Drug makers feel burned: By the time the vaccine was ready—after the peak of the outbreak—public fear of the new flu had subsided; many people didn’t want the vaccine, and some countries refused to take their full orders

From 2018... Who will answer the call in the next outbreak? Drug makers feel burned by string of vaccine pleas. Helen Branswell. Stat News, January 11, 2018. https://www.statnews.com/2018/01/11/vaccines-drug-makers/

Excerpts:

Every few years an alarming disease launches a furious, out-of-the-blue attack on people, triggering a high-level emergency response. SARS. The H1N1 flu pandemic. West Nile and Zika. The nightmarish West African Ebola epidemic.

In nearly each case, major vaccine producers have risen to the challenge, setting aside their day-to-day profit-making activities to try to meet a pressing societal need. With each successive crisis, they have done so despite mounting concerns that the threat will dissipate and with it the demand for the vaccine they are racing to develop.

Now, manufacturers are expressing concern about their ability to afford these costly disruptions to their profit-seeking operations. As a result, when the bat-signal next flares against the night sky, there may not be anyone to respond.

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Drug makers “have very clearly articulated that … the current way of approaching this — to call them during an emergency and demand that they do this and that they reallocate resources, disrupt their daily operations in order to respond to these events — is completely unsustainable,” said Richard Hatchett, CEO of CEPI, an organization set up after the Ebola crisis to fund early-stage development of vaccines to protect against emerging disease threats.

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Nearly all the major pharmaceutical companies that work on these vaccines have found themselves holding the bag after at least one of these outbreaks.

GSK stepped up during the Ebola crisis, but has since essentially shelved the experimental vaccine it once raced to try to test and license. Two other vaccines — Merck’s and one being developed by Janssen, the vaccines division of Johnson & Johnson — are still slowly wending their ways through difficult and costly development processes. Neither company harbors any hope of earning back in sales the money it spent on development.

A number of flu vaccine manufacturers were left on the hook with ordered but unpaid for vaccine during the mild 2009 H1N1 flu pandemic. By the time the vaccine was ready — after the peak of the outbreak — public fear of the new flu had subsided. Many people didn’t want the vaccine, and some countries refused to take their full orders. GSK, Sanofi Pasteur, and Novartis — which has since shed its vaccines operation — produced flu vaccine in that pandemic.

Dr. Rip Ballou, who heads the U.S. research and development center for GSK Global Vaccines, told STAT it’s not in the “company’s DNA” to say “no” to pleas to respond to appeals in an emergency. But the way it has responded in the past is no longer tenable.

“We do not want to have these activities compete with in-house programs,” said Ballou. “And our learnings from Ebola, from pandemic flu, from SARS previously, is that it’s very disruptive and that’s not the way that we want to do business going forward.”

GSK has proposed using a facility it has in Rockville, Md., as a production plant for vaccines needed in emergencies, but the funding commitments that would be needed to turn that idea into reality haven’t materialized.

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Sanofi Pasteur has also taken several enormous hits in the successive rounds of disease emergency responses. In the early 2000s, the company worked on a West Nile virus vaccine. Though the disease still causes hundreds of cases of severe illness in the U.S. every year and is estimated to have been responsible for over 2,000 deaths from 1999 to 2016, public fear abated, taking with it the prospects for sales of a vaccine. Sanofi eventually pulled the plug.

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At the same time, the company bore the brunt of a barrage of criticism for not publicly committing to a low-price guarantee for developing countries. Facing horrible PR and no sales prospects, Sanofi announced late last summer that it was out.

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In an emergency, regulatory agencies may be willing to bend some rules. But once the crisis subsides, they revert to normal operating procedures — as Merck has found out as it tries to persuade regulators to accept data from an innovative ring-vaccination trial conducted on its Ebola vaccine.

“This is sort of a human nature problem. People pay attention to the burning house, and maybe not the one that’s got bad wiring, right, that’s down the street,” Shiver said.