WASHINGTON (AP) – Johnson & Johnson’s single-vaccine 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. tame the pandemic.
The long-awaited shot could provide the country with a third vaccination and help speed up vaccinations by requiring just one dose instead of two. Scientists from the Food and Drug Administration have confirmed that the vaccine is generally about 66% effective in preventing moderate to severe COVID-19, and about 85% effective against the most serious disease. The agency also said J & J’s shot was safe.
The analysis is only one step in the FDA’s evaluation. The agency’s independent advisers will discuss on Friday whether the evidence is strong enough to recommend the shot. With the advice, the FDA is expected to make a final decision within a few days.
The COVID-19 death toll in the US was more than 500,000 this week and the vaccination campaign is slower than hoped, hampered by logistical and weather delays. To date, approximately 44.5 million Americans have received at least one dose of vaccine made by Pfizer or Moderna, and nearly 20 million of them have received the second dose required for full protection.
Tests showed that the Pfizer and Moderna vaccines were 95% effective against the symptomatic COVID-19.
Dr. Paul Offit, a vaccination expert at Philadelphia Children’s Hospital, is part of the FDA advisory panel that will examine the J&J data on Friday and warn that none of the vaccines have been directly compared. He is still encouraged that one dose of the J&J vaccine looks just as good at preventing serious diseases as the two-dose competitors.
“It’s a vaccine to prevent you from going to the hospital and dying at a level that is definitely comparable” with the Pfizer and Moderna vaccines, he said.
J&J has tested its single-dose option among 44,000 adults in the US, Latin America and South Africa. Different mutated versions of the virus spread in different countries, and the FDA analysis warns that it is not clear how well the vaccine works against each variant. But J&J previously announced that the vaccine works better in the US – 72% effective against moderate to severe COVID-19, compared to 66% in Latin America and 57% in South Africa.
South Africa recently started giving the J&J vaccine to health professionals at the forefront on a test basis after deciding that a vaccine from rival AstraZeneca did not show strong enough study results against the particularly particular variant that is distributed there.
“I was reassured” that the J&J shot is still protected against serious diseases despite various variants, said dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief, said. “It’s pretty robust data.”
In all countries, Wednesday’s analysis showed that protection began to emerge about 14 days after vaccination. But 28 days after vaccination, there were no hospitalizations or deaths in the vaccinated group, compared with 16 hospitalizations and seven deaths in study recipients who received a shot.
The FDA said efficiency and safety in racial groups, including black and Latino participants, are consistent.
All of the COVID-19 vaccines in the world have been tested differently, making comparisons nearly impossible. It will not be surprising if one dose turns out to be slightly weaker than two doses, and policymakers will decide whether it is an acceptable compromise to get more people vaccinated faster.
J&J is conducting another major study to see if a second dose of the vaccine works better, giving the prospect that countries may eventually add an enhancer if it turns out to be fair.
Like the other COVID-19 vaccines, the most important side effects of the J&J shot are injection site pain and flu-like fever, fatigue and headache. No participant in the study experienced the severe allergic reaction, called anaphylaxis, which is a rare risk for some other COVID-19 shots, although a less severe reaction was experienced.
The FDA has said that so far no serious side effects have been linked to the vaccine, although it recommends further monitoring of blood clots. In the study, it was reported in approximately 15 vaccine recipients and 10 placebo recipients, which did not differ enough to determine whether the vaccine played any role.
J&J was on track to become the world’s first single-dose option until earlier this month. Mexico has announced that it will use a single-dose version of the Chinese CanSino, which is manufactured using similar technology to the J&J recording, but was initially developed as a two-dose option until a single-dose test begins in the fall. is.
The Pfizer and Moderna vaccines now used in the US and numerous other countries need to be kept frozen, while the J&J shot can last three months in a refrigerator, making it easier to handle. The AstraZeneca vaccine – which is widely used in Europe and Britain – is manufactured in the same way and also requires refrigeration, but takes two doses.
If the FDA approves the J&J survey for US use, it will not significantly increase the vaccine supply immediately. It is expected that only a few million doses will be ready for dispatch in the first week. But J&J told Congress this week that it was expected to provide 20 million doses by the end of March and 100 million by the summer.
European regulators and the World Health Organization are also considering vaccinating J&J. Worldwide, the company aims to produce approximately one billion doses by the end of the year.
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Associated Press video producer Kathy Young contributed to this report.
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The Associated Press Health and Science Division receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.