The United States approves individual Covid-19 vaccines

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

Health experts are eagerly awaiting a one-on-one alternative to speeding up vaccinations, as they compete against a virus that has already killed more than 510,000 people in the United States and is mutating in an increasingly worrying way.

The FDA said that J & J’s vaccine offers strong protection against what matters most: serious illness, hospital stays and deaths. One dose was 85% protective against the most serious COVID-19 disease, in a massive study that stretched across three continents – protection that remained strong even in countries like South Africa, where the variants of most concern are spreading.

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

J&J initially provides a few million doses and deliveries to states can begin as early as Monday. At the end of March, J&J said it expects to deliver 20 million doses to the United States and 100 million in the summer.

J&J is also applying for a permit for emergency use of its vaccine in Europe and from the World Health Organization. Globally, the company aims to produce approximately 1 billion doses globally by the end of the year. On Thursday, the island nation of Bahrain was the first to clear the use.

“This is exciting news for all Americans and an encouraging development in our efforts to end the crisis,” President Joe 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.

On Sunday, a US advisory committee will meet to recommend how to prioritize the use of the single-dose vaccine. And a big challenge is what the public wants to know: Which type is better?

“In this environment, whatever you can get – get”, says Dr. Arnold Monto of the University of Michigan, who chaired an FDA advisory panel that unanimously voted Friday that the benefits of the vaccine outweigh its risks.

The data is mixed about how well all vaccines used around the world work, which gets reports in some countries about people refusing to wait for another.

In the United States, the two doses of Pfizer and Modern were 95% protective against symptomatic COVID-19. J & J’s unit dose efficiency of 85% against severe COVID-19 dropped to 66% when moderate cases were rolled up. However, there is no comparison between apples and apples due to differences in when and where each company conducted its studies, with Pfizer and Modern Research completed before variants began to spread.

NIH’s Collins said the evidence shows no reason to favor one vaccine over another.

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

J&J is also testing two doses of its vaccine in a separate large study. Collins said that if a second dose was eventually considered better, people who received one earlier would be offered another.

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

There are clear benefits besides the convenience of a shot. Local health officials want to use the J&J option in mobile vaccination clinics, homeless shelters, even with sailors who spend months on fishing vessels – 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 handle and lasts for three months in the refrigerator compared to the Pfizer and Moderna alternatives, which must be frozen.

We chat a bit to get more access. That is the limiting factor for us right now “, says Dr. Matt Anderson from UW Health in Madison, Wisconsin, where employees prepare electronic health records, staffing and vaccine storage while waiting to offer J&J shots soon.

The FDA said studies did not detect any serious side effects. Like other COVID-19 vaccines, the main side effects of J&J shots are injection site pain and flu-like fever, fatigue and headache.

An FDA fact sheet for vaccine recipients says that there is a “remote chance” that people may experience a severe allergic reaction to the shot, a rare risk seen with Pfizer and Modern vaccines. Such reactions can be treated and vaccine recipients should be monitored shortly after injection.

The vaccine has been approved for emergency use for adults 18 years and older at the moment. But just like other manufacturers, J&J will study how it works in adolescence before moving to younger children later in the year and is also planning a study on pregnant women.

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

J & J’s shots use a cold virus like a Trojan horse to carry the nail gene into the body, where cells make harmless copies of the protein to prime the immune system if the real virus comes along. This is the same technology that the company used in the manufacture of an Ebola vaccine and similar COVID-19 vaccines manufactured by AstraZeneca and China’s CanSino Biologics.

The Pfizer and Modern vaccines are made with a different technology, a piece of genetic code called messenger RNA that spurs cells to make these harmless spikes.

The AstraZeneca vaccine, already used in the UK and many other countries, completes a major US study needed for FDA approval. Also in operation, Novavax uses a completely different technology, made with lab-cultured copies of the nail protein, and has reported preliminary results from a British study that indicates strong protection.

Still other countries use “inactivated vaccines”, made with killed coronavirus by Chinese companies Sinovac and Sinopharm.


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