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This September 2020 photo provided by Johnson & Johnson shows a single-dose COVID-19 vaccine being developed by the company. Johnson & Johnson is beginning a final large study to try to show whether the single-dose vaccine can protect against the coronavirus. (Cheryl Gerber / Courtesy of Johnson & Johnson via AP)
Johnson & Johnson is beginning a final large study to try to test whether a single-dose COVID-19 vaccine can protect against the virus.
The study that begins on Wednesday will be one of the largest coronavirus vaccine studies in the world so far, testing the vaccine on 60,000 volunteers in the US, South Africa, Argentina, Brazil, Chile, Colombia, Mexico and Peru.
A handful of other vaccines in the US, including injections by Moderna Inc. and Pfizer Inc., and others in other countries are already in the final stage of testing. Hopes are high that answers about at least one candidate being tested in the US could come before the end of the year, maybe sooner.
US health officials insist the race for a vaccine is no shortage.
“We want to do everything we can without sacrificing safety or efficacy, we are not going to do that, to make sure we end up with vaccines that will save lives,” said Dr. Francis Collins, director of the National Institutes. Health, he told reporters.
But many vaccine specialists question whether the Food and Drug Administration will stick to that goal under intense pressure from the Trump administration. President Donald Trump has consistently put forward a faster schedule for a new vaccine than experts say is adequate to fully test candidates.
Meanwhile, testing for another experimental vaccine, made by AstraZeneca, remains on hold in the US As officials examine a safety issue, even though studies have resumed in other countries.
Earlier this week, Vice President Mike Pence urged state governors to “do their part to build public confidence that it will be a safe and effective vaccine.”
And Dr. Anthony Fauci, America’s leading infectious disease expert, added in the call to governors that he relies on “a tried-and-true process” that has checks and balances built in, including an independent board that assesses the progress of each vaccine trial. as well as “the integrity of the FDA.”
A recording of the call was provided to The Associated Press.
The senators were scheduled to question FDA Commissioner Stephen Hahn, Fauci and other administration officials later Wednesday about the response to the pandemic.
Even if the FDA allowed emergency use of a vaccine by the end of the year, supplies would be limited and would be delivered first to vulnerable groups like healthcare workers. It is unlikely that most Americans will receive a vaccine until next year.
The Centers for Disease Control and Prevention wants states to prepare now to roll out vaccines, which will present enormous logistical challenges. On Wednesday, the CDC was set to announce the distribution of $ 200 million in funds approved by Congress to help start establishing operations.
Health and Human Services Secretary Alex Azar said the COVID-19 vaccine campaign will build on longstanding cooperation between the federal government and states on immunizations.
J & J’s vaccine is made with slightly different technology than others in the later stages of testing, modeled after an Ebola vaccine created by the company. Unlike the other three vaccines that began late-stage testing in the US, it only requires one injection, not two. Despite a later start to testing than some of its competitors, Dr. Paul Stoffels, J & J’s chief scientific officer, told reporters that the study was large enough to provide answers possibly early next year.
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