FDA panel endorses Johnson & Johnson vaccine

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UPDATE 5:17 p.m.:

An independent Food and Drug Administration advisory panel recommended that the agency authorize Johnson & Johnson’s coronavirus vaccine for emergency use.

The panel voted 22-0 on Friday in favor of the shot, which is poised to become the third cleared for use in the United States. FDA authorization could come as early as this weekend.

J&J’s vaccine is given as one shot, in contrast to already authorized vaccines from Moderna and Pfizer which are given as two shots. The J&J shot also has less onerous transportation and storage requirements since it can be kept at refrigerator temperatures, rather than frozen.

Johnson & Johnson has said that it will have 4 million doses available upon authorization, with 20 million doses delivered by the end of March. The company has promised the U.S. government a total of 100 million doses by late June.

ORIGINAL STORY:

A Food and Drug Administration advisory committee is expected to endorse Johnson & Johnson’s coronavirus vaccine later Friday, with panel members framing the shot as a crucial third option to vaccinate millions of Americans.

The vaccine appears broadly effective against the virus and is especially good at preventing severe cases, according to data presented by FDA staff and Johnson & Johnson at the meeting. And because the vaccine is given as a single dose and is easy to ship, it presents an appealing profile for public health officials struggling to vaccinate hard-to-reach or skeptical populations — groups of people increasingly in the sights of state leaders launching outreach efforts.

“We need vaccines that are effective and well-tolerated. And importantly, ones that are simple to deploy,” said Gregory Poland, director of the Mayo Clinic’s vaccine research group, who spoke at the meeting as part of J&J’s presentation.

The FDA panel, known as the Vaccines and Related Biological Products Advisory Committee, will vote Friday on the merits of the shot; the agency is not bound by the group’s recommendations but often follows them.

But despite signs that the panel will vote in favor of the J&J vaccine, questions remain about its efficacy in older people with some common health problems.

The company’s limited data on how well the vaccine protects people over 60 years old with risk factors — conditions such as obesity, heart problems and diabetes — suggests the shot may be only about 42 percent effective in that group. Both FDA and the manufacturer say that the sparse data could skew those results and the shot could turn out to be more effective after additional data is collected.

There are also concerns about blood clots in people who received the vaccine, though most of them had prior health conditions. J&J insists there is no tie to the shot, but FDA said it is worth monitoring how often blood clots occur in the broader population to get solid answers about what happened for those people, including a 25-year-old with no prior medical conditions.

Those questions could set the vaccine up for more limited use than its predecessors from Pfizer/BioNTech and Moderna. Both those vaccines — based on messenger RNA technology — are cleared for adults of all ages, without serious concerns about side effects.

The J&J vaccine uses a different technique that relies on an adenovirus modified to pump out harmless copies of the spike protein that the coronavirus uses to latch onto cells.

Data in 193,000 people who have received other J&J vaccines made with the same technology — such as an approved Ebola shot — suggests that it should be safe in seniors, pregnant women and people with conditions like HIV/AIDS, said Johan Van Hoof, global therapeutic head for these types of vaccines at J&J’s pharmaceutical unit Janssen, at the FDA meeting.

Vaccine experts and health care providers insist that the J&J shot could take a key role in curbing Covid-19 hospitalizations and deaths. While the vaccine is less effective than its authorized peers at broadly preventing infection — and significantly less effective against B.1.351, the variant first found in South Africa — it is extremely effective at curbing severe illness.

J&J executives are keen to emphasize this advantage.

“It’s all about the fear of getting really sick and getting sick enough potentially to seek medical attention, and to the point where one might need to go to the hospital or even die,” said Mathai Mammen, Janssen’s global research and development head, on an investor call in January. “Success against severe illness is by far the most important feature from a public health standpoint.”

Experts on the FDA panel largely appear to agree that this is a key benefit — to the point that it could even been considered a primary goal, or endpoint, in vaccine trials along with the current goal to prove broader protection.

“All the vaccines seem to be equally effective at preventing very severe disease, intensive care needs and death. Has FDA considered that perhaps a different endpoint should be considered in terms of granting an [emergency use authorization] in the future?” asked Cody Meissner, a panel member and director of pediatric diseases at Tufts University School of Medicine. An FDA representative said the agency’s expectations had not changed.

The public health advantages of J&J’s shot also took center stage in the first hours of the meeting.

“This one dose regimen offers important logistical and practical advantages for mass vaccination campaigns. It can lead to the ability to reach both individual and herd immunity more quickly,” said Poland, who presented in the company’s session. “Essentially, it simplifies the process. People only have to make one appointment for their complete vaccination.”

But the shot also presents a complex messaging challenge for federal and state health officials who worry that the public will forgo the less broadly effective J&J vaccine for a chance at the Pfizer or Moderna shots.

“That, I think, is not a good idea. I think people should get vaccinated,” said Anthony Fauci, the nation’s top infectious disease expert, on NBC’s “The Today Show” Thursday. “Take the vaccine. This is a race … between the virus and getting vaccines into people. The longer one waits, not getting vaccinated, the better chance the virus has to get a variant or a mutation.”

Members of the advisory committee also voiced concerns about consumer confusion. Paul Offit, a vaccine expert at the University of Pennsylvania, asked J&J representatives about ongoing studies testing two shots — rather than one — in volunteers and possibly people from the placebo arm who want vaccinations.

“You can see where that would be confusing for people” who could think they did not get the full regimen, said Offit. “It’s a messaging challenge.”

Still, state and local public health officials have expressed optimism about the coming J&J shot, which FDA is likely to authorize in a matter of days. New York City Mayor Bill de Blasio said this week that the third option could “supercharge” mass vaccination efforts: “It’s single dose, easier refrigeration standards,” he told reporters.

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