four times more resistant to antibodies from vaccines than BA.2. That subvariant replaced omicron as the U.S.'s dominant version of the coronavirus in April.

the panel didn't say how the new vaccine should be formulated. That


Doctor: COVID Vaccine Boosters Need an ‘Update' to Fight Omicron


As both subvariants continue to spread and more infections are reported across the country, what symptoms are people experiencing? And are these symptoms any different from those commonly seen in other infections?


The U.K., where BA.4 and BA.5 infections also account for the majority of recent COVID cases, reported runny nose, sore throat, headache, persistent cough and fatigue as its most common symptoms last week.

Less than one-third of people surveyed reported fevers, according to data from the Zoe COVID Symptom Study, which allows people to self-report symptoms through smartphone apps. The symptoms are consistent with those reported in the spring, when the BA.2 subvariant was dominant in the country.

According to the University of California Davis Health, the reported symptoms of BA.5 are similar to previous COVID variants: fever, runny nose, coughing, sore throat, headaches, muscle pain and fatigue. At this point, there doesn't appear to be a difference in the symptoms seen in BA.4 or BA.5 cases, compared to earlier omicron strains.

Francois Balloux, the director of the University College London Genetics Institute, said while BA.1 and BA.2 are "pretty different...BA.2, BA.4 and B.5 from a neutralizing antibody perspective are essentially interchangeable."

Because of that, people who had BA.2 infections may have some protection from the latest subvariants, he said. While they spread quicker than any others, BA.4 and BA.5 haven’t been found to cause more severe disease, according to doctors.

"There’s really no clear evidence that they’re more or less likely to make people sick and cause severe illness and death," stated Montefiori.

Dr. Nathan Grubaugh, an epidemiologist at the Yale School of Public Health, said people need to understand that variants like Omicron and BA.5 are a natural part of the progression of the virus.

“Delta was never going to be the last variant—and Omicron is not going to be the last one," he said, according to an article on the school's website. "As long as there is a COVID-19 outbreak somewhere in the world, there is going to be something new that emerges.”

The best way to prevent new variants, he and other doctors say, is to get vaccinated and booster shots. If more people are fully vaccinated, the opportunity for the virus to spread and mutate decreases, they contend.

Thursday, June 30, 2022

June 30, 2022: Johns Hopkins COVID 19 Situation Report

COVID-19 Situation Report

Editor: Alyson Browett, MPH

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

CALL FOR PAPERS In 2023, Health Security will devote a supplement to Global Catastrophic Biological Risks (GCBRs). We encourage submissions of original research articles, case studies, and commentaries that discuss lessons learned from the COVID-19 pandemic response and/or key policy and technology advances that could prevent or better prepare for a future, potentially more severe, globally catastrophic infectious disease pandemic. The deadline is October 3, 2022. Click here more information.

NOTICE The COVID-19 Situation Report will not be published on July 5 or July 7. The report will resume publication the following week on July 12.

EPI UPDATE The WHO COVID-19 Dashboard reports 543 million cumulative cases and 6.33 million deaths worldwide as of June 29. The global weekly incidence increased 21.32% from the previous week. Global weekly mortality increased as well, up 7.43% from the previous week. At the regional level, Europe (+40%), the Americas (+15%), Southeast Asia (+32%), and the Eastern Mediterranean (+47%) experienced increases, while the Western Pacific (-3%) and Africa (-34%) had decreasing trends. The number of new weekly deaths increased in the Eastern Mediterranean (+22%), Southeast Asia (+15%), and the Americas (+11%) and decreased in the Western Pacific (-6%), Europe (-5%) and Africa (-1%).

UNITED STATES

The US CDC is reporting 87.2 million cumulative cases of COVID-19 and 1,012,166 deaths. The average daily incidence has plateaued over the past several weeks, holding relatively steady at approximately 100-110,000 new cases per day. The current 7-day average is 108,505 new cases per day. The average daily mortality has held relatively steady at approximately 250-300 deaths per day since late May* However, the 7-day average appears to be rising and currently is 321 deaths per day.

*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.

Both new hospital admissions (+13% over the past week) and current hospitalizations (+5%) continue to increase. Considering the plateau in daily incidence, it is possible that hospitalizations could also remain elevated, rather than peaking and then declining.

Community transmission in the US is now being driven by the Omicron BA.5 (36.6%) and BA.4 (15.7%) sublineages, which together are now more prevalent than the BA.2.12.1 sublineage (42%). Along with BA.2 (5.7%), these 4 sublineages of the Omicron variant represent all new SARS-CoV-2 infections in the US.

OMICRON BA.4/BA.5 SARS-CoV-2 Omicron subvariants BA.4 and BA.5 have overtaken BA.2.12.1 as the dominant strains in the US. While BA.2.12.1 still makes up approximately 42% of new cases as of June 25, BA.4 accounts for 15.7% and BA.5 accounts for 36.6%, for a combined total of 52.3%. BA.4 and BA.5 were first detected in South Africa in November 2021, and they are now fueling a worldwide increase in cases. Additionally, hospitalizations are on the rise in Israel, Portugal, South Africa, the UK, and the US. The increases in case and hospitalization numbers are likely due to the fact that BA.4 and BA.5 contain mutations that are believed to aid in immune evasion. This means that prior infection with an earlier Omicron strain, such as BA.1 from winter 2022, might not be enough to protect against disease. BA.4 and BA.5 also are capable of escaping some immunity from vaccines, but vaccinated individuals still tend to fare better than those relying on natural immunity alone. It is increasingly likely that more individuals will start experiencing reinfections. There are concerns that multiple reinfections could put individuals at a higher risk for health problems, but research on the matter is ongoing.

In a June 29 briefing, WHO Director-General Dr. Tedros Adhanom Ghebreyesus noted that BA.4 and BA.5 are responsible for an approximately 20% increase in the number of COVID-19 cases worldwide. COVID-19 cases are on the rise in 110 countries and deaths are increasing in half of the 6 regions monitored by the WHO. Dr. Tedros also spoke out against complacency in the face of the pandemic, stressing that the pandemic is changing and not yet over. He urged the international community to quickly work toward achieving 100% vaccination rates for healthcare workers and individuals over age 60 years. Dr. Tedros also re-emphasized the need for a pan-coronavirus vaccine that can stand up to the rapid evolutionary rate of SARS-CoV-2. Notably, BioNTech announced this week that the company and its partner Pfizer will begin human trials of a pan-coronavirus vaccine in the second half of the year.

VACCINE UPDATES FOR OMICRON The US FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) on June 28 voted 19-2 to recommend the agency take steps to authorize updated COVID-19 booster shots targeting some form of the SARS-CoV-2 Omicron variant that has been dominant since the beginning of this year. A confluence of factors makes the US population more susceptible to a winter COVID-19 surge, including waning immunity, the possible emergence of a new variant, and colder weather that pushes more people indoors. Current vaccines and boosters are based on the spike protein structure and characteristics of only the original SARS-CoV-2 virus, so introducing individuals to an Omicron spike protein should broaden the body’s immune response against additional versions of the virus, whether currently circulating or a future but similar variant. Many committee members expressed dismay over the limited amount of data on updated vaccine formulations—including if or how well they might provide additional protection—and unknowns about which variants will be circulating this fall.

In an announcement released today, the FDA said that based on the committee’s discussions, it has advised manufacturers seeking to update their COVID-19 vaccines to develop modified versions that add spike protein components of the Omicron BA.4/BA.4 subvariants to current vaccine formulations to create a 2-component, or bivalent, booster vaccine. The decision paves the way for vaccine companies to start manufacturing Omicron-containing doses to potentially be ready for use beginning in early to mid-fall. The FDA did not recommend a change to the primary vaccination formulations.

Introducing another booster this year may come with its own suite of challenges in terms of communication, including possibly moving away from the term booster to something like “another annual shot.” A significant proportion of individuals in the US who are eligible to receive third or fourth shots have yet to do so, leaving them more vulnerable as BA.4 and BA.5 become predominant and highlighting the need for a comprehensive communication strategy about who should get additional shots, when, and why. The administration of US President Joe Biden on June 29 announced an agreement to purchase 105 million doses of the Pfizer-BioNTech COVID-19 vaccine for US$3.2 billion for a fall vaccination campaign, with options for an additional 195 million doses. Pfizer-BioNTech will provide its new formulation based on FDA recommendations. Both Pfizer-BioNTech and Moderna are working on vaccine booster reformulations.

US MATERNAL MORTALITY A new study examining maternal mortality rates in the US before and during the COVID-19 pandemic was published June 28 in the peer-reviewed journal JAMA Network Open. The study compared pre-pandemic and pandemic maternal mortality using de-identified records from the National Center for Health Statistics. Deaths occurring in 2018, 2019, or January-March 2020 were classified as pre-pandemic. Deaths occurring from April-December 2020 were classified as during the pandemic. The study found that maternal mortality rose from 18.8 per 100,000 live births to 25.1 per 100,000 live births. This represents an increase of 33%, higher than the 22% increase in mortality expected as a result of the pandemic. Late maternal mortality increased 41%.

The largest increases in maternal mortality were seen in Hispanic populations, at 74.2%, and non-Hispanic Black populations, at 40.2%, compared to an increase of 17.2% in non-Hispanic White populations. The largest increases in maternal mortality were seen for underlying cause-of-death codes related to indirect causes of death such as other viral diseases (2,374.7%), diseases of the respiratory system (117.7%), and diseases of the circulatory system (72.1%). Maternal mortality increases associated with direct causes of death were largely due to diabetes (95.9%), hypertension disorders (39%), and other pregnancy-related conditions (48%). The authors call for future studies that examine ethnic and racial disparities along with specific causes of COVID-19-related maternal mortality. They also expressed hope that improvements due to the rollout of vaccines could be realized in future analyses.

The new study further confirms a trend seen before the pandemic, when maternal mortality rates were twice as high in the US as in many other high-income countries. More resources are needed to protect pregnant populations from the dangers associated with COVID-19, but pre-existing issues that lead to high maternal mortality must also be addressed to protect this often overlooked high-risk population in the US.

MONOCLONAL ANTIBODY THERAPIES The US government is expected to use up its supplies of Eli Lilly’s monoclonal antibody therapy for COVID-19 in late August because its pandemic funding is running out. Lilly said it agreed to supply the US with an additional 150,000 doses of bebtelovimab for about US$275 million in order to meet demand through the end of August. The agreement includes an option for an additional 350,000 doses that must be applied no later than September 14. Currently, the federal government is distributing about 30,000 doses per week. The antibody received US FDA emergency use authorization earlier this year for use among non-hospitalized patients with mild-to-moderate COVID-19 who are at high risk of disease progression, and the drug has shown effectiveness against the Omicron variant. If the federal government is unable to procure more doses than currently agreed upon, Lilly will need to sell the treatment directly to hospitals and states, a move that would represent a first test of shifting a COVID-19-related drug to the commercial market.

The US FDA and the Assistant Secretary for Preparedness and Response (ASPR) authorized a shelf-life extension for another monoclonal antibody therapy, Evusheld (tixagevimab co-packaged with cilgavimab) made by AstraZeneca. The shelf life of certain lots of the refrigerated treatment can be extended from 18 months to 24 months. Evusheld is authorized for pre-exposure prophylaxis of COVID-19 in certain adults and pediatric individuals. Several experts are hoping for more funding and research into antibody treatments for COVID-19 and other ailments, with some noting that antibodies can have more long-lasting impacts than vaccines, especially among people with immunodeficiencies, and could serve as a key solution during the next pandemic.

DIGITAL SOLUTIONS FOR INFODEMIC During the COVID-19 pandemic, the public has been faced with an overabundance of information, including false or misleading content, in both online and offline environments. To address the online information epidemic, the WHO Regional Office for Europe published a policy brief on how digital solutions can be used to address this so-called “infodemic” to help improve the public health response to COVID-19 and future health emergencies. The brief outlines what WHO is doing to address the infodemic in Europe and globally and highlights 6 specific policy considerations for policymakers and other key stakeholders to help improve infodemic management, including reinforcing multistakeholder networks for infodemic management; strengthening overall risk communication and community engagement; implementing continuous monitoring of harmful and false online content; improving digital literacy approaches and organizing infodemic management trainings; advocating for infodemic management through communication campaigns; and ensuring safe online platforms, which protect people from harmful content.

RESEARCH ROUNDUP The research roundup provides quick synopses of COVID-19-related research.

From Emerging Infectious Diseases, a case report from Thailand of a veterinarian who was diagnosed with COVID-19 after treating and being sneezed on by a domestic cat owned by a person infected with SARS-CoV-2 at the time. Genetic analysis supports the hypothesis that viral transmission occurred from the owner to the cat and then from the cat to the veterinarian. Notably, the veterinarian was wearing an N95 during the cat’s examination, leading the researchers to postulate her eyes were left vulnerable to infection when the cat sneezed in her face, highlighting the importance of face shields or goggles, in addition to masks, to prevent transmission.

From JAMA Internal Medicine, a study suggesting that patients of African ancestry with sickle cell trait (SCT) and associated history of one of several kidney conditions were at increased risk of mortality and acute kidney failure following COVID-19. The results strongly support advising that patients with SCT be regarded as at high-risk of COVID-19.

From The Journal of Infectious Diseases, a cohort study evaluating the risk of SARS-CoV-2 infection and severe COVID-19 disease in persons with Down syndrome (DS) and matched controls prior to available vaccination. Though the risk of infection among individuals with DS was 32% lower than their matched counterparts (aHR 0.68, 95% CI: 0.56-0.83), the rate of severe COVID-19 disease was 6-fold higher (aHR 6.14, 95% CI: 1.87-20.16). The results support better infection monitoring, early treatment, and vaccination for individuals with DS.

From the New England Journal of Medicine, a cohort study of US children aged 5-11 who were vaccinated on or after November 23, 2021, compared with matched controls who were unvaccinated to estimate the effectiveness of the Pfizer-BioNTech vaccine at the start of the Omicron surge. The estimated vaccine effectiveness against symptomatic COVID-19 was 18% (95% CI: -2 to 34) at 14 to 27 days after the first dose and 48% (95% CI: 29 to 63) at 7 to 21 days after the second dose, showing moderate protection as Omicron was becoming dominant.

From Pediatrics, a multicenter prospective observational cohort study conducted in 25 US pediatric hospitals that followed COVID-19 patients under age 21 who were hospitalized between May 2020 and May 2021 for COVID-19 or multisystem inflammatory syndrome in children (MIS-C) for 2-4 months after admission. The researchers found that more than 1 in 4 children with COVID-19 or MIS-C experienced persistent symptoms or activity impairment for at least 2 months. Those patients with MIS-C who have respiratory problems or obesity had a higher risk of prolonged recovery.

From Scientific Reports, a mathematical modeling study examining how human movement—from home to other locations such as school, work, and elsewhere—social distancing behavior, and other restrictive measures such as quarantine affect COVID-19 dynamics within a population. The study’s model showed that SARS-CoV-2 transmission is most attributable to the home location, including gatherings of relatives and close friends. Therefore, limiting encounters or travel to other locations is only effective if the same social distancing measures are also effectively implemented in the home setting.

Wednesday, June 29, 2022

Monkeypox is an “evolving health threat”

Outbreak Alerts

Monkeypox

Editor: Alyson Browett, MPH

Contributors: Christina Potter, MSPH, Eric Toner, MD, Rachel Vahey, MHS, and Lane Warmbrod, MS, MPH

If you received this email from a colleague and would like to receive these updates to your inbox, please sign up here.

Additional Monkeypox Resources

Recent Outbreak Update as of June 29, 2022 at 2pm EDT

As of 5pm EDT on June 28, there were 4,769 cumulative confirmed cases of monkeypox in 49 countries, territories, and areas where the virus is not endemic, according to the US CDC. As of 2pm EDT today, the Global.health database reports 4,780 confirmed cases and an additional 44 suspected cases. A majority of the cases are being reported in European countries. Notably, the trackers do not include year-to-date cases in endemic countries. No deaths have been reported in non-endemic countries.

WHO DECLINES PHEIC DESIGNATION On June 25, World Health Organization (WHO) Director-General Dr. Tedros Adhanom Ghebreyesus announced the multi-country outbreak of monkeypox constitutes an “evolving health threat” but stopped short of declaring a Public Health Emergency of International Concern (PHEIC), based on 2 days of deliberation by the Emergency Committee.

The PHEIC designation is the WHO’s highest level of alert, showing an event constitutes an extraordinary public health risk to other countries through international spread and requires a coordinated international response. Though the Committee agreed that the outbreak requires coordinated action to stop the spread of the virus—including greater surveillance, improved diagnostics, community engagement and risk communication, and the appropriate use of therapeutics, vaccines, and public health measures such as contact tracing and isolation—there was disagreement among members about whether the event constitutes a PHEIC.

The WHO said it will continue to monitor the outbreak and reconvene the Emergency Committee in the coming days or weeks if it grows in severity or reach, particularly if affecting new countries or new populations. A vast majority of confirmed cases so far have been among men who have sex with men (MSM), signaling the virus is being spread within close-knit communities. Additionally, the Committee said if there is evidence monkeypox has established itself within animal reservoirs outside of Africa, it will reconsider its recommendation regarding a PHEIC declaration to the Director-General.

Many public health experts were surprised that the WHO did not classify the monkeypox outbreak as a PHEIC since it appeared the Emergency Committee concluded the outbreak met all 3 criteria of being extraordinary, at risk of international spread, and in need of a coordinated response. The reasons for not declaring a PHEIC likely vary. Notably, monkeypox has been circulating in several African nations for decades with little international concern. In fact, Nigeria, where monkeypox is endemic, warned this week that the country’s number of confirmed cases could reach its highest level in 5 years if current infection trends persist.

GLOBAL ASSESSMENT In a June 27 situation update, the WHO assessed the overall risk at the global level as moderate, noting this is the first time that cases and clusters are being reported simultaneously in 5 WHO Regions. The agency assessed the risk in the European Region as high due to the geographically widespread outbreak in the region involving newly affected countries. The WHO this week also published guidance for host governments, public health authorities, organizers, and other decision-makers involved in the planning and delivery of small or large gatherings during the current monkeypox outbreak. While the agency calls for organizers to take a risk-based approach to managing close interactions—noting that it remains unclear whether monkeypox can be transmitted by asymptomatic individuals—it did not call for the postponement or cancellation of events.

EUROPEAN REGION RESPONSE In a joint surveillance bulletin released today, the European Centre for Disease Prevention and Control (ECDC) and the WHO Regional Office for Europe report that 4,178 cases of monkeypox have been identified in 31 European countries and areas as of June 28, with 3,082 of those being laboratory-confirmed. The report also contains epidemiological information, demographics and clinical descriptions of cases, and phylogenetic analysis.

The European Commission announced on June 28 that it has delivered an initial 5,300 doses of Bavarian-Nordic’s (BN) smallpox vaccine to Spain, out of a total 109,090 doses procured. The BN vaccine, marketed as Imvanex in Europe and Jynneos in the US, is known to be effective against monkeypox. The vaccine is US FDA-approved for monkeypox, and the European Medicines Agency (EMA) this week began a review of the vaccine to extend its authorization to cover monkeypox in addition to smallpox.

US RESPONSE The US CDC activated its Emergency Operations Center (EOC) this week to respond to the US monkeypox outbreak. In a press release, the CDC said the action will allow the agency “to further increase operational support for the response to meet the outbreak’s evolving challenges.” As part of its overall monkeypox outbreak response, which includes ramping up testing capabilities nationwide, the White House announced a national monkeypox vaccine strategy to significantly expand the availability of the 2-dose Jynneos monkeypox vaccines and broaden eligibility, with the goal of slowing the spread of the virus. In addition to offering the vaccine to people who have had a known exposure to the virus, the vaccine will be available to MSM who have had multiple recent partners in gatherings where monkeypox virus is known to have been spreading or in geographic areas where monkeypox transmission is occurring.

To date, the US Department of Health and Human Services (HHS) has distributed 9,000 doses of Jynneos vaccine to 32 states and jurisdictions, as well as 300 courses of antiviral treatments. HHS plans to allocate an additional 56,000 doses immediately and another 240,000 over the coming weeks. Notably, a combined 1.6 million doses is expected to become available over the coming months. Under a 4-tier distribution plan, areas with the highest monkeypox case rates will be prioritized. Due to a limited supply of the Jynneos vaccine, officials are considering whether to use another, older smallpox vaccine, ACAM2000, that is effective against monkeypox. However, that vaccine comes with risks because it is an attenuated live-virus vaccine, which is presumed to not be safe for use among certain populations, including pregnant people, older adults, and  immunocompromised people, such as those living with HIV.

Many public health experts fear time is running out to effectively stop the transmission of monkeypox before the disease becomes endemic in the US and Europe. Cases with no known link to chains of transmission indicate community spread is occurring, with people possibly spreading the virus without knowledge that they are infected and testing still difficult to obtain. Therefore, the official case count, in the US and globally, likely is an undercount.

Tuesday, June 28, 2022

June 28, 2020: Johns Hopkins COVID 19 Situation Report

COVID-19 Situation Report

Editor: Alyson Browett, MPH

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

MONKEYPOX OUTBREAKS UPDATE Read our latest updates on the monkeypox outbreaks on our resource page. We will continue to analyze the situation and provide updates, as needed. If you would like to receive these updates, please sign up here.

US FDA CONSIDERS VACCINE UPDATES Today, the US FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) is meeting to discuss if and how the strain compositions of COVID-19 vaccines should be modified going forward. The meeting will be livestreamed on the FDA website here with presentation materials also available for download. Presentations and discussion points expected to be covered include: evolution of SARS-CoV-2 variants thus far, as well as models predicting future evolution; current effectiveness of COVID-19 vaccines; related recommendations from the WHO on the subject; clinical trial data evaluating COVID-19 vaccines with varying strain composition; and the FDA perspective on the issue, including considerations for and data required to support authorization of any modified vaccines. The committee will then vote regarding recommendations for a COVID-19 vaccine strain composition, weighing the potential expected increases in immunity against the expense and complexity of a change in composition. Experts are hopeful that an updated strain composition could help provide increased protection from a potential fall surge, although there is concern that the speed of SARS-CoV-2 mutations and slowness of updates to formulations could reduce efficacy of boosters, as vaccine protection wanes and composition becomes outdated compared with circulating variants.

PFIZER-BIONTECH OMICRON-ADAPTED VACCINES Pfizer-BioNTech shared new data over the weekend of 2 Omicron-adapted vaccine candidates, both exhibiting positive safety, tolerability, and immunogenicity, and even outperforming the companies’ current vaccine. Given at 30 microgram and 60 microgram doses as a fourth booster dose, the monovalent candidate elicited a 13.5- and 19.6-fold increase in neutralizing geometric titers against Omicron BA.1, respectively, compared to pre-booster levels. The bivalent candidate, which contains antigens to both Omicron and the original strain, exhibited a 9.1- and 10.9-fold increase at the same dosages against BA.1. Both candidates were well-tolerated among participants of the phase 2/3 trial of adults over age 56. Preliminary lab studies show both candidates neutralize BA.4 and BA.5, but to a lesser extent than BA.1. The companies have shared the data with the US FDA ahead of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting today, alongside data from ongoing COVID-19 booster studies. The companies also shared the data with the European Medicines Agency (EMA) ahead of the June 30 meeting of the International Coalition of Medicines Regulatory Authorities (ICMRA).

MODERNA VACCINE FOR OLDER CHILDREN Children and adolescents aged 6 through 17 years can now receive the Moderna COVID-19 vaccine in the US, following publication of the US CDC Advisory Committee on Immunization Practices’ (ACIP) recommendations and CDC Director Dr. Rochelle Wallensky’s endorsement. The US FDA authorized the vaccine for that age group last week. Adolescents and teens ages 12-17 receive the same dosage as adults, while younger children ages 6-11 receive half of that dose, administered in 2 shots separated by 4-8 weeks. The Pfizer-BioNTech vaccine is already available for adolescents and older children.

A decision on the Moderna vaccine for this age group was delayed due to FDA review of data on the risk of heart problems, including myocarditis and pericarditis, among adolescent boys. However, the FDA said the vaccine’s benefits outweigh the risks, which are very small and also observed with the Pfizer-BioNTech vaccine. COVID-19 carries a much greater risk of heart problems than either vaccine, which are both safe overall. To minimize the risk of transient heart problems related to the vaccines, the CDC recommends that boys and men aged 12 through 39 years space their doses by 8 weeks. That recommendation, particularly for young adult men, is supported by findings from a recent study from Canada published in JAMA Network Open.

LONG COVID/PASC Researchers worldwide are investigating the potential causes of post-acute sequelae of SARS-CoV-2 infection (PASC), commonly known as long COVID. Blood clots, persistent virus, and immune system abnormalities—or a combination of those or other underlying mechanisms—are leading theories about what could be causing long-term symptoms following recovery from acute infection. To date, there is no agreement on how to define and diagnose long COVID, and estimates of its prevalence range from 5% to 50% of recovered patients. Recent data published by the US CDC, collected between June 1 and June 13, 2022, show that nearly 1 in 5 US adults who previously had COVID-19 continue to experience symptoms of long COVID, such as fatigue, rapid heartbeat, shortness of breath, muscle weakness, chronic pain, or cognitive difficulties. Overall, about 1 in 13 US adults, or 7.5% of the population, have symptoms lasting 3 or more months after COVID-19 recovery that were not experienced prior to infection. Women were more likely than men to currently have long COVID (9.4% vs. 5.5%), according to the data, findings that are supported by a review published June 20 in Current Medical Research and Opinion.

The CDC data show that older adults are less likely to have long COVID than younger adults, but the symptoms are often overlooked in older individuals and some research suggests seniors are more likely to develop long-term symptoms. A study from Denmark published June 22 in The Lancet Child & Adolescent Health found that among children ranging in age from 0 through 14 years, those who previously tested positive for SARS-CoV-2 were more likely to experience at least 1 symptom for 2 months or more than children who never tested positive. Additionally, one-third of children who previously tested positive experienced at least 1 long-term symptom they did not have prior to infection, including mood swings, rashes, and stomach aches, memory and concentration problems, and fatigue. While any person of any age can experience long COVID, the question of why remains a mystery. But most scientists and public health officials agree that unraveling that mystery, including standardizing the condition’s definition and diagnosis and finding treatments, represents an urgent global emergency to prevent mass suffering.

ESTIMATES OF DEATHS AVERTED Last week, a study published in The Lancet Infectious Diseases reported results from transmission modeling efforts estimating that COVID-19 vaccination programs may have prevented 19.8 million deaths (95% CI: 19.1-20.4 million) worldwide during their first year of rollout, even though global vaccination targets were not reached. The figure is based on using excess deaths to determine the true mortality burden of COVID-19, although modelers also found that using COVID-19 mortality alone and not excess deaths yielded a finding of 14.4 million deaths prevented (95% CI: 13.7-15.9 million), including 7.4 million (95% CI: 6.8-7.7 million) deaths prevented in countries provided vaccine by the COVID-19 Vaccines Global Access (COVAX) Advance Market Commitment. However, if vaccination coverage targets of 20% or 40% had been met in low-income countries, further reductions in mortality in those nations of 45% (95% CI: 42-49%) and 111% (95% CI: 105-118%), respectively, could have been reached. Experts noted that the study highlighted not only the importance of vaccination but also equitable access, with the majority of predicted prevented deaths occurring among high-income and upper-middle-income nations. Notably, China was not included in the analysis due to its status as the origin of the outbreak and its large influence on estimates due to its population size.

CHINA The National Health Commission of China today announced a reduction of the country’s quarantine policy for overseas travelers to 7 days in a centralized facility and an additional 3 days at home. Previously, travelers were required to stay 14-21 days in centralized quarantine depending on the city of entry and destination. The announcement also includes similar guidelines for close contacts of confirmed COVID-19 cases, requiring 7 days in centralized quarantine and 3 days of health monitoring at home, compared to the prior minimum 14-day requirement. China remains an outlier, as most nations have dropped their vaccination and quarantine requirements for international travelers.

Over the weekend, Beijing said it would allow primary and secondary schools to reopen for in-person instruction, with youth sports soon to follow at non-school locations. Shanghai officials also declared that the city reported no new local cases in 2 months, following a 2-month citywide lockdown that ended June 1. The lockdown effort was in line with China’s zero-COVID policy to stop all outbreaks. The policy is being discussed with renewed interest after authorities in Beijing mentioned that the strict policy could be in place for 5 years. The notice was published Monday on the official Communist Party newspaper of the capital, Beijing Daily, and republished by other media outlets, but officials quickly removed the reference to “5 years” from most online publications, as well as a hashtag on the microblogging site Weibo.

COVID-19 RECOVERY As world leaders drop the COVID-19 pandemic from their agendas, and US federal, state, tribal, and local governments roll back pandemic-related funding and mitigation efforts—such as mask mandates—local officials, grassroots organizations, and frontline community health workers continue to push for and implement piecemeal strategies to help increase vaccination rates, draw attention to the need for research into long COVID, and improve trust in and funding for public health systems. There is a need for the US to create “a sustainable infrastructure that can keep more people from getting COVID, regardless of their social circumstances,” writes Ed Yong in The Atlantic. Indeed, the US Government Accountability Office (GAO) last week released a report recommending that the US Department of Health and Human Services (HHS) prioritize the development of a real-time, public health situational awareness network to help raise public awareness to facilitate the early detection of and rapid response to future and potentially catastrophic disease outbreaks, such as COVID-19.