There may be a Hepatitis A Vaccine Shortage
With the hepatitis A outbreak spreading across San Diego County and vaccination campaigns underway in many cities, some are beginning to ask whether a vaccine shortage could be coming. There is no official word that there is a shortage, but there are some signs that the demand for doses is starting to strain available supplies. Late last month, Merck & Co. Inc., manufacturer of VAQTA, one of two FDA-approved hepatitis A vaccines on the market, said in a short statement that it “anticipates working through some manufacturing constraints in 2017,” most likely as a result of unexpected demand for the product. GSK, maker of Havrix, the other FDA-approved hepatitis A vaccine on the market, said in its own statement that it is experiencing “an increased demand” for the drug but “we have Havrix vials in stock.” Fran Butler-Cohen, chief executive of Family Health Services of San Diego, the region’s largest operator of community clinics, stated:
Right now we’re not having a problem with access to the hep A vaccine, but my worry is that, if we’re grabbing a lot of doses, and L.A.’s grabbing a lot of doses and others in other places are grabbing a lot of doses, will pharma be able to keep up with demand?
Both companies have declined to say how much supply remains or how long they expect to be able to continue to meet increased demand before supplies run dry, however, Merck added that it is “taking steps to continue to increase our capacity to meet global demand in 2018.” According public health officials, San Diego County has had more than 42,000 doses of hepatitis A vaccine administered. Los Angeles County officials recently said they plan to administer 40,000 doses of hepatitis A vaccine in the coming weeks because of its own outbreak detected among its homeless population. According to Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, making more of a vaccine is not as simple as mixing up the right ingredients in the right quantities and filling vials as quickly as possible. Dr. Osterholm noted that even when the culturing phase is complete and antibodies are separated out of the mix and purified, there is still a considerable regulatory process that must be followed, which includes potency testing by the FDA before manufactured doses can be used to fill medical providers’ orders. Hopefully the vaccine supply does not run out and there is enough to contain the outbreaks.