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March 6, 2021

Johnson & Johnson Announces U.S. CDC Advisory Committee Recommends First Single-Shot COVID-19 Vaccine for Adults 18 and Older in the U.S.

Johnson & Johnson

NEW BRUNSWICK, N.J., March 6, 2021 — Johnson & Johnson has announced that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has recommended its first single-shot COVID-19 vaccine. The committee has prescribed it for individuals 18 years of age and older under the Emergency Use Authorization (EUA) issued by the U.S. Food and Drug Administration (FDA).

“For more than 130 years, Johnson & Johnson has come to the aid of people during times of crisis. We believe today’s recommendation from the CDC to begin use of our vaccine as part of the U.S. national immunization program will add a critical tool in the fight against COVID-19,” said Paul Stoffels, M.D. He is Chief Scientific Officer at Johnson & Johnson. “This recommendation follows the FDA’s decision to grant an Emergency Use Authorization for our single-shot vaccine, which has the potential to play a pivotal role in helping to end the COVID-19 pandemic.”

The Company’s single-shot COVID-19 vaccine received EUA from the FDA on February 27, 2021. The terms of the EUA allow the use of the vaccine while more data gets gathered. The Company plans to file for a Biologics License Application (BLA) with the FDA later in 2021.

“Johnson & Johnson is committed to making its COVID-19 vaccine available on a not-for-profit basis for emergency pandemic use. The Company has begun shipping its COVID-19 vaccine and expects to deliver enough single-shot vaccines by the end of March to enable the full vaccination of more than 20 million people in the U.S. The Company plans to deliver 100 million single-shot vaccines to the U.S. during the first half of 2021. The U.S. government will manage allocation and distribution of the vaccine in the U.S.,” the company stated.

Johnson & Johnson also recently announced its submission of a European Conditional Marketing Authorisation Application to the European Medicines Agency and its filing for an Emergency Use Listing with the World Health Organization (WHO) for its COVID-19 vaccine candidate. Also, rolling submissions for the single-dose COVID-19 vaccine candidate have been initiated in several countries worldwide.

The Johnson & Johnson COVID-19 single-dose vaccine is compatible with standard vaccine storage and distribution channels with ease of delivery to remote areas. The vaccine is estimated to remain stable for two years at -4°F (-20°C), and a maximum of three months at routine refrigeration at temperatures of 36-46°F (2 to 8°C), the company said.

The company’s Janssen COVID-19 vaccine leverages the AdVac® vaccine platform. The program had used this proprietary technology to develop and manufacture Janssen’s European Commission-approved Ebola vaccine regimen and construct its investigational Zika, RSV, and HIV vaccines.

Johnson & Johnson’s Janssen COVID-19 vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but FDA has allowed its Emergency Use Authorization (EUA).

Source: Johnson & Johnson

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Edited & Posted by the Editor | 12:59 PM | Link to this Post

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