Johnson & Johnson requests emergency authorization from FDA for Covid vaccine

Source: CNBC

By Berkeley Lovelace Jr.

KEY POINTS

  • Johnson & Johnson applied for an emergency use authorization from the FDA for its coronavirus vaccine.
  • The company released data last week showing it was about 66% effective in protecting against the virus.
  • If J&J’s application is approved, it would be the third Covid-19 vaccine authorized for emergency use in the U.S. behind those developed by Pfizer-BioNTech and Moderna.

Johnson & Johnson applied for an emergency use authorization from the Food and Drug Administration for its coronavirus vaccine after releasing data last week showing it was about 66% effective in protecting against the virus.

If J&J’s application is approved, it would be the third Covid-19 vaccine authorized for emergency use in the U.S. behind those developed by Pfizer-BioNTech and Moderna. Pfizer’s vaccine was authorized by the FDA on Dec. 11, and Moderna’s was authorized a week later.

“Today’s submission for Emergency Use Authorization of our investigational single-shot COVID-19 vaccine is a pivotal step toward reducing the burden of disease for people globally and putting an end to the pandemic,” J&J’s chief scientific officer, Dr. Paul Stoffels, said in a statement.

“Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping,” he said. “With our submission to the FDA and our ongoing reviews with other health authorities around the world, we are working with great urgency to make our investigational vaccine available to the public as quickly as possible.”

The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee on Feb. 26 to discuss the emergency use authorization.

“A public discussion by the advisory committee members about the data submitted in support of safety and effectiveness of Janssen Biotech Inc.’s COVID-19 vaccine will help ensure that the public has a clear understanding of the scientific data and information that FDA will evaluate in order to make a decision about whether to authorize this vaccine,” acting FDA Commissioner Janet Woodcock said in a statement. “The FDA remains committed to keeping the public informed about our evaluation of the data for COVID-19 vaccines, so that the American public and medical community have trust and confidence in FDA-authorized vaccines.”

U.S. officials and Wall Street analysts are eagerly anticipating the authorization of J&J’s vaccine, which could happen as early as this month. President Joe Biden is trying to pick up the pace of vaccinations in the U.S. and experts say his administration will need an array of drugs and vaccines to defeat the virus, which has killed more than 450,000 Americans over the last year, according to data compiled by Johns Hopkins University.

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Categories: Vaccine

15 replies

  1. Johnson & Johnson on Thursday submitted to the Food and Drug Administration an application for emergency authorization for its one-dose coronavirus vaccine, putting the company on track to potentially begin shipping it by early March.

    The agency has scheduled a meeting with its outside advisory panel, which will vote on whether the F.D.A. should authorize the vaccine on Feb. 26, according to people familiar with the planning.

    That leaves regulators about three weeks to pore over a large and complex application that includes clinical and manufacturing data. A decision on whether to authorize the vaccine could come within days of that meeting.

    A similar timeline was used for the review of two-dose vaccines made by Pfizer-BioNTech and Moderna, which were authorized by the F.D.A. in December.

  2. The global economy’s recovery risks being dampened or even derailed by the lag in coronavirus vaccinations for poorer nations relative to their wealthier peers.

    Bloomberg’s Vaccine Tracker shows 4.54 million doses were given on average across the world each day over the last week, but it’s far from an even spread. The U.S. and U.K. make up about 40% of the 119.8 million doses administered globally.

    Developing and emerging markets are, by and large, doing far less well. In Africa, only Egypt, Morocco, Seychelles and Guinea are recorded as having given any of the vaccines at all. Much of Central Asia and Central America has yet to begin vaccinating, or is moving slowly.

    https://www.bloomberg.com/news/articles/2021-02-05/the-9-2-trillion-price-tag-for-failing-to-vaccinate-the-world?srnd=premium&sref=eGA8az79

  3. This bleak reality has pushed back expectations of any meaningful recovery in global travel to 2022. That may be too late to save the many airlines with only a few months of cash remaining. And the delay threatens to kill the careers of hundreds of thousands of pilots, flight crew and airport workers who’ve already been out of work for close to a year. Rather than a return to worldwide connectivity — one of the economic miracles of the jet era — prolonged international isolation appears unavoidable.

    https://www.bloomberg.com/news/articles/2021-02-04/put-away-the-suitcase-vaccines-won-t-bring-back-overseas-travel?sref=eGA8az79

  4. BELGRADE: Inside the dome of Belgrade’s concrete fair hall, dozens of nurses in hazmat suits inject COVID-19 shots into young and old alike, working with an efficiency that has turned Serbia into continental Europe’s fastest vaccinator.

    The small Balkan country has inoculated more than 450,000 of its population of 7 million in almost two weeks, a rate that exceeds all other states in Europe apart from Britain, according to the scientific publication Our World in Data.

    One key difference is that most of the vials are filled with a vaccine made by Chinese pharmaceutical giant Sinopharm.

    As the European Union’s rollout is snagged by delays and controversies, Serbia – which lies outside the bloc’s borders – has raced ahead by turning its gaze to the East, securing deals with Chinese and Russian producers.

    When registering for an appointment, Serbs can tick off their vaccine of choice – the Pfizer-BioNtech, Sputnik V and Sinopharm jabs are currently on the menu.

    https://www.channelnewsasia.com/news/world/serbia-covid-19-vaccine-china-sinopharm-eu-14117740#cxrecs_s

  5. Chancellor of Germany, Angela Merkel, has said that citizens may need to be vaccinated against the coronavirus for “many years to come.”

    Merkel held talks with state governors, pharma industry representatives and representatives of the European Commission on Monday, to discuss ways to beef up the country’s sluggish vaccination campaign.

    Speaking to journalists at a news conference afterwards, Merkel said the situation with COVID-19 is “similar to the flu vaccine, where you re-vaccinate against the new mutation of the virus every time”.

    She added that despite concerns over Germany’s slow kickoff to its vaccination programme, she was hopeful that every German citizen would be offered a jab by September 21 – days before the country holds a national election in which she won’t stand for chancellor again.

    Germany sets general election date and an end to the Merkel era
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    Merkel warns that Germany is entering critical stage as virus accelerates across Europe
    “Even if Johnson & Johnson and CureVac don’t get approval, that supply can be made for everybody according to the numbers that are available now,” Merkel told reporters.

    By Sunday, around 1.93 million people had received their first dose in Germany, a nation of 83 million, and 532,000 had received a second dose.

    https://www.euronews.com/2021/02/02/we-may-need-covid-vaccines-for-many-years-to-come-says-german-chancellor-merkel

  6. LONDON — The U.K. government announced Friday that it plans to work with a German biopharmaceutical company to develop vaccines targeting emerging variants of COVID-19 as public health officials call for new tools to keep the virus in check as it mutates.

    As part of the deal, Tuebingen, Germany-based CureVac said it would supply the U.K. with 50 million doses of the vaccines if they are approved by regulators and that it would manufacture the shots in Britain. The government didn’t say how much it was investing in the project.

    https://abcnews.go.com/Health/wireStory/uk-backs-curevac-effort-make-vaccine-covid-variants-75705332

  7. Just two months ago, the prospects for beating the novel coronavirus with highly effective vaccines couldn’t have seemed better. Shots from Moderna and the Pfizer-BioNTech partnership proved more than 90% effective in preventing Covid-19 symptoms in massive trials, surpassing the most optimistic forecasts. An end to the pandemic appeared imminent.

    Yet pharma companies now suddenly face a daunting challenge that few anticipated we’d see so soon: an onslaught of fast-spreading and potentially dangerous mutations of the virus. So even as they ramp up production in the early stages of a massive rollout, drugmakers have to retool their vaccine strategies. That’s raised the possibility that patients will need extra shots to protect against the new strains—and that drugmakers could get a new revenue stream that, for some, may prove lucrative.

    The highly transmissible B.1.1.7 mutation first identified in the U.K. is spreading across the U.S. But the strains researchers are most worried about come from South Africa and Brazil. The South African variant has spread quickly across Africa and has been seen in at least 24 countries elsewhere. It was reported in South Carolina on Jan. 28 and in Maryland two days later. The strain prominent in Brazil shares one of the same key mutations.

    https://www.bloomberg.com/news/articles/2021-02-04/pfizer-pfe-moderna-mrna-race-to-make-vaccines-for-covid-variants?sref=eGA8az79

  8. (Reuters) – The Biden administration is exploring every option for increasing manufacturing of Johnson & Johnson’s COVID-19 vaccine, which is under regulatory review, and said on Friday that currently expected levels of early doses were less than hoped.

    The White House has invoked the Defense Production Act to help Pfizer Inc ramp up COVID-19 vaccine production and that “every option” was on the table to produce more Johnson & Johnson vaccine should it be authorized.

    It will also use the wartime powers to increase at-home COVID-19 tests, and make more surgical gloves in the United States, officials said at a Friday media briefing.

    “As is the case with other vaccines, we have not found that the level of manufacturing allows us to have as much vaccine as we think we need coming out of the gate,” said Andy Slavitt, senior adviser to the White House’s COVID-19 response team, referring to the J&J vaccine.

    J&J applied on Thursday for U.S. emergency use authorization. It expects to have some vaccine ready for distribution as soon as authorized but has not said how much.

    Emergent Biosolutions’ Chief Executive Robert Kramer said in an interview on Friday that the company currently is making bulk drug substance for J&J “at large scale.” Emergent is only producing bulk vaccine, which is then filled into syringes or vials and packaged for shipment by another contractor.

    https://finance.yahoo.com/news/white-house-says-working-speed-184245029.html

  9. The mutant coronavirus strain first identified in the United Kingdom remains at low levels in the United States but is doubling its reach approximately every 10 days, according to a study published by researchers on Sunday.
    The study bolstered modeling done by the Centers for Disease Control and Prevention, which predicted last month that the more contagious variant could be the dominant strain in the U.S. by March.
    The U.S. still has time to take steps to slow down the new virus strain, the researchers wrote, but they warned that without “decisive and immediate public health action” the variant “will likely have devastating consequences to COVID-19 mortality and morbidity in the U.S. in a few months.”

    https://www.cnbc.com/2021/02/07/uk-coronavirus-strain-doubling-in-the-us-every-10-days-study-finds.html

  10. The federal government plans to increase vaccine allocations by another 5% for the next three weeks, New York Governor Andrew Cuomo said.

    The additional 5%, announced on a White House call with governors Tuesday, follows an initial 20% increase and then a subsequent 5%. Cuomo, during a call afterward with reporters, said he doesn’t expect a major supply boost until Johnson & Johnson’s single-dose vaccine is produced.

    “The supply will only really increase when and if Johnson and Johnson is approved,” Cuomo said. “Johnson and Johnson would be a major and significant increase in production.” There will be more information on that over the next two weeks, he said.

    The Biden administration also told governors they are adamantly opposed to using second doses as first doses, he said. Officials also said they would directly allocate vaccines to some federally qualified community health centers, Cuomo said.

    The state will be reallocating doses from the federal long-term health-care program aimed at vaccinating nursing-home patients and workers, because it was over-allocated, he said.

    https://www.bloomberg.com/news/articles/2021-02-09/cuomo-says-white-house-to-boost-vaccine-allocation-another-5?srnd=premium&sref=eGA8az79

  11. Let’s begin by defining our terms. Herd immunity is the hazy, long-promised end of the pandemic, but its requirements are quite specific. Jennie Lavine, a biologist at Emory University, likens it to wet logs in a campfire. If there’s enough water in the logs—if there’s enough immunity in a population—“you can’t get the fire to start, period,” she says. To be more technical about it, a population reaches herd immunity when the average number of people infected by a single sick person falls below one. Patient zero might infect another person, but that second person can’t infect a third. This is what happens with measles, polio, and several other diseases for which vaccines have achieved herd immunity in the United States. A case might land here, but the spark never finds much dry fuel. The outbreak never sustains itself.

    For COVID-19, the herd-immunity threshold is estimated to be between 60 and 90 percent. That’s the proportion of people who need to have immunity either from vaccination or from prior infection. In the U.S., the countdown to when enough people are vaccinated to reach herd immunity has already begun.

    But what if we still can’t get the logs wet enough? What if they are drying out faster than we can douse them? A number of signs now point to a future in which the transmission of this virus cannot be contained through herd immunity. COVID-19 will likely continue to circulate, to evolve, and to reinfect. In that case, the goal of vaccination needs to be different.

    https://www.theatlantic.com/health/archive/2021/02/herd-immunity-might-be-impossible-even-vaccines/617973/

  12. Hungary will this week begin inoculating people with Russia’s Sputnik V vaccine, among others, becoming the first European Union country to do so, officials there said Tuesday.

    “We will be inoculating using four vaccines beginning this week; vaccination using the Russian Sputnik V vaccine is beginning in Budapest,” Chief Medical Officer Cecília Müller said at an online press conference.

    Müller told reporters that 560 general practitioners in Budapest are being asked to select five people each from their respective practices, who will then receive the Sputnik V vaccine at the designated vaccination points. Some 2,800 doses of the vaccine are currently available, and only to those without chronic illness.

    Hungary does “not have huge amounts of this vaccine available,” Müller said.

    According to a statement from the Hungarian News Agency (MTI), 85,410 doses of the Pfizer vaccine will arrive in Hungary on Tuesday. A further shipment of the AstraZeneca vaccine is expected on Thursday, and 21,600 doses of the Moderna vaccine will also be arriving on Thursday.

    Doctors will receive a list of registered people who are eligible to be vaccinated, and vaccination of the oldest patients will be organised at GP’s clinics.

    A total of 291,396 people have been vaccinated in Hungary to date, and 110,395 have also received their second shot.

    https://www.cnn.com/world/live-news/coronavirus-pandemic-vaccine-updates-02-09-21/index.html

  13. Johnson & Johnson announced it has asked the World Health Organization for emergency use listing for its single-dose Covid-19 vaccine.

    The company said it had delivered the data from its late-stage trial to the WHO.

    An emergency use listing would make the vaccine available in more than 190 countries, including multiple developing countries. If authorized, it would also allow J&J to supply the COVAX program – a global distribution and procurement agency that is helping manage Covid-19 vaccines for 190 participating countries.

    In December, J&J came to an agreement with Gavi, the Vaccine Alliance, that is backing the COVAX program. If authorized, J&J expects to provide up to 500 million doses to COVAX through next year, the company said.

    “Our filing with the World Health Organization marks another important step in our effort to combat COVID-19 and also in our unwavering commitment to equitable access,” Dr. Paul Stoffels, Johnson & Johnson’s vice chair of the executive committee and chief scientific officer, said in a news release. “If we are to end the global pandemic, life-saving innovations like vaccines must be within reach for all countries.”
    J&J filed for a conditional marketing authorization application in the European Union on Monday.

    Next Friday, the US Food and Drug Administration will consider the data the company submitted for an emergency use authorization of the vaccine in the United States. J&J has promised to deliver 100 million doses of its single-dose vaccine to the US by the end of June.

    The Covid-19 vaccine’s efficacy against moderate and severe disease ranged from one country to another:

    72% in the US
    66% in Latin America
    57% in South Africa
    It was 66% effective globally. This was measured starting one month after the shot. The vaccine is 85% effective overall at preventing hospitalization and 100% at preventing death in all regions where it was tested.

    https://edition.cnn.com/world/live-news/coronavirus-pandemic-vaccine-updates-02-19-21/h_c751810b3d7e0dc12fee17bcd9ef3262

  14. The Food and Drug Administration asked states on Tuesday to temporarily halt using Johnson & Johnson’s Covid-19 vaccine “out of an abundance of caution” after six women in the U.S. developed a rare blood-clotting disorder that left one woman dead and another in critical condition.

    “Right now, these adverse events appear to be extremely rare,” the FDA said in a joint statement with the Centers for Disease Control and Prevention. “COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously.”

    All six cases occurred in women ages 18 to 48, with symptoms developing six to 13 days after they received the shot. Doctors typically treat that type of blood clot with heparin, but health regulators noted that could be dangerous in this case and recommended a different treatment.

    J&J said in a statement that “no clear causal relationship” has been identified between the blood clots and the vaccine, adding it is working closely with regulators to assess the data.

    People who got the J&J vaccine more than a month ago are at very low risk for developing the blood clots, Dr. Anne Schuchat, the principal deputy director of the CDC, told reporters on a conference call Tuesday.

    “For people who recently got the vaccine within the last couple weeks, they should be aware to look for any symptoms,” she said. “If you’ve received the vaccine and developed severe headaches, abdominal pain, leg pain or shortness of breathe you should contact your healthcare provider and seek medical treatment.”

    The blood clotting generally occurs about a week after vaccination, but not more than three weeks after, with a median timeframe of 9 days, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said on the call.

    https://www.cnbc.com/2021/04/13/us-regulators-reportedly-call-for-pause-in-use-of-johnson-johnson-vaccine-due-to-clotting-issues.html

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