By LAURAN NEERGAARD and MATTHEW PERRONE
Washington (AP) —Saturday’s Food and Drug Administration clears Johnson & Johnson injections that work with a single dose instead of two, so the US has a third vaccine to prevent COVID-19 I will.
Health experts have already killed more than 510,000 people in the United States and are competing with mutated viruses in increasingly anxious ways, giving them a one-time option to speed up vaccination. I am worried and waiting.
The FDA said J & J’s vaccine provides strong protection against the most important things, including serious illness, hospitalization and death. In a large study across three continents, a single dose provided 85% protection against the most serious COVID-19 disease. Defense was also strong in countries where the most worrisome variants are endemic, such as South Africa.
“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 right now is to take as many shots as possible with as many arms as possible.”
Initially, J & J offers millions of doses, and shipments to the state may begin as early as Monday. J & J announced that it plans to administer 20 million doses to the United States by the end of March and 100 million doses by the summer.
J & J is also seeking permission for emergency use of the vaccine from European and World Health Organizations. The company aims to administer approximately 1 billion doses worldwide by the end of the year. On Thursday, the island nation of Bahrain became the first to clear its use.
“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 to be clear, the fight isn’t over yet,” he added, urging people to stick to masks and other public health measures.
On Sunday, a US advisory board will meet to recommend ways to prioritize the use of single-dose vaccines. And one big challenge is what the general public wants to know. Which type is better?
Dr. Arnold Monto of the University of Michigan chaired the FDA Advisory Board, which unanimously voted on Friday that the benefits of the vaccine outweigh the risks.
Data on how well all vaccines used around the world work are mixed, prompting reports that one country refuses to wait for another. ..
In the United States, two doses of Pfizer and Moderna were 95% protective against symptomatological COVID-19. The efficacy of a single dose of 85% for J & J’s severe COVID-19 was reduced to 66% when moderate cases were rolled in. However, Moderna’s research on Pfizer and variants ended before it began to spread.
Collins of NIH said the evidence did not show any reason to favor one vaccine over another.
“Can the person I think is most interested in really prevent me from getting sick?” Collins said. “Does it prevent me from dying from this terrible illness? The good news is that all of this says so.”
J & J is also testing two doses of the vaccine in another large study. Collins said that if the second dose is ultimately considered good, the person who takes the first dose will be offered another dose.
The FDA has warned that it is too early to determine if a person with a mild or asymptomatic infection despite vaccination can still spread the virus.
Besides the one-shot convenience, there are obvious benefits. Local health officials are considering using the J & J option at mobile vaccination clinics and homeless shelters, even if some sailors spend months on fishing boats.
The J & J vaccine is easy to handle and lasts for 3 months in the refrigerator compared to the Pfizer and Moderna options that require freezing.
“We’re a little at a loss to get more supply. Dr. Matt Anderson of UW Health in Madison, Wisconsin said that in anticipation of providing J & J shots, staff will be staffed with electronic medical records, staffing, I was preparing to store the vaccine.
The FDA said the study did not detect any serious side effects. Like other COVID-19 vaccines, the main side effects of J & J Shot are injection site pain and flu-like fever, malaise, and headache.
The FDA fact sheet for vaccinated people has a “small possibility” that people may experience a severe allergic reaction to shots, a rare risk seen with Pfizer and Moderna vaccines. Is written. Such reactions are treatable and vaccinated persons are to be easily monitored after injection.
The vaccine is currently approved for emergency use by adults over the age of 18. But like any other maker, J & J wants to study how it works as a teenager before moving to younger children later this year. We are also planning a study of pregnant women.
All COVID-19 vaccines usually train the body to recognize the new coronavirus by finding the pointed protein that covers it. But they are made in a very different way.
In J & J’s shots, a Trojan horse-like cold virus is used to carry the spike gene into the body, causing cells to make harmless copies of the protein and stimulate the immune system in the event of a real virus outbreak. I will. This is the same technology that the company used to make the Ebola vaccine, similar to the COVID-19 vaccine manufactured by AstraZeneca and CanSino Biologics in China.
Pfizer and Modana vaccines are made with different technologies. A part of the genetic code called messenger RNA that stimulates cells to make harmless spike copies.
The AstraZeneca vaccine, which is already in use in the United Kingdom and many other countries, has completed the extensive US research required for FDA approval. Also in the pipeline, Novavax uses a different technique made from laboratory-grown copies of peplomer proteins, reporting preliminary findings from a UK study suggesting strong protection. ..
Yet other countries are using “inactivated vaccines” made with the coronavirus killed by Chinese companies Sinovac and Sinopharm.
Associated Press journalists Ricardo Alonso-Zaldivar and Marion Renault contributed to this report.
The Associated Press’s Department of Health Sciences is supported by the Department of Science Education at the Howard Hughes Medical Institute. AP is solely responsible for all content.
One J & J vaccination cleared and the third COVID-19 vaccine in the US –
Source link One J & J vaccination cleared and the third COVID-19 vaccine in the US –