WASHINGTON (AP) – The United States is receiving a third vaccine to prevent COVID-19, as the Food and Drug Administration on Saturday approved an Johnson & Johnson injection that works with just one dose instead of two.
Health experts are eagerly waiting for a unique option to help speed up vaccinations, as they compete against a virus that has killed more than 510,000 people in the United States and is mutating in increasingly worrying ways.
The FDA said the J&J vaccine offers strong protection against what is most important: serious illness, hospitalization and death. One dose was 85% protective against the most serious COVID-19 disease, in a large 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,” said Dr. Francis Collins, director of the National Institutes of Health, to the Associated Press on Saturday. “The most important thing we can do now is to hit as many shots in as many arms as we can.”
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 has announced that it expects 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 plans to produce around 1 billion doses globally by the end of the year. On Thursday, the island nation of Bahrain was the first to release its use.
“This is exciting news for all Americans and an encouraging development in our efforts to end the crisis,” said President Joe Biden in a statement. “But I want to be clear: this fight is far from over,” he added, encouraging people to wear 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 that environment, everything you can get – get,” said Dr. Arnold Monto of the University of Michigan, who chaired an FDA advisory panel that unanimously voted on Friday that the vaccine’s benefits outweigh its risks.
The data are mixed on how well all vaccines being used around the world work, generating reports in some countries of people who refuse one type of waiting for another.
In the USA, the 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 included. But there is no exact comparison because of the differences in when and where each company conducted its studies, with Pfizer and Moderna’s research ended before the variants started to spread.
NIH’s Collins said the evidence shows no reason to favor one vaccine over another.
“What do the people I think are most interested in is whether it will keep me from getting really sick?” Said Collins. “Will it prevent me from dying from this terrible disease? The good news is that everyone says yes to that. “
In addition, J&J is testing two doses of its vaccine in a large separate study. Collins said that if a second dose is considered better, people who have taken one before will receive another.
The FDA has warned that it is too early to say whether anyone who catches a mild or asymptomatic infection despite the vaccination can still spread the virus.
There are clear advantages in addition to the convenience of a shot. Local health officials are looking to use the J&J option in mobile vaccination clinics, shelters for the homeless, 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 handle, lasting three months in the refrigerator compared to the Pfizer and Moderna options, which must be frozen.
“We are looking forward to getting more supplies. That is the limiting factor for us now, ”said Dr. Matt Anderson of UW Health in Madison, Wisconsin, where employees were preparing electronic health, personnel and vaccine storage records in anticipation of the J&J injections offering soon. .
The FDA said the studies did not detect serious side effects. Like other COVID-19 vaccines, the main side effects of the J&J injection are pain at the injection site and a flu-like fever, fatigue and headache.
An FDA information leaflet for recipients of the vaccine says there is a “remote chance” that people may have a severe allergic reaction to the injection, a risk rare seen with the Pfizer and Moderna vaccines. These reactions are treatable and vaccine recipients should be monitored shortly after injection.
The vaccine has been authorized for emergency use in adults aged 18 and over for the time being. But, like other manufacturers, J&J is about to study how it works on teenagers before moving on to younger children later in the year, and also plans a study on pregnant women.
All COVID-19 vaccines train the body to recognize the new coronavirus, usually by detecting the spiny protein that surrounds it. But they are done in very different ways.
The J&J injection uses a cold virus like a Trojan horse to transport the spike gene to the body, where cells make harmless copies of the protein to prepare the immune system in case the real virus appears. It is the same technology the company used to make an Ebola vaccine, and similar to the COVID-19 vaccines made by AstraZeneca and CanSino Biologics in China.
The Pfizer and Moderna vaccines are made with a different technology, a piece of genetic code called messenger RNA that stimulates cells to make those harmless copies.
The AstraZeneca vaccine, already used in Britain and several other countries, is completing a major study in the United States, necessary for FDA clearance. Also in preparation, Novavax uses an even different technology, made with laboratory-grown copies of the spike protein, and reported preliminary findings from a British study suggesting strong protection.
Still other countries are using “inactivated vaccines”, made with killed coronavirus 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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