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WASHINGTON (AP) – The United States receives a third vaccine to prevent COVID-19, as the Food and Drug Administration on Saturday authorized a Johnson & Johnson vaccine that works with one dose instead of two.
Health experts eagerly await a unique option to speed up vaccinations, as they race against a virus that has already killed more than 510,000 people in the United States and mutates in increasingly worrying ways.
The FDA said J & J’s vaccine offers strong protection against what matters most: serious illness, hospitalizations and death. One dose protected 85% against the most serious COVID-19 disease, in a massive study that spanned three continents – protection that has remained strong even in countries like South Africa, where the most worrying variants are spreading .
“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 hits in as many arms as possible.
J&J is initially supplying a few million doses and shipments to the states could begin as early as Monday. By the end of March, J&J announced that it plans to deliver 20 million doses to the United States and 100 million by the summer.
J&J is also seeking authorization for the emergency use of its vaccine in Europe and from the World Health Organization. The company aims to produce around 1 billion doses worldwide by the end of the year. The island nation of Bahrain became the first to allow its use on Thursday.
“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 U.S. 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 guy is better?
“In this environment, all you can get – get,” said Dr. Arnold Monto of the University of Michigan, who chaired an FDA advisory group that voted unanimously on Friday that the vaccine benefits. outweigh its risks.
Data is mixed on the effectiveness of all vaccines used globally, leading some countries to report people refusing one type to wait for another.
In the United States, two-dose injections of Pfizer and Moderna were 95% protective against symptomatic COVID-19. The effectiveness of an 85% dose of J&J against severe COVID-19 dropped to 66% when moderate cases were recorded. But there’s no apple-to-apple comparison due to the differences in when and where each company studied, with Moderna’s research ended before the variants began to spread.
Collins of the NIH said the evidence shows no reason to favor one vaccine over another.
“What interests me the most, I think that will keep me from getting really sick?” Collins said. “Will that keep me from dying of this terrible disease?” The good news is that it all says yes to that.
In addition, J&J is testing two doses of its vaccine in a separate large study. Collins said if a second dose is ultimately found to be better, people who had had one earlier would be offered another.
The FDA has warned that it is too early to say whether a person who contracts a mild or asymptomatic infection despite being vaccinated could still spread the virus.
There are obvious advantages besides the one-shot convenience. Local health officials are looking to use the J&J option in mobile vaccination clinics, homeless shelters, even with sailors spending months on fishing boats – communities where it is difficult to be sure someone will come back in three to four weeks for a second vaccination.
The J&J vaccine is also easier to handle, it lasts three months in the refrigerator compared to the Pfizer and Moderna options, which must be frozen.
“We are trying 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 members were preparing electronic health records, staffing and vaccine storage in anticipation. to offer J&J vaccines soon.
The FDA said the studies found no serious side effects. Like other COVID-19 vaccines, the main side effects of the J&J vaccine are pain at the injection site and fever, fatigue, and flu-like headaches.
An FDA vaccine fact sheet states that there is a “small chance” that people will experience a serious allergic reaction to the vaccine, a rare risk seen with Pfizer and Moderna vaccines. Such reactions are treatable and vaccinees are expected to be briefly monitored after injection.
The vaccine has been approved for emergency use in adults 18 years of age and older at this time. But like other manufacturers, J&J is set to study how it works in adolescents before moving on to younger children later in the year, and is planning a study in pregnant women as well.
All COVID-19 vaccines train the body to recognize the new coronavirus, usually by spotting the spikey protein that covers it. But they are made in very different ways.
J & J’s shot uses a cold virus like a Trojan horse to carry the spike gene around the body, where cells make harmless copies of the protein to prime the immune system in case the real virus does arise. It’s the same technology the company used to make an Ebola vaccine, and similar to COVID-19 vaccines made by AstraZeneca and CanSino Biologics in China.
The Pfizer and Moderna vaccines are made with different technology, a piece of genetic code called messenger RNA that prompts cells to make these harmless, advanced copies.
The AstraZeneca vaccine, already in use in Britain and many other countries, completes a large US study needed for FDA clearance. Also in development, Novavax uses yet another technology, made with lab copies of the cutting edge protein, and reported preliminary results from a UK study suggesting strong protection.
Still other countries use “inactivated vaccines” made with a coronavirus killed by Chinese companies Sinovac and Sinopharm.
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Associated Press journalists Ricardo Alonso-Zaldivar and Marion Renault contributed to this report.
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The Associated Press’s Department of Health and Science receives support from the Department of Science Education at the Howard Hughes Medical Institute. The AP is solely responsible for all content.
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