The Procleix Zika Virus Assay is a qualitative nucleic acid test for the detection of Zika virus RNA in individual plasma specimens obtained from volunteer donors of whole blood and blood components for transfusion. Is an immediate family member or household member of study personnel. The FDA has a critical role in facilitating the development, and availability of investigational products for use against emerging infectious diseases, such as the Zika virus. Has received or is scheduled to receive a live virus vaccine administered within the period from 28 days before, or through 28 days after, any dose of study vaccine. Several investigational vaccines are under development, including early human clinical trials. Negative urine pregnancy test at the Screening visit and at the day of each vaccination for females of childbearing potential. 2016;353(6304):1129-32. Therefore, researchers developed a macaque model of congenital Zika syndrome to provide another way to evaluate the experimental vaccine. Adverse reactions are extremely rare with all of the vaccines. Oxitec is responsible for ensuring all other local, state, and federal requirements are met before conducting the proposed field trial, and, together with its local partner, the Florida Keys Mosquito Control District, to determine whether and when to begin the proposed field trial in Key Haven, Florida. The Commonwealth of Puerto Rico was the first U.S. territory to experience active mosquito-borne Zika transmission.of an investigational test to screen blood donations for Zika virus. Also see Emergency Use Authorization below, April 18, 2019: EUA amendment - In response to Siemens Healthcare Diagnostic Inc.’s request, FDA concurred (PDF, 137 KB) with the request to modify the ADVIA Centaur Zika test to include surfactant in the ADVIA Centaur Zika IgM assay reagent buffers and the related updates of the Instructions for Use (PDF, 2.8 MB). Prior to 2015, Zika virus outbreaks had occurred in areas of Africa, Southeast Asia, and the Pacific Islands. Is in good general health, as determined by medical history, clinical laboratory assessments, vital sign measurements, and physical examination at screening. The only consideration when choosing among the vaccines would be if you are allergic to any of the ingredients: Moderna vaccine ingredients: messenger ribonucleic acid (mRNA),lipids (SM-102,polyethylene glycol . Pregnant women who received the pertussis (Tdap) vaccine in the third trimester compared with postpartum vaccination reduced infant pertussis by 85%. For updates by date before 2019, please visit our archive. 2017;169(1 . Alternatively, blood establishments may use an FDA-approved pathogen-reduction device for plasma and certain platelet products. No cases of early fetal loss occurred in the vaccinated group, which also had no evidence of damage to either the placenta or the fetal brain. More: Prevention, from CDC, November 25, 2019: Publication - FDA Zika virus reference panel for molecular-based diagnostic devices supports product testing for Emergency Use Authorization and 510(k) submissions - read the full publication in The Journal of Molecular Diagnostics. An EUA is an important mechanism that allows broader access to available medical products under specific circumstances. The data collected from this testing, and from additional studies performed by the manufacturer, demonstrated that the cobas Zika test is an effective test to screen blood donors for Zika virus infection. Once screening of blood donations for Zika virus using the investigational test begins, blood establishments in Puerto Rico may resume collecting donations of Whole Blood and blood components. Found insideTo do this, Stuck provides a clear-eyed examination of the social vectors that transmit vaccine rumors, their manifestations around the globe, and how these individual threads are all connected. FDA considers countries and territories outside the U.S. states categorized as “Red” (current outbreak) or “Purple” (any prior or current reports of mosquito-borne Zika transmission) as areas with increased risk of ZIKV transmission. The cobas Zika test is intended for use on the fully automated cobas 6800 and cobas 8800 systems. Reviewing the use of innovative strategies to help suppress the population of virus-carrying mosquitoes is one of many activities in which FDA is engaged to help mitigate the threat of vector-borne epidemics, such as Zika. The FDA also released a preliminary finding of no significant impact (FONSI) (PDF, 148 KB) that agrees with the draft EA’s conclusion that the field trial of such GE mosquitoes will not result in significant impacts on the environment. The interim Phase I data from the Zika vaccine candidate, mRNA-1893, showed all four cohorts of the study had been dosed, 10 µg, 30 µg, 100 µg, and 250 µg. mRNA vaccines do not contain any virus particles. The agency is also encouraging development of diagnostic tests that may be useful for identifying the presence of the virus, and is taking steps to help ensure the safety of our nation’s blood supply. Has a bleeding disorder that would contraindicate IM injections or phlebotomy. Draft EUA review templates for Zika are available to product sponsors/manufacturers by email request to: CII-ArboViroPlex rRT-PCR (Columbia University), Gene-RADAR Zika Virus Test (Nanobiosym Diagnostics, Inc.), RealStar Zika Virus RT-PCR Kit U.S. (altona Diagnostics GmbH), Sentosa SA ZIKV RT-PCR Test (Vela Diagnostics USA, Inc.), TaqPath Zika Virus Kit (Thermo Fisher Scientific), VERSANT Zika RNA 1.0 Assay (kPCR) Kit (Siemens Healthcare Diagnostics Inc.), Zika Virus Detection by RT-PCR (ARUP Laboratories), Zika Virus Real-time RT-PCR Test (Viracor Eurofins), Zika Virus RNA Qualitative Real-Time RT-PCR (Quest Diagnostics Infectious Disease, Inc.), Zika ELITe MGB Kit U.S. (ELITechGroup Inc. Molecular Diagnostics), Unfortunately, during outbreak situations, fraudulent products claiming to prevent, treat or cure a disease almost always appear. Zika virus outbreaks have been explosive and unpredictable and have led to significant adverse health effects—as well as considerable public anxiety. Research has shown that the mRNA vaccines are safe and effective in pregnant people. Pardi, N. et al. Although most infections are asymptomatic or present with benign, self-limited symptoms, a small percentage of patients have complications, such as congenital anomalies in the developing fetus of pregnant women infected with the virus and neurological complications (eg, Guillain-Barré syndrome). FDA will work interactively with developers to support such requests. View information on the safety and effectiveness of FDA-approved medicines and devices for birth control (en Español Guía de Métodos Anticonceptivos (PDF, 433 KB)). The vaccine platform was initially developed in the early 1990s, in an effort to create safe and effective vaccines in a pandemic situation. This guidance updates information in the March 2016 guidance by: This update supports the continuation of recommendations to screen living donors of HCT/Ps for risks of infection with ZIKV based on geographic areas with risk. Before October 5, 2017, several blood collection establishments used the cobas Zika test under IND in order to follow the recommendations in the FDA’s 2016 guidance document. Información de NIH en español. Modified mRNA Vaccines Protect against Zika Virus Infection. Sign up to receive email alerts on emergency preparedness and response topics from FDA, including medical countermeasures and emerging infectious diseases. Publication in Cell Demonstrates Doderna's Zika mRA Vaccine Prevents In Utero Transmission of Zika Virus in Mice, Protects Against Zika-Related Congenital Damage --First Study to Show Protection from Zika Virus during Pregnancy-- Cambridge, Mass., July 13, 2017—Moderna Therapeutics, a clinical stage biotechnology company that is pioneering messenger RNA (mRNA) therapeutics and vaccines to . For a list of FDA-authorized diagnostic tests for detecting Zika virus antibodies, see Diagnostics above.   Two experimental vaccines can restrict Zika virus transmission from pregnant mice to their fetuses and can prevent Zika virus-induced placental damage and fetal demise, according to new findings . In July 2017, FDA also made available a panel of human plasma samples to aid in the regulatory evaluation of serological tests to detect recent Zika virus infection. See Zika Virus Diagnostic Development for information on FDA support for Zika virus diagnostic development and Emergency Use Authorization for information about Zika virus diagnostics available under EUA. Matters considered at the meeting will include testing of the blood supply for Zika virus. Two years after the World Health Organization declared the Zika virus outbreak a Public Health Emergency of International Concern, researchers have made good progress in developing vaccines against the disease, with some candidates now in phase II trials. It is designed to help cells to secrete virus-like particles, helping to mimic the response of the cell after natural infection. Although efficacy with multiple viral vaccine platforms has been established in animals, no study has addressed protection during pregnancy. Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Frequency and grade of each solicited local and systemic reactogenicity adverse event (AE) [ Time Frame: 7-day follow-up period after each vaccination ], Frequency and grade of any unsolicited AEs [ Time Frame: 28-day follow-up period after each vaccination ], Frequency of any medically attended adverse event (MAAE), serious adverse event (SAE), and adverse event of special interest (AESI) [ Time Frame: Day 1 to the end of study (EOS) Visit at Month 13 ], Geometric mean titer (GMT) of serum neutralizing antibodies (nAb) against zika virus (ZIKV) as measured by Plaque Reduction Neutralization Test (PRNT) [ Time Frame: Day 1, Day 29, Day 57, Month 7, and Month 13 ], GMT of nAb in initially seronegative participants against ZIKV as measured by PRNT [ Time Frame: Day 1, Day 29, Day 57, Month 7, and Month 13 ], GMT of nAb in initially seropositive participants against ZIKV as measured by PRNT [ Time Frame: Day 1, Day 29, Day 57, Month 7, and Month 13 ], Percentage of participants who seroconverted [ Time Frame: Day 1 (baseline) to Day 29, from Day 1 to Day 57, from Day 1 to Month 7, and from Day 1 to Month 13 ], Proportion of initially seronegative participants with a seroresponse as measured by PRNT [ Time Frame: Day 29, Day 57, Month 7, and Month 13 ], Proportion of initially seropositive participants with a 2-fold or 4-fold increase in nAb titers as compared with baseline as measured by PRNT [ Time Frame: Day 29, Day 57, Month 7, and Month 13 ], Agrees to comply with the study procedures and provides written informed consent. The screening test may be used under an investigational new drug application (IND) for screening donated blood in areas with active mosquito-borne transmission of Zika virus. The current study is the first animal model study to demonstrate the protection conferred by experimental Zika virus vaccines when administered to female mice before they become pregnant and infected with Zika virus. Previously, on March 30, 2016, FDA announced the availability of an investigational test to screen blood donations for Zika virus. The work could help support development and approval of the experimental Zika DNA vaccine VRC5283, which is currently in early stage trials in humans. Zika virus protection by a single low-dose nucleoside-modified mRNA vaccination. Reports a previous diagnosis of hematologic malignancy or pre-malignancy or a diagnosis of any other malignancy within the previous 10 years (excluding nonmelanoma skin cancer). Preclinical data published in The Journal of Infectious Diseases have shown that vaccination with mRNA-1893 protected against transmission of Zika virus during pregnancy in mice. What is the vaccination schedule? FDA’s Center for Veterinary Medicine reviewed information in an Investigational New Animal Drug (INAD) file from Oxitec, Ltd., regarding the company’s genetically engineered line of the mosquito Aedes aegypti (OX513A), with the intent of suppressing the population of that mosquito at the release site(s). Vaccines for other flaviviruses have been developed and used for over 70 years Active development programs for Dengue and West Nile vaccines have been ongoing for over 30 years; however, knowledge of Zika virus was limited at the outset of the epidemic Past experience was leveraged for ZIKV vaccine development Found inside – Page 379Candidate vaccines have included live attenuated strains, purified inactivated virus, mRNA vaccines, synthetic DNA vaccines, adenovirus vector-based subunit ... While Miami-Dade County is the only part of Florida currently (July 29, 2016 to present) designated by CDC as an area of active ZIKV transmission for the purposes of blood and tissue safety intervention, people in this part of Florida regularly travel within and between these three counties and may not recognize that they have been in an area of active ZIKV transmission. On July 5, 2018, FDA approved the Procleix Zika Virus Assay, manufactured by Grifols Diagnostics Solutions, Inc. More: Oxitec Mosquito. It is estimated that four out of five people with Zika virus infections have no symptoms at all. (Federal Register notice). Also see the FDA’s communication to tissue establishments: Important Information for Human Cell, Tissue and Cellular and Tissue-based Product (HCT/P) Establishments Regarding Zika Virus and the FDA’s communication to blood establishments: Important Information for Blood Establishments Regarding Zika Virus. Numerous posts have falsely claimed that mRNA vaccines used against COVID-19 target a protein called syncytin-1, which is needed for placental formation and successful pregnancies. Areas covered: Both traditional (purified inactivated, live attenuated, viral-vectored, recombinant sub-unit) and novel (DNA, self-replicating RNA, mRNA) vaccine platforms are being utilized. This may prove challenging for Zika virus since its symptoms are often mild or nonspecific. Nevertheless, unique challenges in clinical development and regulatory pathways may hinder the licensure of high-quality, safe, and effective ZIKV vaccines. Their study compared outcomes in 12 unvaccinated pregnant macaques and 13 macaques vaccinated before pregnancy. July 3, 2019: In a letter to FDA dated June 18, 2019, Luminex Corporation requested that the EUA for the xMAP MultiFLEX Zika RNA Assay issued on August 4, 2016, and amended on January 7, 2017, and May 19, 2017, be withdrawn. Has received a vaccine for dengue, Japanese encephalitis, tick-borne encephalitis, West Nile, Yellow Fever, or Zika. 301-796-1500, Diagnostic Product Sponsors/Manufacturers - EUA Templates Diagnostics: FDA-authorized diagnostic tests for detecting Zika virus antibodies: FDA encourages commercial diagnostic developers and researchers developing laboratory developed tests for Zika virus to submit an EUA request or consider pursuing a premarket submission. The finding that Zika virus infection can cause microcephaly and other severe fetal brain defects means that a woman who is infected with Zika during pregnancy has an increased risk of having a baby with these health problems. CAMBRIDGE, MA, USA I July 13, 2017 I Moderna Therapeutics, a clinical stage biotechnology company that is pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced new data demonstrating that its Zika mRNA vaccine prevented Zika virus . Note about the LightMix Zika rRT-PCR Test (Roche Molecular Systems Inc.): In response to Roche Molecular Systems Inc.’s request dated March 10, 2017 to withdraw the LightMix Zika rRT-PCR Test due to technical performance and business considerations, on March 13, 2017 FDA revoked the EUA for emergency use of the LightMix Zika rRT-PCR Test. Nucleic acid testing-based assays (molecular tests) - detect genetic material in samples of bodily fluids, such as serum and urine, to diagnose active Zika infection, Serological assays - detect antibodies against Zika virus in the blood, to assess whether individuals who may have recently been exposed to Zika have actually been infected. Previously, on March 1, 2016, as an additional safety measure against the emerging Zika virus outbreak, FDA issued this guidance as a part of ongoing efforts to protect HCT/Ps and blood products from Zika virus transmission. In the largest study of its kind, researchers found mRNA COVID-19 vaccines are highly effective at protecting pregnant and breastfeeding people against COVID-19. Male participants must agree to practice adequate contraception from the time of the first vaccination and through 3 months following the last vaccination. To date, at least 57,786 pregnant women in the United States have been infected, and 71 pregnant women have died. aegypti is known to transmit the debilitating human virus-caused diseases Zika, dengue, yellow fever, and chikungunya. Has received chronic administration (defined as > 14 total days) of immunosuppressants or other immune-modifying drugs within 6 months before the first study vaccine dose. Previously, the test had been authorized only for emergency use under FDA’s EUA authority. We tested in mice two vaccine platforms, a lipid nanoparticle-encapsulated modified mRNA vaccine encoding ZIKV prM and E genes and a live-attenuated ZIKV strain encoding an NS1 protein without . Zika virus protection by a single low-dose nucleoside-modified mRNA vaccination. Researchers gave 20 non-pregnant female mice two injections of the mRNA vaccine candidate 28 days apart and gave a separate group . mRNA vaccines have been developed for other diseases like rabies, Ebola, and Zika, and a large-scale influenza trial was carried out in humans from 1993 to 1996. It is notable that as of April 26, 2021, more than 100,000 pregnant women reported having received a Covid-19 vaccination and yet only a small fraction (4.7%) have enrolled in the v-safe pregnancy . Has a body mass index that is ≤ 18 or ≥ 35 kg/m2. Is acutely ill or febrile on the day of screening (Day 0) or randomization (Day 1). Has a positive test result at the Screening Visit for hepatitis B surface antigen, hepatitis C virus antibody, or HIV type 1 or 2 antibodies. Repellent used on older children should contain no more than 10 percent DEET. Before sharing sensitive information, make sure you're on a federal government site. Luminex has decided to discontinue manufacture of the product and there is no remaining viable inventory of the xMAP MultiFLEX Zika RNA Assay. Preclinical data published in The Journal of Infectious Diseases have shown that vaccination with mRNA-1893 protected against transmission of Zika virus during pregnancy in mice. (Federal Register notice), FDA has posted new tables detailing performance characteristics of Zika virus diagnostic tests (assays) currently available for use under EUA. Revised guidance - On July 6, 2018, FDA announced the availability of a revised final guidance: Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components (PDF, 222 KB). A vial of the NIAID Zika virus investigational DNA vaccine, taken at the NIAID Vaccine Research Center’s Pilot Plant in Frederick, Maryland. mRNA vaccines work like an instruction manual. Zika virus can be transmitted from a pregnant mother to her fetus. 2016;354(6309):237-40. 1-888-INFO-FDA / (1-888-463-6332), Report a Fraudulent Zika ProductReport form and instructions, Press General Info/Consumers The work could help support development and approval of the experimental Zika DNA vaccine VRC5283, which is currently in early stage trials in humans. An EUA is an important mechanism that allows broader access to available medical products under specific circumstances. The side effects pregnant people have reported from getting the mRNA COVID vaccines, as documented in the NEJM research above, are pretty comparable to those non-pregnant people are experiencing . An experimental vaccine against the Zika virus reduced the amount of virus in pregnant rhesus macaques and improved fetal outcomes. On February 28, 2019, FDA published a web page: While many people with Zika virus infection experience no symptoms, the virus can pose potentially serious risks to the public health. 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