Johnson & Johnson started a 60,000-person trial of an experimental single-shot COVID-19 vaccine that, if proven effective, could simplify the delivery of millions of doses compared to major rivals that require two doses. The company expects the results of the phase III trial by the end of the year or early next, said Dr. Paul Stoffels, J & J’s chief scientific officer, in a joint press conference with officials from the National Institutes of Health and the Trump administration. J&J plans to make up to 1 billion doses in 2021, and more after that, Stoffels said. Rival vaccines from Moderna Inc, Pfizer Inc and AstraZeneca require two injections several weeks apart, which makes them more difficult to administer and means twice as much vaccine is needed to inoculate the same number of people. “The benefits of a single injection vaccine are potentially profound in terms of mass immunization campaigns and control of the global pandemic,” Dr. Dan Barouch, a Harvard vaccine researcher who helped design the COVID vaccine, said in a telephone interview. -19 from J&J.
The J&J vaccine also doesn’t need to be stored in extremely cold temperatures, Barouch noted, another advantage over some rival candidate vaccines. J&J shares were up 1.2%. “Great news. Numerous large companies are getting fantastic results. The FDA (Food and Drug Administration) must act quickly,” US President Donald Trump said in a tweet. J&J published a detailed study protocol for its Phase III trial Wednesday on the company’s website, joining the three other vaccine manufacturers that have made these details available in recent weeks after calling for greater transparency on the essays.
Stoffels said J&J began the late-stage study after seeing positive results in its combined Phase I / II trial in the United States and Belgium. The company plans to publish those results imminently. Stoffels said the safety and level of protection demonstrated in the previous trial were on par with what was seen in the company’s animal studies. The results showed that a single dose could offer sufficient protection “for a long time,” he said. J & J’s last stage test will take place at up to 215 sites in the United States, South Africa, Argentina, Brazil, Chile, Colombia, Mexico and Peru.
The trial will assess whether the vaccine can prevent moderate to severe COVID-19 after a single dose. It will also look to find out if the vaccine can prevent serious illnesses that require medical intervention and if it can prevent milder cases of the virus. Stoffels said it will likely take six weeks to two months to fully enroll the test. J&J plans to manufacture doses prior to approval, so it will be ready to begin distribution shortly after a green light from the FDA.
The trial will be overseen by an independent Data and Safety Monitoring Board (DSMB) that will review the safety and effectiveness of the vaccines at pre-set intervals. Dr. Francis Collins, director of the National Institutes of Health, said that all three vaccines supported by the federal government’s Operation Warp Speed - J & J’s, Moderna’s and AstraZeneca’s – share a common DSMB. Pfizer is running its own test and has a separate DSMB, Collins said.
The J&J trial would be considered a success if it turns out to be 60% effective, with a study protocol that could have an efficacy response after 154 people were infected with the virus. Stoffels said the company will begin counting COVID-19 infections within the study population 15 days after people are vaccinated.
The DSMB will test the efficacy of the vaccine for the first time after 20 trial participants have been infected. Collins said the DSMB does not include any government employees and is made up of “very experienced” scientists and statistical experts. “Until they are convinced that there is something in there that looks promising, nothing is cleared up and it is sent to the FDA. So everyone should feel pretty calm,” Collins said.
His comments follow concerns that government scientists may be pressured to speed up the vaccine testing process to push for the re-election of US President Donald Trump. In August, J&J signed an agreement with the British government on a global phase III clinical trial to study a two-dose version of its vaccine, which will run in parallel with the single-dose trial. Stoffels, in the briefing, said the single-dose version would be “very important for emergency use.” Later, the company will test a booster dose that could produce even greater immunity to the virus, he added.
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