Johnson & Johnson begins Phase 3 Covid-19 vaccine trial in U.S.

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Source: NBC news

By Erika Edwards

The drugmaker’s vaccine candidate is the fourth to enter final-phase human trials in the country.

A fourth Covid-19 vaccine candidate has gone into the final stage of clinical trials in the U.S., with Johnson & Johnson announcing the start of its Phase 3 trial Wednesday.

The drugmaker follows Pfizer and Moderna, whose Phase 3 trials began in late July. AstraZeneca also started its Phase 3 vaccine trial this month, but it remains on pause in the U.S. after a participant in the U.K. was reported to have developed a spinal cord injury.

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The Johnson & Johnson trial is not expected to yield preliminary results for at least two months.

President Donald Trump has repeatedly pressed for faster work on vaccine research — even suggesting that there could be some kind of approval before the Nov. 3 election. That timeline would be impossible, at least for Johnson & Johnson, whose interim results are not expected until late November at the earliest.

Johnson & Johnson’s vaccine candidate, which is being developed in partnership with Janssen Pharmaceuticals, differs in several ways from the others that have reached the final stage of trials.

Unlike Pfizer’s and Moderna‘s vaccines — which require two doses about a month apart — the Johnson & Johnson vaccine can be administered fully in one dose, avoiding the complicated coordination to require that people return in time for the second dose.

In addition, the Johnson & Johnson vaccine requires basic refrigeration for storage. Pfizer’s vaccine must be stored at minus 94 degrees Fahrenheit. (For comparison, that’s colder than the South Pole’s average winter temperature: minus 76 degrees.)

Moderna has aimed to enroll 30,000 participants, and Pfizer expects to sign up 44,000 in U.S. Phase 3 trials. Johnson & Johnson’s enrollment will be much larger, aiming for 60,000 people.

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Categories: Vaccine

3 replies

  1. Fauci ‘cautiously optimistic’ about coronavirus vaccine approval by end of 2020

    Fauci reiterated that he has no qualms about receiving an FDA-approved vaccine.

    “If a vaccine that is shown to be, and proven to be and authorized by the FDA to be safe and effective, I certainly would take that vaccine, and I would recommend to my family that they take this vaccine,” Fauci said.

    Fauci said having an approved coronavirus vaccine by Election Day was “unlikely,” although not “impossible,” in an interview with PBS NewsHour earlier in September.

    President Trump has said a coronavirus vaccine could be available “during the month of October,” putting its arrival before Election Day.

    https://www.foxnews.com/politics/coronavirus-vaccine-timeline-dr-fauci-covid-19

  2. Hahn says F.D.A. decisions are based on science and the agency would ‘not permit any pressure from anyone to change that.’
    Four of the Trump administration’s top health officials helping to steer the government’s coronavirus response tried to defend their scientific integrity on Wednesday, amid mounting evidence that President Trump and his administration are trying to interfere with their agencies’ decision making and growing public doubts about whether a Covid-19 vaccine will be safe.

    In testimony before the Senate health committee, the officials — Dr. Anthony S. Fauci, the director of the Institutes of Allergy and Infectious Diseases; Dr. Stephen Hahn, the commissioner of food and drugs; Dr. Robert R. Redfield, the director of the Centers for Disease Control and Prevention and Adm. Brett P. Giroir, the assistant secretary for health — each said they would take a vaccine and recommend their families do the same should the Food and Drug Administration deem it safe and effective.

    Their vows carried echoes of an earlier era, when Jonas Salk, the inventor of the polio vaccine, inoculated himself and his children before testing it on the public. In their remarks, just a day after the U.S. surpassed 200,000 virus-related deaths, the doctors all acknowledged — without pointing fingers at the president — that faith in their institutions had been shaken, and said they were committed to restoring it.

    “Every one of the decisions we have reached has been made by career F.D.A. scientists based on science and data, not politics,” Dr. Hahn told the panel, adding that he would “not permit any pressure from anyone to change that.” especially regarding whether to grant emergency approval to any Covid-19 vaccine. The agency, he added, will seek guidance from a panel of outside experts and the process “will be transparent and independent.”

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