As Saudi and U.N. health authorities report new infections from a troubling new respiratory disease, there are concerns that the approaching Hajj – the annual Muslim pilgrimage to Mecca – could increase the risk of spreading the virus as pilgrims return to their home countries.
Meanwhile the U.S. government, in a notice published in the Federal Register Wednesday, declared that the Middle East respiratory syndrome coronavirus (MERS-CoV, or simply MERS) could potentially “affect national security or the health and security of United States citizens living abroad.”
Saudi Arabia is currently the undisputed center of the scare.
According to the Centers for Disease Control and Prevention (CDC) the majority of the 55 confirmed MERS cases – 40 infections, 24 deaths – have occurred in the kingdom, while two deaths each have been reported in Britain and Jordan and one death each in France and the United Arab Emirates. (The fatalities in Europe were linked to visits to the Middle East.)
Infections also have been reported in Qatar, Tunisia and Italy.
The notice published in the Federal Register Wednesday said Health and Human Services Secretary Kathleen Sebelius has determined that “there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad.”
That determination in turn allows the Food and Drug Administration (FDA) to bypass standard processes and fast-track approval for products or drugs in relation to MERS, on the basis of an “emergency use application” (EUA).
The FDA may under the prescribed circumstances issue an EUA “authorizing (1) the emergency use of an unapproved drug, an unapproved or uncleared device, or an unlicensed biological product; or (2) an unapproved use of an approved drug, approved or cleared device, or licensed biological product,” the notice says.