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JOHNSON & JOHNSON’S (J&J) coronavirus vaccine was approved for use in the US, making available a third vaccine that could fill gaps in the nation’s immunization campaign as the concern about the influx of virus variants.
The Food and Drug Administration The (FDA) said in a statement Saturday that it had granted an emergency use authorization for the single-dose vaccine for people over 18 years of age.
The decision comes after virus deaths surpassed 500,000 in the US and when health officials raise the alarm that a recent decline in new cases may be stagnant.
The J&J injection is highly effective in preventing severe coronavirus disease 2019 (COVID-19), with no serious side effects, agency staff said in a report Wednesday. On Friday, a committee of external advisers to the FDA unanimously voted that the benefits of the vaccine outweigh any risks. In the next week, J&J is set to ship 3-4 million doses.
“We are in a race between mutating the virus (new variants that could cause more disease) and stopping it,” said Jay Portnoy, director of the division of allergy, asthma and immunology at Children’s Mercy Hospital, who supported an emergency clearance. “We need to get this vaccine out.”
The authorization is another milestone in an unprecedented global science sprint. Since the World Health Organization declared the coronavirus a pandemic nearly a year ago, numerous vaccines have been deployed around the world, including injections developed in China and Russia. Worldwide, more than 231 million doses have been administered in 100 countries, according to data compiled by Bloomberg.
The J&J injection is expected to be easier to distribute and administer than the Pfizer, Inc.-BioNTech SE vaccine and Moderna, Inc. injection that were cleared by the FDA late last year. For maximum effectiveness, the first injections require two doses several weeks apart. They should also be kept at very cold temperatures, while J&J doses can be stored in the refrigerator for extended periods.
President Joseph R. Biden praised the authorization of the vaccine, calling it “exciting news” in a statement Saturday.
“Thanks to the brilliance of our scientists, the resilience of our people and the enthusiasm of Americans in every community to protect themselves and their loved ones by getting vaccinated, we are moving in the right direction,” said Biden.
The inoculation campaign in the United States has accelerated in recent weeks, with more than 70.5 million doses administered as of Friday, according to Bloomberg’s Vaccine Tracker. However, Biden warned that the rise in new variants of the coronavirus still poses a threat.
Rapidly spreading mutations first reported in the UK, South Africa and Brazil have appeared in the US, while the domestic variants detected in California and New York are raising new concerns among some scientists.
J&J is on track to supply 20 million doses to the US by the end of March and 100 million by the end of June, an executive said at a congressional hearing on February 23. Globally, J&J expects to produce 1 billion doses this year. European Union regulators could clear the shot in early March.
The J&J injection is unlikely to be the last available in the US AstraZeneca Plc and Novavax, Inc. are expected to apply for approval in the coming months for their vaccines, pending the results of large US trials. Who are now fully enrolled.
DIFFERENT PLATFORM
The J&J vaccine is made from a common cold virus that does not replicate in the body but triggers an immune response to fight infection. In the US part of a worldwide trial of more than 43,000 people, it was found to be 72% effective in preventing moderate to severe COVID.
That’s a lower overall efficacy rate than the Pfizer-BioNTech and Moderna vaccines, which are based on a technology called messenger RNA that prepares the body to protect itself from the virus. Each of them was found to be more than 90% efficient.
Still, all three injections are extremely reliable in preventing hospitalizations and deaths. YJ & J’s does it quickly, with protection against serious illness that begins just seven days after vaccination and increases over the course of about two months.
Public health officials hope that as more people get them, they will greatly reduce the strain the pandemic has placed on the health care system. Already, more people in the US have received at least one dose of vaccine than have tested positive for the virus.
The FDA prescribing document for the J&J vaccine said that it should not be given to people with a known history of severe allergic reactions, including anaphylaxis, and that the injection sites should have treatments to control such reactions. The same protocols apply for the Pfizer and Moderna intakes.
The most frequently reported side effects were injection site pain, headache, fatigue, muscle aches, and nausea. Most were of mild to moderate severity and lasted one to two days.
Policy makers are eager to vaccinate more people before virus mutations can take hold more firmly in the US.
The J&J vaccine provided less protection against the new variants, the trial data suggested. In Brazil, the injection was 68% effective against moderate to severe disease 28 days after vaccination, while in South Africa it was 64% effective. But around the world, even in countries with emerging variants, the vaccine successfully prevented all hospitalizations and deaths.
Mathai Mammen, head of global research and development for J & J’s pharmaceutical division, said in an interview last month that it is impossible to compare the overall levels of efficacy between vaccines, given that the trials were conducted in different locations at different times. over the course of the pandemic.
“What people fear is getting sick, so sick that they have to go to an emergency room, or to the hospital, and even die,” he said. “This one-shot vaccine completely protects against that kind of fear.”
J&J is still testing a two-injection regimen in a large global trial that is expected to produce results before the end of the year. Like Pfizer and Moderna, the company is working on enhancers tailored to the variants. And it foresees studies soon in children, pregnant women and immunosuppressed.
J&J executives have said the company will not charge more than $ 10 per dose for the vaccine during the pandemic, a price it will not benefit from. The Pfizer-BioNTech vaccine costs $ 39 for the full regimen and the Moderna vaccine costs $ 33 for both doses.
PANDEMIC PREPARATION
J&J, based in New Brunswick, NJ, has spent more than a century fighting infectious diseases. He created the so-called Epidemic Mask to prevent the spread of the 1918 Spanish flu and developed an Ebola vaccine that was approved in Europe in 2020.
Its COVID-19 vaccine uses the same adenovirus platform that is the basis for the Ebola vaccine. The company collaborated on its development with researchers at Harvard University and US health agencies, including the Biomedical Advanced Research and Development Authority and the National Institutes of Health.
Like the Pfizer-BioNTech and Moderna injections, J & J’s vaccine was one of six that was selected by the Trump administration’s Operation Warp Speed program, receiving about $ 1.5 billion in support from the US government. USA, which has options to purchase additional supply.
J&J Chief Scientific Officer Paul Stoffels said he expects another hundred years to pass before another pandemic hits the world, but realistically the United States should be on higher alert that it could happen at any moment.
“A whole new field of science and pandemic preparedness is needed,” Stoffels said. – Bloomberg
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