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of updates to formulations could reduce efficacy of boosters, as vaccine protection wanes and composition becomes outdated compared with circulating variants.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.