Illustration of Johnson & Johnson Coronavirus vaccine
Dat Ruvic | Reuters
The Johnson & Johnson single-dose coronavirus vaccine is safe and appears to generate a promising immune response in both young and elderly volunteers, according to studies 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 aged 65 and over to receive a high or low dose of the vaccine – called Ad26.COV2.S – or a placebo. Some participants in the 18-55 age group were also selected to receive the second dose of 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 the study. By 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 to 55 age group.
The most common side effects were fever, fatigue, headache, muscle aches and pain at the injection site, according to the study. Side effects were less common in the older age group, who received a single dose of vaccine, as well as in those who received a lower dose of vaccine, according to the data.
Phase one and two clinical trials show that a single photo of the vaccine “gives lasting antibodies,” Dr. Paul Stoffels, chief scientific officer at J&J, told CNBC’s Meg Tirrell. He added that he gave the company “confidence” that the vaccine would be extremely effective against the virus.
The trial tested 805 volunteers. The company is expected to release results from its third phase study, with 45,000 people, by the end of 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 looking forward to the release of the J&J vaccine, which could take place as early as next month. Public health officials and infectious disease experts say world leaders will need a range of drugs and vaccines to defeat the virus, which has killed at least 382,120 Americans since the beginning 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 United States behind the Pfizer-BioNTech and Moderna vaccines. The Pfizer vaccine was released on December 11, and Moderna was released a week later on December 18.
The data comes as US 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 basing it on how quickly states can administer vaccines and the size of their elderly population.
The Trump administration will also stop holding millions of doses reserved for the second round of two-dose vaccines Pfizer and Moderna, the official said, adding that they released doses that were kept in reserve on Sunday. President-elect Joe Biden’s transition team announced a similar plan on Friday.
Unlike the Pfizer and Moderna licensed vaccines, which require two doses three to four weeks apart, J&J requires a single dose. This means that patients will not have to return for another dose, 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 100 million doses of vaccine. The agreement gives the federal government the option to order another 200 million doses, according to the announcement.
Stoffels said the company plans to deliver the vaccine at 2 to 8 degrees Celsius, which is about 36 to 46 degrees Fahrenheit.
“We have three months of stability right now, from 2 to 8,” he said. “This will be extended throughout the year as we generate more stability data. We know from our other vaccines that it can take up to a year, but at first we can’t do this because we don’t have it for this vaccine. “