Johnson & Johnson : J&J's Covid-19 Vaccine Is Safe and Effective, FDA Says--Update 2

By Thomas M. Burton and Peter Loftus

The U.S. Food and Drug Administration said Johnson & Johnson's single-dose Covid-19 vaccine works safely, paving the way for the approval of a third vaccine in the U.S. as early as this weekend.

The vaccine was 66.1% effective in preventing moderate to severe disease and appeared safe, the U.S. Food and Drug Administration said Wednesday, and the shot also showed tantalizing signs of slowing the spread of the virus.

J&J's shot would be the third cleared for use in the U.S., as health authorities pick up the pace of vaccinations and try to lock in gains reducing daily cases, hospitalizations and deaths while staying ahead of any new variants that threaten to evade treatment.

Health authorities have been looking forward to adding a new Covid-19 vaccine to their arsenal. J&J's shot wasn't quite as effective in its late-stage trial as the pair already in use, but it worked safely by a number of measures, the FDA said, after reviewing a 44,000-subject study.

J&J's vaccine "met the prespecified success criteria" for the study, the FDA said.

Health experts say people shouldn't hold out for the other shots and get the J&J vaccine if it is authorized and offered, because it provides protection, especially against severe disease.

Aside from effectiveness, the J&J vaccine comes with advantages over the available shots that could help it accelerate and broaden mass vaccination efforts. Unlike the two vaccines in use, J&J's shot requires just a single dose.

Intriguingly, J&J released new information, in an analysis that the FDA posted along with its own, suggesting the vaccine might also help reduce asymptomatic spread of the coronavirus. The vaccine reduced infections that didn't cause symptoms in study subjects, J&J said.

Public-health officials say that a vaccine that can block such infections will be critical to limit the spread of the coronavirus and ease the pandemic. One of the reasons the virus has spread so widely is because of asymptomatic transmission.

A committee of outside medical specialists convenes Friday to evaluate analyses of the vaccine's pivotal-study results by both the FDA and the company, as the panel did for the first two Covid-19 vaccines to be cleared for use.

The advisory committee is expected to recommend the FDA authorize the J&J vaccine, and the agency is expected to make its decision soon after. FDA authorization could come as early as this weekend, according to a person familiar with the matter.

The regulatory green light would bolster vaccination efforts just as health authorities pick up the pace to get people back to schools, offices and other establishments ahead of new strains that threaten to evade medicines.

Health authorities expect the initial supply of the J&J vaccine will help ease, though not eliminate, the frustration felt by people unable to sign up for shots because there aren't enough doses available.

J&J has said it would deliver about 20 million doses for U.S. use by the end of March, which may be enough to boost the countrywide capacity for completed vaccinations by about 20%.

The two other Covid-19 vaccines authorized in the U.S. come from Moderna Inc. and from a partnership between Pfizer Inc. and Germany's BioNTech SE. The companies have projected delivering enough of their two-dose vaccines by the end of March to immunize 100 million people.

Each of those vaccines requires two shots to confer their full benefit. The J&J vaccine involves only one shot, a factor that also may ease the logistics of delivering doses. The shot also doesn't require ultracold temperatures, meaning that sites without expensive freezers can start vaccinations.

The late-stage study evaluating J&J's vaccine primarily measured whether the vaccine prevented cases of Covid-19 that resulted in moderate to severe symptoms. The study took place in the U.S., South Africa and other countries.

FDA issued its analysis of the data, and the agency also posted J&J's analysis.

On the vaccine's ability to curb the spread of the virus, J&J said a preliminary analysis of a subset of study subjects suggested the vaccine was 65.5% effective in preventing infections that caused no symptoms. J&J cautioned, however, that more analysis is needed to confirm whether the vaccine prevents asymptomatic infections.

Generally in the study, the vaccine proved to be effective protecting against moderate and severe Covid-19. There were seven Covid-19 deaths among study subjects getting a placebo, compared with no deaths among those who got the vaccine, the FDA said. Likewise, fewer people who got the vaccine developed critical Covid-19 cases than volunteers on placebo did.

The vaccine's efficacy was roughly comparable across most demographic subgroups in the study. However, it was only 42.3% protective in people 60 and over who had certain medical conditions such as diabetes and hypertension, J&J said.

The FDA found there were two Covid-19 hospitalizations starting 14 days in the vaccine group, versus 29 in the placebo group. There were no new hospitalizations after 28 days in people vaccinated, while in the placebo group there were 29.

In the U.S. alone, the vaccine was 72% effective, J&J said. The shot wasn't as effective in South Africa alone, where a new and more transmissible variant of the virus has emerged.

J&J said the vaccine's efficacy ranged from 52% to 64% from two weeks to a month after vaccination among South Africa trial subjects.

The company said its vaccine performed even better protecting against severe disease in South Africa, with the vaccine from 73.1% to 81.7% effective two weeks to a month after vaccination. South Africa has begun rolling out vaccinations with J&J's shot.

The vaccine's efficacy was even higher in Brazil, where another variant has spread.

Several Covid-19 vaccine makers including Moderna and J&J have said they are working on modified shots that could prove more effective against new Covid-19 variants.

The Pfizer-BioNTech and Moderna vaccines recorded higher effectiveness rates -- 95% and 94.1% respectively -- in their late-stage trials than J&J's vaccine.

Those companies' trial results, however, occurred largely before new variants are known to have emerged.

Health authorities have said that the J&J vaccine was sufficiently protective -- especially against severe disease -- which, together with its single-dose regimen and favorable temperature requirements, should help make a difference in the pandemic.

The FDA analysis and advisory-committee meeting are intended to reinforce public confidence in the vaccine, and the FDA's evaluation would appear to do that.

The vaccine appeared generally safe. The most common side effects, J&J said, were headache, fatigue, muscle ache and injection-site pain. Most weren't severe. There were no severe allergic reactions known as anaphylactic reactions in studies of its vaccine -- something that has occurred rarely in those receiving the Pfizer and Moderna vaccines.

J&J said there were three non-Covid deaths among vaccine recipients in the study but none was considered related to the vaccine, while 16 people who had received a placebo died, some from non-Covid causes.

J&J said one vaccine recipient in the study experienced a condition called transverse sinus thrombosis, a type of blood clot in the brain, resulting in cerebral hemorrhage.

This serious event led to a pause in testing of J&J's vaccine in October because researchers initially thought it was related to the vaccine. J&J said study investigators subsequently determined it was related to the patient's pre-existing medical conditions and not the vaccine. The study resumed enrollment later in October.

The expected FDA action is known as an emergency-use authorization, a designation created by federal law to deal with situations like the current global pandemic.

It falls short of a full FDA approval. Yet the FDA has nevertheless required large clinical studies, as well as following study volunteers for a median of two months following vaccination.

J&J has said it expects to ship 100 million doses throughout the U.S. by late June and to supply more than one billion doses world-wide during 2021.

Pfizer and Moderna have committed to supplying enough doses by the end of July to vaccinate 300 million people in the U.S.

Write to Thomas M. Burton at [e-mail] and Peter Loftus at [e-mail]

(END) Dow Jones Newswires

02-24-21 1444ET