‘J&J Janssen Vaccine’ is finally approved for the third time in the US…

Joe Biden’s U.S. administration has given final approval for the vaccine vaccine developed by Johnson & Johnson (J&J). It is the third time after Pfizer and Biontech and Modena. In particular, J&J’s vaccines are expected to accelerate the distribution of vaccines because the supply of vaccines is not only abundant, but also can be distributed at room temperature and is only given once.

Corona 19 vaccine (JNJ-78436735 or Ad.26.COV2.S) developed by Janssen, an affiliate of Johnson & Johnson (J&J).[사진=EPA·연합뉴스]

According to CNBC and the Wall Street Journal (WSJ) on the 28th (local time), the US Centers for Disease Control and Prevention (CDC) was inoculated in the United States with a vaccine (JNJ-78436735 or Ad.26.COV2.S) developed by Janssen under J&J. Finally approved.

On that day, CDC Director Rochelle Wallensky tweeted, “Today we have taken an encouraging step toward the end of the corona 19 pandemic.” “I just signed a recommendation from the Committee (ACIP).”

This completes all administrative procedures for the initiation of the Janssen vaccine in the United States. The U.S. vaccine approval process goes through two steps: the U.S. Food and Drug Administration (FDA) release and CDC license.

Earlier, on the 26th, the FDA convened the Vaccine and Biological Drugs Advisory Committee (VRBPAC), an advisory body under its subsidiary, to deliberate on whether the Janssen vaccine was approved for emergency use (EUA), and approved the EUA on the 27th.

After that, the CDC opened the ACIP, an affiliated advisory body on the same day, to discuss whether to recommend Janssen vaccination, and then decided on the recommendation based on unanimous results (12:0). Accordingly, Director Wallensky quickly signed the recommendation the same day after it was sent.

Earlier, the CDC Advisory Committee said, “We strongly support the effect of this white diet in protecting patients from hospitalization and death from corona19 infection.”, and Director Wallensky also said, “Jansen’s vaccine prevents serious corona diseases, hospitalization and death. It has been shown to be safe and effective,” he fully agreed with the advisory committee’s recommendations.

Twitter by Rochelle Wallensky, Director of the Centers for Disease Control and Prevention (CDC).[사진=트위터]

This rapid decision is interpreted as an attempt to increase vaccine shipments in the week beginning with the first day, in line with the schedule of the US authorities to distribute the vaccine on a weekly basis.

J&J plans to start shipping vaccines immediately after completing all administrative procedures on this day, and will distribute and inoculate the first quantity in each region of the United States on the 2nd of the following month.

This week, 3.9 million to 4 million doses of Janssen vaccine will be distributed to hospitals and pharmacies in the United States, and 16 million to 20 million doses will be supplied by the end of March, and 100 million doses will be supplied by the end of June. .

CDC said that as of 12:32 pm on the same day, about 96.4 million doses of the vaccine were distributed throughout the United States, of which about 75.24 million doses had completed at least one dose.

Based on Modena, Pfizer and Bioentech, the population who received up to two vaccinations was 24,77,9920, or 7.5% of the total US population (9.7% of the vaccinations).

In particular, Janssen’s vaccine utilizes viral vector (carrier) vaccine technology such as Oxford University and AstraZeneca, unlike existing Modena and Pfizer vaccines that utilize mRNA (messenger ribonucleic acid) vaccine technology.

Accordingly, the Janssen vaccine can be distributed and distributed at room temperature or through refrigeration facilities without a separate refrigeration device, and it is the only approved vaccine that can form an immunity effect with a single vaccination, thereby accelerating the speed of vaccine distribution. I’m looking forward to it.

However, in a phase 3 clinical trial, the Janssen vaccine was found to be somewhat less effective in vaccinations over 60 years of age suffering from certain underlying diseases such as diabetes and hypertension.

The results of the final phase 3 clinical analysis of the Janssen vaccine showed an average of 66.1% of the efficacy of preventing mild and severe symptoms of COVID-19, and 68.6% of the elderly over 65 years of age. Hospitalization prevention and death prevention efficacy were found to be 85% and 100%, respectively.

In addition, the Janssen vaccine showed 64% efficacy against the South African mutant virus (B.1.351), which is known to have stronger infectivity, and was evaluated as maintaining relatively performance compared to other vaccines.

For each vaccine, Pfizer (BNT-162b2) and Modena (mRNA-1273), which were approved for vaccination in the U.S. on December 9 last year, proved average efficacy of 95% and 94.1%, respectively, but the result was before the spread of the mutant virus. .

On the other hand, although it has not yet been approved in the US, the UK, the European Union (EU), and the UK Oxford University-AstraZeneca vaccine (AZD-1222), which started vaccination in Korea, shows about 62-67% efficacy. The International Health Organization (WHO) estimates the vaccine’s efficacy at an average of 63.09%, and AstraZeneca reports up to 67% of additional clinical results.

Comparison of efficacy by COVID-19 vaccine.[출처=NEJM·아스트라제네카 ]



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