WASHINGTON (AP) – The United States will receive a third vaccine to prevent COVID-19, as the Food and Drug Administration authorized a Johnson & Johnson injection on Saturday that works with a single dose instead of two.
Health experts eagerly await a unique option to help accelerate vaccines, as they compete against a virus that has already killed more than 510,000 people in the US and is mutating in increasingly worrying ways.
The FDA said the J&J 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 remained strong even in countries like South Africa, where the variants of greatest concern 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 now is take as many shots in as many arms as we can.”
J&J is initially providing a few million doses and shipments to the states could begin Monday. By the end of March, J&J has said it expects to deliver 20 million doses to the US and 100 million by the summer.
J&J also requests 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. On Thursday, the island nation of Bahrain became the first to authorize its use.
“This is exciting news for all Americans and an encouraging advance 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 with 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 is better?
“In this environment, whatever you can get, get,” said 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.
There is conflicting data on how well all the vaccines used around the world work, prompting reports in some countries of people refusing to wait for one type to another.
In the US, Pfizer and Moderna two-dose injections protected 95% against symptomatic COVID-19. The effectiveness of an 85% J&J dose against severe COVID-19 was reduced to 66% when moderate cases were incorporated. But there is no apples-to-apples comparison due to differences in when and where each company conducted its studies, with Pfizer and Moderna’s investigation ending before the variants began to spread.
NIH’s Collins said the evidence shows no reason to favor one vaccine over another.
“I think what most interests people is, will it keep me from really getting sick?” Collins said. “Will it prevent me from dying of this terrible disease? The good news is that they all say yes. “
Additionally, J&J is testing two doses of its vaccine in a separate large study. Collins said that if a second dose is ultimately deemed better, people who received one earlier would be offered another.
The FDA warned that it is too early to know if someone who contracts a mild or asymptomatic infection despite vaccination could still spread the virus.
There are clear advantages in addition to the convenience of a single shot. Local health officials are looking to use the J&J option in mobile vaccination clinics, homeless shelters, even with sailors who spend months on fishing boats, communities where it’s hard to be sure someone will return in three to four weeks for a second vaccine.
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 eating a little 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 medical records, personnel, and vaccine storage in anticipation of offering the 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 injection are injection site pain and flu-like fever, fatigue, and headache.
An FDA fact sheet for vaccine recipients says there is “a remote chance” that people will experience a severe allergic reaction to the injection, a rare risk seen with the Pfizer and Moderna vaccines. Such reactions are treatable and vaccine recipients are supposed to be monitored briefly after injection.
The vaccine has been licensed for emergency use in adults over the age of 18 for now. But like other manufacturers, J&J is about to study how it works in teens before moving on to younger children later in the year, and also plans a study in pregnant women.
All COVID-19 vaccines train the body to recognize the new coronavirus, usually by detecting the spikey protein that covers it. But they are made in very different ways.
The J&J injection 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 prime the immune system in case the real virus appears. It’s the same technology the company used to make an Ebola vaccine and similar to the COVID-19 vaccines made by AstraZeneca and CanSino Biologics of China.
The Pfizer and Moderna vaccines are made with a different technology, a piece of genetic code called messenger RNA that stimulates cells to produce those harmless spike copies.
The AstraZeneca vaccine, already used in Britain and many other countries, is completing a large study in the US required for FDA approval. Also in the works, Novavax uses still different technology, made with lab-grown copies of the spike protein, and has reported preliminary findings from a British study suggesting strong protection.
Other countries are using “inactivated vaccines” made from the coronavirus killed by Chinese companies Sinovac and Sinopharm.
Associated Press journalists Ricardo Alonso-Zaldivar and Marion Renault contributed to this report.
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