Trump is threatening to permanently pull U.S. funding from the World Health Organization. China, on the other hand, is pledging $2 billion to fight the virus.
Health experts largely agree that the federal government should issue guidelines for priority groups this time around, given the massive and severe scope of the coronavirus pandemic.
But the chaotic initial distribution of remdesivir has some worried that most of the decisions will be made by the president’s task force, with little transparency into the reasoning. That could stoke anger from Americans who believe a ready vaccine means they should be able to get it quickly.
“It was pretty challenging at the beginning of H1N1 when doses were in short supply. Every step of the way, stuff goes wrong, and that’s just how it is. You have to count on that,” said Lurie.
Some of the questions about who gets vaccinated first will be answered by whichever vaccine succeeds first. The Moderna candidate that is racing into Phase II and III trials after promising early data has so far only been studied in people over 18 years old. Without trials in children at some point, it would not be authorized for pediatric use.
Vaccines can sometimes be risky to administer to the elderly and others with weakened immune systems because they might not mount an effective immune response — and some might become sicker if they then got the virus than they would have without the shot. These potential dangers are usually identified during late-stage clinical studies that have not been completed for any experimental coronavirus vaccine.
Even if an eventual vaccine does not pose special risk to older people, it may make more sense to prioritize vaccinating people who interact with the elderly, said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.
In pandemic fiction like the popular movie “Contagion,” the vaccine is the hero, says Offit. But in reality, “it’s never that clean” — especially when candidates are hurtling through trials at a record-breaking speed.
“Because you’re making this in a ‘break the glass’ mentality, you are making it very quickly, you’re going to find things out later that you didn’t know,” Offit said. These include possible safety concerns or how long a vaccine lasts or which groups have the best immune response. “And vaccine confidence in this country, and the world, is already fragile.”
There will most certainly be a need for multiple vaccines, even if Moderna can bring its candidate to market quickly. Dozens of potential vaccines are in the pipeline — many of which are being developed by scientists in China and European countries.
Trump and his officials — including the newly tapped vaccine czar Slaoui, GlaxoSmithKline’s former vaccine chief — have said the government is evaluating 14 candidates. While the president has said a vaccine could be ready before the end of the year, others, such as HHS Secretary Alex Azar, have suggested that would not happen before January 2021.
Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, has stressed that the government’s timeline assumes everything goes perfectly as manufacturers forge on into increasingly large and complex trials. Unlike the handful of swine flu vaccines in 2009 — built using the foundations developed for annual flu shots — there has never before been a vaccine for any coronavirus.
“It wasn’t easy in 2009 and they had an easier task. You knew all these things that you do not know right now about coronavirus,” said Ostroff.
There have also been notable shifts in vaccine manufacturing since the swine flu epidemic. A central allegation of the anti-vaccination movement is that the preservatives used to make multidose vials work — so that several people can receive a vaccine from the same vial — are dangerous. There is not evidence that that is the case, but manufacturers have drifted away from multidose vials all the same.
Ostroff recalls some days during the swine flu outbreak where the multidose options were all that was available — and people against vaccinations refused to get them.