Johnson & Johnson Vacid One-Shot Receives FDA Advisory Panel Approval | Coronavirus

The battle against Covid-19 took a big step forward on Friday as the United States approached the distribution of its first Covid-19 vaccine, after an advisory panel of independent experts recommended that drug regulators authorize the Johnson vaccine. & Johnson for emergency use.

The authorization would be a significant boost to the Biden administration’s vaccination plans, making Johnson & Johnson’s third vaccine available to the public. Johnson & Johnson vaccine subsidiary Janssen said at a congressional hearing this week that it expects to deliver 20 million doses by March and a total of 100 million doses before the end of June.

The Johnson & Johnson vaccine, along with those from Pfizer and Moderna, is expected to provide the United States with more than enough supplies to vaccinate all people eligible for the vaccine.

“We are still in the middle of this deadly pandemic,” said Dr. Archana Chatterjee, a voting member of the panel and a pediatrician for infectious diseases at the Chicago School of Medicine, while explaining her vote in favor of the vaccine recommendation. “There is a shortage of vaccines that are currently authorized, and I think that the authorization of this vaccine will help to meet the needs at the moment.”

Although regulators in the United States Food and Drug Administration (FDA) do not always follow the advice of their advisory panels, the agency is expected to authorize the vaccine for emergency use.

“We urgently need more vaccines [authorized] to protect the millions of Americans who remain at risk ”from Covid-19 infection, said Dr. Greg Poland, editor-in-chief of the medical journal Vaccine and leader of the Vaccine Research Group at the Mayo Clinic.

“Today, we have seen clear and convincing evidence that the Janssen candidate vaccine is well tolerated, has an acceptable safety profile and, most importantly, is highly effective against Covid-19,” he said. “It is clear to me that the known benefits far outweigh the known risks.”

The recommendation comes just after the U.S. scored 500,000 deaths from Covid-19, a figure that comes as the number of cases decreases in the U.S. and in many countries around the world. More than 28 million Americans have been infected with Covid-19.

“We are seeing positive trends in terms of declining cases,” said Dr. Adam MacNeil, a member of the Covid-19 epidemiology task force at the US Centers for Disease Control and Prevention. He added later: “We are certainly not out of danger yet.”

It is important to note that the Johnson & Johnson vaccine would also be the easiest to distribute. Unlike Pfizer and Moderna vaccines, which require storage below zero, the Johnson & Johnson vaccine can be stored in standard refrigerator temperatures for up to three months. When frozen, it has a shelf life of three years.

The convenience of the Johnson & Johnson vaccine comes with caveats. The company’s clinical tests were the first to show the potential impacts of Covid-19 variants, or evolutionary changes in the virus.

The vaccine was found to be 85% effective in preventing serious illness and providing complete protection against hospitalization and death related to Covid-19 after 28 days. The Johnson & Johnson vaccine has been shown to be 72% effective in clinical trials in the USA, but only 57% effective in South Africa, where a variant called B1351 originated.

However, vaccination remains a powerful weapon, even with threats represented by variants. “Even with decreased efficacy, vaccination can still provide partial protection against variants,” said MacNeil.

Like the Modern vaccine, the Johnson & Johnson product will only be available to people aged 18 and over. The Pfizer vaccine is available for teenagers over the age of 16. In addition, as with other vaccines, researchers are unsure how long the vaccine protects against Covid-19 and reduces asymptomatic transmission of the virus, although the studies are promising.

The Johnson & Johnson vaccine uses different technology than the two vaccines currently available in the United States. The new vaccine uses “viral vector” technology, which presents the body with the genetic code of the spike protein that covers the outside of the coronavirus. This code is transmitted by a second weakened virus, called adenovirus.

Immunity is triggered when the body’s immune system recognizes coronavirus by this key structure. The vaccines developed by Pfizer and Moderna also stimulate the body to recognize spike proteins on the outside of the coronavirus, but deliver the genetic code through lipid nanoparticles, or tiny fatty acid molecules.

Because scientists are still researching the extent to which any of the authorized vaccines prevents people from spreading Covid-19 to others, public health officials recommend that people continue to distance themselves socially and wear masks after being vaccinated. In theory, a vaccinated person can still transmit the SARS-CoV-2 virus, even if he does not show any symptoms of Covid-19 disease.

Johnson & Johnson vaccines and doses already scheduled to be delivered by Moderna and Pfizer, manufacturers of the two vaccines currently authorized in the U.S., mean that there may be enough supply to vaccinate 400 million people by July. Approximately 267 million people in the United States are eligible for the vaccine.

This storage facility and single dose regime is likely to increase pressure on the US government to promise doses to low- and middle-income countries, which often lack the cold chain infrastructure needed to distribute Pfizer or Moderna vaccines. Currently, dozens of low- and middle-income countries do not expect to begin to widely distribute vaccine doses by 2022.

Activists, many of whom also worked to expand access to AIDS drugs, described this as “vaccine apartheid” and a threat to the “global population immunity project”.

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