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PANDEMIC PREDICTIONS Recent increases in COVID-19 cases in the UK could signal that the US is heading into a fall and winter COVID-19 surge. Historically, the US lags the UK in case trends by about one month, and the UK trend began rising the week of September 17. Some models predict US case trends will continue to decrease into October before beginning to rise, and while current predictions suggest a big increase in infections, the infection-detection rate likely will remain low due to declines in testing. Because the US population has some underlying immunity, and most experts agree the country has the pandemic under control, the death toll is expected to be rather modest.
But this modeling is based on the Omicron BA.5 subvariant, and the emergence of a new variant or subvariant could upend these predictions, particularly if there is a reduction in cross-variant immunity. BA.5 continues to account for the majority of new COVID-19 cases in the US (83.1%), but BA.4.6 (12%) and BF.7 (2.3%), an offspring of BA.5, are beginning to show growth advantage over BA.5. BF.7 has an additional genetic mutation in the spike protein compared with BA.5, which could reduce the efficacy of the monoclonal antibody treatment Evusheld, one of the few remaining therapies effective against BA.4 and BA.5. The mix of variants in the UK appears to be about the same as the US, although epidemiologists are watching to see whether emerging variants such as BQ.1.1 and BA.2.75 grow in proportion.
US President Joe Biden's declaration that the COVID-19 pandemic is "over" during a "60 Minutes" interview on September 18 raised eyebrows among many experts, most of whom agree that while some countries are in a better place than during the first year of the pandemic—exemplified by the fact that many in the US and elsewhere are returning to their pre-pandemic lifestyles—COVID-19 should remain an urgent priority. In the US, around 400 people die every day due to COVID-19, more than triple the average number who die from influenza.
The declaration by President Biden came shortly after WHO Director-General Dr. Tedros Adhanom Ghebreyesus stated that the end of the pandemic was "in sight." Both statements drew condemnation from WHO Senior Advisor Dr. Bruce Aylward, who called on high-income countries comfortable with the state of the pandemic within their borders to increase aid to low- and middle-income countries (LMICs) that are still struggling to get COVID-19 under control and gain access to vaccines, therapeutics, diagnostics, and other tools. Additionally, allowing the SARS-CoV-2 virus to maintain footholds in LMICs and elsewhere could lead to new variants with the ability to escape immunity. There remains much work to do, experts agree, as many health disparities between high-income nations and LMICs persist and will only get worse if aid is reduced or cut off. While some may feel COVID-19 is under control in places like the US, the pandemic is not over.
US CDC INFECTION CONTROL GUIDANCE The US CDC published changes to its guidance on infection prevention and control recommendations for healthcare personnel during the COVID-19 pandemic. One of the major alterations includes ending the overarching recommendation that everyone wear masks in nursing homes and hospitals. Previously, the guidance asked that everyone wear appropriate masks and respirators in these facilities, but the update only maintains that recommendation in communities experiencing high levels of transmission. The CDC said the change was made to reflect the high levels of immunity derived from vaccinations and prior infection, as well as the availability of effective treatments.
Nevertheless, elderly populations have been hit hard by the pandemic and remain among the most vulnerable. There are concerns that the new recommendation could make life even more difficult for elderly and immunocompromised people to safely navigate healthcare settings, potentially leading to fewer care options and increased stress and isolation among populations that already have suffered greatly. Additionally, many public health experts highlighted the importance of masking in the US as the nation heads into its fall and winter seasons and predictions of a new surge in COVID-19 cases. Appropriately worn masks and respirators serve as source controls that can prevent transmission during a season when many people are gathering indoors, but public appetite for new mask mandates is at an all-time low. The CDC’s guidance leaves the responsibility to take actions to protect vulnerable populations in individuals’ hands.
UPDATED BOOSTERS FOR YOUNGER CHILDREN Updated bivalent booster vaccine doses for younger children in the United States likely will be available before the end of this year. On September 23, Moderna announced in a tweet that the company is requesting emergency use authorization (EUA) from the US FDA for its vaccine booster bivalent vaccine that targets both the original strain of SARS-CoV-2 and the BA.4/5 subvariants of Omicron for adolescents aged 12 to 17 years and children aged 6 to 11 years. The company’s application for the youngest children, ages 6 months to under-6 years, is expected to be completed by year's end.
On September 26, Pfizer-BioNTech announced they have completed a submission to the FDA requesting EUA for the companies' Omicron-adapted bivalent booster for children aged 5 to 11 years. The companies also have begun a Phase 1/2/3 study to evaluate the safety, tolerability, and immunogenicity of different doses and dosing regimens of bivalent vaccine in children ages 6 months through 11 years of age. Additionally, they expect to file for marketing authorization of the bivalent booster for children aged 5-11 with the European Medicines Agency (EMA) in the coming days. Bivalent boosters from both Moderna and Pfizer-BioNTech are already authorized for adults and individuals aged 12 years and older, respectively, in the US. The FDA could make a decision on bivalent boosters for younger children before the next meeting of the US CDC's Advisory Committee on Immunization Practices (ACIP), scheduled for October 19-20.
GLOBAL VACCINE SUPPLY Last year, the US government committed to providing 1.1 billion doses of the Pfizer-BioNTech SARS-CoV-2 vaccine to low- and middle-income countries (LMICs). Last week, however, Pfizer and the US government agreed to lower the number of Pfizer-BioNTech SARS-CoV-2 vaccine doses going to LMICs this year, with Pfizer agreeing to reduce its delivery commitment from 1 billion doses to 600 million doses. Pfizer said while it can meet its previous 1 billion dose commitment, the revised commitment reflects reduced demand for vaccine doses in LMICs, barriers in administration, and vaccine hesitancy, and provides more time for the US and its partners to address delivery and administration challenges. The US will retain an option to purchase the additional 400 million doses for its international program after this year. Under the US contract, Pfizer previously delivered more than 400 million vaccine doses to 79 countries through the COVAX initiative.
During earlier stages of the COVID-19 pandemic, many experts criticized high-income countries for hoarding vaccines and other pandemic supplies, thereby perpetuating inequitable access to lifesaving supplies during the height of the pandemic. The COVAX program was designed to ensure equitable access to vaccines and has donated more than 1.7 billion COVID-19 vaccine doses to 146 countries. While the program ramped up, demand for SARS-CoV-2 vaccines outmatched the supply of approved products and vaccine manufacturers prioritized bilateral customers. Pfizer executives shared that the global effort to develop, manufacture, and distribute vaccines during the COVID-19 pandemic revealed important lessons around how to configure supply chains and design tighter logistics strategies for the future. While some countries are declaring an end to the COVID-19 pandemic, supply chain issues persist in many parts of the world, and only 24% of people in low-income countries have received at least one dose of vaccine. The shift in attention away from the pandemic was highlighted last week during the United Nations General Assembly (UNGA) meetings, where discussions about vaccine equity remained notably absent.
Despite slowing vaccine donation efforts, the US government and Pfizer remain committed to providing other critical supplies to LMICs. On the sidelines of the UNGA at the COVID Global Action Plan Ministerial Meeting, the US government announced plans to establish a clearinghouse of medical supplies to help other countries combat COVID-19, expand its program to distribute therapeutic drugs in 10 countries, expand access to medical oxygen, train healthcare workers in LMICs, and introduce early testing systems that can help healthcare workers identify COVID-19 patients who qualify for treatment. Additionally, Pfizer recently announced its intent to supply up to 6 million treatment courses of Paxlovid, its COVID-19 oral treatment, to the Global Fund as part of its COVID-19 Response Mechanism (C19RM). Depending on local regulatory approvals, 132 Global Fund-eligible LMICs will be able to procure Paxlovid beginning this year. These commitments are a crucial component of a global response to COVID-19, which exposed and continues to worsen concerning gaps in global pandemic preparedness and response systems.
CRYPTIC LINEAGES Nature examines the work of a team of scientists using wastewater surveillance to hunt for the next SARS-CoV-2 variant. In January 2022, the team identified a lineage that shared several mutations with the predominant Omicron variant of concern (VOC) but came from a different branch of the viral family tree. They then traced the cryptic lineage back to one Wisconsin business employing fewer than 30 people. None of the employees tested by nasal swab have shown signs of the lineage, leading the researchers to suspect an individual might be harboring the virus in their gut. While it does not appear the cryptic lineage is spreading, it has gained additional mutations since first being identified. Even if they do not identify the Wisconsin individual in which the virus is evolving, the researchers hope their sleuthing will inform future efforts to identify, track, and forecast emerging SARS-CoV-2, or other virus, variants.
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