Come spring, Americans may have their choice of several so-so coronavirus vaccines — with no way of knowing which one is best.
By Carl Zimmer
The United States may be within months of a profound turning point in the country’s fight against the coronavirus: the first working vaccine.
Demonstrating that a new vaccine was safe and effective in less than a year would shatter the record for speed, the result of seven-day work weeks for scientists and billions of dollars of investment by the government. Provided enough people can get one, the vaccine may slow a pandemic that has already killed a million people worldwide.
It’s tempting to look at the first vaccine as President Trump does: an on-off switch that will bring back life as we know it. “As soon as it’s given the go-ahead, we will get it out, defeat the virus,” he said at a September news conference. But vaccine experts say we should prepare instead for a perplexing, frustrating year.
The first vaccines may provide only moderate protection, low enough to make it prudent to keep wearing a mask. By next spring or summer, there may be several of these so-so vaccines, without a clear sense of how to choose from among them. Because of this array of options, makers of a superior vaccine in early stages of development may struggle to finish clinical testing. And some vaccines may be abruptly withdrawn from the market because they turn out not to be safe.
“It has not yet dawned on hardly anybody the amount of complexity and chaos and confusion that will happen in a few short months,” said Dr. Gregory Poland, the director of the Vaccine Research Group at the Mayo Clinic.
Some of this confusion is inevitable, but some is the result of how coronavirus vaccine trials were designed: Each company is running its own trial, comparing its jab with a placebo. But it didn’t have to be this way.
In the spring, when government scientists began discussing how to invest in vaccine research, some wanted to test a number of vaccines all at once, against each other — what’s known as a master protocol.
Dr. Anthony S. Fauci, the director of the National Institute of Allergy and Infectious Diseases, was in favor of the idea. But these mega-trials pose a business risk for any given vaccine maker because they reveal how a vaccine stacks up against its competitors.
Instead, the government offered to bankroll large vaccine trials if companies agreed to some common ground rules and shared some data. The companies were still allowed to run the trials on their own.
“You have to have the total cooperation of the pharmaceutical companies to get involved in a master protocol,” Dr. Fauci said. “That — I don’t know what the right word is — didn’t turn out to be feasible.”
Coronavirus Vaccine Tracker
A look at all the vaccines that have reached trials in humans.
The vaccine vetting system wasn’t set up for this logjam. Typically, scientists take several years to prepare a vaccine before testing it on people. Early safety trials, known as Phase 1 and 2, may take several years.
If all goes well — and it typically doesn’t — then Phase 3, the final stage, can begin, comparing thousands of people who receive a vaccine with thousands who are given a placebo. It may take three more years to get these results. Only then — a decade or more after the research has begun — will a vaccine manufacturer build a factory to make the products.
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