AFTER FDA APPROVES JOHNSON & JOHNSON COVID-19 VACCINE, BIDEN INVOKES DEFENSE PRODUCTION ACT TO SPEED UP MANUFACTURING

By Miriam Raftery

 

Photo via National Institute of Allergy and Infectious Diseases

 

March 2, 2021 (Washington D.C.) – The U.S. Food & Drug Administration has approved a COVID-19 vaccine by Johnson & Johnson (J&J). To expedite getting Americans vaccinated as quickly as possible, President Joe Biden has invoked the Defense Production Act.

 

 

Unlike the Pfizer and Modern vaccines, the J&J vaccine can be given in a single dose and requires only standard refrigeration. 

 

“This week marked a devastating milestone of 500,000 deaths from COVID-19 here in the United States,” says Dr. Francis Collins, National Institute of Health Director. “To have a third vaccine that meets the expectations of an EUA for safety and effectiveness at preventing severe disease and death from COVID-19 brings us one step closer to protecting the American public, staying ahead of concerning viral variants, and finding our way out of the pandemic.

 

Dr, Anthony Fauci, the nation’s top infectious disease specialist, called the J&J vaccine a “very welcome addition to the arsenal of COVID-19 vaccines and other prevention strategies.”

 

When tested among 45,000 volunteers, the single-injection vaccine proved 77 percent effective in preventing severe/critical COVID-19 occurring at least 14 days after vaccination and 85 percent effective in preventing severe/critical COVID-19 occurring at least 28 days after vaccination. The vaccine was approximately 67 percent effective in preventing moderate-to-severe/critical COVID-19 disease occurring at least 14 days after vaccination and 66 percent effective in preventing moderate-to-severe/critical COVID-19 disease occurring at least 28 days after vaccination. 

 

But Dr. Fauci notes,”Importantly, the vaccine was 100 percent effective in protecting against death from the disease everywhere it was tested.”

 

The J&J vaccine, unlike other vaccines now in use, was also tested in multiple nations around the world and appears to have some effectiveness against certain variant strains of COVID-19.

 

The J&J vaccine is a recombinant vector vaccine that uses a human adenovirus to express the spike protein found on the surface of the SARS-CoV-2 virus that causes COVID-19. Adenoviruses are a group of viruses that cause infections in the respiratory and gastrointestinal tracts; the adenovirus vector used in the Janssen COVID-19 vaccine has been modified so it no longer can replicate in humans and cause illness. 

 

 

Today, President Joe Biden announced that his administration has helped forge a manufacturing collaboration between Merck and J&J, two of the largest U.S. healthcare and pharmaceutical companies, to expand production of J&J’s vaccine.

 

The collaboration will increase manufacture of vaccine drug substance, as well as its fill-finish capacity – two of the biggest bottlenecks facing J&J in the production of its vaccine.

 

The U.S. Department of Health and Human Services (HHS) will collaborate with Merck to repurpose some existing Merck facilities for rapid large-scale manufacturing of vaccines and therapeutics for use in public health emergencies including the current pandemic. The facilities will be available to private sector partners working with the federal government on the COVID-19 response or to produce Merck products against COVID-19. 

 

Janssen Pharmaceuticals, part of Johnson & Johnson, will be the first federal partner to use repurposed Merck facilities to manufacture COVID-19 vaccine. Merck will use two of its facilities to produce drug substance, formulate and fill vials of J&J’s vaccine.

 

Consistent with the Administration's mission to ensure that the United States has sufficient long-term sustainable capacity to manufacture vaccines, the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response, will leverage the Defense Production Act to provide an initial investment of $105 million for Merck, at the Administration's request, to convert, upgrade and equip Merck facilities to the standards necessary to safely manufacture the vaccine. The company will address all the necessary qualification and validation activities needed for the facilities to be used for large-scale manufacturing.

 

To further accelerate production of the J&J vaccine, President Biden also announced he has invoked the Defense Production Act to expedite materials in vaccine production, such as equipment, machinery and supplies like single use bags, and he has directed the Department of Defense to provide daily logistical support to strengthen J&J’s efforts. J&J also will begin operating its manufacturing facilities 24/7 to maximize production output.

 

These efforts will contribute to J&J’s ability to accelerate delivery of their vaccine doses from 100 million doses by the end of June to at or near 100 million doses by the end of May. In the long term, these actions will ultimately double J&J’s U.S. capacity to produce drug substance and increase the U.S. capacity for fill-finish, according to the White House.

 

For more on BARDA’s portfolio for COVID-19 diagnostics, vaccines and treatments and about partnering with BARDA, visit medicalcountermeasures.gov. To learn more about coronavirus, visit cdc.gov/coronavirus.