Merck & Co. Inc. will not be able to submit its Ebola candidate for U.S. Food and Drug Administration approval this year, FiercePharma reported, citing a company statement.
Merck spokeswoman Pamela Eisele said the company is committed to developing and seeking approval of the vaccine, known as rVSV-ZEBOV, as soon as possible.
Eisele said the company will submit the vaccine for approval to a "major regulatory agency in 2018," noting that the company is working with the FDA and European Medicines Agency on its filings.
In 2016, the drugmaker signed a $5 million advance purchase commitment with the Gavi global vaccine alliance. Under the agreement, Gavi said it would buy the vaccine to protect against future outbreaks of the deadly virus.
The delay of the filing could put the commitment at risk, as the commitment was signed on the understanding that the vaccine will be submitted for approval by the end of 2017.
Merck is engaging with regulators through priority medicine and breakthrough therapy designations in the EU and U.S., respectively, Eisele told the news outlet.
The Democratic Republic of the Congo approved the use of rVSV-ZEBOV in May to contain the virus' outbreak in the country.
