Johnson & Johnson Covid vaccine with one shot gets a nod from the FDA Coronavirus advisory panel

The fight against Covid-19 took a big step forward on Friday as the US moved closer to distributing its first Covid-19 vaccine, after an independent advisory panel recommended that drug regulators may use the Johnson & Johnson vaccine for emergencies.

The authorization would provide a significant boost to the Biden administration’s vaccination plans, which would make Johnson & Johnson’s third vaccine available to the public. Janssen, the subsidiary of the vaccine for Johnson & Johnson, said at a congressional hearing this week that he 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 that of Pfizer and Moderna, should provide the US with more than enough stock to vaccinate every person eligible for vaccines.

“We are still in the midst of this deadly pandemic,” said Dr. Archana Chatterjee, a voting member of the panel and an infectious pediatrician at Chicago Medical School, explaining her voice in favor of recommending the vaccine. has. “There is currently a shortage of vaccines, and I think the authorization of this vaccine at the moment will help meet the needs.”

While regulators at the U.S. Food and Drug Administration (FDA) do not always take the advice of their advisory panels, the agency is expected to authorize the vaccine for emergency use.

‘We urgently need more vaccinations [authorized] to protect the millions of Americans at risk of a 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 compelling evidence that the Janssen vaccine candidate is well tolerated, has an acceptable safety profile and in particular Covid-19 is very effective,” he said. “To me, it’s clear that the known benefits outweigh the known risks.”

The recommendation comes shortly after the US lost 500,000 lives due to Covid-19, a toll that is declining in the US and in many countries worldwide. More than 28 million Americans have been infected by 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 U.S. Centers for Disease Control and Prevention. He later added: “We are definitely not out of the woods yet.”

It is important that Johnson & Johnson’s vaccine is also the easiest to distribute. Unlike Pfizer and Moderna vaccines, which must be stored below zero, Johnson & Johnson’s vaccine can be stored for up to three months at normal refrigerator temperatures. When frozen, it has a shelf life of three years.

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

The vaccine was found to be 85% effective in preventing serious diseases and in fully protecting against Covid-19-related hospitalization and death after 28 days. The Johnson & Johnson vaccine was found to be 72% effective in clinical trials in the USA, but only 57% in South Africa, where variant B1351 originated.

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

Like the Moderna vaccine, Johnson & Johnson’s product will only be available to people 18 and older. Pfizer’s vaccine is available for teens older than 16. As with other vaccines, researchers are unsure about how long the vaccine protects against Covid-19, and whether it reduces the asymptomatic transmission of the virus, although studies are promising.

Johnson & Johnson’s vaccine uses different technologies than the two vaccines currently available in the US. The new vaccine uses ‘viral vector’ technology, which introduces the body with the genetic code for the ear protein that covers the outside of the coronavirus. This code is transmitted by a second, attenuated virus called an adenovirus.

Immunity is caused when the body’s immune system then recognizes the coronavirus through this key structure. Vaccines developed by Pfizer and Moderna also encourage the body to recognize vein proteins on the outside of the coronavirus, but deliver the genetic code through lipid nanoparticles, or small molecules of fatty acids.

Because scientists are still investigating the extent to which any of the authorized vaccines prevent people from spreading Covid-19 to other people, the public health authorities recommend that people continue to distance themselves socially and wear masks after being vaccinated. In theory, a vaccinated person can still spread the SARS-CoV-2 virus, even if they have no symptoms of Covid-19 disease.

The vaccines from Johnson and Johnson and the doses that Moderna and Pfizer, the manufacturer of the two vaccines currently approved in the United States, had to deliver mean that there could be enough stock to vaccinate 400 million people by July. About 267 million people in the US are eligible for a vaccine.

This ease of storage and a single-dose regimen are likely to increase pressure on the U.S. government to promise doses to low- and middle-income countries, which often do not have the cold-chain infrastructure needed to distribute the Pfizer or Modern vaccines. Currently, dozens of low- and middle-income countries do not expect to distribute the vaccines in general until 2022.

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

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