The Associated Press
The US is getting a third vaccine against COVID-19 as the Food and Drug Administration on Saturday approved a Johnson & Johnson shot that works with just one dose instead of two.
Health professionals are eagerly awaiting a one-off option to speed up vaccinations as they battle a virus that has 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, hospitalization, and death. One dose was 85 percent protected from the most serious COVID-19 disease. This was the result of a comprehensive study that spanned three continents – a protection that remained strong even in countries like South Africa, where the most worrisome variants are spreading.
“This is really good news,” said 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 get as many shots in as many arms as possible.”
J&J is initially shipping a few million cans, and shipments to states could begin as early as Monday. J&J is expected to ship 20 million cans in the US by the end of March and 100 million by the summer.
J&J is also applying for approval for the emergency use of its vaccine in Europe and with the World Health Organization. The company plans to produce around 1 billion cans worldwide by the end of the year. The island state of Bahrain was the first to open 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.
A U.S. advisory committee will meet on Sunday to recommend how to prioritize use of the single-dose vaccine. And a big challenge is what the public wants to know: which kind is better?
“In this environment, you can get whatever you can get,” said Dr. Arnold Monto of the University of Michigan, chairman of an FDA advisory panel, unanimously voted Friday that the benefits of the vaccine outweigh the risks.
The data on how well all vaccines used around the world work is inconsistent. In some countries it is reported that people refuse to wait for another.
In the US, the two-dose Pfizer and Moderna doses were 95% protected from symptomatic COVID-19. J&J’s one-time 85% effectiveness against severe COVID-19 dropped to 66% when moderately severe cases occurred. There is no apple-to-apples comparison, however, as there are differences in when and where each company conducted their studies with Pfizer and Moderna research, which was completed before variants spread, began to spread.
“What people I think are most interested in is is it going to keep me from getting really sick?” Said Collins. “Will it keep me from dying of this terrible disease? The good news is that all these people are saying yes to it.”
J&J is also testing two doses of his vaccine in a separate large study. Collins said that if at some point a second dose is considered better, people who got one earlier will be offered a different one.
The FDA warned that it was too early to tell if someone who got a mild or asymptomatic infection despite being vaccinated could still spread the virus.
In addition to the convenience of a shot, there are clear advantages. Local health officials are trying to use the J&J option in mobile vaccination clinics and homeless shelters, even with seafarers who spend months on fishing vessels – communities where it is difficult to be sure someone will come back for a second vaccination in three to four weeks .
The J&J vaccine is also easier to use and lasts three months in the refrigerator compared to the Pfizer and Moderna options which require freezing.
“We are in the process of getting more care. This is the limiting factor for us right now,” said Dr. Matt Anderson of UW Health in Madison, Wisconsin, where staff was preparing to offer J&J recordings in anticipation of electronic health records, staff and vaccine storage.
The FDA said studies have not found any serious side effects. As with other COVID-19 vaccines, the main side effects of the J&J shot are pain at the injection site, as well as flu-like fever, fatigue and headache.
An FDA bulletin for vaccine recipients states that there is “a remote likelihood” that people will have a severe allergic reaction to the shot, a rare risk associated with Pfizer and Moderna vaccines. Such reactions are treatable and vaccine recipients should be monitored shortly after the injection.
The vaccine is initially approved for emergencies in adults aged 18 and over. But like other manufacturers, J&J is in the process of studying how it works in teenagers before switching 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 recognizing 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 transport the spike gene into the body, where cells make harmless copies of the protein to activate the immune system in the event the real virus occurs. It’s the same technology the company used to make an Ebola vaccine and is similar to the COVID-19 vaccines from AstraZeneca and CanSino Biologics of China.
Pfizer and Moderna vaccines are made using a different technology, a genetic code called messenger RNA, that encourages cells to make these harmless spike copies.
Already used in the UK and numerous other countries, the AstraZeneca vaccine completes a large US study required for FDA approval. Also in the pipeline, Novavax is using yet another technology made from laboratory-grown copies of the spike protein and has reported preliminary results from a UK study suggesting strong protection.
Still other countries are using “inactivated vaccines” made by Chinese companies Sinovac and Sinopharm with killed coronavirus.
This September 2020 photo by Johnson and Johnson shows a single-dose COVID-19 vaccine being developed by the company becomes. (Cheryl Gerber / Courtesy Johnson & Johnson via AP, file)
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