FDA urgently approves Johnson & Johnson vaccine for one dose… “Prevention effect is 66%, but death is 0”

On the 27th, the US FDA approved emergency use approval for the Corona 19 vaccine developed by the US pharmaceutical company Johnson & Johnson. [AFP=연합뉴스]

The U.S. Food and Drug Administration (FDA) approved the emergency use of a novel coronavirus infection (Corona 19) vaccine developed by Janssen, a subsidiary of Johnson & Johnson (J&J), a US pharmaceutical company on the 27th (local time). This has increased the number of vaccines available in the United States with Pfizer and Modena to three. This is the first time that a single vaccination vaccine has been approved for use.

In a press release that day, the FDA said, “Comprehensive review of the data provided shows clear evidence that the Janssen vaccine may be effective in preventing COVID-19. It was revealed that the known potential benefit of the vaccine is greater than the known potential risk. “Emergency use authorization (EUA) has been granted to adults over the age of the year,” he said.

FDA accepted that the Vaccine and Biological Drug Advisory Committee (VRBPAC), an external advisory body of the FDA, recommended urgent use of the Janssen vaccine through a vote the previous day. The advisory committee recommended the EUA for the Johnson & Johnson vaccine in a 22-0 vote after discussion.

The vaccine’s preventive efficacy report card does not reach that of Pfizer, Moder, or vaccines, but it has been shown to have the effect of preventing Corona 19 from progressing to severe. In clinical trials involving 40,000 people in the United States, South America and South Africa, the overall preventive effect was 66%. The effect of preventing development into a severe or serious condition was 85%. There was no case of death from Corona 19 after being vaccinated.

Pfizer and Moderna vaccines were reported to be 94% and 95% effective in preventing symptoms from appearing in clinical trials in the United States, respectively. Because of this, the New York Times said health officials are concerned that despite strong data indicating that the Johnson & Johnson vaccine is prophylactic, some will consider the vaccine a “inferior option.”

However, because the timing and region of the clinical trials are different for each pharmaceutical company, one-to-one comparisons cannot be made. In particular, it should be noted that Pfizer and Moderna completed clinical trials before the spread of the mutant virus, the Associated Press reported.

Francis Collins, director of the National Institutes of Health (NIH) said, “What people are wondering right now is whether this vaccine will prevent me from being seriously ill or dying from Corona 19. The good news is, the answers to both questions are’Yes. “It is.”

In July of last year, a researcher in Belgium shows a Johnson & Johnson vaccine being developed. [AP=연합뉴스]

The advantage of the Johnson & Johnson vaccine is that the vaccination ends once and can be stored in the refrigerator. It is easier to manage than Pfizer, Moder, or vaccine, which must be vaccinated twice and stored frozen at -20 degrees or 80 degrees Celsius, and it can increase the accessibility of vaccines in rural areas with small populations and lack of facilities.

The advantage of a single vaccination is that it can be vaccinated by a mobile vaccination station, so that even people who have difficulty coming to receive a second injection after 3 to 4 weeks, such as a homeless or a deep-sea fishing crew.

Separately, Johnson & Johnson is conducting a large-scale study on how to get the vaccine twice, according to the Associated Press. “If it turns out that two doses can be effective, the second dose will go back to those who get the first vaccine,” Collins said.

Johnson & Johnson plans to supply the U.S. with 4 million doses (4 million doses), less than originally expected, by the end of this month. The company said that there will be no disruptions to the existing plan to supply 100 million doses by the end of June by expanding supply afterwards.

US President Joe Biden said in a statement that day: “Exciting news for all Americans and encouraging progress in our efforts to end this crisis. But it is still a long way to end this fight.” He said it should be kept.

The AstraZeneca vaccine, which has been vaccinated in Korea and the UK, is in the final stage of clinical trials in the US. Upon completion of this large-scale clinical trial, it will apply for emergency use approval to the FDA.

Washington = Correspondent Park Hyun-young [email protected]