Illustration of the Johnson & Johnson coronavirus vaccine
Atès Ruvic | Reuters
Johnson & Johnson’s single-dose coronavirus vaccine is safe and appears to generate a promising immune response in both young volunteers and the elderly, according to data from the trial published Wednesday in the New England Journal of Medicine.
J&J scientists randomly assigned healthy adults between the ages of 18 and 55 and those over 65 to receive a high or low dose of their vaccine (called Ad26.COV2.S) or a placebo. Some participants in the 18 to 55 age group were also selected to receive a second dose of the vaccine.
Most volunteers produced detectable neutralizing antibodies, which the researchers believe play an important role in defending the cells against the virus, after 28 days, according to trial data. At day 57, all volunteers had detectable antibodies, regardless of vaccine dose or age group, and remained stable for at least 71 days in the 18–55 age group.
The most common side effects were fever, fatigue, headache, muscle aches and pain at the injection site, according to the trial data. Side effects were less common in the older age group, who received only one dose of the vaccine, as well as in those who received a lower dose of the vaccine, according to the data.
Data from first- and second-phase clinical trials show that a single shot of the vaccine “provides sustainable antibodies,” CNBC’s Meg Tirrell told Dr. Paul Stoffels, scientific director of J&J. He added that it gives the company “confidence” that the vaccine will be highly effective against the virus.
The trial tested 805 volunteers. The company is expected to release the results of its phase three trial of 45,000 people later this month. J&J uses the same technologies it used to develop its Ebola vaccine for the Covid-19 vaccine.
U.S. officials and Wall Street analysts are eagerly anticipating the release of the J&J vaccine, which could pass as early as next month. Public health officials and infectious disease experts say world leaders will need a plethora of drugs and vaccines to defeat the virus, which has killed at least 382,120 Americans since the start of the pandemic.
If the J&J vaccine is authorized by the Food and Drug Administration, it would be the third approved for use in the U.S. behind the Pfizer-BioNTech and Moderna’s vaccine. The Pfizer vaccine was authorized on December 11 and the Modern one a week later on December 18.
The data comes when U.S. officials complain that the pace of vaccinations has been too slow as supply of vaccine doses exceeds demand. The Centers for Disease Control and Prevention on Tuesday extended eligibility guidelines for the Covid vaccine to include people 65 and older, as well as people with pre-existing conditions. The government is also changing the way it allocates doses of Covid vaccine, now based on how quickly states can administer shots and the size of their large population.
The Trump administration will also stop withholding millions of doses reserved for the second round of two-dose shots from Pfizer and Moderna, the official said, adding that they have released doses that were kept in reserve on Sunday. President-elect Joe Biden’s transition team announced a similar plan on Friday.
Unlike authorized Pfizer and Moderna vaccines, which require two doses between three or four weeks apart, J&Js only require one dose. This means patients will not have to take another dose again, simplifying logistics for healthcare providers.
The Department of Health and Human Services announced in August that it had reached an agreement with Janssen, J & J’s pharmaceutical subsidiary, worth about $ 1 billion for every 100 million doses of its vaccine. The agreement gives the federal government the option to order an additional 200 million doses, according to the announcement.
Stoffels said the company plans to send the vaccine between 2 and 8 degrees Celsius, which is about 36 to 46 degrees Fahrenheit.
“We have three months of stability from now on, from 2 to 8,” he said. “This will expand throughout the year as we generate more stability data. We know from the other vaccines that it can take up to a year, but at first we can’t do that because we don’t have it for that vaccine.”