Experts say distributor reps should “remain nimble” as RSV, COVID could create uncertainty
Repertoire – September 2021
Anticipating the upcoming respiratory season is like expecting a baby: An ultrasound may give you some idea of what the little one will look like, but you never really know what you’re getting until delivery. “There is always significant uncertainty with the respiratory season, and now that COVID-19 is part of the mix, it only increases that uncertainty,” says David Morris, principal product manager, SEKISUI Diagnostics.
The incidence of non-COVID respiratory diseases, particularly influenza and respiratory syncytial virus (RSV), was greatly affected in the 2020-21 season due to infection control measures like social distancing, stay-at-home orders and mask usage, he says. “While these incidence rates were at historic lows in 2020-21, we are already seeing an increase in RSV incidence as infection control measures are being dropped. This is a good indicator that we should start to see similar increases in infections and testing of other non-COVID respiratory diseases.
“Our preparations for the 2021-22 respiratory season are more similar to what we traditionally did before the emergence of COVID-19,” he says. “The drop in childhood vaccinations [administered during the pandemic] appears to be correlated with reduction in doctor visits due to concerns related to the pandemic. Now that visits are trending back to normal, we expect respiratory-related testing and routine vaccinations to also trend back toward historic norms in the upcoming year.”
Pediatricians are concerned about the potential impact of missed childhood visits and vaccinations during the pandemic. “We are concerned that children are not up to date on a number of vaccines and may be at risk for transmission of vaccine-preventable diseases,” Bonnie Maldonado, MD, FAAP, chairperson of the American Academy of Pediatrics’ Committee on Infectious Diseases, and Professor, Departments of Pediatrics and Health Research and Policy at Stanford University School of Medicine, told Repertoire this spring. As of June, the U.S. was behind on childhood vaccinations by over 11 million doses since the first surge of the pandemic in March 2020.
Children who are behind schedule or overdue for their vaccinations will be at risk for developing respiratory-related illness, says Joseph Mann, BD’s global medical science liaison. “Furthermore, the more individuals who are unvaccinated and without immunity, the more transmissible the infection will be in the community. Therefore, vaccination not only protects the individual from infection, but also protects the community as a whole, since vaccinated individuals are unable to develop and transmit the infection to other people. This concept is commonly referred to as ‘herd immunity.’”
Not everyone will get vaccinated, but Mann believes the level of herd immunity will be sufficient to cancel the ill effects of the past year’s reduction in childhood vaccination rates. “With the exception of influenza, I don’t believe one year of lower vaccination rates in children will result in a significant increase in respiratory-related tests due to the concept of herd immunity. Again, the vast majority of the general public likely remains immune, which makes it difficult for these infections to spread. [But] if a trend of reduced childhood vaccination rates continues, we will undoubtedly see outbreaks happen, as we saw at Disneyland and other places recently with measles.”
RSV
Health officials are concerned about a potential spike in RSV this coming respiratory season. In June, the Centers for Disease Control and Prevention (CDC) issued a health advisory about increased interseasonal RSV activity across parts of the Southern United States. (Typically, in the United States, RSV infections occur primarily during the fall and winter cold and flu season – not the spring and summer months.)
RSV can be associated with severe disease in young children and older adults, and is the most common cause of bronchiolitis and pneumonia in children under one year of age in the United States.
Due to the reduced circulation of RSV during the winter months of 2020–2021, older infants and toddlers might now be at increased risk of severe RSV-associated illness, because they have likely not had typical levels of exposure to RSV during the height of the pandemic, according to the agency. In infants younger than six months, RSV infection may result in symptoms of irritability, poor feeding, lethargy and/or apnea with or without fever. In older infants and young children, rhinorrhea and decreased appetite may appear one to three days before cough, often followed by sneezing, fever and sometimes wheezing. Symptoms in adults are typically consistent with upper respiratory tract infections, including rhinorrhea, pharyngitis, cough, headache, fatigue, and fever. There is no specific treatment for RSV infection, nor is there a vaccine for it.
Due to the increased RSV activity, CDC is encouraging broader testing for RSV among patients presenting with acute respiratory illness who test negative for SARS-CoV-2.
Looking ahead to the 2021-2022 respiratory season, Sekisui’s David Morris advised Repertoire readers to remain nimble. “While we currently expect a trend toward normalcy, new breakthrough variants of COVID could rapidly change the current trend overnight.”
Meanwhile, BD’s Jeffrey Andrews offered advice applicable not only to Repertoire readers, but providers, patients and consumers: “Get vaccinated against COVID-19! Get vaccinated against flu in the fall! Don’t expose others when you are feeling ill!”
Sidebar:
Your growing respiratory toolbox
During public health emergencies (such as the SARS-CoV-2 pandemic), the Food and Drug Administration can issue emergency use authorizations (EUAs), which authorize unapproved medical products or unapproved uses of approved medical products for diagnosing, treating or preventing serious or life-threatening diseases or conditions. Companies whose diagnostic products received EUAs for respiratory-related tests include:
- BD: Received EUA in February and March 2021 for the BD® SARS-CoV-2/Flu assay, which is run on the BD MAX™ System; and the BD Veritor™ System for Rapid Detection of SARS CoV-2 & Flu A+B test.
- Cepheid: In September 2020, received EUA for Xpert® Xpress SARS-CoV-2/Flu/RSV for qualitative detection of the viruses causing COVID-19, Flu A, Flu B, and RSV infections from a single patient sample.
- Quidel: In October 2020: received EUA to market the Sofia® 2 Flu + SARS Antigen FIA, to be used with the Sofia® 2 Fluorescent Immunoassay Analyzer.
- Abbott: In March 2021, received EUA for the Alinity™ m Resp-4-Plex molecular assay to detect and differentiate SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus (RSV) in one test.
- Sekisui: In March 2020, Mesa Biotech received an EUA for the AcculaTM SARS-CoV-2 test, which is distributed by SEKISUI Diagnostics.
Sidebar 2:
Coming up: mRNA
Much-heralded messenger RNA (mRNA) vaccines for SARS CoV-2 from Pfizer-BioNTech and Moderna are probably just the first of a new family of vaccines for influenza, RSV, even cancer.
Instead of putting a weakened or inactivated germ into our bodies, like traditional vaccines, mRNA vaccines teach our cells how to make a protein – or even just a piece of a protein – that triggers an immune response inside our bodies, according to the Centers for Disease Control and Prevention.
mRNA vaccines have been studied before for flu, Zika, rabies, and cytomegalovirus (CMV). But as soon as information about SARS-CoV-2 became available, scientists began designing the mRNA instructions for cells to build the unique spike protein into an mRNA vaccine. Here’s some of what’s happening today.
In June 2021, Sanofi Pasteur, the vaccines global business unit of Sanofi, and Translate Bio, a clinical-stage mRNA therapeutics company, initiated a Phase 1 clinical trial evaluating an mRNA-based investigational vaccine against seasonal influenza. The trial will evaluate the safety and effectiveness of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. That same month, Sanofi announced it would invest €400 million annually in an mRNA Center of Excellence. Approximately 400 employees will work on the project in Cambridge, Massachusetts, and Marcy l’Etoile, Lyon (France).
In February 2021, GlaxoSmithKline plc and Vir Biotechnology Inc. signed an agreement giving GSK exclusive rights to collaborate with Vir on the development of monoclonal antibodies (mAbs) for the prevention or treatment of influenza. (Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful antigens such as viruses.) These include VIR-2482, an intramuscularly administered investigational mAb designed as a universal prophylactic for influenza A, which has completed a Phase 1 trial, as well as next generation antibodies for the prevention or treatment of influenza during a three-year research period.
In July 2021, Moderna Inc. announced the first participants were dosed in the Phase 1/2 study of mRNA-1010, the company’s quadrivalent seasonal influenza mRNA vaccine candidate. This study will evaluate the safety, reactogenicity and immunogenicity of mRNA-1010 in healthy adults 18 years and older in the U.S. The company said it also plans to explore potential combination vaccines against flu, SARS-CoV-2, respiratory syncytial virus and human metapneumovirus (hMPV).