“PANDEMIC IS OVER” In an interview with “60 Minutes” at the North American International Auto Show in Detroit, Michigan, US President Joe Biden said he believes that the COVID-19 “pandemic is over” while simultaneously acknowledging that the disease continues to be a “problem.” Notably, a White House team that reviewed the transcript of the interview, which aired September 18 but was taped last week, did not alert its COVID-19 response team about the declaration, leaving senior federal health officials surprised and without a coordinated response for the immediate reactions. President Biden had not originally planned to make headlines on COVID-19, nor had he discussed an end to the pandemic with his health advisors. The day after the interview aired, US HHS Secretary Xavier Becerra supported the president’s comments, saying that effective vaccines, tests, and treatments put the nation on a better path than earlier in the pandemic and noted the administration is reviewing whether it will renew the national declaration of a public health emergency.

But President Biden’s comments drew swift and sharp reactions from public health experts and appeared to further divide opinions over when and how the nation will move out of a pandemic state and into one of endemicity. Some experts supported the president’s comments, noting that while COVID-19 should continue to qualify as a top national priority, much of the nation is settling into a new way of life. Other experts fear that President Biden’s declaration further muddles the messaging surrounding the pandemic and comes at an inopportune time, when the US government is rolling out new bivalent vaccine boosters and asking the US Congress for additional emergency spending. Additionally, virologists are seeing signs of viral resurgence, underlining the enormous amount of uncertainty surrounding the future.

While there are no clear markers to the end of a pandemic, some experts point to 2 ways to determine when an outbreak emergency is over: by looking at what the disease is doing physically and psychologically to a population. To be sure, President Biden’s comments reflect a general national sentiment that people want to move on from the pandemic and that the situation differs significantly from 2 years ago. Schools are open; air travel has returned to pre-pandemic levels; workers are returning to offices at the highest rates since the start of the pandemic, although 1 in 3 say they fear infection by working in offices; and COVID-19 testing labs and at-home test manufacturers are downsizing, but primarily due to a lack of funding.

However, many, including White House Chief Medical Advisor Dr. Anthony Fauci, are worried the nation is not where it needs to be in order to “live with the virus.” The US continues to record more than 400 daily deaths, and the world counts more than 1,600 deaths each day. Notably, this means the US accounts for nearly 25% of the worldwide daily COVID-19 mortality, despite representing only 4% of the global population. A significant portion of the US population remains unvaccinated or under-vaccinated, and therefore at elevated risk of severe disease and death. Nationally, 68% of the population has received a primary vaccine series but only 35% of those over age 5 have gotten a first vaccine booster dose. The president’s remarks could further hinder efforts to increase vaccination and booster rates ahead of what many expect will be a surge in cases over the winter. Additionally, the pandemic has had crippling health, social, and economic impacts on essential workers and vulnerable populations, such as those who are immunocompromised, and on the estimated 18-23 million US residents who are suffering the long-term physical and mental health effects of long COVID.

President Biden’s remarks also likely will undercut his administration’s efforts to procure additional emergency spending for COVID-19. The White House has requested US$22.4 billion from the US Congress, but leading Republicans, who were already skeptical about authorizing additional funding, said the president’s comments essentially shut the door on negotiations as well as raise questions about other pandemic-related measures. Without additional funds for vaccine, treatment, and diagnostic supplies, or for research into next generation vaccines that could prevent SARS-CoV-2 transmission, the burden to pay for pandemic-related tools and stop chains of transmission will shift to the US public, and it remains to be seen whether federal and state policymakers will learn lessons from this pandemic in order to strengthen public health infrastructure to prepare for the next.

US VACCINATION CAMPAIGN The US Department of Health and Human Services last week released a video advertisement to encourage people to get updated SARS-CoV-2 vaccine booster shots. The ad specifically highlights those who are aged 50 and older, and shares the importance of getting the updated, bivalent vaccines, which are expected to provide additional protection against currently circulating SARS-CoV-2 Omicron subvariants. More than 200 million people are eligible for the new vaccines, however demand has dropped considerably with each new round of shots. More than half of people eligible for previous boosters never got them. Nevertheless, several pharmacies and hospitals in California, Hawaii, and Washington, DC, have reported running out of doses of the updated Moderna booster but expect additional supplies soon. 

Additionally, several reports have raised concerns over the potential for vaccine administration errors, particularly among children. While there is no evidence vaccine mix-ups have caused more severe adverse events, the complexity involved in keeping straight up to 11 different vaccine brands and formulations has led the US CDC to produce visual guides for vaccine administrators. The potential for errors further undercuts parents’ already low interest in vaccinating their young children. Only about 410,000 children aged 5 and younger have been fully vaccinated since the vaccines became available for this age group in June, according to CDC data. The number of COVID-19 deaths among children is low, but scientists remain concerned about possible long-term complications of COVID-19 among children. Many physicians, and parents, have cited failures among government and local public health agencies to adequately promote the vaccine, communicate about its availability, and debunk circulating myths. Some health officials are concerned that hesitancy to vaccinate children against COVID-19, as well as other diseases, could lead to future outbreaks of other childhood infections.

Public health experts had hoped that another vaccine option—the adjuvanted protein-based SARS-CoV-2 vaccine from Novavax that uses a more traditional platform—would help win over those who were hesitant to receive the newer mRNA-based vaccines. But since it was authorized in July, uptake remains low, with only 6,278 people fully vaccinated using the Novavax vaccine. Outside of the US, the Novavax vaccine has been approved in 38 other countries, including in Japan and Australia, which each recently approved the vaccine for use as a booster. 

EU EMERGENCY SUPPLY CHAIN POWERS The European Commission has shared a proposed rule that would make EU Member States prioritize the production of key goods and services to preserve supply chains in a crisis. The Single Market Emergency Instrument would create a crisis governance framework to prevent market fragmentation, drawing on lessons from the COVID-19 pandemic. Among the interventions available to the European Commission, breaking contracts to facilitate the production and stockpiling of critical products would be an option, as well as repurposing production lines and facilitating expansion to prevent bottlenecks like those experienced during the COVID-19 pandemic and the Russian invasion of Ukraine. The emergency powers of the proposal aim to reorganize supply chains as quickly as possible and support the increase and availability of crisis-relevant goods. The proposal includes fines up to 300,000 euros for companies that share incorrect or misleading information. The effort, which echoes similar efforts in the United States and Japan, will likely face pushback from businesses concerned with the expanded power the ruling is overreaching and intrusive. 

VACCINE PRODUCTION IN AFRICA Amid slowing global demand for SARS-CoV-2 vaccines, the world’s largest producers of vaccines for COVID-19—Pfizer-BioNTech and Moderna—continue to face pressure to allow low- and middle-income countries (LMICs) to produce their vaccines after much of the supply was purchased by high-income countries. Under a fill and finish agreement with Pfizer-BioNTech, the South Africa-based Biovac Institute, which is partly owned by the South African government, recently produced its first batch of the companies’ vaccine. The doses, the first of Pfizer-BioNTech’s shots to be produced in Africa, will undergo regulatory review and additional batches are expected to be commercially available next year. Aspen Pharmacare, which is authorized to fill and finish vials of the J&J-Janssen SARS-CoV-2 vaccine under its Aspenovax brand for distribution in Africa, earlier this year cautioned it might have to halt its vaccine production lines because it had not received a single order. At the end of August, Aspen announced it signed a deal with the Serum Institute of India to manufacture and sell 4 Aspen-branded vaccines for Africa, effectively keeping the production lines open. Moderna reportedly is seeking a partner on the continent to produce its SARS-CoV-2 vaccine. 

In related news, Moderna has allowed the use of its vaccine in clinical trials to test a shot developed by Afrigen Biologics & Vaccines, another South African biotechnology company working with the WHO as part of its mRNA Vaccine Technology Transfer Hub. Afrigen is working to develop mRNA-based SARS-CoV-2 vaccines to increase production and access for LMICs. Instead of supplying the vaccine directly, Moderna approved the Medicines Patent Pool to provide its vaccine to Afrigen for use in early-stage clinical trials; Pfizer-BioNTech refused a similar request because the companies did not see the need as urgent. Afrigen expects to begin human trials of its mRNA vaccine candidate by May 2023. Additionally, Moderna last week said it is open to supplying the Chinese government with its vaccine, although no final decision has yet to be reached. China has not authorized the use of any foreign-made SARS-CoV-2 vaccines, relying on several domestically produced shots. 

TREATMENT ACCESS & UPDATES Amid heightened demand from low- and middle-income countries (LMICs) for expanded access to COVID-19 therapeutics, little progress has been made at the World Trade Organization (WTO) toward reaching an agreement to include COVID-19 therapeutics and diagnostics in a limited deal reached earlier this year to temporarily waive patents on SARS-CoV-2 vaccines. High-income countries, including the UK, Switzerland, EU Member States, and the US, as well as pharmaceutical companies, appear opposed to extending the deal to treatments and tests by the end-year deadline. 

Separately, a program aimed at bringing oral COVID-19 antivirals to 10 LMICs in sub-Saharan Africa and Asia—Ghana, Kenya, Laos, Malawi, Nigeria, Rwanda, South Africa, Uganda, Zambia, and Zimbabwe—recently launched. With support from nonprofit organizations and other partners, the COVID Treatment Quick Start Consortium will provide Pfizer’s Paxlovid (nirmatrelvir-ritonavir) through pilot programs to evaluate the best ways to implement test-to-treat programs in areas with limited healthcare resources and infrastructure. 

In other treatment news, the European Medicines Agency (EMA) last week extended its authorization of AstraZeneca’s preventive COVID-19 therapy Evusheld (tixagevimab co-packaged with cilgavimab) as a treatment for the disease among adults and adolescents with COVID-19 who do not need supplemental oxygen but who are at increased risk of disease progression. Last month, Japan became the first country to approve the monoclonal antibody for COVID-19 treatment. Several nations already have authorized Evusheld as a preventive therapy among people with compromised immune systems who do not respond to vaccination in several nations, including the US. 

Additionally, the WHO last week strongly advised against the use of 2 different antibody therapies—sotrovimab as well as casirivimab-imdevimab—to treat patients with COVID-19 because they have limited clinical activity against currently circulating viral variants. The US FDA previously pulled or limited the use of the drugs, and some experts criticized the WHO for waiting to make the updated recommendation. The WHO expanded its conditional recommendation for the antiviral remdesivir to cover patients with severe COVID-19 and those with non-severe infections but who are at high risk of hospitalization. 

Only a handful of COVID-19 therapeutics remain useful against currently circulating SARS-CoV-2 strains. While researchers quickly developed 4 effective treatments for hospitalized COVID-19 patients in the year between January 2020 and February 2021, no new therapies for hospitalized patients have been authorized since February 2021, raising concerns about whether treatment advancements have stalled.