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J&J 1 shot shot cleared giving US 3rd COVID-19 vaccine

WASHINGTON (AP) – The United States is receiving a third vaccine to prevent COVID-19 as the Food and Drug Administration on Saturday cleared staff at Johnson & Johnson, which only works on one dose instead of two.

Health professionals are eagerly awaiting the only way to help speed up vaccinations as they fight the virus, which has already killed more than 510,000 people in the United States, and is being mutated into more and more worms.

The FDA says the J&J vaccine offers strong protection against the most important: serious illness, hospitalization or death. One dose was 85% safe against the most severe COVID-19 disease as a result of a large-scale study covering three continents. A defense that has remained strong even in countries such as South Africa, where the most troubling options 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 now is get as many shots as we can.”

J & J is initially providing several million doses և Deliveries to countries can start as early as Monday. In late March, J&J said it expected to ship 20 million doses to the United States and 100 million by the summer.

J&J is also seeking permission from the World Health Organization for emergency use of its vaccine in Europe. The company aims to produce about 1 billion doses by the end of the year. The state of the island of Bahrain was the first to clarify its use on Thursday.

“This is exciting news for all Americans, an encouraging development in our efforts to end the crisis,” Biden said in a statement. “But I want to be clear. “This struggle is not over yet,” he added, encouraging people to wear masks and other health care products.

A meeting of the US Advisory Committee will be held on Sunday to suggest how to prioritize the use of a single-dose vaccine. And one big challenge is what the society wants to know. Which type is better?

“Get what you can in this environment,” said Dr. Arnold Monto of the University of Michigan, who chaired the FDA Advisory Committee, which voted unanimously on Friday that the benefits of the vaccine outweighed the risks.

Data is mixed on how well vaccines are used around the world, which in some countries has led to reports that people are refusing to wait for another.

In the United States, two doses of Pfizer և Moderna provided 95% protection against symptomatic COVID-19. J & J’s 85% single-dose efficacy against severe COVID-19 dropped to% 66% in moderate cases. But there is no apple-to-apple comparison, as the difference is when և where each company did its research P Pfizer անակ’s modern research was completed before the versions began to be distributed.

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

“What I think people are mainly interested in, will it stop me from having a real illness?” Collins said. “Will it stop me from dying from this terrible disease?” The good news is that all of this is true. “

In addition, J&J is testing two doses of its large vaccine in a separate large study. Collins said that if the second dose eventually turned out to be better, people who received it earlier would be offered another one.

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

In addition to the convenience of one shot, there are clear advantages. Local health officials try to use the J&J version in mobile vaccination clinics, homeless shelters, and even with sailors who spend months on fishing boats. Communities where it is difficult to be sure that someone will return in three to four weeks for a second vaccination.

The J&J vaccine is also easier to process in the refrigerator for three months compared to the Pfizer և Moderna versions, which need to be frozen.

“We are having a little fun to get more supplies. That’s the limiting factor for us right now, “said Matt Anderson, of UW Health in Madison, Wisconsin.

The FDA said the study found no serious side effects. Like COVID-19 vaccines, the main side effects of J&J shots are pain at the injection site, flu-like fever, fatigue, and headache.

The FDA vaccine document states that there is a “remote possibility” that people may have a severe allergic reaction to the shot, a rare risk seen with Pfizer և Moderna vaccines. Such reactions are treatable, and vaccine recipients are expected to be briefly monitored after injection.

The vaccine is now approved for emergency use in adults over 18:. However, like other manufacturers, J&J plans to study how it works in adolescents before moving to young children by the end of the year, as it plans to study pregnant women.

All COVID-19 vaccines prepare the body to recognize a new coronavirus, usually by detecting the protein that surrounds it. But they are made with very different eggs.

J&J staff 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 boost the immune system if a real virus occurs. It is the same technology that the company used to make the Ebola vaccine, similar to AstraZeneca և COVID-19 vaccines made by China’s CanSino Biologics.

Pfizer և Moderna vaccines are made with different technologies. A piece of genetic code called a tape recorder RNA that stimulates cells to make copies of these harmless spikes.

The AstraZeneca vaccine, which has already been used in the UK and many other countries, completes a major US study needed to clean up the FDA. He points out that Novavax uses a different technology, based on laboratory-grown samples of laser protein, reports preliminary results from a British study that suggests strong protection.

Other countries use “inactive vaccines” made with the Chinese company Sinovac և Sinopharm with the killed coronavirus.

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Associated Press reporters Ricardo Alonso- ald Aldivar և Marion Reno contributed to this report.

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The Associated Press Department of Health and Science receives support from the Department of Science Education at Howard Hughes Medical Institute. The AP is solely responsible for all content.

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