FDA Authorizes Johnson & Johnson’s One-Shot COVID-19 Vaccine

A health care employee holds a vial of the Johnson & & Johnson COVID-19 vaccine at Klerksdorp Medical facility in Klerksdorp, South Africa, on Feb. 18.

PHILL MAGAKOE/AFP via Getty Images

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A health care employee holds a vial of the Johnson & & Johnson COVID-19 vaccine at Klerksdorp Hospital in Klerksdorp, South Africa, on Feb. 18.

PHILL MAGAKOE/AFP via Getty Images

Besides mitigation steps like physical and mask-wearing distancing, vaccination is an essential public health tool. More than 48 million individuals, or nearly 15% of the U.S. population, have actually received a minimum of one dose of a COVID-19 vaccine, according to CDC finds out Saturday. More than 23 million, or 7% of the population, have actually gotten 2 doses of the either the Moderna or Pfizer vaccines.

The Food and Drug Administration authorized Johnson & & Johnsons vaccine for emergency situation use Saturday, a day after a panel of advisers to the firm voted all (22-0) in its favor.

The total efficacy figures are lower than Pfizers 95% in preventing COVID-19 illness and 94% for Moderna. However direct contrasts are challenging since of differences in the medical trials and development of new stress of the coronavirus.

” Things are tenuous. Now is not the time to unwind restrictions,” Walensky stated. “Although we have been experiencing big declines in cases and healthcare facility admissions over the previous six weeks, these decreases follow the greatest peak we have actually experienced in the pandemic.”

A 3rd COVID-19 vaccine is on the way, and this one requires only one shot for immunization.

The FDAs analysis of the security data found that “a favorable security profile with no specific safety issues” for the vaccine. As part of the vaccine research study more than 6,000 people were asked about their reactions, and the most common negative effects they reported were discomfort at the injection website (49%), headache (39%), fatigue (38%) and muscle discomfort (33%).

Johnson & & Johnsons addition to the coronavirus battle will be restricted at. When the FDA green lights its vaccine, the business has stated it would have 4 million doses ready to go. By the end of March, the company expects to be able to provide 20 million dosages and to deliver 100 million dosages by the end of June.

The Johnson & & Johnson vaccine was checked in an international study of about 40,000 individuals, half of whom got the vaccine and half of whom got a placebo. The research study discovered the companys vaccine to be 66% effective general in preventing moderate to severe COVID-19 disease. The Johnson & & Johnson vaccine “is very reliable … at preventing severe illness after a single dose and it induces the kind of action, so-called cellular immune reaction, that looks like its going to have fairly long-lived memory, which is all good,” Dr. Paul Offit, a member of the FDAs advisory panel, told NPRs Scott Simon on Weekend Edition Saturday. Variants initially seen in South Africa and Brazil, where the Johnson & & Johnson vaccine was evaluated, established anomalies that help them evade the immune response triggered by previous infections with the initial kind of the virus and vaccines created versus it. More than 48 million individuals, or nearly 15% of the U.S. population, have actually gotten at least one dose of a COVID-19 vaccine, according to CDC figures out Saturday.

While COVID-19 cases in the U.S. have actually fallen significantly considering that their January peak, Centers for Disease Control and Prevention Director Rochelle Walensky cautioned throughout a White House briefing Friday that the 7-day average of verified cases had actually ticked up in the previous three days and represents a “very worrying shift in trajectory.” The 7-day average for cases was 67,207 on Friday, up from 65,426 on Tuesday.

In the South African portion of the Johnson & & Johnson study, the companys vaccine was 64% reliable in preventing moderate to serious disease. In the Latin American region, the vaccine was 61% reliable.

As the pandemic has actually drawn on, the coronavirus has actually altered. Variants initially seen in South Africa and Brazil, where the Johnson & & Johnson vaccine was checked, established anomalies that assist them evade the immune reaction prompted by previous infections with the original type of the infection and vaccines designed versus it. A few of the versions, consisting of one very first recognized in the U.K, are more contagious.

The Johnson & & Johnson vaccine “is really effective … at avoiding extreme illness after a single dosage and it causes the kind of action, so-called cellular immune reaction, that looks like its going to have relatively long-lived memory, which is all good,” Dr. Paul Offit, a member of the FDAs advisory panel, told NPRs Scott Simon on Weekend Edition Saturday. Offit is likewise director of the Vaccine Education Center at the Childrens Hospital of Philadelphia.

The main research study consisted of in the companys application found that 28 days or more after immunization, the Johnson & & Johnson vaccine prevented hospitalizations and deaths associated with COVID-19.

” The authorization of this vaccine expands the schedule of vaccines, the best medical prevention technique for COVID-19, to assist us in the battle versus this pandemic, which has actually declared over half a million lives in the United States,” stated a declaration by Acting FDA Commissioner Janet Woodcock.

The Johnson & & Johnson vaccine was tested in a global study of about 40,000 people, half of whom got the vaccine and half of whom got a placebo. The study found the companys vaccine to be 66% efficient overall in preventing moderate to serious COVID-19 disease.

She likewise warned that the continued spread of coronavirus versions in the U.S. threatens to reverse gains in consisting of the pandemic.