FDA advisers to consider recommending one-dose Johnson & Johnson vaccine

    The vaccine is the third under consideration for the US market, and will be the first single-dose COVID-19 shot available here. Like earlier COVID-19 vaccines, it was developed and tested at a remarkable pace, condensing into months that could take years before the epidemic.

    But there are no answers to what and if it is authorized. The White House said on Monday that it had not yet made any plans to distribute the vaccine if it won the authority. It is unclear how many doses will be received immediately and no word will be exactly as to where those doses will go.

    The Biden administration said last week that, if it is authorized, there are probably single-digit millions of doses available in the coming weeks. On Tuesday, Johnson & Johnson’s Drs. Richard Nettles will say the plan is to “start shipping immediately on the Emergency Use Authority, and deliver enough single-doses by the end of March to enable the vaccination of more than 20 million Americans,” according to the prepared comment on Energy and Commerce Be given before a House Committee of the Subcommittee.

    Nevertheless, clinical trial investigators are confident that the Johnson & Johnson vaccine will be quickly authorized, as happened with the Pfizer / BioNotech and Modern COVID-19 vaccines.

    “We hope it will happen early, if not sooner,” Dr. of St. Jude Children’s Research Hospital in Memphis. Said Pat Flynn, one of the principal investigators of the J&J trial.

    Johnson & Johnson officially asked the FDA for the Emergency Use Authority on 4 February. Adding a third vaccine to the mix – specifically a vaccine that requires only one dose – will add both supply and flexibility to US vaccination efforts.
    “It seemed to work really well in preventing the most severe form of the disease,” Dr. Said Jeff Carson, who co-led the trial at Rutgers Biomedical and Health Sciences. His hand in the trial, J & J’s second largest, was more than 800 volunteers. “We were not shown any side effect data from the company, but I think this is not a major problem.”

    “I hope it’s going to be approved, and we definitely need it,” Carson said.

    Carson said he is eager to see more data about the vaccine; Details about what was submitted to the FDA should be available online before Wednesday, according to the agency.

    How do vaccines differ

    On Friday, the FDA committee will look into any potential safety issues. For example, with modern and Pfizer vaccines, the committee asked questions about some cases of severe allergic reaction to those vaccines. Serious adverse reactions were extremely rare.

    The committee will also look at how effective the vaccine is. According to the interim results of Johnson & Johnson, the vaccine was 66% effective in preventing moderate and severe illness. The vaccine is 85% effective at hospitalization and 100% effective at preventing death in all areas where it was tested.
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    Its efficacy against moderate and severe disease varies from country to country: 72% in the US, 66% in Latin America, and 57% in South Africa. It was launched a month after the shot.

    Experts said differences in regional effectiveness may be due to the number of variations in prevalence.

    In the South African arm of clinical trials, the majority of cases were due to a variant known as B.1.351, which is more infectious and carries mutations that make it less susceptible to antibody immune responses – to antibodies. Which would be induced by vaccination.

    While the Pfizer vaccine showed an efficacy of 95% to prevent a symptomatic COVID infection, one person received two doses and the modern vaccine was 94.1% effective, the scientist said, comparing vaccines against each other is not appropriate. The test was not done.

    Pfizer and modern vaccines, with almost equal efficacy, were tested at 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 investigators with the St. Jude arm of the trial, said that people need to understand that the Jammu and Kashmir vaccine does its job very well.

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

    Carson said patients and friends are asking him if he should take the J&J vaccine when it becomes available.

    “My advice to all my patients and all my friends would be to get vaccinated first. That’s what matters the most,” said Carson.

    All vaccine manufacturers are looking into whether booster doses can provide better protection against coronavirus variants. A two-dose vaccination program is underway in Jammu and Kashmir. The company expects those results in the second half of 2021.

    What will happen next

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

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    A J&J spokesperson said in an email to CNN, “The company’s EUA submission is based on topline efficacy and safety data from Phase 3 ENSEMBLE clinical trials, indicating that the investigative single-dose vaccine is at all primary and major secondary endpoints. See you at “One-dose vaccines are considered the best choice in epidemic settings by the World Health Organization, increasing access, delivery, and compliance.”

    If the committee recommends an emergency use authority for the Jammu and Kashmir vaccine, the FDA will next decide whether it wants to accept that recommendation. This usually happens, and it can make its decision almost immediately, as it did with Pfizer and Modern Vaccines.

    Next, the US Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices will discuss whether the vaccine should be given to Americans, and if so, this committee prioritizes who should get the vaccine first. The committee is to have an emergency meeting on 28 February and 1 March.
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    For Pfizer, the process took a little over three weeks. For the modern, it was slightly more than two.

    Vaccination may begin shortly. Johnson & Johnson’s vaccines are expected to be easy to deliver, and will require only one shot.

    The principal investigator of the Jammu and Kashmir trial at Stanford University Medical Center, Dr. Philip Grant said, “If you think about it on a population basis, the Jammu and Kashmir vaccine may provide greater protection.” “You know that if you give 10 shots of the J&J vaccine, it’s protection for 10 people. Ten shots of Pfizer or Modern are protecting five people. You know, even in the short term. , It is going to play a big role in the United States. ”

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    Nevertheless, the question is how many doses will be available. Asked if the company would not directly address specific week-to-week production numbers. The US government has ordered 100 million doses by June and Jammu and Kashmir told Granthshalathat it could fulfill that commitment.

    The company is wrestling with boosting its production, and the Biden administration has been closely monitoring manufacturing, saying it is “doing everything we can” to speed up the delivery schedule.

    According to the prepared comment by Johnson & Johnson Nettles, “The production of our vaccines is a highly complex process, requiring very specialized abilities and experiences.” “As a result, there are significant challenges inherent in boosting manufacturing output and accelerating the timeline required for a COVID-19 vaccine.”

    Director of the National Institute of Allergy and Infectious Diseases and Chief Medical Advisor of the White House, Dr. Anthony Fauci said on Monday that more doses would hit the road.

    “The EU will not have the right amount of doses on its heels, but when we are given 100 million doses, we will meet in months towards arranging the contract.”

    It is also not clear who may be in the queue for the vaccine. Andy Slavitt, a senior adviser with the White House Coronavirus response team, said on Monday that the federal government would wait on a decision by the FDA and guidance from the CDC committee.

    Fauci said that the FDA can find information in test data that would suggest the best strategy to deliver it.

    “The data may contain clues about how it will be used appropriately and most effectively. When we find out, the policy of distribution will become more scientifically based,” Fauci said.


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