Home 5 Clinical Diagnostics Insider 5 The Diagnostics Pipeline: FDA Issues Groundbreaking Clearance for an RSV Vaccine

The Diagnostics Pipeline: FDA Issues Groundbreaking Clearance for an RSV Vaccine

by | May 31, 2023 | Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, FDA-dtet

In early May, GSK’s Arexvy became the first RSV vaccine to be cleared by the FDA for use in the US in adults aged 60 and up.

It was an eventful month for the FDA, with several groundbreaking approvals. Here is a look at two of the most impactful product clearances, both of which were announced in early May.

GSK Nabs First Clearance for RSV Vaccine

While most people were unaware of respiratory syncytial virus (RSV) prior to its role in the “tripledemic” during the most recent US cold and flu season, RSV is a common virus that can cause fatal pneumonia or bronchiolitis in infants, young children, the elderly, and people with weakened immune systems. The virus is highly contagious and spreads through coughs, sneezes, and other releases of respiratory secretions like mucus or saliva. Adding to the danger is that RSV can survive on surfaces for several hours, making it easy to pick up from contaminated objects.1

With reduced public health measures against COVID-19 infection, RSV cases have been on the rise. RSV hospitalizations for the 2022-2023 season were running around 51 per 100,000 people as of late April according to the US Centers for Disease Control and Prevention (CDC), compared with about 19 hospitalizations per 100,000 people by the same point in the 2021-2022 season.2

Unlike SARS-CoV-2, RSV is not a novel virus. Initial efforts to develop an RSV vaccine date back to the 1960s when two infants died during trials. The tragedy paused further vaccine development for several decades. The breakthrough came when researchers learned that RSV vaccines must target a specific protein on the surface of the virus before the virus can change its original shape.3

On May 3, nearly 60 years of research and development came to fruition when GSK’s Arexvy became the first RSV vaccine to be approved by the FDA for use in the US.4 In a late-stage clinical trial, the one-dose shot reduced the risk of symptomatic and severe illness by 82.6 and 94.1 percent, respectively. The trial showed that the protection against RSV provided by the shot lasted for about six months.5

GSK edged out Pfizer, Moderna, and Bavarian Nordic in the race to bring the first RSV vaccine to the multibillion-dollar US market. But there are still hurdles to clear. The FDA clearance is limited to use on adults ages 60 and over. In addition, the CDC must still recommend the vaccine before it can become available to the public. An agency advisory committee is scheduled to discuss how Arexvy should be used in meetings this June. Meanwhile, GSK is manufacturing doses of the vaccine.6

“The goal is to have shots available in the fall so that people can get them before the next RSV season coming up late fall and winter,” noted Phil Dormitzer, MD, PhD, senior vice president and global head of vaccines research and development for GSK, in a NBC News report.7

QuidelOrtho Gets First De Novo Clearance for SARS-CoV-2 Serology Tests

Although FDA emergency use authorization (EUA) for COVID-19 products did not immediately terminate with the end of the public health emergency (PHE) on May 12, products cleared via the EUA pathway are now on borrowed time. The agency has published guidelines to help test developers seeking to remain in the US COVID-19 market transition their products from EUA to full premarket approval.8

On May 9, the FDA announced that a pair of assays from QuidelOrtho— VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrator, and VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack and Calibrator—had become the first COVID-19 serology products to receive De Novo clearance. Both tests, which received EUA clearance at the start of the PHE in 2020, qualitatively detect IgG antibodies to SARS-CoV-2 in human serum and plasma samples collected at least 15 days after symptom onset.9

QuidelOrtho has staked out an early claim for leadership in the post-PHE COVID-19 diagnostics market. This latest serology clearance comes nearly two months from the date that the company’s Sofia® 2 SARS Antigen+ FIA test nabbed the first De Novo authorization for a COVID-19 antigen test.10


    1. https://www.cdc.gov/rsv/index.html#:~:text=Respiratory%20Syncytial%20Virus%20(RSV)%20Infection,for%20infants%20and%20older%20adults

    1. https://www.cdc.gov/rsv/research/rsv-net/dashboard.html

    1. https://www.nature.com/articles/d41586-023-01529-5

    1. https://www.fda.gov/news-events/press-announcements/fda-approves-first-respiratory-syncytial-virus-rsv-vaccine

    1. https://www.nejm.org/doi/full/10.1056/NEJMoa2209604

    1. https://www.gsk.com/en-gb/media/press-releases/us-fda-approves-gsk-s-arexvy-the-world-s-first-respiratory-syncytial-virus-rsv-vaccine-for-older-adults/

    1. https://www.nbcnews.com/health/health-news/fda-approves-rsv-vaccine-rcna82461

    1. https://www.fda.gov/media/155039/download?utm_source=substack&utm_medium=email

    1. https://www.fda.gov/news-events/press-announcements/fda-roundup-may-09-2023

    1. https://www.businesswire.com/news/home/20230308005731/en/QuidelOrtho-Receives-De-Novo-FDA-Authorization-for-Sofia%C2%AE-2-SARS-Antigen-FIA

Here are the other key new laboratory testing and diagnostics product clearances that were announced from mid-April through mid-May 2023:

New FDA Approvals & Emergency Use Authorizations (EUAs)

Manufacturer(s) Product
QuidelOrtho From EUA to De Novo clearance for VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrator
QuidelOrtho From EUA to De Novo clearance for VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack and Calibrator
Nucleix 510(k) clearance for Bladder EpiCheck® cancer recurrence test
Access Medical Laboratories EUA for Global Direct RT-PCR Test for SARS-CoV-2
Drexel University College of Medicine EUA for SARS-CoV-2 DUCoM-PDL Modified Tetracore Assay
Foundation Medicine Clearance for FoundationOne®Liquid CDx assay as companion diagnostic for Takeda’s Exkivity (mobocertinib) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
Kurin 510(k) clearance for Kurin® blood culture collection set with Kurin Lock technology
Tempus Premarket clearance for xT CDx 648-gene next-generation sequencing test for solid tumor profiling in cancer patients with solid malignant neoplasms
University of Massachusetts, Amherst EUA for ICTC SARS-CoV-2 RT-PCR Assay
Promis Diagnostics Breakthrough device designation for EarlyTect ® BCD test for bladder cancer via qualitative detection of PENK methylation
YourBio Health 510(k) clearance for Touch Activated Phlebotomy (TAP) ® Micro Select remote bladeless blood collection device for microcapillary blood diagnostic testing
Mawi DNA Technologies 510(k) clearance for iSWAB-Respiratory Tract Sample Collection Media-Extraction Less™ (iSWAB-RC-EL) for collection, transport, and storage of upper respiratory tract and saliva samples at ambient temperature
MedArbor Diagnostics EUA for MedArbor Diagnostics SARS-CoV-2 Assay
Princeton BioMeditech Corp EUA for Status COVID-19 Antigen Rapid Test for Home Use
Selux Diagnostics 510(k) clearance for Selux Gram-Negative Panel run on firm’s Next Generation Phenotyping System for rapid antimicrobial susceptibility (AST)
Meridian Bioscience 510(k) clearance for Curian Shiga Toxin immunoassay
Azure Biotech, Inc. EUA for Azure Fastep COVID-19 Antigen Pen Home Test, rapid test for over-the-counter use

New CE Marks & Global Certifications

Notable European CE certifications announced during the period:

New Approvals in Europe

Manufacturer(s) Product(s)
Norlase ECHO Green Pattern Laser photocoagulator

Other international clearances announced during the period:

Manufacturer(s) Country(ies) Product(s)
bioLytical Laboratories Canada INSTI® multiplex HIV-1/2 Syphilis Antibody Test

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