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The downside of releasing two COVID vaccines so quickly

By Arthur Allen, KHN

As I prepared to get vaccinated in mid-December as part of a COVID-19 vaccine trial led by Janssen Pharmaceuticals, I considered the exit routes. The bailout of the trial was a very real consideration since two other vaccines, manufactured by Moderna and Pfizer-BioNTech, had been found to be safe and effective for emergency approval.

Leaving the trial would make a perfect sense for me or anyone who had volunteered for an ongoing COVID experience. Why risk getting COVID if I was given a placebo, an injection without a vaccine? The way the tests are designed, I may not be told if I received the vaccine before the clinical trial is over, in months.

Dropping the placebo arm could also be ethically valid from a business perspective. Researchers frequently stop trials when they have a product that works – or clearly doesn’t. And the two approved vaccines are 95% effective.

This very real choice for the thousands of people who are offering to participate or stay in the ongoing vaccine trials creates an enigma for science and for society. If the trials cannot proceed, it could very well have an impact on the global supply of COVID vaccines and possibly on vaccine prices, especially if booster shots are required in the years to come. In markets where there are only two competing drugs, prices can soar. If there are four or five in the market, competition usually comes in to control costs.

In short, the welcome arrival of two COVID vaccines deemed safe has revealed a series of ethical and logistical challenges. And it has governments, businesses and scientists looking for solutions.

“Global vaccine experts say the longer we can run a placebo-controlled trial the better,” Matthew Hepburn, who heads the vaccine development arm of Operation Warp Speed, told me. multi-billion dollar federal government fight against COVID-19. . “But as a volunteer in the Janssen trial, you can always give up.”

As to how best to solve larger problems, “it’s a real-time debate,” he said.

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