November 2: 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.

New Report: Together with our partner The Council on Foreign Relations, we released a new report urging governments, multilateral and international institutions, and private actors to act immediately to strengthen planning for future pandemic vaccines by incorporating lessons learned from successes and failures of the current global rollout of COVID-19 vaccines. The new report, Navigating the World that COVID-19 Made: A Strategy for Revamping the Pandemic Research and Development Preparedness and Response Ecosystem, identifies how the COVID-19 pandemic has exposed and redefined the realities of the global vaccine research, development, production and delivery ecosystem, one which has so far failed in rapid, equitable allocation and distribution of vaccines globally. You can read the full report here.

PEDIATRIC VACCINES The US FDA on October 29 authorized the emergency use of the Pfizer-BioNTech SARS-CoV-2 vaccine for children ages 5 to 11 years, making the vaccine the first to be authorized in the US for about 28 million US school-age children. The 2-dose regimen for this younger age group is one-third the dosage given to individuals aged 12 and older (10μg versus 30μg), administered 3 weeks apart. The US CDC’s Advisory Committee on Immunization Practices (ACIP) is meeting today and will vote around 4:15 pm EDT on whether to recommend the vaccine. If the panel votes that the CDC should recommend the Pfizer-BioNTech vaccine for 5- to 11-year-olds, which is likely, CDC Director Dr. Rochelle Walensky is expected to sign off on the recommendation, possibly within a few hours. While that scenario will make the vaccine available for some by the end of this week, a White House official on November 1 said the pediatric vaccination program will be “hitting full strength” the week of November 8, after vaccine doses are shipped to pediatrician offices, pharmacies, and other vaccine administrators.

Moderna recently provided an update on the FDA’s review of its SARS-CoV-2 vaccine for adolescents aged 12 to 17, saying the regulatory agency needs additional time to evaluate data on the risk of myocarditis after vaccination—inflammation of the heart muscle characterized by a rapid or irregular heartbeat. The FDA informed Moderna that regulators expect the assessment will not be completed by January 2022. Both the Moderna and Pfizer-BioNTech vaccines have been associated with rare instances of myocarditis, but COVID-19 disease is more likely to lead to the condition, and possibly cause lasting damage. The absolute risk of vaccine-associated myocarditis remains very small, and most cases are mild and recover fully quickly. So far, data suggest that the risk is highest after the second dose of an mRNA vaccine among males ages 16 to 29. Some researchers have seen a possible association between puberty hormones and myocarditis—which typically develops annually in about 10-20 people out of every 100,000 after a viral or bacterial infection—and that could explain why the condition seems to be less common among younger children. Moderna said it will wait to request authorization for its vaccine in younger children ages 6 to 11 until after an FDA decision on adolescent use.

NOVAVAX The National Agency of Drug and Food Control of the Republic of Indonesia, or Badan Pengawas Obat dan Makanan (Badan POM), on November 1 authorized the use of a SARS-CoV-2 vaccine developed by Novavax and manufactured by the Serum Institute of India (SII), marking the first authorization for the company’s recombinant nanoparticle protein-based vaccine. The company said shipments to Indonesia are expected to begin soon, with the country set to receive 20 million doses this year. Novavax has applied for authorization in India, the Philippines, the UK, and Australia, and announced on November 1 it submitted for authorization with Health Canada and completed rolling review submissions with the European Medicines Agency (EMA). The vaccine, NVX-CoV2373, appeared to provide 100% protection from moderate-to-severe COVID-19 based on data from a large Phase 3 clinical trial conducted in the US and Mexico, with 90.4% overall efficacy. Notably, Indonesia is not on the list of countries recognized by the WHO as having strict regulatory processes, so Novavax still has to win authorization elsewhere before it can fulfill a promise to COVAX to supply 1.1 billion vaccine doses. The company expects to request authorization from the US FDA by the end of this year.

NATURAL/INDUCED IMMUNITY The scientific community’s understanding of natural and induced COVID-19 immunity continues to evolve with the increasing number of vaccinated and recovered individuals. Late last week, the US CDC published a study in its Morbidity and Mortality Weekly Review (MMWR) examining the odds of hospitalization among adults with COVID-19 whose previous infection or vaccination occurred 90-179 days earlier. The study found that the odds of hospitalization were 5.5 times higher in individuals who previously had COVID-19 compared to people fully vaccinated with an mRNA vaccine and no previous SARS-CoV-2 infection. The CDC said the study affirms their recommendation for those who have had SARS-CoV-2 infections to get vaccinated. Throughout vaccination rollouts in the US, some unvaccinated individuals cite their own natural immunity from previous SARS-CoV-2 infection as a reason to avoid vaccination. An essay published in The New York Times on October 28 suggests there should be a strong effort to promote the power of so-called “hybrid immunity,” the protection previously infected individuals get when they are vaccinated. Some research suggests that individuals who have recovered from COVID-19 have a stronger immune response to new coronavirus exposures after vaccination when compared to vaccinated people who had not been previously exposed. In theory, this should allow these groups to have a better immune response to new variants.

Overall, the general consensus is that recovered individuals have a lot to gain from SARS-CoV-2 vaccination. A new poll from Axios/Ipsos shows people in the US are confused about SARS-CoV-2 vaccines’ effectiveness. According to the poll, 40% of respondents either don't believe or don't know that unvaccinated people are at least 10 times more likely to die of COVID-19. The results show the importance of public health officials underlining that vaccination continues to be the best protection from severe COVID-19 and not equating an individual’s decision to rely on natural immunity as being “anti-vax.” Research continues to explore the benefits of both natural and vaccine-induced SARS-CoV-2 immunity to develop a better understanding of the pathways that lead to more successful antibody responses.

HOUSEHOLD TRANSMISSION A study led by researchers from Imperial College of London and the UK Health Security Agency found that individuals vaccinated against SARS-CoV-2 had a reduced but still significant risk of transmission among household contacts. Published in The Lancet Infectious Diseases, the analysis determined a secondary attack rate (SAR) in household contacts exposed to contacts with the Delta variant was 25% for fully vaccinated individuals compared with 38% in unvaccinated individuals. The SAR among household contacts exposed to fully vaccinated index cases was similar to household contacts exposed to unvaccinated index cases (25% vs 23%). Peak viral loads were similar among vaccination groups and viral variants, but vaccinated individuals had a faster rate of viral load decline, implying they might become less infectious more quickly. The time interval between vaccination and study recruitment was greater in fully vaccinated PCR-positive contacts than fully vaccinated PCR-negative contacts, which the researchers note may indicate increased susceptibility to infection consistent with waning immunity as soon as 2-3 months following vaccination. They concluded that vaccination continues to protect against serious COVID-19 disease and that booster doses are warranted.

OVERWEIGHT & OBESITY People with overweight or obesity (OWOB) who become infected with SARS-CoV-2 are at a higher risk of severe COVID-19 and long-term symptoms, according to research published recently in the journal Influenza and Other Respiratory Viruses. Notably, adolescents with OWOB had longer-lasting respiratory symptoms (7 vs 4 days) and were more likely to be symptomatic than adolescents without OWOB (67% vs 34%). Recognizing these disparities, some countries—including the UK, Mexico, and Chile—are acknowledging diet-related diseases such as obesity and diabetes as risk factors for more severe COVID-19 and taking actions to curb sales of junk food, sugary drinks, and fast food and encourage people to exercise more. Less attention is being given to the association between OWOB and more severe COVID-19 in the US, where nearly 75% of adults and about 20% of children have OWOB. Additionally, almost two-thirds of COVID-19 hospitalizations in the US are estimated to be related to obesity, diabetes, hypertension, or heart failure. With no national strategy to address OWOB in the US, some researchers worry the problem could worsen in the future, as the rate of obesity during the first year of the pandemic rose among children ages 2 to 19 from 19.3% in 2019 to 22.4% in 2020. A study published November 1 in JAMA Pediatrics estimates that screen time spent outside of virtual schooling—also known as recreational screen time—among teenagers doubled from 3.8 hours a day before the pandemic to 7.7 hours per day during the pandemic. The findings imply that teenagers are spending more time engaging in sedentary behaviors, increasing their risk of developing OWOB, and could have mental health implications.

US SCHOOL SCREENING TESTING PROGRAMS In a joint effort between the US Department of Education, the US CDC, and the Rockefeller Foundation, the Biden administration is launching a new push to accelerate school-based COVID-19 screening testing for students and staff. The effort hopes to expand the reach of federal and state partners through additional resources, including a guide on how to start a school testing program, and will establish weekly “office hours” to connect schools to national testing experts for assistance in setting up and maintaining screening testing programs beginning November 2 and running through December 22. Additional personnel will be available to assist state health departments coordinate school testing programs through the CDC Foundation and the COVID Workforce Initiative as well as assist with contact tracing and other public health activities. A new directory, launched by the CDC, also aims to simplify the search for testing providers for schools to establish their testing programs. As part of the COVID-19 Action plan announced in September, US President Joe Biden allocated $10 billion for screening testing for teachers, staff, and students in K-12 schools, but not all states have accepted or utilized their share of the funding. According to a survey by the Center on Reinventing Public Education of the nation’s 100 largest school districts, less than 15% of those schools are utilizing that funding to establish COVID-19 screening testing programs.

G20 SUPPORT FOR ACT-A The Access to COVID-19 Tools Accelerator (ACT-A) last week launched a new strategic plan and budget for the next year, calling on nations to contribute US$23.4 billion through September 2022 to help the partnership close gaps in access to COVID-19 vaccines, diagnostics, treatments, and other resources in low- and middle-income countries (LMICs). Under the new plan, ACT-A partner agencies will aim to support LMICs in vaccinating 70% of their populations, increasing testing rates to at least 1 per 1,000 people per day, and treating up to 120 million COVID-19 cases by improving access to existing and emerging therapeutics. In announcing the new plan, a WHO official said 5 billion additional vaccine doses will be needed to reach the vaccination goal, requiring more transparency from manufacturers and countries with existing vaccine contracts or those that have pledged doses to COVAX, the vaccines arm of ACT-A.

WHO Director-General Dr. Tedros Adhanom Ghebreyesus called on the Group of 20, which met over the weekend in Rome, to use their political and financial power to fund ACT-A and create a legally binding treaty on pandemic preparedness and response. In a joint communiqué issued at the end of their meeting on October 29, G20 health and finance ministers agreed to continue to support ACT-A and take steps to reach a goal of vaccinating 70% of the world’s population by mid-2022—earlier than its previous goal—by “helping boost the supply of vaccines, medical countermeasures, and inputs in developing countries and remove relevant supply and financing constraints.” The ministers also agreed to establish a G20 Joint Finance-Health Task Force to prepare for future pandemics. Notably, the G20 ministers did not make any firm financial commitments, instead calling for further cooperation and exploration of funding mechanisms to address the current pandemic or future preparedness efforts. G20 leaders concluded their meeting on October 31, agreeing to “work together towards the recognition of COVID-19 vaccines deemed safe and efficacious by the WHO and in accordance with national legislation and circumstances, and to strengthen the organization’s ability regarding approval of vaccines.” The language apparently is in response to comments from both Russia President Vladimir Putin and China President Xi Jinping, who separately complained about lags in review time and lack of mutual recognition for the countries’ domestically produced SARS-CoV-2 vaccines.

LOCKDOWNS RISE & FALL Australia, Israel, and Thailand on November 1 significantly eased international border restrictions for the first time since the beginning of the COVID-19 pandemic, while parts of Eastern Europe and China took steps to tighten lockdowns amid rising cases. Australia opened its borders to permanent residents, citizens, and their families, allowing reunions after more than 18 months apart. Australians are now free to travel internationally without an exemption, and fully vaccinated individuals are no longer required to quarantine for 2 weeks upon arrival. All other non-resident international travelers need an exemption to enter the country, even if they are fully vaccinated. In Thailand, the government hopes the return of foreign visitors will help boost the economy, for which tourism accounts for about 20%. Israel is allowing international travelers who have received vaccine boosters, but not if more than 6 months has passed since their last dose.

In contrast to its Asia-Pacific neighbors, China is becoming more isolated, implementing new lockdowns and continuing its efforts to maintain a “zero COVID-19” policy. In an extreme example, officials kept more than 30,000 visitors to the Shanghai Disneyland in the park and forced them to undergo SARS-CoV-2 testing before being able to leave after one visitor tested positive for the virus. The South Pacific island nation of Tonga entered lockdown today, after recording the country’s first imported COVID-19 case last week. The case—a traveler from New Zealand incoming on a repatriation flight—spurred thousands of residents to get vaccinated. Meanwhile, parts of Russia have implemented their strictest lockdowns in more than a year, as the country continues to hit record numbers of daily new cases, with an average of 38,194 on November 1, more than double its recent low on September 10.

SARS-COV-2 ORIGIN The US Intelligence Community last week released a declassified report on the origins of SARS-CoV-2, the novel coronavirus that caused the COVID-19 pandemic. The nation’s intelligence agencies were unable to conclude whether the pandemic began as a result of animal-to-human viral transmission or a laboratory incident, saying that while both are both plausible, analysts could not agree on which was more likely or whether an assessment can be made at all based on current knowledge. In order to provide a more clear picture of the pandemic’s origin, the agencies would need more information from China or another breakthrough in new information, according to the report. Notably, the intelligence report does rule out allegations that the virus was developed as a bioweapon, although with low confidence. Additionally, the report clarifies that intelligence analysts agree that Chinese officials did not know about the novel coronavirus until after its detection in the general population. In response to the report, a Chinese official said the fact that a potential lab leak was included as a plausible origin was “a lie,” and he called for an investigation led by a cooperative of scientists from around the world.

In a process to name such a group, the WHO on November 1 reopened its call for applications for experts to join its newly established Scientific Advisory Group for the Origins of Novel Pathogens (SAGO). Interested individuals have until November 3 24:00 CET to submit their documents. Last week, only a day before the public comment period closed for a group of 26 previously named nominees, the investigative research group US Right to Know submitted a letter to the WHO expressing concerns over several of the nominees. It is expected that the WHO will choose additional applicants and reopen a 2-week comment period, further delaying the finalization of the group.