WHO AND GAVI MEET REGULATORY RESISTANCE IN PUSH TO ADMINISTER MERCK EBOLA VACCINES IN CONGO


From Statnews
The World Health Organization and outside experts are making arrangements to send an experimental Ebola vaccine to the Democratic Republic of Congo, should officials there say they need it to quell an outbreak there.

The DRC has not yet formally requested the vaccine, and it’s unclear if or when it will. The country’s drug regulatory agency would also have to authorize emergency use of the vaccine, which is not yet licensed.

Transporting medical supplies and teams of investigators to the outbreak zone is slow work — as is getting patient samples back to the capital, Kinshasa, for testing.

It will also be challenging to get doses of vaccine to the area if the government decides to use it. The experimental Ebola vaccine must be stored at -80 Celsius, which would involve transporting it in freezers.

In an agreement with Gavi, Merck is required to have on hand at all times at least 300,000 doses of the Ebola vaccine. There is also currently a small number of doses — around 800 or 1,000 — in Geneva, Berkley said.

A spokeswoman for Merck said the company is in contact with WHO, Doctors without Borders — which has sent a response team to the outbreak site — and other organizations about the outbreak.

“We stand ready to ship our investigational vaccine for Ebola Zaire … once appropriate approvals are in place,” she said in an email.

Berkley pointed out that because the vaccine has not yet been licensed, there are regulatory hurdles to clear before it can be used, and that can take some time.

https://www.statnews.com/2017/05/16/ebola-drc-vaccine/

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