Health experts are eagerly awaiting a definitive option to help speed up vaccinations as they compete against a virus that has already killed more than 510,000 people in the U.S. 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. A dose was 85% protective against the most severe disease of COVID-19, in a massive study spanning three continents, a protection that remained strong even in countries such as South Africa, where variants are widespread. more worrying.
“This is 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 shots in as many arms as we can.”
Shipments of several million doses to be split between states could begin as early as Monday. In late March, J&J said it expects to deliver 20 million doses in the U.S. and 100 million in the summer.
J&J is also seeking authorization for the emergency use of its vaccine in Europe and by the World Health Organization. Worldwide, the company aims to produce approximately 1 billion doses worldwide by the end of the year. On Thursday, the island nation of Bahrain became the first to clean up its use.
On Sunday, a U.S. advisory committee will meet to recommend how to prioritize single-dose vaccine use. And a big challenge is what the public wants to know: what kind of vaccine is best?
“In this environment, all you can get,” Dr. Arnold Monto of the University of Michigan, who chaired an FDA advisory group that voted unanimously Friday that the benefits of the vaccine outweigh its risks.
Data are mixed on the operation of all vaccines used around the world, leading to reports in some countries of people rejecting one type to expect another.
In the U.S., two-dose shots from Pfizer and Moderna protected 95% against symptomatic COVID-19. The effectiveness of an 85% dose of J&J against severe COVID-19 dropped to 66% when moderate cases were introduced. But there is no comparison between apples and apples because of the differences in when and where each company conducted its studies, with Pfizer and The research on Modern ended before it began to spread about variants.
Collins from NIH said evidence of efficacy shows no reason to favor one vaccine over another.
“What I think is what interests me most about people is what will keep me from getting really sick?” said Collins of NIH. “Will it prevent me from dying from this terrible disease? The good news is that they all say 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 finally considered better, another would be offered to people who received one before.
The FDA warned that it is too early to know if someone who has a mild or asymptomatic infection despite vaccination can still spread the virus.
There are clear advantages apart from 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 to make a second vaccination.
The J&J vaccine is also easier to handle and lasts three months in the fridge compared to the Pfizer and Moderna options, which have to be frozen.
“We save to get more supply. That’s the limiting factor for us right now,” said Dr. Matt Anderson of UW Health in Madison, Wisconsin, where employees were preparing electronic health records, staffing and vaccine storage in anticipation. to offer J&J shots soon.
The FDA said the studies did not detect any serious side effects. Like other COVID-19 vaccines, the main side effects of the J&J shot are pain at the injection site and flu, fatigue, and flu-like headaches.
The FDA said there is a “remote chance” that people may experience a severe allergic reaction to the shot, a rare risk seen with Pfizer and Moderna vaccines.
The vaccine has been authorized for emergency use in adults 18 years of age or older by now. But like other vaccine manufacturers, J&J is about to begin a study of its vaccine in teens before moving on to younger children by the end of 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 spiked protein that coats it. But they are made in very different ways.
The J&J trait uses a cold virus like a Trojan horse to transport the ear 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 COVID-19 vaccines manufactured by AstraZeneca and CanSino Biologics of China.
Pfizer and Moderna vaccines are made with a different technology, a piece of genetic code called messenger RNA that stimulates cells to make these copies of harmless spikes.
The AstraZeneca vaccine, which is already used in Britain and many other countries, is finishing a major U.S. study needed for FDA clarification. Also in the pipeline, Novavax uses an even different technology, made with laboratory copies of the ear protein, and has reported preliminary findings from a British study suggesting strong protection.
Still other countries use “inactivated vaccines,” made with the dead 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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The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
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