Johnson & Johnson coronavirus vaccine illustration
Given Ruvic | Reuters
Johnson & Johnson’s single-dose coronavirus vaccine is safe and appears to generate a promising immune response in young and elderly volunteers, according to test data published Wednesday in the New England Journal of Medicine.
J&J scientists randomly assigned healthy adults between 18 and 55 years old and those 65 and older 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 of the volunteers produced detectable neutralizing antibodies, which the researchers believe play an important role in defending cells against the virus after 28 days, according to the trial data. On day 57, all volunteers had detectable antibodies, regardless of the 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 pain and 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 phase one and two clinical trials show that a single injection of the vaccine “gives sustainable antibodies,” said Dr. Paul Stoffels, J&J’s scientific director, CNBC’s Meg Tirrell in an interview. He added that this gives the company “confidence” that the vaccine will be highly effective against the virus.
The trial tested 805 volunteers. The company expects to release the results of its phase three test with 45,000 people later this month. J&J is using the same technologies it used to develop its Ebola vaccine for the Covid-19 vaccine.
American officials and Wall Street analysts are eagerly awaiting authorization for the J&J vaccine, which could happen as early as next month. Public health officials and infectious disease experts say world leaders will need a variety of drugs and vaccines to defeat the virus, which has killed at least 382,120 Americans since the pandemic began.
If the J&J vaccine were authorized by the Food and Drug Administration, it would be the third approved for use in the United States, behind the Pfizer-BioNTech vaccine and Moderna. The Pfizer vaccine was authorized on December 11, and Moderna was authorized a week later, on December 18.
The data are released at a time when US officials complain that the pace of vaccinations has been very slow, as the supply of doses of the vaccine exceeds demand. The Centers for Disease Control and Prevention expanded Covid vaccine eligibility guidelines on Tuesday to include people age 65 and older, as well as people with pre-existing illnesses. The government is also changing the way it allocates doses of the Covid vaccine, now based on how quickly states can administer vaccines and the size of their elderly population.
The Trump administration will also stop retaining millions of doses reserved for the second round of two-dose vaccines from Pfizer and Moderna, the official said, adding that he released doses that were being kept in reserve on Sunday. President-elect Joe Biden’s transition team announced a similar plan on Friday.
Unlike authorized vaccines from Pfizer and Moderna, which require two doses every three to four weeks, J&J requires only one dose. This means that patients will not have to go back for another dose, simplifying logistics for healthcare professionals.
The Department of Health and Human Services announced in August that it had reached an agreement with Janssen, a pharmaceutical subsidiary of J&J, worth approximately $ 1 billion for 100 million doses of its vaccine. The deal gives the federal government the option of ordering an additional 200 million doses, according to the announcement.
Stoffels said the company plans to distribute the vaccine between 2 and 8 degrees Celsius, which is around 36 to 46 degrees Fahrenheit.
“We have three months of stability right now at 2-8,” he said. “This will be expanded over the year as we generate more stability data. We know from our other vaccines that it can go up to a year, but at the beginning we cannot do that because we don’t have it for this vaccine. “