WASHINGTON (AP) – Johnson & Johnson’s single dose vaccine offers strong protection against severe COVID-19, according to an analysis released on Wednesday by US regulators that sets the stage for a final decision on a new, more effective vaccine. easy to use to help master the pandemic.
The long-awaited injection could offer the country a third vaccine option and help speed up vaccinations by requiring only one dose instead of two. Scientists from the Food and Drug Administration have confirmed that, in general, the vaccine is 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 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 the injection. With that advice, the FDA is expected to make a final decision within a few days.
The number of COVID-19 deaths in the U.S. has exceeded 500,000 this week, and the vaccination campaign has been slower than expected, hampered by logistical and weather delays. To date, about 44.5 million Americans have received at least one dose of the Pfizer or Moderna vaccine, and nearly 20 million of them have received the second dose needed for total protection.
Tests showed that the Pfizer and Moderna vaccines were 95% effective in protecting against symptomatic COVID-19.
Dr. Paul Offit, a vaccine specialist at Children’s Hospital of Philadelphia, is on the FDA advisory panel that will examine J&J data on Friday and warns that none of the vaccines have been compared directly. Still, he was excited that one dose of the J&J vaccine looks just as good at preventing serious illnesses as its two-dose competitors.
“This is a vaccine to prevent you from going to the hospital and dying at a level that is certainly comparable” to 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 mutant versions of the virus are circulating in different countries, and the FDA’s analysis warned that it is unclear how the vaccine works against each variant. . But J&J previously announced that the vaccine worked best in the U.S. – 72% effective against moderate to severe COVID-19, compared with 66% in Latin America and 57% in South Africa.
South Africa recently started giving the J&J vaccine to frontline healthcare professionals on a test basis after deciding that a vaccine from rival AstraZeneca had not shown results of studies strong enough against the particularly worrying variant that spread there. .
“I was cool,” because despite the different variants, the J&J injection still protected against serious illnesses, said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief. “It is very 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 dummy injection.
The FDA said that effectiveness and safety were consistent across racial groups, including black and Latino participants.
All the COVID-19 vaccines in the world have been tested differently, making comparisons almost impossible. It wouldn’t be surprising if one dose turned out to be a little weaker than two doses, and lawmakers will decide whether that is an acceptable trade-off to vaccinate more people more quickly.
J&J has another large study underway to see if a second dose of its vaccine works better, raising the prospect that countries may eventually add a boost if needed.
Like other COVID-19 vaccines, the main side effects of the J&J injection are pain at the injection site and flu-like fever, fatigue and headache. No study participant experienced a severe allergic reaction, called anaphylaxis, which is a rare risk of some other injections of COVID-19, although one experienced a less serious reaction.
The FDA said there have been no serious side effects related to the vaccine so far, although it has recommended additional monitoring for blood clots. In the study, this was reported in about 15 vaccine recipients and 10 placebo recipients, not enough 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 announced that it would use a one-dose version of China’s CanSino, which is made with technology similar to the J&J injection, but was initially developed as a two-dose option until it began a one-dose test in the fall.
The Pfizer and Moderna vaccines, now used in the United States and several other countries, must be kept frozen, while the J&J injection can last for three months in the refrigerator, making handling easier. The AstraZeneca vaccine – widely used in Europe and Britain – is made in a similar way and also requires refrigeration, but takes two doses.
If the FDA authorizes the injection of J&J for use in the United States, it will not significantly increase vaccine supplies immediately. Only a few million doses are expected to be ready for shipment in the first week. But J&J told Congress this week who expected to deliver 20 million doses by the end of March and 100 million by the summer.
European regulators and the World Health Organization are also considering the J&J vaccine. Worldwide, the company plans to produce around 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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