The US Food and Drug Administration Authorizes J&J COVID-19 Vaccine for Emergency Use: Coronavirus Updates: NPR


A healthcare worker holds a vial of Johnson & Johnson COVID-19 vaccine at Clerksdorp Hospital in Klerksdorp, South Africa, on February 18th.

PHILL MAGAKOE / AFP via Getty Images

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PHILL MAGAKOE / AFP via Getty Images

A healthcare worker holds a vial of Johnson & Johnson COVID-19 vaccine at Clerksdorp Hospital in Klerksdorp, South Africa, on February 18th.

PHILL MAGAKOE / AFP via Getty Images

A third COVID-19 vaccine is on the way, and this vaccine requires only one injection for immunization.

Food and Drug Administration Johnson & Johnson Vaccine License For emergency use, Saturday, the day after the agency’s advisory committee unanimously (0-22) voted in favor.

A statement issued by the World Health Organization said: “The mandate for this vaccine expands the availability of vaccines, which is the best medical way to prevent COVID-19, to help us fight this epidemic, which has killed more than half a million people in the United States.” Acting Food and Drug Administration Commissioner Janet Woodcock.

The Johnson & Johnson vaccine was tested in an international study of nearly 40,000 people, half of whom got the vaccine and half got a placebo. The study found that the company’s vaccine is 66% effective overall in preventing moderate to severe COVID-19 disease. For disease judged severe or serious, the efficacy was 85%. The study was conducted in the United States, South America, and South Africa.

The main study included on the company’s app found that after 28 days or more of vaccination, the Johnson & Johnson vaccine prevented hospitalization and deaths related to COVID-19.

The overall effectiveness numbers are less than 95% for Pfizer in preventing COVID-19 disease and 94% for Modena. But direct comparisons are difficult due to differences in clinical trials and the emergence of new strains of the Coronavirus.

Johnson & Johnson Vaccine is “very effective … in preventing severe disease after a single dose, and it triggers a kind of response, what’s called a cellular immune response, that looks like it will have a fairly long-lived memory, and it’s all right,” Dr. Paul Offitt Member of the Food and Drug Administration Advisory Committee, Scott told Simon of NPR running Saturday weekend edition. “This definitely provides protection against what matters to you, which is hospitalization, ICU admission and death. It’s nearly 100% effective at doing that.” Offit is also director of the Center for Vaccine Education at Children’s Hospital of Philadelphia.

As the epidemic approaches, the Coronavirus has mutated. Variants first seen in South Africa and Brazil, where the Johnson & Johnson vaccine was being tested, have developed mutations that help them evade the immune response resulting from previous infections with the original form of the virus and vaccines designed against it. Some variants, including one that was first identified in the UK, are more contagious.

In the South African portion of the Johnson & Johnson study, the company’s vaccine was 64% effective at preventing moderate to severe disease. In the Latin American region, the vaccine was 61% effective.

FDA analysis of safety data found the vaccine “an adequate safety profile with no specific safety concerns.” As part of the vaccine study, more than 6,000 people were asked about their reactions, and the most common side effects they reported were pain at the injection site (49%), headache (39%), fatigue (38%) and muscle pain (33%).

While cases of COVID-19 in the United States have fallen dramatically since their peak in January, Rochelle Wallinsky, director of the Centers for Disease Control and Prevention, warned during a White House briefing on Friday that the average confirmed cases for 7 days had risen in the past three days It represents a “very disturbing shift in course”. The average of cases in 7 days was 67,207 on Friday, up from 65,426 on Tuesday.

“Things are fragile,” Wallinski said. “Now is not the time to relax restrictions.” “Although we have seen a significant drop in cases and hospitalizations over the past six weeks, these declines follow the highest peak we’ve seen in the epidemic.”

It also warned that the continued spread of coronavirus variants in the United States threatens to reverse gains in containing the epidemic.

Besides mitigation measures such as wearing masks and physical distancing, vaccination is an important public health tool. More than 48 million people, or nearly 15% of the US population, have received at least one dose of the COVID-19 vaccine, according to CDC figures on Saturday. More than 23 million, or 7% of the population, have received two doses of the Moderna or Pfizer vaccine.

Johnson & Johnson’s addition to the coronavirus fight will be limited initially. The company said it will have 4 million doses ready to run when the US Food and Drug Administration lights up its vaccine. By the end of March, the company expects to be able to supply 20 million doses and deliver 100 million doses by the end of June.

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