No FDA approval yet for monkeypox antivirals — DOH

This undated electron microscopic (EM) handout image provided by the Centers for Disease Control and Prevention depicts a monkeypox virion, obtained from a clinical sample associated with the 2003 prairie dog outbreak. It was a thin section image from a human skin sample. On the left were mature, oval-shaped virus particles, and on the right were the crescents, and spherical particles of immature virions.

Cynthia S. Goldsmith / Centers for Disease Control and Prevention / AFP

By Angelica Y. Yang - Philstar.com

MANILA, Philippines — Department of Health Secretary Francisco Duque III said Saturday that the country's Food and Drug Administration has not yet given approval or authorization for the use of monkeypox antivirals.

Several cases of monkeypox, endemic to Africa, were detected in North American and European countries in early May. To date, the Philippines has no confirmed monkeypox case, although the Health department has said it is intensifying border control measures and actively monitoring the developments. 

"Wala pang approval ng FDA natin. Wala pang emergency use authorization (EUA). Ito 'yung mga legal na batayan para makapagpasok ng mga antivirals against monkeypox," Duque said in an interview with Dobol B TV on Saturday. 

("The FDA has not given its approval. There is also no emergency use authorization yet. These are the legal basis which will allow for the import of antivirals against monkeypox.")

On Friday, DOH said it is participating in talks on the possible acquisition of antivirals in case the country experiences an outbreak or if there are severe cases. 

There is already a monkeypox vaccine which has been developed, but the World Health Organization said it is not yet widely available, DOH said in an earlier statement. 

"The DOH is exploring all possible available sources and expedient legal methods for the procurement of Monkeypox vaccines," the agency told reporters.

Monkeypox vaccination is not yet part of the country's national immunization program. 

Monkeypox can be transmitted to humans after experiencing close contact with an infected individual or animal, or with contaminated materials. Symptoms of the disease include fever, rashes and swollen lymph nodes.