Thursday, October 21, 2021

October 21: 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.

EPI UPDATE The WHO COVID-19 Dashboard reports 241.4 million cumulative cases and 4.91 million deaths worldwide as of October 20. Global weekly incidence decreased by 2.28% compared to the previous week, and mortality fell by 0.16%. These declines are smaller than those seen since mid-August, showing signs of stabilization.

Global Vaccination

The WHO reported 6.55 billion cumulative doses of SARS-CoV-2 vaccines administered globally as of October 19. A total of 3.7 billion individuals have received at least 1 dose, and 2.77 billion are fully vaccinated. Analysis from Our World in Data indicates that the overall trend in global daily vaccinations reached a recent low on October 17 at 20 million and is beginning to rise, up to 22.25 on October 20.* The global trend continues to closely follow Asia. Our World in Data estimates that there are 3.79 billion vaccinated individuals worldwide (1+ dose; 48.1% of the global population) and 2.88 billion who are fully vaccinated (36.58% of the global population).

*The average daily doses administered may exhibit a sharp decrease for the most recent data, particularly over the weekend, which indicates effects of reporting delays. In an effort to reflect the longer-term trends, the numbers reported here may not correspond to the most recent data.

UNITED STATES

The US CDC reports 45.07 million cumulative COVID-19 cases and 728,125 deaths. The current daily incidence average is approximately 75,988 new cases per day and appears to be decreasing. Daily mortality reached a recent low of 1,206 on October 17 but appears to be rising, up to 1,256 on October 19. Since August 13, 11.25 million fully vaccinated individuals have received a booster or additional dose of vaccine, including 15.3% of fully vaccinated adults aged 65 or older.

On October 15, the CDC began reporting hospitalization, infection, and death rates by vaccination status. For all adults aged 18 years and older, the cumulative COVID-19-associated hospitalization rate was about 12 times higher in unvaccinated persons between April 2021 and the end of August. In August, unvaccinated individuals were about 6 times more likely to test positive for SARS-CoV-2 and 11 times more likely to die of COVID-19 than those who were fully vaccinated. Notably, the COVID-19 case and death rates were slightly higher among J&J-Janssen vaccine recipients, followed by Pfizer-BioNTech recipients, and then Moderna. The incidence rate estimates are based on data collected from 16 health departments representing 30% of the US population.

*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.

US Vaccination

The US has administered 410 million cumulative doses of SARS-CoV-2 vaccines. The daily vaccination trend rose briefly following authorization of booster doses of the Pfizer-BioNTech vaccine for some populations on September 22 but continues to decline after a recent peak on October 1*. A similar increase in the daily vaccination trend could occur in the coming months as booster doses likely will be made available for millions more people. There are 219.4 million individuals who have received at least 1 vaccine dose, equivalent to 66.1% of the entire US population. Among adults, 79.1% have received at least 1 dose, as well as 14.8 million adolescents aged 12-17 years. A total of 189.7 million individuals are fully vaccinated, which corresponds to 57.1% of the total population. Approximately 68.6% of adults are fully vaccinated, as well as 12.3 million adolescents aged 12-17 years.

*Due to delays in reporting, estimates for the average daily doses administered are less accurate for the most recent 5 days. The most current average provided here corresponds to 5 days ago.

VACCINE BOOSTERS As expected, the US FDA on October 20 authorized booster doses of the Moderna SARS-CoV-2 vaccine for certain populations and the J&J-Janssen vaccine for all recipients. The agency also authorized a “mix & match” booster strategy allowing the use of each of the available SARS-CoV-2 vaccines as a heterologous booster dose in eligible individuals who have completed their primary vaccination with a different vaccine. The FDA amended the EUA for the Moderna vaccine to allow for a single half-dose booster for fully vaccinated individuals at least 6 months from their second prime-boost dose who are also aged 65 or older, or aged 18 to 64 and at high risk of severe COVID-19, or aged 18 to 64 and have frequent institutional or occupational exposure to SARS-CoV-2. For the J&J-Janssen vaccine, the FDA authorized a single booster dose for all adult recipients at least 2 months after the primary shot. Additionally, the agency clarified the Pfizer-BioNTech authorization to allow it to be used for heterologous booster doses. The FDA already authorized boosters of the Pfizer-BioNTech vaccine for certain populations, and the companies today released topline results from a Phase 3 clinical trial showing a relative vaccine efficacy of 95.6% among booster dose recipients when compared with those who did not receive a booster. The data are not yet published or peer-reviewed.

In its communications, the FDA did not show preference for any of the vaccines and did not say whether it is better to receive a booster dose with the same vaccine. The US CDC’s Advisory Committee on Immunization Practices is scheduled to vote this afternoon on its own recommendations for the vaccine boosters. Notably, with various populations cleared to get boosters from different vaccines, and the FDA expected to soon authorize a different dose of the Pfizer-BioNTech vaccine for children ages 5 to 11, pharmacies, immunization programs, physicians, and others face challenges in tracking inventory, minimizing waste, and ensuring the correct dose is being given to the correct individual.

US PEDIATRIC VACCINATION PLANNING On October 20, the US White House released a plan for the rollout of SARS-CoV-2 vaccinations for children ages 5 to 11 when the US FDA and US CDC authorize their use. The largest parts of the plan involve the purchasing of 28 million doses of the Pfizer-BioNTech vaccine—enough to cover every child in that age group—and operational changes to make vaccination conveniently located and accessible. To support jurisdictional planning, the CDC published an Operational Planning Guide indicating that as soon as regulatory agencies make a decision, the US government will begin shipping pediatric vaccine formulations, initial allocations of which will be made pro-rata and are available for preorder. The White House plans to distribute the vaccines to 25,000 pediatrician offices and 100 children’s hospitals nationwide, in addition to sending doses to pharmacies and rural health clinics. Additional plans for public education will ramp up closer to the expected time of authorization, potentially the beginning of November. Speaking at a recent White House briefing, Dr. Anthony Fauci, Chief Medical Advisor to US President Joe Biden, reiterated the importance of achieving high vaccine coverage across all eligible age groups, noting data show that children can become infected with and transmit SARS-CoV-2 as readily as adults, although half of them remain asymptomatic.

UK & “DELTA PLUS” Late last week, the UK Health Security Agency released its 25th Technical Briefing on SARS-CoV-2 variants of concern and variants under investigation. Data on a new sublineage of the SARS-CoV-2 Delta variant—newly designated as AY4.2 and sometimes called “Delta Plus”—show incidence has been expanding within the country, accounting for 6% of all samples sequenced. Health officials expect this proportion to increase in the coming weeks, and many in the public health community are watching the sublineage to see how it impacts the COVID-19 epidemiological situation. The UK recently has experienced a drastic increase in new COVID-19 cases, reporting a daily average of 45,461 new cases on October 20, up more than 12,000 cases from 2 weeks ago. Additionally, the number of daily deaths are rising. Reports suggest that an increase in cases among children has been fueling this most recent spike, especially as this age group returned to schools. Notably, vaccine uptake has lagged since early September, although there has been an uptick in average daily vaccinations over the past several days. The UK has a higher vaccination rate than some of its European counterparts, with 79% of the eligible population fully vaccinated.

Public health experts are pleading with the UK government to reinstate COVID-19 restrictions that were rolled back this summer in order to avoid reaching a critical point where the virus becomes much more difficult to contain. The government has pushed back on these calls, saying the UK will not go back to a lockdown scenario and that people should “learn to live with this virus.” In September, Prime Minister Boris Johnson announced a “Plan B” for the country, to be implemented if the National Health Service (NHS) becomes overwhelmed. The plan includes reimplementing some restrictions like mask mandates and vaccine passports but would work to keep major operations running. Others are calling for a “Plan B Plus” that would go a few steps further and include urging people to get vaccinated or get boosters, using the healthcare system wisely, and volunteering to support frontline workers.

BRAZIL A parliamentary commission of inquiry (CPI) in Brazil is recommending that President Jair Bolsonaro be charged with 9 serious offenses—including charlatanism, incitement to commit crimes, the propagation of pathogenic germs, and crimes against humanity—for allegedly intentionally allowing the COVID-19 pandemic to spread unabated through the country and killing hundreds of thousands of people, according to a 1,180-page final draft of its report. The commission’s senators are scheduled to vote on the final report on October 26, and if approved, the accusation of crimes against humanity will be referred to the International Criminal Court for further investigation. The document also recommends criminal charges for at least 65 other people, including current and former government officials and 3 of President Bolsonaro’s sons. While it is unclear whether the accusations will lead to criminal charges, the report could prove damaging to President Bolsonaro’s reelection campaign. President Bolsonaro, a self-confessed vaccine skeptic, pushed unproven treatments, discouraged mask-wearing and encouraged mass gatherings as COVID-19 incidence increased nationwide. Of the 11-member committee, 7 are members of the opposition, suggesting the report will be approved.

MOLNUPIRAVIR Concerns are rising that access to Merck’s yet-to-be-authorized COVID-19 treatment will be limited for low- and middle-income countries (LMICs)—in ways similar to SARS-CoV-2 vaccines—leading the WHO and the Gates Foundation to make commitments to help improve access to the antiviral, called molnupiravir. In a draft document, the WHO-supported Access to COVID-19 Tools Accelerator (ACT-A) outlines plans to procure antiviral drugs to treat up to 120 million patients with mild COVID-19 for as little as $10 per course, although it does not specifically name molnupiravir. The Gates Foundation is committing US$120 million to support the production of generic versions of the still-experimental molnupiravir. Merck has already signed licensing agreements with at least 8 generic drug manufacturers, which will receive various types of incentives from the Gates Foundation to produce the drug as expeditiously as possible. Merck and its partner Ridgeback Biotherapeutics applied for Emergency Use Authorization (EUA) from the US FDA after releasing interim clinical trial results showing the drug cut COVID-19-related hospitalizations and deaths by about half. An FDA advisory committee is scheduled to meet on November 30 to discuss the companies’ EUA request. Although molnupiravir is easy to distribute and can be taken at home, price and availability likely will remain obstacles for poorer nations. Notably, several wealthy nations—including the US and at least 8 Asia-Pacific region nations—already have pre-purchase agreements for the antiviral, potentially setting the stage for access inequities to plague treatments in addition to vaccines.

GLOBAL VACCINE ACCESS The world continues to need more SARS-CoV-2 vaccines, especially in low-income countries that lack sufficient supplies, in part due to wealthy nations’ vaccine hoarding—including oftentimes secretive contracts between vaccine makers and governments—driving global inequalities. According to the International Federation of Pharmaceutical Manufacturers and Associations, global vaccine production is increasing and is expected to reach 12.5 billion doses by the end of 2021 and double to 24 billion doses by June 2022. But more production does not equal equitable distribution, and with many nations beginning vaccine booster initiatives, the onus lies on nations with excess supplies to donate those shots to countries in need. According to a new report from The People’s Vaccine alliance, only 14% of the 1.8 billion vaccine doses pledged for donation have been delivered to low- and middle-income countries (LMICs) to date, and pharmaceutical companies have delivered only 12% of the doses allocated to the COVAX initiative. Global health experts recently encouraged the US to donate its surplus doses, speed up the timeline for delivering the 1 billion doses of the Pfizer-BioNTech vaccine already promised, and use emergency powers under the Defense Production Act to increase vaccine production and force manufacturers to share technology with foreign producers. While the US International Development Finance Corporation is looking into supporting vaccine manufacturing and hubs in South Africa and India, those efforts are expected to produce 2 billion doses by the end of 2022, not quickly enough to meet current global demand.

In a POLITICO opinion piece, 2 senior EU officials warned the bloc is lagging in vaccine donations to LMICs, risking a loss of political influence as well as the emergence of new SARS-CoV-2 variants. Meanwhile, in a recent video address, Pope Francis encouraged vaccine makers to share their patents with producers in LMICs as a “gesture of humanity.” The pharmaceutical industry—along with the EU and other countries—continues to resist a proposal at the World Trade Organization (WTO) to implement a temporary waiver of intellectual property for COVID-19-related medical products, despite support from the US and around 100 other nations. Frustrated with the lack of cooperation, the WHO announced this week it has hired the South African pharmaceutical startup Afrigen Biologics and Vaccines to crack the code on Moderna’s mRNA SARS-CoV-2 vaccine in order to produce a generic version. If successful, Afrigen would serve as a “technology transfer hub,” essentially teaching other companies how to make the vaccine. Moderna, which has said it will not enforce its intellectual property during the pandemic and used US taxpayer funding to develop its vaccine, is under increasing pressure to share its technology.

Reportedly, India has delayed on its plan to resume vaccine exports to fulfill commitments to the COVAX initiative, which stopped in April, one day after the WHO requested additional data to make a decision on an emergency use listing for India’s homegrown vaccine Covaxin. The Serum Institute of India (SII) is contracted to supply hundreds of millions of doses of a version of the AstraZeneca-Oxford vaccine to COVAX and had said those shipments would resume this month.

HEALTH SYSTEM RESILIENCE The COVID-19 pandemic has had a profound impact on health systems worldwide, greatly affecting access to and quality of healthcare services. To better prepare for future pandemics, improve health systems, and work toward health-related Sustainable Development Goals (SDGs), the WHO released a position paper on and 7 recommendations for building resilience and strengthening health security within health systems. The paper calls for the international community and individual nations to invest in health systems, strengthen public health preparedness, and ensure political and public engagement to place health as a central tenet of socioeconomic recovery, growth, and resilience. At an event to launch the paper, Dr. Mike Ryan, Executive Director of the WHO Health Emergencies Programme, called for health to be viewed as an investment, not a cost, and spoke of the importance of thoughtful design in building resilient health systems. The WHO also published a brief highlighting key messages for government officials, leaders outside and within the health sector, and communities.

SEX OF FETUS New research indicates that the sex of a fetus may influence a pregnant person’s immune response when infected with SARS-CoV-2. In 2 studies published in Science Translational Medicine, researchers examined the immune responses of pregnant and lactating individuals to SARS-CoV-2 infection and vaccination, showing they mount robust antibody responses to both but could benefit from booster doses. In an interesting finding, one of the studies found that male placentas switched on more pro-inflammatory immune activation genes than placentas supporting female fetuses. Reduced maternal SARS-CoV-2 specific antibody titers and impaired placental antibody transfer also were seen in pregnancies of male fetuses. Sex-specific changes in both placental innate and humoral immunity indicated male vulnerability to maternal SARS-CoV-2 infection. The new data may provide insight on the previously reported sex differences among COVID-19 patients, including that, in general, males become more severely ill, are 3 times more likely to require intensive care admission, and also have higher odds of death than female patients.