Contemporary Clinic Editorial Staff

The FDA has granted emergency use authorization (EUA) to a molecular polymerase chain reaction (PCR) assay test manufactured by Becton, Dickinson and Company (BD) and CerTest Biotec for detection of monkeypox (Mpox) virus. The VIASURE Monkeypox Virus Real Time PCR Reagents for BD MAX System may help to inhibit the global spread of the infectious virus.

"The Mpox outbreak continues to be designated as a global health emergency—the World Health Organization's highest level of alert," said Nikos Pavlidis, vice president of Molecular Diagnostics at BD, in a press release. "The large installed base of the BD MAX System in hospital labs provides broad access to testing for a wide range of infectious diseases, now including the mpox virus. EUA for the assay enables it to be used for timely diagnosis and may help avert further global spread of the disease."

 is a double-stranded DNA viral infection that was initially discovered when 2 outbreaks occurred in 1958 in a research laboratory with monkeys in Africa. Signs and symptoms of the virus typically present within 3 weeks of exposure with a painful, blister-like rash frequently occurring around the genitals; however, the rash may also develop around the face, chest, hands, or feet.

Other symptoms of Mpox include swollen lymph nodes, fever, fatigue, muscle ache, or respiratory symptoms that present as a cough or sore throat. The virus is self-limiting with a recovery period typically lasting 2 to 4 weeks; however, until the rash resolves and new skin forms, the virus can still spread. Individuals with an active infection should isolate, avoid intimate activity, avoid sharing personal household items, and sanitize hands and any objects or surfaces they come in contact with.

According to the CDC, there have been more than 80,000 Mpox cases reported worldwide. There have been more than 29,000 cases and 14 deaths reported in the United States. The number of Mpox cases is expected to rise, which requires ongoing testing, vaccinations, and medication services by health care providers, including pharmacists.

The fully integrated, automated BD MAX System allows nucleic acid extraction and real-time PCR to produce results for up to 24 samples across multiple syndromes in under 3 hours, according to BD. The system provides an extensive variety of tests for health care-associated infections, respiratory infections, sexually transmitted infections, gastrointestinal infections, and women's health, according to BD.

The VIASURE Monkeypox Virus PCR Detection assay for the BD MAX System is available in a lyophilized format. The assay is available in a tube that snaps into a test-specific position on the BD MAX ExK TNA extraction strip supplied by BD.

"We were able to quickly develop the VIASURE mpox molecular test by leveraging the BD MAX System's open system reagent suite," said Nelson Fernandes, managing director of CerTest Biotec, in a press release. "The EUA for the assay enables use for clinical diagnosis of the disease, in addition to surveillance and the research and development of vaccines and treatments."

BD, CerTest Biotec Announce Emergency Use Authorization for Mpox Diagnostic Test. BD. News release. 

https://news.bd.com/2023-01-09-BD,-CerTest-Biotec-Announce-Emergency-Use-Authorization-for-Mpox-Diagnostic-Test

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The number of Mpox cases is expected to rise, which requires ongoing testing, vaccinations, and medication services by health care providers.

FDA Grants Emergency Use Authorization to PCR Assay Test for Monkeypox Virus

The FDA has authorized expanded eligibility for the updated bivalent COVID-19 boosters for children between 6 months and 4 years of age, the agency announced today. Omicron variant-targeted booster shots made by Pfizer-BioNTech and Moderna were already available to individuals 5 years of age and older.

“More children now have the opportunity to update their protection against COVID-19 with a bivalent COVID-19 vaccine, and we encourage parents and caregivers of those eligible to consider doing so—especially as we head into the holidays and winter months where more time will be spent indoors,” FDA Commissioner Robert M. Califf, MD, said in a press release “As this virus has changed, and immunity from previous COVID-19 vaccination wanes, the more people who keep up to date on COVID-19 vaccinations, the more benefit there will be for individuals, families and public health by helping prevent severe illnesses, hospitalizations, and deaths.”

The FDA action authorizes children 6 months through 5 years of age who were administered the original monovalent Moderna COVID-19 vaccine to receive a single booster of the updated bivalent Moderna COVID-19 vaccine 2 months following completion of a primary series with the monovalent vaccine.

For children 6 months through 4 years of age who have yet to begin the 3-dose primary series of the Pfizer-BioNTech COVID-19 vaccine or who have not yet received the third dose of the primary series, the updated bivalent Pfizer-BioNTech COVID-19 vaccine can now be administered as the third dose in the primary series after 2 doses of the original monovalent vaccine.

Notably, children 6 months through 4 years of age who completed the 3-dose Pfizer-BioNTech COVID-19 primary vaccine series with the original monovalent vaccine are not eligible for the updated bivalent booster dose at this time.

“Children in this age group who already completed their primary series would still be expected to have protection against the most serious outcomes from the currently circulating omicron variant,” the FDA said in a press release. “The data to support giving an updated bivalent booster dose for these children are expected in January. The agency is committed to evaluating those data as quickly as possible.”

Both the Moderna and Pfizer-BioNTech bivalent COVID-19 vaccines include an mRNA component that corresponds to the original COVID-19 strain to induce a broadly protective immune response against COVID-19. The updated bivalent vaccines also contain an mRNA component that corresponds to the Omicron variant BA.4 and BA.5 lineages to confer superior protection against Omicron, according to the FDA.

In terms of adverse events (AEs), those administered the updated bivalent vaccines may experience similar AEs to individuals who were previously administered the original monovalent mRNA COVID-19 vaccines, according to the FDA.

“Vaccines remain the best defense against the most devastating consequences of disease caused by the currently circulating omicron variant, such as hospitalization and death. Based on available data, the updated, bivalent vaccines are expected to provide increased protection against COVID-19,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “Parents and caregivers can be assured that the FDA has taken a great deal of care in our review, and we encourage parents of children of any age who are eligible for primary vaccination or a bivalent COVID-19 vaccine booster dose to consider seeking vaccination now as it can potentially help protect them from COVID-19 during a time when cases are increasing.”

Coronavirus (COVID-19) Update: FDA Authorizes Updated (Bivalent) COVID-19 Vaccines for Children Down to 6 Months of Age. FDA. News release. December 8, 2022. 

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-updated-bivalent-covid-19-vaccines-children-down-6-months

Booster shots updated for the Omicron variant BA.4 and BA.5 lineages cleared for children 6 months through 4 years of age.

FDA Authorizes Bivalent COVID-19 Vaccine Booster for Children 6 Months to 4 Years of Age

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Tomika S Harris, DNP, CPNP-PC; Traci Gonzales, APRN, CPNP; and Cheryl L. Grave, RN, CPNP-PC are leaders of the Children and Youth with Special Health Care Needs Special Interest Group at the National Association of Pediatric Nurse Practitioners.