Johnson & Johnson Covid-19 vaccine: FDA advisers consider recommending single-dose vaccine


The vaccine is the third under study for the US market and is believed to be the first single dose Covid-19 vaccine available here. Like previous Covid-19 vaccines, it has been developed and tested at a remarkable rate, condensing into months what could have taken years before the pandemic.

But there are few answers on what will happen if and when it is allowed. The White House said on Monday that it had yet to plan to distribute the vaccine if it got clearance. There are vague totals on the number of doses available immediately and no word on where exactly those doses are going.

The Biden administration said last week that, if allowed, there would likely be millions of single-digit doses available in the coming weeks. Johnson & Johnson’s Dr Richard Nettles on Tuesday will say the plan “is to begin shipping immediately after emergency use clearance, and to deliver enough single doses by the end of March to allow for vaccination of more than 20 million Americans, “according to prepare remarks to be presented to a subcommittee of the House Committee on Energy and Commerce. Yet clinical trial researchers are convinced that Johnson’s vaccine & Johnson will be cleared quickly, as happened with the Pfizer / BioNTech and Moderna Covid-19 vaccines.

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

Johnson & Johnson formally applied to the FDA for emergency use clearance on February 4. Adding a third vaccine to the mix – especially a vaccine that only requires a single dose – would add both supply and flexibility to U.S. vaccination efforts.

“It seemed to work very well in preventing the more severe form of the disease,” said Dr. Jeff Carson, who co-led the trial at Rutgers Biomedical and Health Sciences. Its trial arm, J&J’s second largest, had more than 800 volunteers. “We haven’t received any data on side effects from the company, but I feel it’s not a big deal at all. ”

“I think it will be approved, and we definitely need it,” Carson said.

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

How vaccines differ

On Friday, the FDA committee will review any potential safety concerns. With the Moderna and Pfizer vaccines, for example, the committee asked about a handful of cases of severe allergic reactions to these vaccines. Serious side effects were extremely rare.

The committee will also review the efficacy of the vaccine. According to the Johnson & Johnson interim results, the data showed the vaccine to be 66% effective in preventing moderate and severe disease. Overall, the vaccine is 85% effective in preventing hospitalization and 100% effective in preventing death in all areas where it has been tested.

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Its effectiveness against moderate and severe disease varies from country to country: 72% in the United States, 66% in Latin America and 57% in South Africa. This was measured from one month after firing.

The regional efficiency differences may be partly due to the number of variants in circulation, the experts said.

In the South African arm of the clinical trial, the majority of 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 caused by the vaccination.

While the Pfizer vaccine was shown to be 95% effective in preventing symptomatic Covid infection after a person received two doses and the Moderna vaccine was 94.1% effective, the scientist said he did not was not fair to compare the vaccines because they had not been tested against each other.

The Pfizer and Moderna vaccines, with almost identical efficacy, were tested at around the same time. The J&J vaccine was tested a few months later, as other variants circulated.

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

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

“It’s the outcome of preventing hospitalization and death that is important, and for that, it’s comprehensive,” Guar said. “It’s effective with just one dose of vaccine and it works. ”

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

“My advice to all of my patients and friends will be to get the first vaccine you can get. That’s what matters most, being protected, ”Carson said. All vaccine makers are looking at whether a booster dose might offer better protection against the coronavirus variants. J&J also has an ongoing late phase trial to test a two-dose vaccination program; the company is expected to achieve these results in the second half of 2021.

What happens next

Johnson & Johnson say they are confident about their single dose vaccine candidate.

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“The company’s EUA submission is based on leading efficacy and safety data from the ENSEMBLE phase 3 clinical trial, demonstrating that the investigational single-dose vaccine met all endpoints primary and key secondary, ”a J&J spokesperson said in an email to CNN. “A single dose vaccine is considered by the World Health Organization to be the best option in pandemic situations, improving access, distribution and adherence. ”

If the committee recommends an emergency use authorization for the J&J vaccine, the FDA will then decide whether it wishes to accept that recommendation. This is usually the case, and he could make his decision almost immediately, as he did with the Pfizer and Moderna vaccines.

Next, the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet to discuss whether the vaccine should be given to Americans, and if so, this committee helps. decide who 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 soon after. Johnson & Johnson’s vaccine is expected to be easier to distribute and would only require one vaccine.

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

Push for more doses

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However, questions remain about the number of doses available. When asked, the company would not directly address specific weekly production numbers. 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 grappling with ramping up production, and the Biden administration has been monitoring manufacturing closely, saying it is doing “everything we can” to speed up the delivery schedule.

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

Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and chief medical adviser to the White House, said on Monday that more doses would come later.

“There won’t be a lot of doses right after the EUA, but it will accelerate as we move into the months towards the contractual arrangement where 100 million doses will be administered,” Fauci said.

It’s also unclear who might be in line for the vaccine. Andy Slavitt, senior advisor to the White House Coronavirus Response Team, said on Monday that the federal government would await a decision from the FDA and advice from the CDC committee.

Fauci said the FDA could find information in the trial data that would suggest the best strategies for distributing it.

“In the data, there may be clues as to how it would be used in the most appropriate and efficient way. When we find out, then the distribution policy would become much more scientific, ”said Fauci


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