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The FDA has released the single-dose COVID-19 vaccine from Johnson & Johnson



The United States is receiving a third vaccine to prevent COVID-19 as the Food and Drug Administration cleared a shot of Johnson & Johnson on Saturday, which works with only one dose instead of two.

Health experts are looking forward to a one-off opportunity to speed up vaccinations as they compete with a virus that has already killed more than 510,000 people in the United States and is mutating in increasingly alarming ways.

The FDA says the vaccine, made by Johnson & Johnson Janssen’s subsidiary, offers strong protection against the most important: serious illness, hospitalization and death. One dose was 85% protective against the most severe disease, COVID-1

9, in a large-scale study covering three continents, a protection that remains strong even in countries such as South Africa, where the most widespread variants are prevalent.

“This is really good news,” Dr. Francis Collins, director of the National Institutes of Health, told the Associated Press on Saturday. “The most important thing we can do right now is get as many shots in as many hands as we can.”

The Jansen shot joins two other vaccines against COVID-19, Pfizer-BioNTech and Moderna, but these require two-dose regimens.

Deliveries of several million doses of Jansen vaccine, which will be split between the states, could begin as early as Monday. By the end of March, Johnson & Johnson said it expected to deliver 20 million doses to the United States and 100 million by the summer.

Johnson & Johnson is also seeking permission for the emergency use of its vaccine in Europe and from the World Health Organization.

Globally, the company aims to produce about 1 billion doses worldwide by the end of the year. On Thursday, the island nation of Bahrain became the first to allow its use.

“This is exciting news for all Americans and an encouraging development in our efforts to end the crisis,” President Biden said in a statement. “But I want to be clear: this fight is far from over,” he added, encouraging people to stick to masks and other public health measures.

A US advisory committee will meet on Sunday to recommend how to prioritize the use of the single-dose vaccine. And one big challenge is what the public wants to know: which type of vaccine is better?

“In this environment, take whatever you can get,” said Dr. Arnold Monto of the University of Michigan, chairman of an FDA advisory committee that unanimously voted Friday that the benefits of the vaccine outweigh the risks.

Data is mixing up on how well all vaccines used in the world work, leading to reports in some countries of people refusing one species to wait for another.

In the United States, two-dose images of Pfizer and Moderna are 95% protective against symptomatic COVID-19. The effectiveness of Janssen at a single dose of 85% against severe COVID-19 decreased to 66% when moderate cases were included. But there is no comparison between apples and apples because of the differences in when and where each company conducted its research; Research by Pfizer and Moderna was completed before the options became widespread.

Collins of the NIH said the evidence for effectiveness showed no reason to prefer one vaccine to another.

“What I think people are most interested in is will it really stop me from getting sick?” Collins said. “Will it stop me from dying from this terrible disease?” The good news is that they all say yes to that. “

Jansen tested two doses of his vaccine in a separate large study. Collins said that if a second dose was eventually considered better, people who had received one earlier would be offered another.

The FDA has warned that it is too early to say whether anyone who gets a mild or asymptomatic infection despite vaccination can still spread the virus.

There are obvious advantages besides the convenience of a single shot. Local health officials are seeking to use the Jansen option in mobile vaccination clinics and shelters for the homeless and sailors who spend months on fishing boats – communities where it is difficult to be sure that someone will return for a second shot.

The Jansen vaccine is also easier to work with, lasting three months in the refrigerator, compared to the Pfizer and Moderna options, which must be frozen.

“We are looking for less to get more supply. That’s the limiting factor for us right now, “said Dr. Matt Anderson of UW Health in Madison, Wisconsin, where staff were preparing electronic health records, staff and vaccine storage in anticipation of offering pictures of Jansen soon.

The FDA said the studies found no serious side effects. Like other COVID-19 vaccines, the main side effects of a Jansen shot are injection site pain and flu-like fever, fatigue and headache.

The FDA said there was a “distant chance” that people would develop a severe allergic reaction to the shot, a rare risk seen with the Pfizer and Moderna vaccines.

The vaccine is currently approved for emergency use in adults 18 years of age and older. But like other vaccine manufacturers, Jansen is about to start a study in teenagers before moving on to younger children later in the year, and also plans to test pregnant women.

All COVID-19 vaccines train the body to recognize the new coronavirus, usually by noticing the protein that covers it. But they are made in different ways.

Jansen’s shot uses a cold virus like a Trojan horse to carry the spike gene into the body, where cells make harmless copies of the protein to prepare the immune system in case the real virus appears. This is the same technology that the company uses to make the Ebola vaccine.

The Pfizer and Moderna vaccines are made with different technology, in which part of the genetic code, called messenger RNA, stimulates cells to make these harmless hopping copies.

The AstraZeneca vaccine, which is already in use in the UK and many other countries, completes a large US study needed to be cleared by the FDA. Novavax, which uses another technology, is also under development. It was made with laboratory-grown copies of the spike protein and reported preliminary findings from a British study suggesting strong protection.

Other countries still use “inactivated vaccines” made with killed coronavirus from the Chinese companies Sinovac and Sinopharm.




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