Considerations for developing a Zika virus vaccine

A safe and effective vaccine to protect against Zika virus infection is essential and should be feasible to develop, according to a new perspective from federal officials in The New England Journal of Medicine. The experts describe three potential strategies for conducting Zika vaccine clinical trials with each strategy dependent on disease incidence and likelihood of generating reliable data.

Related Information

Zika response updates from FDA
Zika virus information from NIAID, including vaccines in development
BARDA's medical countermeasure response to Zika, including information for product developers on submitting ideas

Image: A healthy volunteer receives the NIAID Zika virus investigational DNA vaccine as part of an early-stage trial to test the vaccine’s safety and immunogenicity. (Image: NIAID, August 2016)

Zika EUA updates

On September 28, 2016, FDA issued an EUA for emergency use of ARUP Laboratories’ Zika Virus Detection by RT-PCR test for the qualitative detection of RNA from Zika virus in human serum, EDTA plasma and urine. Test results are for the identification of Zika virus RNA. Additional technical information, including Instructions for Use and fact sheets

On October 7, 2016, in response to Focus Diagnostics, Inc.'s request to amend its Zika Virus RNA Qualitative Real-Time RT-PCR EUA, FDA reissued the April 28, 2016 EUA in its entirety with the requested amendments incorporated. The amendments include allowing use of a commercially sourced inactivated Zika virus as a positive control material in addition to the Zika virus strain FLR (live virus) and allowing the addition of urine (when collected alongside a patient-matched serum specimen) as an authorized specimen type. Additional technical information, including revised Instructions for Use and fact sheets

Emergency Use Authorization (EUA) banner

Guidance and information for industry

On November 9-10, 2016, FDA will hold a public hearing - Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products (Silver Spring, MD and webcast). The purpose of this public hearing is to obtain comments on FDA's regulation of firms' communications about medical products, with a particular focus on firms' communications about unapproved uses of their approved/cleared medical products. To attend or present at the public hearing, register by October 19, 2016. Comments will be accepted until January 9, 2017.
FDA is proposing to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies to require a complete quality system approach, referred to as a GLP Quality System, when safety and toxicity studies support or are intended to support applications or submissions for products regulated by FDA. As part of proposed changes to this rule, FDA seeks comment on the impact of expanding part 58 to include covered Animal Rule studies, and what other changes to the regulations, beyond amending the scope and definitions, are needed to address issues unique to covered Animal Rule studies. Comment by November 22, 2016. (initially announced in August 2016)

Events

October 13, 2016: Vaccines and Related Biological Products Advisory Committee(Silver Spring, MD and teleconference) - the committee will meet in open session to discuss and make recommendations on the selection of strains to be included in an influenza virus vaccine for the 2017 southern hemisphere influenza season
New! October 13, 2016: Maximizing MCM Shelf Life and Mitigating Public Health Concerns (webcast) - 1:30-2:30 p.m. ET - this informational webinar will help participants better understand the importance of shelf life and the impact of this dynamic on MCM preparedness planning capabilities, sponsored by CDC
New! November 7, 2016: The FDA Risk Communication Advisory Committee will hold a public meeting (Silver Spring, MD) to discuss and make recommendations on FDA's draft Strategic Plan for Risk Communication and Health Literacy
New! November 8, 2016: Public Workshop - CDC/FDA/NLM/ONC/CMS Workshop on Promoting Semantic Interoperability of Laboratory Data (Bethesda, MD and webcast) - to receive and discuss input from stakeholders regarding proposed approaches to facilitate the adoption and implementation of interoperability standards in a manner that enables consistent, accurate, and harmonized descriptions of in vitro diagnostic tests and results
November 17-18, 2016: FDA will hold a public advisory committee meeting of the Blood Products Advisory Committee in Silver Spring, MD - on November 18, 2016, the Committee will meet in open session to hear an informational session on Zika virus and blood safety in the United States

In case you missed it

After a disaster, it is important to inspect all drugs, and ensure food safety. Learn more about safe clean-up after Hurricane Matthew.
FDA received a U.S. Patent and Trademark Office Patents for Humanity award for developing an improved meningitis vaccine production process that has been used to immunize 235 million people in high-risk African countries. (September 29, 2016)
FDA has updated the Expedited Access Pathway Program website with two Data Development Plan examples that serve as a resource for sponsors. (September 28, 2016)
To promote consistent use of biomarker terms and concepts, FDA and NIH have developed the Biomarkers, EndpointS, and other Tools (BEST) Resource, which clarifies terminology and uses of biomarkers and endpoints as they pertain to the progression from basic biomedical research to medical product development to clinical care. Fact sheet (PDF, 252 KB) (September 28, 2016)