October 26: Johns Hopkins COVID 19 Report

COVID-19 Situation Report

Editor: Alyson Browett, MPH

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

Webinar Available: The COVID-19 pandemic has shown that accurate and timely health-related information is crucial to mounting an effective response to a public health crisis. As can be seen in setbacks during the COVID-19 response, health-related misinformation and disinformation can lead to more infections, deaths, disruption, and disorganization of the effort. The latest session of The Capitol Hill Steering Committee on Pandemic Preparedness & Health Security, titled “Combating Misinformation and Disinformation for COVID-19 and Future Public Health Threats,” evaluated the role misinformation has played in health emergencies and offered solutions to increase trust in future public health messaging. A recording of the webinar is available for viewing.

VACCINES FOR CHILDREN The US FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is meeting today to consider recommending the authorization of the Pfizer-BioNTech SARS-CoV-2 vaccine for children ages 5 to 11 years. Last week, the FDA posted Pfizer-BioNTech’s briefing on the vaccine for this age group, which suggested a 2-dose series of 10μg shots delivered 3 weeks apart—one-third of the adult dose—was 91% effective in preventing symptomatic disease among this younger age group, with low incidence of adverse events. The companies said no cases of heart inflammation were reported in 3-months follow-up after the second shot, although the study population was small. In its own briefing, the FDA said the benefits of the Pfizer-BioNTech vaccine among children ages 5 to 11 clearly outweigh the risks of potential side effects. The FDA’s advisory committee is expected to recommend authorizing the lower-dose Pfizer-BioNTech vaccine for young children today. After the FDA issues a final decision—which usually follows the recommendations of its advisors—the US CDC Advisory Committee on Immunization Practices will make recommendations at its next meeting, scheduled for November 2-3. Following the approval of those recommendations by CDC Director Dr. Rochelle Walensky, children ages 5 to 11 could become eligible for SARS-CoV-2 vaccination by November 3-4.

According to 2 recent studies—one published in the New England Journal of Medicine (NEJM) and the other in the CDC’s Morbidity and Mortality Weekly Report (MMWR)—the Pfizer-BioNTech vaccine is effective at preventing symptomatic COVID-19 disease and related hospitalization in adolescents aged 12 to 18 years. The studies demonstrate the importance of vaccines in protecting children from COVID-19, and they could factor into today’s FDA advisory committee meeting.

On October 25, Moderna announced interim results from its Phase 2/3 KidCOVE study evaluating its SARS-CoV-2 vaccine in children aged 6 to 11 years. According to the company, the data—which are not yet published or peer-reviewed—showed that participants in the 6- to 11-year-old range had a robust immune response to a 2-dose 50μg regimen delivered 4 weeks apart. Side effects included mild to moderate symptoms such as fatigue, fever, headache, and pain at the injection site. The company indicated plans to submit their data to US and European regulators soon, although there is no indication when the FDA might review the vaccine for use in children. Moderna’s vaccine currently is authorized for use in adults, and it is awaiting a response from the FDA to its June request for authorization for children aged 12 to 17.

US TRAVEL POLICIES On October 25, US President Joe Biden issued a proclamation on international air travel requiring nearly all inbound international travelers to be fully vaccinated. Notably, there are exceptions to the new policy: children under 18, those with certain medical conditions, and non-tourists traveling from specific countries with low vaccine access will instead be required to report a negative COVID-19 test prior to departure. There are no religious exemptions for inbound passengers, according to the US CDC, which issued new contact tracing rules the same day. Those travelers staying in the US are expected to receive a vaccine within 60 days, a decision which takes advantage of the large repository of vaccine doses in the country. The travel industry is welcoming these changes to the existing regulations, which issued travel restrictions on a country-by-country basis. With a more uniform travel policy, airlines are looking forward to simpler implementation and logistics moving forward. The new air travel policy will take effect on November 8, and more details on a similar plan to lift travel restrictions on land border crossings are expected later this week.

Additionally, the CDC extended its Framework for Conditional Sailing Order through January 15, 2022. While the CDC makes important recommendations for other forms of travel, CDC maintains authority over whether or not cruise ships are allowed to operate in US waters. Given the short, but fraught, history of COVID-19 on cruise ships, the CDC has taken many steps to work with the cruise ship industry to ensure the safety of passengers and crew. The Framework for Conditional Sailing Order was initially implemented in October 2020 following the expiration of the CDC’s No Sail Order. Since then, the cruise industry has adopted numerous COVID-19 prevention measures, such as masking and testing requirements. The temporary extension states that CDC intends to transition to a voluntary program upon the conclusion of the extension deadline, which will involve close coordination between the CDC and the cruise industry.

US BOOSTER DOSES Tens of millions more people in the US became eligible for SARS-CoV-2 vaccine boosters last week following CDC Director Dr. Rochelle Walensky’s endorsement of the agency’s Advisory Committee on Immunization Practices’ (ACIP) recommendation for booster shots in certain populations. Now, all 3 of the vaccines approved or authorized in the US—all of which remain highly effective in reducing the risk of severe disease, hospitalization, and death—are available for additional or booster doses among certain populations. For those who received primary shots with either the Pfizer-BioNTech or Moderna vaccines, booster doses are available 6 months after the initial series for individuals aged 65 or older and those aged 18 or older who live in long-term care settings, have underlying medical conditions, or work or live in high-risk settings. The Moderna booster is half of the initial shots (50 μg versus 100 μg), while the Pfizer-BioNTech booster is the same dosage. Anyone who received the J&J-Janssen vaccine is eligible to receive a booster dose 2 months following their initial shot. Additionally, the CDC’s recommendations allow for people to choose which of the 3 available vaccines they get for a booster, a strategy known as “mix & match” or heterologous dosing. Notably, health experts emphasized that anyone who received 2 mRNA vaccine doses or a single J&J-Janssen dose are—for now—considered fully vaccinated. Several members of the FDA and CDC advisory panels expressed frustration over the limited data on the safety and efficacy of boosters, how questions were posed to the committees, and a burden to approve the extra doses after they were promised by US President Joe Biden in August.

GLOBAL VACCINE ACCESS The US government has now delivered 200 million SARS-CoV-2 vaccines to more than 100 countries, out of a pledge of 1.1 billion doses. A US Department of State official said many of the donated doses are surplus supply and more needs to be done to increase supply to low- and middle-income countries (LMICs), including manufacturers increasing production and other countries donating excess shots. Notably, the US government continues to deny requests from state or local governments to donate soon-to-expire doses to countries in need. In an agreement facilitated by the US government, Moderna announced it will make up to 110 million of its vaccine doses available at the lowest price to the African Union. The US undoubtedly is a leader in global vaccination efforts, but the government—and other wealthy countries—can and should do more to improve access in LMICs, public health advocates urge.

During comments to reporters last week, White House Principal Deputy Press Secretary Karin Jean-Pierre called on all World Trade Organization (WTO) member states to support a proposal to temporarily waive intellectual property rights for COVID-19 medical products, including vaccines. Formal talks on the proposal—which is endorsed by more than 100 countries—are stalled despite US backing. Notably, 2 senior officials in the administration of US President Joe Biden told The Washington Post that the government lacks the authority to share technology of Moderna's SARS-CoV-2 vaccine, despite the company receiving nearly US$10 billion in federal funding to develop, research, and expand manufacturing of the shots. Last week, the WHO urged the G20 nations, which are holding a summit this week, to increase vaccine donations, and finance ministers from member states of the Asia-Pacific Economic Cooperation (APEC) agreed to take steps to support equitable distribution of vaccines and expand manufacturing. The Kaiser Family Foundation (KFF) updated its Global COVID-19 Vaccine Coverage Tool on October 25, providing data on vaccine coverage by country, income-level, region, and globally, as well as estimates on future vaccine coverage levels.

HEALTHCARE WORKERS As many as 180,000 healthcare workers died of COVID-19 between January 2020 and May 2021, according to estimates from a WHO working paper, which urged nations worldwide to do more to support and protect healthcare workers amid the pandemic. In addition to calling for better access to vaccines for healthcare workers—only 2 of 5 are fully vaccinated globally, with greater disparities between poor and wealthy nations—the WHO warned that an increasing proportion of the workforce faces burnout, stress, anxiety, and fatigue, and the industry faces a worker shortage. A study published in the November issue of the American Journal of Nursing shows that in 2017, prior to the pandemic, 5.5% of 7,378 nurse survey respondents reported having suicidal ideation within the past year, and other surveys have shown that 25% to 50% of healthcare providers report high stress, anxiety, work overload, or symptoms of burnout. In the US, which needs more nurses, shortages in nursing school instructors, clinical sites, and financial resources has led to a bottleneck in available slots for students.

AY.4.2 VARIANT UNDER INVESTIGATION The UK Health Security Agency last week designated the Delta sublineage AY.4.2—commonly known as “Delta Plus”—as a Variant Under Investigation (VUI) and officially named the variant VUI-21OCT-01. The agency made the designation because the sublineage has become increasingly common in the UK in recent months, accounting for approximately 6% of all sequenced Delta cases. Currently, there is no evidence AY.4.2 causes more severe disease, although 2 mutations on the spike protein—A222V and Y145H—could be contributing to an increased growth rate, but more evidence is needed. COVID-19 cases caused by the Delta sublineage have been detected in at least 118 countries, including the US, India, Israel, and Russia. At a briefing last week, US CDC Director Dr. Rochelle Walensky said health officials are keeping an eye on the sublineage but that so far there is no evidence it impacts the effectiveness of vaccines or available treatments.

NEUROLOGICAL IMPACTS Many people who recover from COVID-19 suffer various symptoms of cognitive dysfunction, commonly known as “brain fog,” although the prevalence and severity of these symptoms are not well-known. In a research letter published in JAMA Open Network, researchers from the Icahn School of Medicine at Mount Sinai in New York (US) describe results from a study examining rates of cognitive impairment among 740 COVID-19 survivors who were treated in outpatient, emergency department, or inpatient hospital settings between April 2020 and May 2021. They found that up to nearly one-quarter of recovered patients continue to experience some sort of cognitive impairment 7 months post-infection, including problems with memory, processing speed, executive functioning, attention, or phonetic and category fluency. The researchers note the “considerable implications” for COVID-19 patients’ long-term rehabilitation and occupational, psychological, and functional outcomes. Even younger patients, in their 20s, 30s, and 40s, who had milder cases of the disease reported cognitive impairments, potentially heavily impacting their ability to engage in work, community, and family activities.

Another study published last week in Nature Neuroscience describes how SARS-CoV-2 can damage small vessels in the brain, potentially leading to neurological symptoms in COVID-19 patients. The team of European and US researchers suggest a potential therapeutic target to potentially treat or prevent long-term neurological symptoms of COVID-19.

ASTRAZENECA-OXFORD VACCINE A recent study published in Nature Medicine reports an association between the AstraZeneca-Oxford SARS-CoV-2 vaccine and Guillain-Barre Syndrome (GBS), a rare neurological condition. Researchers estimated that there were 38 extra cases of GBS per 10 million persons receiving the AstraZeneca-Oxford vaccine. The same study also estimated that there were 145 extra cases of GBS per 10 million persons with a positive COVID-19 test. Importantly, while there are some rare complications associated with SARS-CoV-2 vaccines, it appears that the risk of developing these neurological complications is much higher following natural infection with SARS-CoV-2. The study also examined the same outcomes among people who received the Pfizer-BioNTech vaccine, but there was no significant association between this vaccine and GBS. There was, however, a positive association between the Pfizer-BioNTech vaccine and hemorrhagic stroke. The European Medicines Agency previously added GBS as a possible adverse event to the AstraZeneca-Oxford vaccine, and the UK added the warning last week. These new findings support the overall safety of vaccines against SARS-CoV-2 and the importance of protecting oneself against the worst outcomes of infection.

CHINA Chinese health officials announced new lockdowns and other measures to contain several local SARS-CoV-2 outbreaks, with the average number of daily new COVID-19 cases more than doubling since October 16. Officials warned the outbreaks, mainly in the northern part of the country, are expected to worsen. Marathons in Wuhan and Beijing were postponed, with organizers citing the safety of runners, staff, and residents. On October 25, health officials announced children as young as 3 years old will be eligible for vaccination, with at least 5 provinces announcing compulsory vaccination for children. SARS-CoV-2 vaccines from both Sinopharm (2 versions) and Sinovac are authorized for use in children, however the shots have only been used among individuals aged 12 and older until now.

China is one of only a few countries continuing to enforce a zero-COVID policy, and the Chinese government is concerned the outbreaks will spread into Beijing, where the 2022 Winter Olympics are set to begin in February. According to new guidelines released this week, athletes at the games must be vaccinated to avoid a 21-day quarantine, will need to take daily SARS-CoV-2 tests, and will be restricted to a closed loop system dictating travel between venues and interactions with other participants. China already has said international spectators will not be allowed at the Olympics, which are set to run from February 4-20. About 75% of the Chinese population is fully vaccinated, and those who received their last dose at least 6 months ago are eligible for a booster dose.