Johnson & Johnson appeals for approval of one-shot vaccine – Orange County Register

Virus Outbreak Vaccine 1

By Lauran Neergaard | Related Press

Johnson & Johnson requested U.S. regulators Thursday to clear the world’s first single-dose COVID-19 vaccine, an easier-to-use possibility that might increase scarce provides.

J&J’s vaccine was secure and provided sturdy safety in opposition to reasonable to extreme COVID-19, in accordance with preliminary outcomes from an enormous worldwide research.

It didn’t seem fairly as sturdy as two-dose rivals made by Pfizer and Moderna — a discovering that could be extra notion than actuality, given variations in how every was examined.

However the Meals and Drug Administration is asking its impartial advisers to publicly debate all the info behind the single-dose shot — identical to its rivals had been put below the microscope — earlier than it decides whether or not to inexperienced gentle a 3rd vaccine possibility within the U.S. The panel will meet Feb. 26.

Dr. Peter Marks, FDA’s vaccine chief, has cautioned in opposition to making comparisons earlier than the proof is all in.

“With a lot must get this pandemic below management, I feel we will’t ignore any device within the device chest,” he informed the American Medical Affiliation final week. “We must do our greatest to attempt to guarantee that we discover the populations that profit probably the most from every of these vaccines and deploy them in a really considerate method.”

What the numbers present

Total, the single-dose vaccine was 66% efficient at stopping reasonable to extreme COVID-19, in accordance with early findings from a research of 44,000 individuals within the U.S., Latin America and South Africa.

However it was 85% protecting in opposition to probably the most critical signs — and beginning 28 days after their shot, researchers discovered nobody who received the vaccine wanted hospitalization or died.

Weaker however nonetheless fights mutating virus

The one-dose possibility labored higher within the U.S. — 72% efficient in opposition to reasonable to extreme COVID-19 — in contrast with 66% in Latin America and 57% in South Africa, the place a extra contagious mutant virus is spreading.

Scientists have been wanting for real-world proof about how vaccines work because the world races to remain forward of the quickly mutating virus, and welcomed the information that the J&J possibility — whereas weaker — did nonetheless supply safety.

Different choices

In massive U.S. research, two doses of the Pfizer and Moderna vaccines proved 95% protecting in opposition to any symptomatic COVID-19.

However these research had been completed earlier than the file virus surges of latest months and the looks of the worrisome mutants, which means such testing may not end up the identical if repeated at the moment.J&J is also finding out a two-dose model of its vaccine, however outcomes gained’t be accessible for a number of extra months.

The provision

J&J stated it could have some vaccine able to ship if the FDA permits emergency use of the shot, however it didn’t reveal how a lot. The pharmaceutical big stated it expects to produce 100 million doses to the U.S. by the tip of June.

It expects to file an analogous software with European regulators quickly.

The Related Press Well being and Science Division receives help from the Howard Hughes Medical Institute’s Division of Science Schooling. The AP is solely accountable for all content material.