Health experts eagerly await a one-off option to help speed up vaccinations as they race 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 J & J’s vaccine offers strong protection against what matters most: serious illness, hospitalizations, and death. One dose was 85% protective against the most severe COVID-19 disease, in a large-scale study spanning three continents – protection that remained strong even in countries like South Africa, where the most troubling variants are spreading.
“This is really good news,” said Dr. Francis Collins, director of the National Institutes of Health, Saturday at The Associated Press. “The most important thing we can do now is get as many shots as possible into as many arms as possible.”
Shipments of a few million doses to be distributed to the states could begin as early as Monday. J&J has said it expects 20 million doses to the US by the end of March and 100 million by the summer.
J&J is also seeking emergency approval for its vaccine in Europe and from the World Health Organization. Globally, the company aims to produce approximately 1 billion doses worldwide by the end of the year. On Thursday, the island of Bahrain was the first to clean up its use.
On Sunday, a US advisory committee will meet to recommend how to prioritize single-dose use of the vaccine. And a big challenge is what the public wants to know: Which kind of vaccine 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 vaccine’s benefits outweigh its risks.
Data on how well all the vaccines in use around the world work has been mixed, prompting reports in some countries that people are refusing to wait one strain for another.
In the US, the two-dose Pfizer and Moderna shots were 95% protective against symptomatic COVID-19. J & J’s 85% single dose effectiveness against severe COVID-19 dropped to 66% when moderate cases were brought in. But there is no comparison from apples to apples due to differences in where and when each company conducted its studies, with the Pfizer and Moderna research being completed before variants-related variants began to spread.
Collins of the NIH said the evidence of effectiveness shows no reason to prefer one vaccine over another.
“What people I think are most interested in is, will it keep me from really getting sick?” said Collins of the NIH. ‘Will it keep me from dying from this terrible disease? The good news is that they all say yes to that. ‘
J&J is also testing two doses of its vaccine in a separate large study. Collins said that if a second dose is ultimately considered better, people who received one earlier would receive another.
The FDA warned that it is too early to say whether someone who develops a mild or asymptomatic infection despite vaccination will still be able to spread the virus.
In addition to the convenience of one shot, there are clear advantages. 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’s hard to be sure someone will return for a second vaccination in three to four weeks.
The J&J vaccine is also easier to handle and will keep for three months in the refrigerator compared to the Pfizer and Moderna options, which must be frozen.
“We’re chewing hard 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 await electronic medical records, staff and vaccine storage were in progress. to offer J&J shots soon.
The FDA said studies have not found any 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.
The FDA said there is “a small chance” that people could experience a severe allergic reaction to the injection, a rare risk seen with the Pfizer and Moderna vaccines.
The vaccine has been provisionally approved for emergency use in adults 18 years of age and older. But like other vaccine manufacturers, J&J is about to begin a study of the vaccine in teens before moving it to younger children later in the year, and is also planning a study in pregnant women.
All COVID-19 vaccines train the body to recognize the new coronavirus, usually by spotting the spikey protein that envelops it. But they are made in very different ways.
J & J’s shot uses a cold virus like a Trojan horse to deliver the spike gene into the body, where cells make harmless copies of the protein to boost the immune system in case the real virus comes along. It’s the same technology the company used to create an Ebola vaccine, and is comparable to COVID-19 vaccines made by AstraZeneca and China’s CanSino Biologics.
The Pfizer and Moderna vaccines are made with a different technology, a piece of genetic code called messenger RNA that spurs cells to make those harmless peak copies.
Already in use in Britain and many other countries, the AstraZeneca vaccine is completing a major US trial that is needed for FDA approval. Also in the pipeline, Novavax uses yet another technology, made with lab-grown copies of the spike protein, and has reported preliminary findings from a UK study suggesting strong protection.
Still other countries use “inactivated vaccines” made with killed coronavirus by Chinese companies Sinovac and Sinopharm.
Associated Press journalists Ricardo Alonso-Zaldivar and Marion Renault contributed to this report.
The Associated Press Department of Health and Science is supported by the Science Education Department of the Howard Hughes Medical Institute. The AP is solely responsible for all content.
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