[ad_1]
WASHINGTON (BLOOMBERG) – Johnson & Johnson has begun dosing up to 60,000 volunteers in a study of its Covid-19 vaccine, marking the first large trial in the US of an inoculation that can work after a single injection.
J&J is the fourth vaccine manufacturer to move its candidate to late-stage human studies in the US.
If enrollment goes as expected, the test could return results as early as the end of the year, allowing the company to seek an emergency clearance early next year, if effective, it said on Tuesday (Sept. 22). Johnson & Johnson Chief Scientific Officer Paul Stoffels.
“We are convinced that the single dose could be very effective,” he said in a press call, citing promising results from previous research.
The study will compare the vaccine to a placebo injection, with the aim of showing whether it reduces Covid-19 cases from moderate to severe.
J&J will publish detailed test plans on Wednesday, Stoffels said. Leaders Pfizer Inc, Moderna Inc and AstraZeneca Plc have already done the same.
“Multiple Covid-19 vaccine regimens will likely be required to meet the global need,” said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, in a statement.
The J&J vaccine “may be especially helpful in controlling the pandemic if it is shown to be protective after just one dose.”
The J&J study is nearly two months behind those of Moderna, which works with NIAID, and Pfizer, in association with BioNTech SE, whose final-stage testing began in late July. Pfizer has said it could get effective results by the end of October. Those vaccines use two-dose regimens.
The J&J vaccine could offer a distribution advantage over two-shot inoculations that will require vaccination sites to ensure recipients return for their second dose. The company said its vaccine can be stored at refrigerator temperature for three months, much longer than the Pfizer vaccine that requires deep freezing for long-term storage.
The product is made from a cold virus, called an adenovirus, which is modified to make copies of the coronavirus spike protein, which the pathogen uses to enter cells.
The altered virus cannot replicate in humans, but it induces an immune response that prepares the body for an actual Covid-19 infection. The vaccine was developed with researchers at Harvard University who have spent years working on the adenovirus vaccine platform, which is also used in J & J’s Ebola vaccine.
The healthcare giant is running the study together with the NIAID and the Advanced Biomedical Research and Development Authority at sites in the US, Brazil, Mexico, South Africa and other countries.
It will include significant representation among those over the age of 60, as well as minorities at disproportionate risk of infection, including Black, Hispanic, American Indian and Alaska Native peoples, according to a statement.
J&J has also agreed to collaborate with the UK on a separate phase 3 clinical trial that will test a two-dose regimen of the vaccine in several countries, according to Stoffels.
The decision to begin the final phase of the trial was based on data from a previous human study that showed that a single injection was safe and stimulated a strong immune response, Stoffels said.
Animal studies showed that a single injection protected five out of six macaque monkeys from infection after exposure, according to a study published in Nature in July.
Like other end-stage vaccine trials, the J&J study is monitored by an independent board of physicians and statisticians who wait for a certain number of coronavirus cases to accumulate before looking at the data.
The trial aims to accumulate 154 cases of Covid-19 for a final efficacy analysis. If the vaccine turns out to be more than 90 percent effective, the trial could produce results after just 20 cases, Stoffels said. However, he said that scenario is unlikely.
The single injection test may also take less time to complete than two doses. Scientists will begin counting cases only 15 days after patients receive their vaccines or placebo injections.
Despite accelerated timelines, Operation Warp Speed will not take shortcuts to confirm the vaccine’s safety or efficacy, National Institutes of Health Director Francis Collins said on the call.
“That will not be allowed at all,” he said.
[ad_2]
