Johnson & Johnson’s unique coronavirus vaccine is safe and appears to produce promising immune responses in both young and elderly volunteers. This emerges from the 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 over 65 to receive a high or low dose of the vaccine – called Ad26.COV2.S – or a placebo. Some participants in the 18- to 55-year-old age group were also selected to receive a second dose of the vaccine.
Most volunteers produced detectable neutralizing antibodies after 28 days, according to the experimental data, which researchers believe play an important role in the defense of cells against the virus. By day 57, all volunteers had detectable antibodies regardless of vaccine dose or age group, and were stable for at least 71 days in the 18- to 55-year-old age group.
According to experimental data, the most common side effects were fever, tiredness, headache, muscle pain and pain at the injection site. Side effects were found to be less common in the older age group who received only one dose of vaccine and in those who received a lower dose of vaccine, according to the data.
Data from the first and second phase clinical trials show that a single shot of the vaccine “delivers sustainable antibodies,” said Dr. Paul Stoffels, Chief Scientific Officer at J & J, in an interview with Meg Tirrell at CNBC. He added that it gave the company “confidence” that the vaccine will be highly effective against the virus.
805 volunteers were tested in the study. The company is expected to release the results of its 45,000-person Phase 3 study later this month. J&J uses the same technologies that it used to develop its Ebola vaccine for its Covid-19 vaccine.
US officials and Wall Street analysts are eagerly anticipating J & J’s vaccine approval, which could come as early as next month. Public health officials and infectious disease experts say world leaders will need a range of drugs and vaccines to fight the virus, which has killed at least 382,120 Americans since the pandemic began.
If J & J’s vaccine is approved by the Food and Drug Administration, it will be the third approved for use in the US after Pfizer BioNTech and Modernas. Pfizer’s vaccine was approved on December 11th and Moderna’s vaccine a week later on December 18th.
The data comes as US officials complain that the pace 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 approving Covid vaccines to include people aged 65 and over and people with pre-existing medical conditions. The government is also changing the way Covid vaccine doses are allocated, now based on how quickly states can administer shots and how large their elderly population is.
The Trump administration will also stop holding back millions of doses reserved for the second round of vaccinations with Pfizer and Moderna in two doses, the official said, adding it had released doses that were held in reserve Sunday. President-elect Joe Biden’s transition team announced a similar plan on Friday.
Unlike the vaccines approved by Pfizer and Moderna, which require two doses three to four weeks apart, J&J only requires one dose. This means that patients do not have to return for another dose, which simplifies logistics for healthcare providers.
The Department of Health and Human Services announced in August that it had signed a contract 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 opportunity to order another 200 million cans, according to the announcement.
Stoffels said the company plans to ship the vaccine at 2 to 8 degrees Celsius, which is around 36 to 46 degrees Fahrenheit.
“We have three months of stability at 2 through 8 from that point,” he said. “This will expand later in the year as we generate more stability data. We know from our other vaccines that it can take up to a year, but at the beginning we can’t because we don’t have it for this vaccine.” “