Stay ahead of developments in federal and state health care law, regulation and transactions with timely, expert news and analysis.
Feb. 10 — Early phase, human testing of a Zika vaccine could happen as early as August with approval by the end of 2017, the head of the nation's infectious disease research programs told a House panel Feb. 10.
Vaccine development typically takes anywhere from three to eight years to demonstrate safety and efficacy that would yield approval from the Food and Drug Administration. But Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, said that in the case of Zika, scientists have the advantage of already having certain vaccine candidates in place as well as regulatory mechanisms to speed up the approval process. The FDA could conceivably grant accelerated approval for a Zika virus vaccine by the end of 2017, he said, “which is really rocket speed for a vaccine.”
“If you look at the timetable, you always know that in vaccinology you have to be careful that things could slip,” he said. “We feel pretty confident that we’ll have enough construct to be able to do preclinical [testing] by the summer, which means we could start a phase I trial let’s say in August. And they usually take three to four months, which means we’ll be finished by the end of 2016.”
Fauci was one of three public health witnesses testifying before a joint Global Health and Western Hemisphere panel of the House Foreign Affairs Committee on the Zika virus. The Obama administration is asking Congress for $1.8 billion to combat the outbreak, which has spread to 33 countries and has been declared a global health emergency by the World Health Organization. The Senate Appropriations panel will hold a similar hearing Feb. 11.
Phase I clinical trials typically test for toxicity, and it's the second phase that studies whether the vaccine candidate is safe and effective. Fauci said scientists may be able to demonstrate safety and efficacy in phase II trials in six to eight months, which means the FDA could grant an accelerated approval of the drug by the end of 2017, if there is still an outbreak. Full approval would still take a few years, he said.
When asked by Rep. Ami Bera (D-Calif.) if he foresees any problems getting a vaccine commercialized, Fauci said he didn't think so. “Unlike other emerging infections, we're getting calls from pharmaceutical companies—big pharmaceutical companies—that are very interested in partnering with us.”
Rep. Christopher H. Smith (R-N.J.), who presided over the hearing and is chairman of the House Foreign Affairs Subcommittee on Global Health, criticized the Obama administration for cutting global health funding. He called for enactment of his bill (H.R. 1797) to support research and treatment on neglected tropical diseases.
“In the face of the waves of infectious disease epidemics in recent years,” Smith said in his opening statement, “the administration's habitual disregard of the increasing danger from infectious disease is simply inexcusable.” He added later, “Before the next explosive global health crises appears, we must provide sufficient resources to the study of tropical diseases.”
“We have to step up our domestic efforts to control mosquitoes before warmer weather leads to an explosion of the mosquito population during an imminent epidemic in the homeland,” Smith said.
The hearing was a joint effort by the House Foreign Affairs Subcommittee on Africa, Global Health, Global Human Rights, and International Organizations and the Subcommittee on the Western Hemisphere. Ariel Pablos-Mendez, assistant administrator for the U.S. Agency for International Development's Bureau for Global Health, and Tom Frieden, director of the Centers for Disease Control and Prevention, also testified.
Fauci and Frieden also are scheduled to testify before the Senate appropriations panel Feb. 11.
Meanwhile, lawmakers in both houses have introduced bills to authorize the use of Ebola funds for Zika response and preparedness. Sen. Ron Johnson (R-Wis.) introduced such a bill (S. 2518) Feb. 9, which has been referred to the Health, Education, Labor, and Pensions Committee; Rep. Chris Stewart (R-Utah) introduced similar legislation (H.R. 4446) Feb. 3, which has been referred to the Committee on Energy and Commerce, as well as to the Foreign Affairs and Armed Services committees.
“We need to be prepared for emerging diseases that could prove devastating,” Johnson said in a Feb. 9 statement. “The swiftest way of funding necessary steps is to broaden the uses permitted for unspent funds reserved for an outbreak that has generally been contained in the United States.”
A separate team of senators is pushing for Zika to be added to the Food and Drug Administration's priority review voucher program, which allows the developer of a vaccine or treatment for a qualifying tropical disease to receive a voucher for FDA priority review for a second product of its choice. Sens. Al Franken (D-Minn.), Bill Nelson (D-Fla.), Johnny Isakson (R-Ga.) and Sherrod Brown (D-Ohio) introduced legislation (S. 2512) Feb. 9 to add Zika and asked Health and Human Services Secretary Sylvia Mathews Burwell to “expeditiously consider the addition of Zika” to the program in a Feb. 5 letter. Reps. G.K. Butterfield (D-N.C.) and Susan W. Brooks (R-Ind.) already introduced a similar bill (H.R. 4400) in the House. But the voucher program doesn't need congressional authorization; the FDA can add Zika on its own, and the agency previously declined to comment on diseases that may be under consideration .
To contact the reporter on this story: Jeannie Baumann in Washington at email@example.com
To contact the editor responsible for this story: Lee Barnes at firstname.lastname@example.org
More information on the hearing is available at http://foreignaffairs.house.gov/hearing/subcommittee-hearing-global-zika-epidemic-emerging-americas.
More information on the Senate hearing scheduled for Feb. 11 is available at http://www.appropriations.senate.gov/hearings/labor-health-and-human-services-and-education-hearing-on-emerging-health-threats-and-the-zika-supplemental-funding-request.
The Senate letter to Burwell is available at http://www.franken.senate.gov/files/letter/160205_HHS_Zika_Letter.pdf.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to email@example.com.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to firstname.lastname@example.org.
Put me on standing order
Notify me when new releases are available (no standing order will be created)