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03/01/2021

Janssen’s COVID-19 vaccine gets emergency use authorization, shipments begin

Sandra Levy
Senior Editor
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The Food and Drug Administration on Sunday granted emergency use authorization to Johnson & Johnson's Janssen single dose COVID-19 vaccine for use in individuals 18 years of age and older, making it the third vaccine to prevent COVID-19 that has been cleared for use in the United States.

Pfizer and BioNTech’s vaccine and Moderna’s vaccine were cleared for EU use in December. 

The shipment of 3.9 million doses of Janssen's COVID-19 vaccine began today. Some 800,000 of those doses are expected to go directly to pharmacies, according to an ABC News report. 

J&J said it 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 United States. The company plans to deliver 100 million single-shot vaccines to the U.S. during the first half of 2021.

McKesson began distributing Janssen's vaccine on Monday. McKesson was selected by the U.S. government in August 2020 to operate as the centralized distributor for frozen and refrigerated COVID-19 vaccines and ancillary supply kits needed to administer them.

McKesson has established four dedicated distribution centers which will be specifically used to distribute the J&J COVID-19 vaccine and future refrigerated vaccines. The U.S. government makes the administration decisions, including where, when and how many vaccine doses McKesson will distribute, the company said.

FedEx Express, a subsidiary of FedEx has begun shipping Janssen's COVID-19 vaccine on behalf of McKesson to dosing centers throughout the United States.

The company has shipped millions of COVID-19 vaccines since U.S. distribution began in mid-December 2020 and is prepared to scale up to accommodate anticipated growth in vaccine volume throughout the spring and summer. Nearly three months after COVID-19 vaccine distribution began, FedEx has shipped COVID-19 vaccines and supply kits to administration sites across all 50 states, Puerto Rico, the U.S. Virgin Islands, and Wash., D.C. COVID-19 vaccine volume is split evenly with FedEx moving approximately half the doses allocated by the federal government.

“As vaccine production ramps up and more vaccines are approved, we expect to see a significant uptick in COVID-19 vaccine and supply kit volume moving through our network,” said Don Colleran, president and CEO for FedEx Express. “As manufacturers obtain approval to ship COVID-19 vaccines with greater temperature ranges and varying dosing allotments, we anticipate more of these packages moving to more places through our global network.”

FedEx Express will transport the new COVID-19 vaccines and kits of supplies for administration of the vaccine, using its FedEx Priority Overnight service supported by FedEx Priority Alert advanced monitoring – the same process used for all COVID-19 vaccines packed out by McKesson and Pfizer.

"The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States," said acting FDA Commissioner Janet Woodcock. "The FDA, through our open and transparent scientific review process, has now authorized three COVID-19 vaccines with the urgency called for during this pandemic, using the agency's rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization."

“For more than 130 years, Johnson & Johnson has come to the aid of people during times of crisis, and 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, vice chairman of the executive committee and chief scientific officer at J &J. “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 single-dose vaccine candidate 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 vaccine is manufactured using a specific type of virus called adenovirus type 26, or Ad26. The vaccine uses Ad26 to deliver a piece of the DNA, or genetic material, that is used to make the distinctive "spike" protein of the SARS-CoV-2 virus. While adenoviruses are a group of viruses that are relatively common, Ad26, which can cause cold symptoms and pink eye, has been modified for the vaccine so that it cannot replicate in the human body to cause illness. After a person receives this vaccine, the body can temporarily make the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.

"After a thorough analysis of the data, the FDA's scientists and physicians have determined that the vaccine meets the FDA's expectations for safety and effectiveness appropriate for the authorization of a vaccine for emergency use," said Peter Marks, director of the FDA's Center for Biologics Evaluation and Research. "With today's authorization, we are adding another vaccine in our medical toolbox to fight this virus. At the same time, the American people can be assured of the FDA's unwavering commitment to public health through our comprehensive and rigorous evaluation of the data submitted for vaccines to prevent COVID-19."

The FDA’s decision was based on data that showed that overall, the vaccine was approximately 67% effective in preventing moderate to severe/critical COVID-19 occurring at least 14 days after vaccination and 66% effective in preventing moderate to severe/critical COVID-19 occurring at least 28 days after vaccination.

Additionally, the vaccine was approximately 77% effective in preventing severe/critical COVID-19 occurring at least 14 days after vaccination and 85% effective in preventing severe/critical COVID-19 occurring at least 28 days after vaccination.

 

 

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