Merck & Co in pole position for Ebola vaccine approval as FDA begins review
The FDA is to review Merck & Co’s Ebola vaccine, giving the US pharma a chance to grab a first approval within six months.
US-based Merck said the FDA had accepted its filing for the investigational Ebola Zaire strain vaccine known as V920, adding that the regulator is due to make a decision by March 14 next year after a faster six-month review.
This follows the European Medicines Agency’s decision in March to begin a review, which could lead to approval in Europe around the same time.
The news puts Merck & Co in pole position to get the first Ebola vaccine approved by major regulators, although there are already plenty of doses available for use in clinical trials.
Early last month, GlaxoSmithKline exited development of Ebola vaccines by handing over rights to three vaccines, for two Ebola strains and the related Marburg virus, to the US Sabin Vaccine Institute.
Johnson & Johnson has also started a two-year study in Uganda of a two-shot vaccine co-developed with Bavarian Nordic, for the Zaire strain.
As well as targeting regulatory approval Merck has scaled up the number of investigational V920 Ebola vaccine doses being produced to support governments and help public health officials deal with outbreaks in the Democratic Republic of the Congo and neighbouring countries.
Since last May Merck has donated 245,000 doses of the investigational vaccine to the World Health Organization and there is a stockpile of more than 190,000 doses available and ready to ship to the outbreak region at the WHO’s request.
The company is building a new manufacturing site in Germany and gearing up for production at a new US site in order to build an additional supply of up to 650,000 doses.
Merck & Co has applied for prequalification status with the World Health Organization, and to health authority representatives of the African Vaccine Regulatory Forum.
Dr Paula Annunziato, vice president, Merck Research Laboratories, said: “Merck has worked with government partners and the global health community to accelerate development of our investigational V920 Ebola vaccine. FDA’s priority review designation underscores our long-standing partnership with the US government toward its development and licensure.
“A top priority for us remains achieving registration of V920 and regulatory approval of our German manufacturing site, so that licensed supply can be produced over time to support global public health preparedness and health security objectives. We look forward to continuing to work with the FDA throughout the review process.”
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