US, EU & WHO Launch Efforts to Accelerate Zika R&D

Posted 08 February 2016 By Michael Mezher


One week after the World Health Organization (WHO) declared a public health emergency in response to Zika-linked clusters of microcephaly, it and authorities in the US and EU are mobilizing to accelerate the development of treatments and diagnostics for the disease.

Obama Calls for $1.8 Billion in Funding

On Monday, the White House announced it will ask Congress for more than $1.8 billion to establish an emergency fund to combat the Zika virus in the US and abroad.

Nearly $1.5 billion would be allocated to the Department of Health and Human Services (HHS), while the remaining funds would be allocated to the U.S. Agency for International Development (USAID) and the State Department.

The lion's share of the funding to HHS would be given to the Centers for Disease Control and Prevention (CDC) to bolster defensive efforts against mosquitoes, conduct research into the link between Zika and microcephaly, improve surveillance and develop diagnostics for the disease.

As part of the package, the president is requesting $250 million to go to Puerto Rico's Medicaid Federal Medical Assistance Program (FMAP) to increase health services for pregnant women and children with microcephaly in the territory. On Friday, Puerto Rico declared Zika a public health emergency, and the CDC reports the territory is experiencing active transmission of the virus.

The fund would also include $200 million to support the development and use of vaccines and diagnostics and would make resources available to FDA to "support Zika virus medical product development including next generation diagnostic devices."

A Priority Review Voucher for Zika?

On 1 February 2016, Rep. G.K. Butterfield (D-NC) and Rep. Susan Brooks (R-IN) submitted a bill to add the Zika virus to the list of tropical diseases eligible for a priority review voucher from FDA to further incentivize development of products to treat the disease.

"Work is already underway to create a vaccine, but without a Priority Review Voucher in place, a vaccine may not be available for years," Brooks said.

If added, any company that gets product approved to treat Zika would be granted a priority review voucher, which guarantees a six-month priority review for a future product. These vouchers have proven to be highly valuable. In August 2015, United Therapeutics sold one to AbbVie for a record-setting $350 million.

Last Wednesday, Senators Lamar Alexander (R-TN) and Richard Burr (R-NC) sent a letter to HHS pressing the agency on whether it planned to add Zika to the list of tropical diseases eligible for a priority review voucher. Under the Food and Drug Administration Amendments Act both Congress and FDA have the ability to add diseases to the program.

EMA Task Force

On Monday, EMA announced the launch of a new task force intended to advise sponsors on scientific and regulatory issues for products in development to treat or prevent Zika.

"There are currently no vaccines or medicines to protect from or treat Zika virus infection that are approved or undergoing clinical studies," EMA notes in a press release.

The agency says the task force will include vaccine and infectious disease experts who can provide guidance to sponsors on clinical trial design, manufacturing issues, and postmarket surveillance.

EMA is also encouraging sponsors to contact the agency if they are working on any "promising projects" related to Zika. Additionally, the agency says it will "proactively reach out to companies already planning to work on investigational vaccines."

These efforts, the agency says, have the potential to "significantly speed up the development of medicines."

EMA says it can also leverage its experts to assist in product reviews under the Article 58 procedure, which allows the agency to review products "intended exclusively for markets outside the European Union."

European Commission Funding

Just days before WHO made its declaration, Carlos Moedas, EU commissioner for research, science and innovation, announced the commission would devote €10 million to finance the development of vaccines to treat Zika.

"As Commissioner responsible for Research, Science and Innovation, I believe I must use all the means at my disposal within the Horizon 2020 programme to contribute to the international efforts underway to tackle the spreading Zika virus," Moedas said in a blog post.

The funding will come out of the €50 million earmarked for vaccine development in 2016-17 under the Horizon 2020, an €80 billion program to promote research and innovation across a number of sectors in the EU.

WHO Emergency Assessment: Diagnostics and Vaccines

On Friday, WHO issued a call urging companies to submit products, especially diagnostics, to the agency's emergency use assessment and listing (EUAL) procedure.

"Diagnostics are a top urgency in order to ascertain the presence of the Zika virus as opposed to other similar diseases … very few tests are available," the agency said in a press release Monday.

Under the procedure, WHO reviews products to determine "acceptable levels of quality and performance and allows UN agencies, NGOs and countries to procure the product with confidence."

The EUAL procedure was first established to expedite the review of vaccines, drugs and diagnostics during WHO's response to the 2014 Ebola outbreak in West Africa.

According to WHO, at least 12 groups are in the early stages of development for Zika virus vaccines, and others are investigating the use of prophylactic drugs to prevent the disease.

The agency also says efforts to control mosquito populations including fogging and the release of genetically modified mosquitoes "may be worth considering."



European Commission


White House

Share this article:

Categories: In vitro diagnostics, Research and development, Regulatory strategy, Submission and registration, News, US, Europe, Latin America and Caribbean, FDA, EMA, EC, WHO

Tags: Zika virus, Emergency Use Assessment and Listing, EUAL, Priority Review Voucher, PRV

Regulatory Exchange: Latest Updates From the Community