FDA could authorize the Johnson & Johnson COVID vaccine this week. How will it help NC?

Adam Wagner
·6 min read

A critical U.S. Food and Drug Administration committee will meet this week to consider signing off on a third COVID-19 vaccine, a step that North Carolina health leaders say could help the state meet the huge demand for vaccine.

The FDAs vaccine advisory committee will meet Friday to consider an emergency use authorization for the vaccine developed at Johnson & Johnson’s Janssen Pharmaceuticals. Emergency use authorizations for both the Pfizer-BioNTech and Moderna vaccines were issued the day after their committee hearings in December.

J&J’s vaccine uses a different technology than the previously approved shots and only requires one dose, rather than two. While its efficacy data did not meet the extremely high results of Moderna and Pfizer’s, health officials have stressed that the J&J vaccine is still viable and could play a crucial role in ending the COVID-19 pandemic.

“If it were the vaccine that were available, or if it were the vaccine that had been available first, it’s the one that I would have lined up to get,” said Dr. Tony Moody, a professor in the Duke University Human Vaccine Institute, in an interview with The News & Observer.

Here are some answers to common questions about the Johnson & Johnson vaccine and how it could affect North Carolina.

Will the Johnson & Johnson vaccine make it easier for me to get a shot?

Assuming the J&J vaccine receives necessarily approvals, it would be a third option available to the public.

In addition to only requiring one shot, the vaccine does not necessarily need the ultra cold temperatures required by the Pfizer formula. Instead, it can last for at least three months in a standard refrigerator without expiring. That could make it easier to reach rural areas.

Dr. Richard Nettles, a Johnson & Johnson executive, testified before a U.S. Congressional committee on Tuesday. He said the company will begin to ship doses as soon as it receives regulatory approval. The company stands prepared to provide more than 20 million doses by the end of March and 100 million doses in the first half of 2021, Nettles said.

Dr. Mandy Cohen, Secretary of the N.C. Department of Health and Human Services, said the state developed its timeline for frontline essential workers with the J&J vaccine in mind.

“What we were anticipating was this additional vaccine, with Johnson & Johnson in the coming weeks,” Cohen said Tuesday while answering questions from the N..C. House Health Standing Committee.

Cohen went on to say that she is hopeful the J&J vaccine is available by March 10, the date North Carolina has said frontline essential workers — those who aren’t teachers — will be eligible to receive a COVID-19 vaccine. Frontline essential workers are part of Group 3, a diverse group that includes farm workers, firefighters, grocery store staff and police officers, among any others.

“We’re hopeful that that timing will align, us getting more vaccine and moving on in the additional prioritization,” Cohen said.

Is the Johnson & Johnson vaccine less effective?

In clinical trials, the J&J vaccine was 66% effective at preventing moderate to severe cases of COVID-19, with protections rising as soon as two weeks after inoculation.

By comparison, the Pfizer-BioNTech vaccine was 95% effective at preventing symptomatic COVID-19 in clinical trials, while the Moderna vaccine was 94.1% effective.

Moody, the Duke doctor, said he would urge everyone to take whichever vaccine is available.

“Is the difference between 90 and 70 (percent) really that big?” Moody said. “Well, it is if you were gambling money, probably. But if you’re talking about having to wait a month or two months or six months to get the ‘better’ vaccine versus getting the one that’s available now that gives you some protection, by all means get the one now. Because some protection is better than no protection.”

During a call with investors in late January, Mathai Mammen, the global head of research and development for J&J’s pharmaceutical division, urged against comparing the clinical trial results.

J&J’s vaccine was tested at a different point in the pandemic than the Moderna or Pfizer vaccines, Mammen said. That meant it often faced different, more infectious variants of the coronavirus.

For instance, the J&J vaccine was 57% effective in South Africa, where nearly every case was a new, highly infectious strain of the virus that was first sequenced in that country. The same strain has since been found in North Carolina.

“The pandemic’s evolved a lot, and an apples-to-apples (comparison) simply isn’t possible,” Mammen said. “If one took the same vaccine and studied it prior or now, you’d very likely see different data.”

But, J&J officials said, the vaccine was 85% effective at preventing severe disease after four weeks in every region where it was tested, with those receiving the vaccine reporting no hospitalizations or deaths after four weeks. And after seven weeks, J&J said, there were no cases of severe COVID-19.

“These vaccines seem to be really, really good at preventing severe disease,” Moody said, “which is a big deal not just for personal protection but for limiting impact on the health system.”

How is the J&J vaccine different?

For one thing, the J&J vaccine was tested using a single shot, where both the Moderna and Pfizer vaccines are two shots.

“From a public health perspective, a vaccine that could be given as one shot is advantageous,” Moody said.

For instance, those giving the vaccine would only have to schedule one appointment, not two. And those receiving it would only have to worry about getting to a vaccine site one time.

Johnson & Johnson is still conducting clinical trials on a two-dose regimen to see if it offers more protection.

Does the J&J vaccine work differently?

Yes, the J&J vaccine uses a different technology than the two that are already available.

“You’re basically delivering the same thing, you’re just doing it in a different way,” Moody said.

Both Moderna and Pfizer-BioNTech developed their vaccines using messenger RNA, injecting a piece of code that tells the body to make a piece of the spike protein that is a hallmark of the virus that causes the coronavirus. Once the protein is made, the body learns how to create antibodies that it can use to fight the virus, all without the threats posed by an active infection, according to the Centers for Disease Control and Prevention.

The J&J vaccine works by infecting someone with an adenovirus that is carrying information about the spike protein, Moody said. Adenoviruses are common and cause a wide range of illnesse, from the common cold to pink eye. J&J said in a press release that it has modified the virus in its vaccine in order to avoid replicating.

Once the vaccine has been injected, the adenovirus enters cells and makes the coronavirus spike protein, allowing the body to learn how to fight off a potential infection.

“The goal is to get the body to essentially train itself to respond to the natural SARS-CoV-2 and prevent you from getting sick, and this vaccine seems to do that,” Moody said.