Johnson & Johnson asks US regulators to OK its one-shot COVID-19 vaccine

Coronavirus

(NEXSTAR/AP) — Johnson & Johnson asked U.S. regulators Thursday to clear the world’s first single-dose COVID-19 vaccine, an easier-to-use option that could boost scarce supplies.

J&J’s vaccine was safe and offered strong protection against moderate to severe COVID-19, according to preliminary results from a massive international study.

Dr. Peter Marks, FDA’s vaccine chief, has cautioned against making comparisons before the evidence is all in.

“With so much need to get this pandemic under control, I think we can’t ignore any tool in the tool chest,” he told the American Medical Association last week. “We will have to do our best to try to make sure that we find the populations that benefit the most from each of these vaccines and deploy them in a very thoughtful manner.”

Earlier Thursday, the nation’s top infectious disease expert, Dr. Anthony Fauci said he expects Johnson & Johnson to apply for an emergency-use authorization for its COVID-19 one-shot vaccine this month.

“If FDA determines it meets their standards, the vaccine could be available this March,” Dr. Anthony Fauci said in a Twitter Q and A.

In results published late January, Johnson & Johnson found its COVID-19 vaccine provides good protection against the illness.

The pharmaceutical giant’s preliminary findings suggest the single-dose option may not be as strong as Pfizer’s or Moderna’s two-dose formula, and was markedly weaker against a worrisome mutated version of the virus in South Africa.

However, the Food and Drug Administration is asking its independent advisers to publicly debate all the data behind the single-dose shot — just like its competitors were put under the microscope — before it decides whether to green light a third vaccine option in the U.S.

But amid a rocky start to vaccinations worldwide, that may be an acceptable trade-off to get more people inoculated faster with an easier-to-handle shot that, unlike rival vaccines that must be kept frozen, can last months in the refrigerator.

“Frankly, simple is beautiful,” said Dr. Matt Hepburn, the U.S. government’s COVID-19 vaccine response leader.

Johnson & Johnson expects to supply 100 million doses to the U.S. by June — and a billion doses globally by year’s end — but declined to say how much could be ready if the Food and Drug Administration gives the green light.

Defeating the scourge that has killed more than 2 million people worldwide will require vaccinating billions. The shots being rolled out in different countries so far all require two doses a few weeks apart for full protection.

In late January, regulators also cleared a third option, AstraZeneca’s vaccine, for use throughout the European Union. The decision came amid criticism that the 27-nation bloc is not moving fast enough, as well as concern that there’s not enough data to tell how well the vaccine works in older people.

Johnson & Johnson studied its one-dose option in 44,000 people in the U.S., Latin America and South Africa. Interim results found the shot was 66% effective overall at preventing moderate to severe COVID-19 and much more protective — 85% — against the most serious symptoms. There were no serious side effects.

“Gambling on one dose was certainly worthwhile,” Dr. Mathai Mammen, global research chief for J&J’s Janssen Pharmaceutical unit, told The Associated Press.

The Associated Press contributed to this report.

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