Johnson & Johnson on Wednesday said its coronavirus vaccine will enter Phase 3 of clinical trials in which up to 60,000 participants will receive the single-dose vaccine in the United States and other countries.
That makes the vaccine the fourth in the U.S. to go into large-scale trials, following AstraZeneca, Moderna, and Pfizer/BioNTech. J&J’s trial, however, is the largest so far. A Phase 3 trial compares the effects of a vaccine with those of a placebo.
The new vaccine has advantages over others: It does not need to be stored in subzero temperatures, and it may require just one dose instead of two, The New York Times reported. The company said it may be able to determine by the end of the year if the vaccine is safe and effective.
President Donald Trump praised the report. “Big news. Numerous great companies are seeing fantastic results. @FDA must move quickly!” he wrote on Twitter on Wednesday.
Big news. Numerous great companies are seeing fantastic results. @FDA must move quickly! https://t.co/2pDrmRPOxc
— Donald J. Trump (@realDonaldTrump) September 23, 2020
“Johnson & Johnson has continued the scaling up of its manufacturing capacity and remains on track to meet its goal of providing one billion doses of a vaccine each year,” the company said in a statement. “The Company is committed to bringing an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use and anticipates the first batches of a COVID-19 vaccine to be available for emergency use authorization in early 2021, if proven to be safe and effective.”
Dr. Anthony Fauci said last week that he expects a COVID-19 vaccine to be fully tested and proven safe and effective well before the end of 2020.
“I would still put my money on November, December,” Fauci said at a Congressional Hispanic Caucus Institute panel, CNN reported.
Fauci, an immunologist and director of the National Institute of Allergy and Infectious Diseases who serves on the White House Coronavirus Task Force, said testing a vaccine requires about 150 subjects to actually get the virus.
“Right now, the trials are over two thirds enrolled – really close to full enrollment on one, and over full enrollment on the other,” he said. “It really depends on where the sites are and how many infections there are in a site. So you could get your answer sooner, or you can get your answer a bit later.”
“Fauci said his projection of November or December is informed by calculations based on where the clinical trial sites are in their studies,” CNN reported.
Under new plans released last week by the Department of Defense and federal health agencies, all Americans will be able to get a vaccine against SARS-CoV-2, the virus that causes COVID-19, for free once one is developed and approved by the U.S. Food and Drug Administration (FDA).
The agencies are eyeing January as a target date to begin a vaccination campaign, although that date may shift, according to a report to Congress and a “playbook” for states and local governments, The Associated Press reported.
“We are working closely with our state and local public health partners … to ensure that Americans can receive the vaccine as soon as possible and vaccinate with confidence,” Health and Human Services Secretary Alex Azar said in a statement.
According to the playbook drafted by the Centers for Disease Control and Prevention (CDC), the vaccination campaign will be “much larger in scope and complexity than seasonal influenza or other previous outbreak-related vaccination responses.”
Trump has said the U.S. government could begin distributing a vaccine as early as October.
“We’re very close to that vaccine as you know and I think much closer than I think most people want to say,” Trump said during a White House press briefing last week. “We think we can start some time in October. So as soon as it’s announced we’ll be able to start. That will be from mid-October on. It may be a little bit later than that.”