By Lauren Nergaard and Matthew Peron, Associated Press
WASHINGTON (AP) – Johnson & Johnson’s single-dose vaccine provides tougher protection against severe COVID-19, according to an analysis released Wednesday by US regulators, which makes the final decision on a new and easier-to-find shot. Sets the stage to help take. Due to the epidemic.
The long-awaited shot can offer the country a third vaccine option and help speed vaccination by requiring just one dose instead of two. Food and Drug Administration scientists confirmed that the vaccine is about 66% overall, which is effective in preventing moderate to severe COVID-19 and is about 85% effective against the most severe disease. The agency also said that J & J’s shot was safe.
The analysis is just one step in the FDA’s assessment. On Friday, the agency’s independent advisers will debate whether the evidence is strong enough to recommend firing. With that advice, the FDA is expected to make a final decision within days.
COVID-19 deaths in the US topped 500,000 this week, and vaccination campaigns have been slower than expected and disrupted by weather delays. So far, about 44.5 million Americans have received at least one dose of the vaccine made by Pfizer or Modern, and about 20 million of them have received the second dose required for complete protection.
Tests showed that Pfizer and Modern vaccines were 95% effective in protecting against symptomatic COVID-19.
Dr., a vaccine specialist at Children’s Hospital Philadelphia. Paul Offit is part of the FDA advisory panel that will examine Jammu and Kashmir data on Friday and warn that none of the vaccines have been directly compared. Nevertheless, they were encouraged that one dose of the J&J vaccine was as good at preventing serious illness as it was among its two-dose competitors.
“It’s a vaccine that prevents you from going to the hospital and is about to die on a level that’s certainly comparable,” according to Pfizer and Modern Vaccines, he said.
J&J tested its single-dose option in 44,000 adults in the US, Latin America and South Africa. Different mutated versions of the virus are circulating in different countries, and FDA analysis cautioned that it is unclear how well the vaccine works against each variant. But J&J previously announced that the vaccine had worked better in the US – 72% effective for moderate to severe COVID-19, with 66% in Latin America and 57% in South Africa.
Nevertheless, South Africa recently began to tell front-line health workers to test the J&J vaccine on the basis that a vaccine from rival AstraZeneca has not shown good enough study results.
In all countries, Wednesday’s analysis showed that protection began about 14 days after vaccination. But after 28 days of vaccination, there were no hospitalizations or deaths in the vaccinated group, compared to 16 hospitalizations in the vaccinated group and seven deaths of the studyers who received the dummy shot.
The FDA stated that effectiveness and safety were consistent with racial groups, including Black and Latino participants.
All COVID-19 vaccines in the world have been tested separately, making comparisons virtually impossible. It would not be surprising if one dose was slightly weakened by two doses, and policymakers would decide whether there was an acceptable trade-off to get more people vaccinated faster.
J&J has conducted another large study to see if a second dose of its vaccine works better, raising the possibility that countries may eventually add a booster if a warrant goes out.
Like other COVID-19 vaccines, the main side effects of the J&J shot are pain at the injection site and flu-like fever, fatigue, and headache. None of the study participants experienced an acute allergic reaction, known as anaphylaxis, which is a rare risk of some other COVID-19 shots, although one experienced a less severe reaction.
The FDA stated that there were no serious side effects associated with the vaccine yet, although it recommended further monitoring for blood clots. In the study, about 15 of those vaccine recipients and 10 placebo recipients were reported not to have a sufficient difference to tell if the vaccine played any role.
J & J was on track to become the world’s first one-dose option by the beginning of this month. Mexico announced that it would use a one-dose version from China’s casino, made with the same technology as J & J’s Shot, but initially a two-dose option until starting a one-dose test in the fall. Was developed as.
Pfizer and Moderna vaccines are now being used in the US and should be kept frozen in many other countries, while the J&J shot can last up to three months in a refrigerator, making it easier to handle. AstraZeneca vaccine – widely used in Europe, Britain and Israel – is made similarly and also requires refrigeration, but takes two doses.
If the FDA approved the J&J shot for US use, it would not significantly increase the vaccine supply. Only a few million doses are expected to be ready for shipping in the first week. But Jammu and Kashmir told the Congress this week that it expected to provide 20 million doses by the end of March and 100 million in the summer.
European regulators and the World Health Organization are also considering the Jammu and Kashmir vaccine. Worldwide, the company aims to produce approximately one billion doses by the end of the year.
Associated Press video producer Kathy Young contributed to this report.
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