WASHINGTON (AP) – Johnson & Johnson single-dose vaccine offers strong protection against severe COVID-19, according to an analysis released Wednesday by U.S. regulators, which sets the stage for a final decision on a new and easier-to-use photo. used to help tame the pandemic.
The long-awaited shooting could give the nation a third vaccination option and could help speed up vaccinations, requiring only one dose instead of two. Food and Drug Administration scientists have confirmed that the vaccine is generally approximately 66% effective in preventing moderate to severe COVID-19 and approximately 85% effective against the most serious diseases. The agency also said J & J’s shooting was safe.
The analysis is just a step in the FDA assessment. On Friday, the agency’s independent advisers will debate whether the evidence is strong enough to recommend the shooting. With this advice, the FDA is expected to make a final decision in a few days.
The death toll from COVID-19 in the United States exceeded 500,000 this week, and the vaccination rate was slower than expected, hampered by logistical and weather delays. To date, approximately 44.5 million Americans have received at least one dose of vaccine produced by Pfizer or Moderna, and nearly 20 million of them have received the second dose required for complete protection.
Tests showed that Pfizer and Moderna vaccines were 95% effective in protecting against symptomatic COVID-19.
Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia, is part of the FDA’s advisory group, which will review J&J data on Friday and warns that none of the vaccines have been compared directly. However, it has been encouraged that one dose of J&J vaccine seems as good at preventing serious illness as its two-dose competitors.
“This is a vaccine to prevent you from going to the hospital and dying to a level that is certainly comparable to the Pfizer and Moderna vaccines,” he said.
J&J tested its single dose option on 44,000 adults in the United States, Latin America and South Africa. Different mutated versions of the virus are circulating in different countries, and the FDA analysis has warned that it is not clear how well the vaccine works against each variant. But J&J previously announced that the vaccine worked better in the US – 72% effective against moderate to severe COVID-19, compared with 66% in Latin America and 57% in South Africa.
South Africa recently began administering the J&J vaccine to front-line healthcare workers on a test basis after deciding that a vaccine from rival AstraZeneca did not show strong enough results in the study against the particularly prevalent variant. .
“I was reassured that, despite the various options, the J&J shot was still protected against serious disease,” said Dr. Jesse Goodman of Georgetown University, a former head of the FDA vaccine. “It’s pretty robust data.”
In all countries, Wednesday’s analysis showed that protection began to appear about 14 days after vaccination. But 28 days after vaccination, there were no hospitalizations or deaths in the vaccinated group, compared to 16 hospitalizations and seven deaths in the study beneficiaries who received a false blow.
The FDA said that efficacy and safety are consistent across all racial groups, including black and Latino participants.
All COVID-19 vaccines in the world have been tested differently, making comparisons almost impossible. It would not be surprising if one dose turns out to be slightly lower than two doses, and policy makers will decide whether this is an acceptable compromise to vaccinate more people faster.
J&J has another extensive study underway to see if a second dose of the vaccine works better, raising the prospect that countries could eventually add a booster if it proves justified.
Like other COVID-19 vaccines, the main side effects of the J&J vaccine are pain at the injection site and flu-like fever, fatigue and headache. No study participants experienced a severe allergic reaction, called anaphylaxis, which is a rare risk of other COVID-19 photos, although one had a less severe reaction.
The FDA said there had been no serious vaccine-related side effects so far, although it recommended additional monitoring of blood clots. In the study, they were reported in about 15 patients who received the vaccine and 10 patients who received placebo, there is not enough difference to say whether the vaccine played a role.
J&J was on track to become the world’s first single-dose option by the beginning of this month. Mexico has announced that it will use a single-dose version of China’s CanSino, which is made with technology similar to J&J’s, but was initially developed as a two-dose option until a test with a single dose in the fall.
The Pfizer and Moderna vaccines now used in the US and many other countries need to be kept frozen, while the J&J shot can last three months in the refrigerator, making it easier to handle. The AstraZeneca vaccine – widely used in Europe and the UK – is similarly manufactured and also requires refrigeration, but takes two doses.
If the FDA eliminates the J&J vaccine for use in the United States, it will not significantly increase the immediate supply of vaccines. Only a few million doses are expected to be ready for delivery in the first week. But J&J told Congress this week that he expected to deliver 20 million doses by the end of March and 100 million by summer.
European regulators and the World Health Organization are also considering the J&V vaccine. The company aims to produce around one billion doses worldwide by the end of the year.
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Associated Press video producer Kathy Young contributed to this report.
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