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These are the COVID-19 vaccine prospects that have made it to phase three trials and beyond..
More than 150 coronavirus vaccines are in development across the world—and hopes are high to bring one to market in record time to ease the global crisis. Several efforts are underway to help make that possible, including the U.S. government’s Operation Warp Speed initiative, which has pledged $10 billion and aims to develop and deliver 300 million doses of a safe, effective coronavirus vaccine by January 2021. The World Health Organization is also coordinating global efforts to develop a vaccine, with an eye toward delivering two billion doses by the end of 2021.
It can typically take 10 to 15 years to bring a vaccine to market; the fastest-ever—the vaccine for mumps—required four years in the 1960s. Vaccines go through a three-stage clinical trial process before they are sent to regulatory agencies for approval—which can be a lengthy process itself.
VACCINE CLINICAL TRIAL PROCESS
Even after a vaccine is approved, it faces potential roadblocks when it comes to scaling up production and distribution, which also includes deciding which populations should get it first—and at what cost. Many vaccines also stay in what’s called phase four, a perpetual stage of regular study. (Here’s how we’ll know when a COVID-19 vaccine is ready.)
Given the urgent need, some vaccine developers are compressing the clinical process for SARS-CoV-2 by running trial phases simultaneously. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, has stated that independent Data and Safety Monitoring Boards can end trials early if their interim results are overwhelmingly positive or negative. Meanwhile, the Trump Administration pressured the U.S. Food and Drug Administration to quickly approve a vaccine by Election Day, which some observers worried was politically motivated. By mid-October, several states—including California, New York, and West Virginia—announced plans to independently review the data for any vaccine the FDA approves. On November 7, the presidential election was called for Democratic challenger Joe Biden.
While the FDA has agreed to expedite the approval process, on October 6 the independent federal agency released more stringent safety standards that had been initially opposed by the White House. In a meeting on October 23, the primary advisory panel for the FDA approval process appeared hesitant to issue an emergency use authorization—which allows the use of an unapproved medical product in a life-threatening situation—to any vaccine candidate. Members said doing so could interfere with ongoing trials; participants may drop out of the trials to ensure they receive the actual vaccine rather than the placebo, which would muddy the data and make it close to impossible to prove the efficacy of a vaccine. CDC director Robert Redfield, vaccine developers, and the FDA have also said it’s unlikely a vaccine will be widely available until the middle of 2021.