Johnson & Johnson Coronavirus Vaccine Illustration
Dado Ruvic | Reuters
Johnson & Johnson’s single-dose coronavirus vaccine is safe and appears to elicit a promising immune response in young and elderly volunteers, according to trial data published in the New England Journal of Medicine on Wednesday.
Scientists from J&J randomly assigned healthy adults between 18 and 55 and 65 years and older to receive a high or low dose of its vaccine – Ad26.COV2.S – or a placebo. Some participants in the age group 18 to 55 were also selected to receive a second dose of the vaccine.
According to the trial data, after 28 days, most volunteers produced detectable neutralizing antibodies, which researchers say play an important role in defending cells against the virus. 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 to 55 age group.
According to the trial data, the most common side effects were fever, fatigue, headache, muscle aches and pain at the injection site. Side effects were less common in the older age group, who received only one dose of the vaccine, as well as those who, according to the data, received a lower dose of the vaccine.
Phase one and two clinical trial data show that a single uptake of the vaccine ‘gives sustainable antibodies’, said dr. Paul Stoffels, chief scientific officer at J&J, said in an interview with CNBC’s Meg Tirrell. He added that it gives the company ‘confidence’ that the vaccine will be very effective against the virus.
The trial tested 805 volunteers. The company is expected to announce the results of the phase three trial of 45,000 people later this month. J&J uses the same technologies it used to develop its Ebola vaccine for its Covid-19 vaccine.
U.S. officials and analysts on Wall Street are expecting the approval of J & J’s vaccination, which could happen as early as next month. Public health officials and infectious disease experts say world leaders need a variety of drugs and vaccines to defeat the virus, which has killed at least 382,120 Americans since the start of the pandemic.
If J & J’s vaccine is approved by the Food and Drug Administration, it’s the third US approved for use behind the Pfizer BioNTech vaccine and Moderna’s. Pfizer’s vaccine was approved on December 11, and Moderna’s was approved on December 18 a week later.
The data comes as U.S. officials complain that the rate of vaccinations was too slow because the supply of vaccine dose exceeds demand. The Centers for Disease Control & Prevention on Tuesday expanded the guidelines for admission to Covid vaccine to include people 65 and older as well as people with a pre-existing condition. The government is also changing the way it administers Covid vaccine doses, and now bases it on how quickly states can administer shots and the size of their elderly population.
The Trump administration will also stop withholding millions of doses reserved for the second-round shots of Pfizer and Moderna’s dual-dose vaccines, the official said, adding that they released doses held in reserve Sunday. President-elect Joe Biden’s transition team announced a similar plan on Friday.
Unlike Pfizer and Moderna’s authorized vaccines, which require two doses of approximately three to four weeks apart, J&J requires only one dose. This means that patients do not have to come back for another dose, which simplifies the 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 approximately $ 1 billion for 100 million doses of the vaccine. According to the announcement, the federal government has the option to order an additional dose of 200 million.
Stoffels said the company plans to ship the vaccine at 2 to 8 degrees Celsius, which is about 36 to 46 degrees Fahrenheit.
“We have three months of stability at the moment at 2 to 8,” he said. “It will expand over the year as we produce more stability data. We know from other vaccines that it could rise to a year, but at the beginning we can not do that because we do not have it for this vaccine.”