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.
UPCOMING WEBINAR ON PANDEMIC PREPAREDNESS FUNDING The COVID-19 pandemic has caused trillions of dollars in US economic losses and made clear that the country must bolster its public health emergency preparedness posture. In fact, the President’s FY23 budget request includes US$88.2 billion in mandatory funding for emerging biological catastrophes. Hosted by the Johns Hopkins Center for Health Security, this webinar will explore the outlook for this budget request and the options for future pandemic preparedness and health security funding. Please join us on Wednesday, May 25 at 12:00pm ET. Registration is available here.
MONKEYPOX OUTBREAKS UPDATE Read our latest update from May 23 on the monkeypox outbreaks. A new fact sheet also is available. We will continue to analyze the situation and provide updates, as needed. If you would like to receive these updates, please sign up here.
SARS-COV-2 VACCINE FOR YOUNG CHILDREN Three doses of the Pfizer-BioNTech SARS-CoV-2 mRNA vaccine were 80.3% effective at preventing infection among children 6 months to under 5 years of age when the Omicron variant was predominant, according to preliminary data. The companies cautioned that the data are based on only 10 cases diagnosed among the 1,678 study participants by the end of April, a number lower than the study’s 21-case threshold for analysis. The dose for the youngest children is at the 3 mcg level, one-tenth the adult dose, chosen for its tolerability and safety data. The companies plan to complete their submission for emergency use authorization (EUA) of the vaccine for children under age 5 this week. 

Hours after the companies released the preliminary data, the US FDA announced its Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on June 14 and June 15 to review EUA requests from both Moderna and Pfizer-BioNTech. On June 14, the committee will discuss Moderna’s request for EUA of its SARS-CoV-2 mRNA vaccine for older children and adolescents aged 6 to 17 years, and on June 15, the committee will review the companies’ data on the youngest children. Moderna is requesting EUA for its vaccine for children aged 6 months to 5 years and Pfizer-BioNTech for its vaccine for children aged 6 months to 4 years. The Pfizer-BioNTech vaccine is currently authorized for use among individuals aged 5 years and older and Moderna’s is available for adults aged 18 and older. 

Children under 5 are the last group for which the FDA has not yet authorized a SARS-CoV-2 vaccine, and the agency is under increasing pressure to do so. Some parents are eager to vaccinate their children, although many do not plan to vaccinate their children unless required to do so, according to polls. As of May 18, about 35% of US children ages 5 to 11 years had received at least 1 dose of vaccine and 28% had completed the 2-dose series. If the VRBPAC recommends either or both vaccines for young children, the FDA could quickly authorize the vaccines, making it possible toddlers and kindergartners could be eligible to begin receiving their shots by the summer. 

US CDC BOOSTER RECOMMENDATIONS Last week, the US CDC Advisory Committee on Immunization Practices (ACIP) expanded SARS-CoV-2 vaccine booster eligibility to include everyone aged 5 years and older. The CDC recommends that children ages 5 to 11 should receive a Pfizer-BioNTech booster, or third, shot 5 months after completing the 2-dose primary series with the same vaccine, the only one currently authorized for use among that age group. In its announcement, the CDC noted that more than 4.8 million children in this age group have been diagnosed with COVID-19, 15,000 have been hospitalized, and at least 180 have died of the disease. The agency said a third dose would help enhance immunity among this age group to help protect against severe disease. Notably, many ACIP members acknowledged that data suggest mRNA SARS-CoV-2 vaccines are really 3-dose primary series vaccines versus 2-dose primary series plus a booster dose. 

However, some parents have hesitated to get their children vaccinated, arguing that children have a lower risk of severe disease, despite record numbers of children being hospitalized during the height of the Omicron surge. Additionally, nearly 4,000 children have been diagnosed with multisystem inflammatory syndrome (MIS-C), a rare but potentially severe condition, since the start of the pandemic. Altogether, less than one-third of children in this age group have both doses of the vaccine, leaving them vulnerable to serious illness, according to CDC Director Dr. Rochelle Walensky. Dr. Walensky also announced the CDC strengthened its recommendation that people aged 50 and older and immunocompromised people aged 12 and older “should,” instead of “may,” get a second booster shot (fourth dose) to remain current on their vaccinations and help protect themselves from severe disease as the US experiences a sixth wave of COVID-19.

US MASK RECOMMENDATIONS/MANDATES As of May 19, at least 45% of the US population lived in areas experiencing medium-to-high COVID-19 community levels, meaning people should be wearing masks or considering masking based on their personal risk. COVID-19 community levels are calculated using new COVID-19 hospital admissions and percent of inpatient beds occupied by patients with COVID-19, both lagging indicators of COVID-19 transmission. But the agency’s data on community transmission shows more than 75% of the country is experiencing high or substantial numbers of new cases, suggesting much of the nation should be wearing masks in indoor public spaces and prompting some experts to recommend localities, businesses, and other entities reinstate mask mandates. The 7-day moving average of new daily cases is at 102,940 as of May 22, rising over 100,000 cases for the first time since February. 

While no states have reissued mask mandates, the CDC on May 13 reissued its recommendation that people ages 2 and older wear masks while on public transportation and in transit stations, after the federal mandate was struck down by a judge on April 18. Additionally, some school districts are reinstating mask mandates as the number of cases increase among students and staff. Mask mandates have returned to schools in Philadelphia, PA, Brookline, MA, and Providence, RI, in recent days. New York City and most school districts in the Washington, DC-region are not bringing back mask mandates despite having high levels of community transmission. Despite the nationwide increase in cases, many US residents feel the country has moved beyond the pandemic being a crisis, making the reinstatement of public health measures difficult for local and national leaders.  

TRAVEL GUIDANCE Ahead of the summer travel season, the US CDC has added new advice regarding testing to their domestic travel guidance page. The agency now recommends that all individuals get tested for COVID-19 3 days or less prior to domestic travel, regardless of vaccination status. Prior to this change, CDC only recommended testing prior to domestic travel for individuals who were not up-to-date on their SARS-CoV-2 vaccinations (ie, primary series and booster[s] if eligible). CDC also now recommends testing after travel if the traveler engaged in higher risk activities, such as being in a crowded space without a well-fitting mask. 

In addition to recommendations for domestic travel, CDC requires that individuals aged 2 years and older flying from international locales to the US show documentation of a negative COVID-19 test within 1 day of departure or proof of recovery from COVID-19 in the last 90 days. However, there is massive public pressure, particularly among travel industry businesses, for CDC to remove the international requirement due to the agency’s inability to fully articulate the rationale behind the rule. Attendees of a recent side event at the International Migration Review Forum (IMRF)—including representatives of the International Organization for Migration (IOM), Migration Policy Institute, governments, and non-governmental partners—called for the establishment of common appropriate standards for international travel to reduce confusion and impediment of cross-border mobility while supporting equitable pandemic recovery among nations.

PAXLOVID Following multiple anecdotal reports of symptoms and positive SARS-CoV-2 test results returning among some people who take a 5-day course of the COVID-19 treatment Paxlovid, the US NIH announced last week it in talks with manufacturer Pfizer to study a longer course of the antiviral. More than 660,000 courses of Paxlovid have been administered in the US, and it is unclear how often patients who take the drug experience so-called “Paxlovid rebound.” Experts from the Infectious Diseases Society of America (IDSA) briefed reporters on May 20 about the rebound effect and potential drug interactions, with information on the latter also contained in the organization’s recently updated guidance. While access to Paxlovid has increased in the US over the past several months, some physicians remain reluctant to prescribe the pills. Additionally, access to the treatment in low- and middle-income countries (LMICs) remains scarce due to limited production and affordable pricing. Experts hope that Pfizer’s licensing agreement with the Medicines Patent Pool (MPP) and supply agreement with UNICEF will improve access in LMICs later this year and into next.

ASTRAZENECA-OXFORD VACCINE The European Medicines Agency (EMA) has authorized the AstraZeneca-Oxford SARS-CoV-2 vaccine to be used as a booster (third) dose among adults who have completed the primary 2-dose course or the primary series of an approved mRNA vaccine, according to a company statement. The authorization is based on review by the EMA’s Committee for Medicinal Products for Human Use (CHMP). The AstraZeneca-Oxford vaccine, branded as Vaxzevria and Covishield, has received conditional marketing or emergency use authorization (EUA) in more than 125 countries, as well as emergency use listing (EUL) from the WHO, allowing it to be distributed through the COVAX initiative. The vaccine was AstraZeneca’s second bestseller last year, but sales are expected to fall in 2022 due to setbacks in production, rare but potentially serious adverse events, limited shelf life, global oversupply, and preferences for the mRNA vaccines made by Pfizer-BioNTech and Moderna. AstraZeneca never filed for EUA in the US, and the White House quietly canceled its contract with the company in December. The cancellation, though it saved the government some money, could hurt its global vaccine donation program, which was expected to give tens of millions of those doses to low-income countries.

WHO EUL FOR 11TH SARS-COV-2 VACCINE The WHO last week issued an emergency use listing (EUL) for CONVIDECIA, a SARS-CoV-2 vaccine made by China’s CanSino Biologics. In clinical trials, CONVIDECIA had 58% efficacy against symptomatic infection and 92% efficacy against severe COVID-19, and the single-dose vaccine can be used in adults aged 18 years and older, according to the WHO’s Strategic Advisory Group of Experts on Immunization (SAGE). The vaccine is the 11th SARS-CoV-2 vaccine to receive WHO EUL.