Illustration of the Johnson & Johnson Coronavirus Vaccine
Given Ruvic | Reuters
Johnson & Johnson’s single-dose coronavirus vaccine is safe and appears to generate a promising immune response in both young and elderly volunteers, according to study data 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 65 and older to either a high or low dose of the 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 researchers say play an important role in the defense of cells against the virus after 28 days, according to the study 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 to 55 years age group.
The most common side effects were fever, fatigue, headache, muscle aches and pain at the injection site, according to the study data. Side effects were less common in the older age group, who received only one dose of the vaccine, and in those who received a lower dose of the vaccine, according to the data.
The data from the phase one and two clinical studies show that a single injection of the vaccine “produces durable antibodies,” said Dr. Paul Stoffels, Chief Scientific Officer at J&J, in an interview to 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 release the results of its phase three study of 45,000 individuals later this month. J&J uses the same technologies it used to develop its Ebola vaccine for its Covid-19 vaccine.
US officials and Wall Street analysts are eagerly awaiting the approval of J & J’s vaccine, which could happen 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 start of the pandemic.
If J & J’s vaccine is approved by the Food and Drug Administration, it would be the third approved for use in the US behind the Pfizer-BioNTech vaccine and Moderna’s. Pfizer’s vaccine was approved on December 11 and Moderna’s a week later, on December 18.
The data comes as US officials complain that the rate of vaccinations has been too slow as the supply of vaccine doses exceeds demand. The Centers for Disease Control and Prevention on Tuesday expanded the guidelines for the suitability of Covid vaccines to include people 65 and older and those with pre-existing conditions. The government is also changing the way it assigns Covid vaccine doses and is now basing it on how quickly states can give injections and the size of their elderly population.
The Trump administration will also stop withholding millions of doses reserved for the second round of shots of Pfizers and Moderna’s two-dose vaccines, the official said, adding that they have released doses held in reserve on Sunday. President-elect Joe Biden’s transition team announced a similar plan on Friday.
Unlike Pfizer and Moderna’s approved vaccines, which require two doses three to four weeks apart, J & J’s only needs one dose. This means that patients do not have to come back for a new dose, simplifying logistics for healthcare providers.
The Department of Health and Human Services announced in August that it had reached a deal with Janssen, J & J’s pharmaceutical subsidiary, worth approximately $ 1 billion for 100 million doses of its vaccine. The deal gives the federal government the ability to order an additional 200 million doses, the announcement said.
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 from this point on at 2 to 8,” he said. “That will expand over the year as we generate more stability data. We know from our other vaccines it can take up to a year, but we can’t do that at the beginning because we don’t have it for this vaccine.”