• February 8, 2023

FDA Authorizes J&J COVID-19 Vaccine For Emergency Use : Coronavirus Updates : NPR

A healthcare worker holds a vial of the Johnson & Johnson COVID-19 vaccine at Klerksdorp Hospital in Klerksdorp, South Africa on February 18. PHILL MAGAKOE / AFP via Getty Images Hide caption

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PHILL MAGAKOE / AFP via Getty Images

A health care worker holds a vial of Johnson & Johnson’s COVID-19 vaccine at Klerksdorp Hospital in Klerksdorp, South Africa on February 18.

PHILL MAGAKOE / AFP via Getty Images

A third COVID-19 vaccine is on the way, and this one only requires one shot to immunize.

The Food and Drug Administration Authorized vaccine from Johnson & Johnson in case of emergency on Saturday, one day after an advisory panel of the agency voted unanimously (22-0) for them.

“The approval of this vaccine expands the availability of vaccines, the best medical prevention tool for COVID-19, to help us fight this pandemic that has killed over half a million people in the United States,” one said Statement by FDA Deputy Commissioner Janet Woodcock.

The Johnson & Johnson vaccine was tested in an international study on approximately 40,000 people, half of whom received the vaccine and half of whom received a placebo. The study found that the company’s vaccine was 66% overall effective in preventing moderate to severe COVID-19 illnesses. For a disease judged to be severe or critical, the effectiveness was 85%. The study was carried out in the United States, South America, and South Africa.

The main study included in the company’s application found that the Johnson & Johnson vaccine prevented hospitalizations and deaths related to COVID-19 for 28 days or more after immunization.

Overall efficacy scores are lower than Pfizer’s 95% for COVID-19 disease prevention and 94% for Moderna. However, direct comparisons are difficult due to differences in clinical trials and the emergence of new strains of the coronavirus.

Why the Johnson & Johnson vaccine got a bad rap - and why that's not fair

The Johnson & Johnson vaccine “is very effective … in preventing serious illnesses after a single dose, and induces the type of response called the cellular immune response that appears to have a fairly long-lasting memory,” said Dr. Paul Offit, FDA Advisory Board member. told Scott Simon from NPR weekend edition Saturday. “This undoubtedly offers protection from what is important to you, namely hospitalization, ICU admission, and death. This is practically 100% effective.” Offit is also the director of the Vaccine Education Center at the Philadelphia Children’s Hospital.

With the outbreak of the pandemic, the coronavirus mutated. Variants first observed in South Africa and Brazil, where the Johnson & Johnson vaccine was tested, developed mutations that help them evade the immune response triggered by previous infections with the original form of the virus and vaccines developed against it . Some of the 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 in preventing moderate to severe illnesses. In the Latin America region, the vaccine was 61% effective.

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

While COVID-19 cases in the US have declined dramatically since their peak in January, Rochelle Walensky, director of the Centers for Disease Control and Prevention, warned during a briefing at the White House on Friday that the 7-day average of confirmed cases has risen in the past three days represents a “very worrying shift in trajectory.” The seven-day average for cases was 67,207 on Friday versus 65,426 on Tuesday.

“Things are difficult. Now is not the time to relax the restrictions,” said Walensky. “Although we’ve seen a sharp drop in cases and hospital admissions over the past six weeks, those drops follow the highest peak we’ve seen in the pandemic.”

She also warned that the continued spread of coronavirus variants in the US threatens to reverse profits in containing the pandemic.

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

Johnson & Johnson’s addition to the coronavirus fight will be limited for now. The company has announced that it will have 4 million doses ready to use when the FDA gives the go-ahead for their vaccine. By the end of March, the company expects to deliver 20 million cans and 100 million cans by the end of June.

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