WASHINGTON (AP) – Johnson & Johnson’s single-dose vaccine provides strong protection against severe COVID-19, according to an analysis released Wednesday by US regulators paving the way for a final decision on a new and easier to use injection to help tame the pandemic.
The long-awaited shot could provide the country with a third vaccine option and speed up vaccinations by requiring just one dose instead of two. Food and Drug Administration scientists have confirmed that the vaccine is generally about 66% effective in preventing moderate to severe COVID-19 and about 85% effective against the most severe disease. The agency also said J & J’s shot is safe.
The analysis is just one step in the FDA’s evaluation. On Friday, the agency’s independent advisers will debate whether the evidence is strong enough to recommend the shot. With that advice, the FDA is expected to make a final decision within days.
The death toll from COVID-19 in the US hit more than 500,000 this week, and vaccination coverage has been slower than hoped, hampered by logistical and weather delays. So far, about 44.5 million Americans have received at least one dose of vaccine from Pfizer or Moderna, and nearly 20 million of them have received the second dose needed for complete protection.
Tests showed that the Pfizer and Moderna vaccines were 95% effective in protecting against symptomatic COVID-19.
Dr. Paul Offit, a vaccine expert at Children’s Hospital in Philadelphia, is part of the FDA advisory panel that will review the J&J data on Friday, warning that none of the vaccines have been directly compared. Still, he was encouraged that one dose of the J&J vaccine appears to be just 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 at a level that is certainly comparable,” he said.
J&J has tested the single-dose option on 44,000 adults in the US, Latin America and South Africa. Different mutated versions of the virus are circulating in different countries, and the FDA analysis 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 to 66% in Latin America and 57% in South Africa.
South Africa recently started giving the J&J vaccine to primary health care workers on a trial basis after deciding that a vaccine from rival AstraZeneca had not produced strong enough research results against the variant of particular concern spreading there.
“I was reassured” that despite several variants, the J&J shot still protected against serious illness, said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine leader. “That’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 dummy injection.
The FDA said effectiveness and safety were consistent across racial groups, including Black and Latino participants.
All COVID-19 vaccines in the world have been tested differently, making comparisons nearly impossible. It would not be surprising if one dose turns out to be slightly weaker than two doses, and policymakers will decide whether that is an acceptable trade-off to get more people vaccinated faster.
J&J has another major investigation underway to see if a second dose of its vaccine works better, increasing the likelihood that countries can eventually add a booster if warranted.
Like other COVID-19 vaccines, the main side effects of the J&J injection are injection site pain and flu-like fever, fatigue, and headache. No study participant had the serious allergic reaction called anaphylaxis, which is a rare risk from some other COVID-19 injections, although there was a less severe reaction in one.
The FDA said there were no serious side effects associated with the vaccine so far, although it recommends further monitoring for blood clots. In the study, those reported in about 15 vaccine recipients and 10 placebo recipients, not enough of a difference to say whether the vaccine played a role.
J&J was on track to become the world’s number one option until earlier this month. Mexico announced it would use a single-dose version of China’s CanSino, which is made with similar technology to J & J’s shot, but was initially developed as a two-dose option until a single-dose test in the fall began.
The Pfizer and Moderna vaccines now in use in the US and many other countries need to be stored frozen, while the J&J injection can stay in the refrigerator for three months, making it easier to handle. The AstraZeneca vaccine – widely used in Europe and Great Britain – is made in the same way and also requires refrigeration, but it requires two doses.
If the FDA approves the J&J shot for use in the US, it won’t significantly increase vaccine stock right away. Only a few million doses are expected to be ready for shipment in the first week. But J&J told Congress this week that it 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 J & J’s vaccine. Globally, the company aims to produce approximately one billion doses by the end of the year.
Video producer Kathy Young of Associated Press contributed to this report.
The Associated Press Department of Health and Science is supported by the Science Education Department of the Howard Hughes Medical Institute. The AP is solely responsible for all content.