Last-stage study of Johnson & Johnson’s single-shot vaccine begins in the US

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New York: Johnson & Johnson is beginning a huge final study to try to prove if a single-dose COVID-19 vaccine can protect against the virus. The study starting Wednesday will be one of the world’s largest COVID-19 vaccine studies so far. The vaccine will be tested 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 shots made by Moderna and Pfizer —are already in final-stage testing. Hopes are high that answers about at least one candidate being tested in the US could come by year’s end, maybe sooner.

US health officials have insisted the race for a vaccine isn’t cutting corners. “We want to do everything we can without sacrificing safety or efficacy. We’re not going to do that — to make sure that we end up with vaccines that are going to save lives,” Dr Francis Collins, director of the National Institutes of Health, 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 presented a faster timeline for a new vaccine than experts say is adequate to fully test the candidates.

Meanwhile testing of still another experimental vaccine, made by AstraZeneca, remains on hold in the US as officials examine a safety question, even though studies have resumed in other countries.

Earlier this week, US Vice-President Mike Pence urged state governors to ‘do your part to build public confidence that it will be a safe and effective vaccine’.

Dr Anthony Fauci, the top US infectious disease expert, said in the call to governors that he is confident in ‘a tried and true process’ that has checks and balances built in, including an independent board evaluating the progress of each vaccine trial, as well as ‘the integrity of the FDA’. A recording of the call was provided to this agency.

Even if the FDA were to allow emergency use of a vaccine by year’s end, supplies would be limited and given first to vulnerable groups such as health workers. Most Americans aren’t likely to receive a vaccine until sometime next year.

The Centers for Disease Control and Prevention wants states to get ready now to roll out vaccinations, which will present enormous logistical challenges. The CDC was set to announce Wednesday the distribution of $200 million in congressionally approved funds to help begin setting up operations.

J&J’s vaccine is made with slightly different technology than others in late-stage testing, modeled on an Ebola vaccine the company created. Unlike the other three vaccines that started late-stage testing in the US, it requires only one shot, not two.

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