Johnson & Johnson one-shot safe, generates an immune response

Johnson & Johnson’s single-dose coronavirus vaccine is safe and appears to generate a promising immune response in young and elderly volunteers, according to trial data published Wednesday in the New England Journal of Medicine.

J&J scientists randomly assigned healthy adults aged 18 to 55 and 65 and older to receive a high or low dose of its 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 said play an important role in the cells’ defense against the virus, after 28 days, according to the test data. 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 age group.

The most common side effects were fever, fatigue, headache, muscle pain, and pain at the injection site, according to trial data. Side effects were less common in the older group, who received only one dose of the vaccine, as well as those who received a lower dose of the vaccine, the data showed.

Data from phase one and two clinical trials show that a single shot of the vaccine “produces lasting antibodies,” Dr. Paul Stoffels, scientific director at J&J, told CNBC’s Meg Tirrell in an interview. He added that this 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 trial of 45,000 people later this month. J&J uses the same technologies used to develop its Ebola vaccine for its Covid-19 vaccine.

U.S. officials and Wall Street analysts are eagerly awaiting J & J’s vaccine clearance, 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 start of the pandemic.

If J & J’s vaccine is cleared by the Food and Drug Administration, it would be the third approved for use in the United States behind the Pfizer-BioNTech and Moderna vaccine. Pfizer’s vaccine was cleared on December 11, and Moderna’s was cleared a week later, on December 18.

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 broadened the Covid vaccine eligibility guidelines to include people 65 and older as well as people with pre-existing conditions. The government is also changing the way it allocates Covid vaccine doses, now based on how quickly states can administer vaccines and the size of their elderly population.

The Trump administration will also stop withholding millions of doses set aside for the second round of two-dose vaccines from Pfizer and Moderna, the official said, adding that they released doses that were being held in reserve on Sunday. President-elect Joe Biden’s transition team announced a similar plan on Friday.

Unlike the licensed vaccines from Pfizer and Moderna, which require two doses about three to four weeks apart, J & J’s only require one dose. This means that patients won’t have to come back 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, the pharmaceutical subsidiary of J&J, worth about $ 1 billion for 100 million doses of its vaccine. The deal gives the federal government the ability to order an additional 200 million doses, according to the announcement.

Stoffels said the company plans to ship the vaccine between 2 and 8 degrees Celsius, or around 36 to 46 degrees Fahrenheit.

“We have three months of stability from this point between 2 and 8,” he said. “This will be expanded over the course of the year as we generate more stability data. We know that with our other vaccines it can be up to a year, but at first we can’t do it. because we don’t have it for this vaccine. “