Johnson & Johnson Covid-19 vaccine: FDA committee to consider authorization for single-dose injection this week


The vaccine is the third being considered for the US market, and it would be the first single-dose Covid-19 injection available here. Like previous Covid-19 vaccines, it was developed and tested at a remarkable rate, condensing into months what could have taken years before the pandemic.

But there are few answers about what will happen if and when it is authorized. The White House said Monday it has not yet made plans to distribute the vaccine if it gets clearance. There are vague totals of how many doses will be immediately available and it is not known exactly where those doses will go.

The Biden administration said last week that, if authorized, there will likely be millions of single-digit doses available in the coming weeks. On Tuesday, Johnson & Johnson’s Dr. Richard Nettles will say the plan “is to begin shipping immediately after emergency use authorization and deliver enough single doses by the end of March to allow vaccination of more than 20 million Americans. “according to comments prepared to be presented to a subcommittee of the Chamber’s Energy and Commerce Committee.

Still, clinical trial researchers are confident that the Johnson & Johnson vaccine will be licensed quickly, as was the case with the Pfizer / BioNTech and Moderna Covid-19 vaccines.

“We hope it’s just as fast, if not faster,” said Dr. Pat Flynn of St. Jude Children’s Research Hospital in Memphis, one of the lead investigators on the J&J trial.

Johnson & Johnson officially applied to the FDA for an emergency use authorization on February 4. Adding a third vaccine to the mix, particularly a vaccine that needs only one dose, would add supply and flexibility to US vaccination efforts.
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“It seemed to work very well in preventing the most serious form of the disease,” said Dr. Jeff Carson, who co-led the trial at Rutgers Biomedical and Health Sciences. Their trial arm, J & J’s second-largest, had more than 800 volunteers. “We were not shown any side effect data from the company, but my feeling is that it is not a big problem at all.”

“I would anticipate that it will be approved, and we certainly need it,” Carson said.

Carson said he is eager to see more data on the vaccine; Details about what was sent to the FDA should be available online no later than Wednesday, according to the agency.

How are vaccines different?

On Friday, the FDA committee will look at potential safety issues. With the Moderna and Pfizer vaccines, for example, the committee asked questions about some cases of severe allergic reactions to those vaccines. Serious adverse reactions were extremely rare.

The committee will also look at how effective the vaccine is. According to interim results from Johnson & Johnson, the data showed that the vaccine was 66% effective in preventing moderate and severe disease. The vaccine has an overall efficacy of 85% in preventing hospitalization and 100% in preventing death in all regions where it was tested.
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Its efficacy against moderate and severe diseases varied from country to country: 72% in the US, 66% in Latin America, and 57% in South Africa. This was measured from one month after injection.

Differences in regional effectiveness may be due in part to the number of variants in circulation, experts said.

In the South African arm of the clinical trial, most cases were due to a variant known as B.1.351, which is more transmissible and carries mutations that make it less susceptible to the immune response of antibodies, including antibodies that would be boosted. by vaccination.

While the Pfizer vaccine was 95% effective in preventing a symptomatic Covid infection after a person received two doses and the Moderna vaccine was 94.1% effective, the scientist said that it is not fair to compare the vaccines, since they did not test each other.

The Pfizer and Moderna vaccines, with this nearly identical efficacy, were tested at approximately the same time. The J&J vaccine was tested a few months later, when more variants were circulating.

“I think in the end, we don’t know if one is better than the other,” Carson said.

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Dr. Aditya Guar, one of the researchers in the trial’s St. Jude group, said people need to understand that the J&J vaccine does its job very well.

“It is the result of preventing hospitalization and death that is important, and for that, it is complete,” Guar said. “It is effective with one dose of the vaccine and it works.”

Carson said patients and friends have been asking him if they should take the J&J vaccine when it becomes available.

“My advice to all my patients and all my friends will be to get the first vaccine they can get. That’s what matters most, protect yourself,” Carson said.

All vaccine manufacturers are investigating whether a booster dose could provide better protection against variants of the coronavirus. J&J also has an ongoing late-stage trial testing a two-dose vaccination schedule; The company is expected to have those results in the second half of 2021.

What happens next

Johnson & Johnson says it is confident in its single-dose vaccine candidate.

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“The company’s US submission is based on first-line safety and efficacy data from the ENSEMBLE Phase 3 clinical trial, demonstrating that the investigational single-dose vaccine met all key primary and secondary endpoints.” a J&J spokesperson said in an email to CNN. “The World Health Organization considers a one-dose vaccine to be the best option in pandemic settings, as it improves access, distribution and compliance.”

If the committee recommends an emergency use authorization for the J&J vaccine, the FDA will then decide whether to accept that recommendation. Usually you do, and you could make your decision almost immediately, as you did with the Pfizer and Moderna vaccines.

Next, the Advisory Committee on Immunization Practices of the US Centers for Disease Control and Prevention will meet to discuss whether the vaccine should be administered to Americans, and if so, this committee helps prioritize who you should get the vaccine first. The committee has an emergency meeting scheduled for February 28 and March 1.
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For Pfizer, the process took a little over three weeks. For Moderna, it was a little more than two.

Vaccinations could start shortly after. The Johnson & Johnson vaccine is expected to be easier to distribute and would only require one injection.

“If you think about it on a population basis, the J&J vaccine may offer more protection,” said Dr. Philip Grant, principal investigator of the J&J trial at Stanford University Medical Center. “You know if you give 10 shots of the J&J vaccine, that’s protection for 10 people. Ten shots of Pfizer or Moderna protect five people. You know, even in the short term, it will have a very important role in the United States.”

Press for more doses

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Still, questions remain about how many doses will be available. When asked, the company did not directly address specific production figures from week to week. The US government has ordered 100 million doses to be delivered by June, and J&J told CNN it can meet that commitment.

The company has been struggling to ramp up its production, and Biden’s management has been following manufacturing closely, saying it is doing “everything it can” to speed up the delivery schedule.

“The production of our vaccine is a very complex process that requires very unique skills and experiences,” according to comments prepared by Johnson & Johnson’s Nettles. “As a result, there are significant challenges inherent in scaling up production and speeding up the schedule required for a COVID-19 vaccine.”

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and the White House’s chief medical adviser, said Monday that more doses will arrive in the future.

“There won’t be many doses immediately after the USA, but that will accelerate as we move through the months toward the contractual agreement of when 100 million doses will be administered,” Fauci said.

It’s also unclear who might be in line to get the vaccine. Andy Slavitt, senior adviser to the White House coronavirus response team, said Monday that the federal government will await a decision from the FDA and guidance from the CDC committee.

Fauci said the FDA can find information in the trial data that suggests the best strategies for distributing it.

“There may be hints in the data about how this would be used in the most appropriate and effective way. When we find that out, then the distribution policy will have a much more scientific basis,” Fauci said.

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