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Third COVID-19 Vaccine Approved by FDA

Back to News

March 04, 2021

Third COVID-19 Vaccine Approved by FDA

Jennifer Morency

picture Third COVID-19 Vaccine Approved by FDA

On February 27, 2021, the U.S. Food and Drug Administration (FDA) approved Janssen’s coronavirus vaccine for emergency use. This vaccine, which falls under the pharmaceutical companies of Johnson & Johnson, is the third to be approved by the FDA and cleared to be used across the United States.

Devastatingly, according to the Johns Hopkins University COVID-19 Map, over 28.7 million Americans have contracted the coronavirus since the start of the pandemic, leading to an unfortunate toll of over 515,600 deaths.

Thankfully, the first two FDA approved vaccines started rolling out earlier this year. The Pfizer-BioNTech and Moderna vaccines, which started being administered earlier this year, have provided hope in diminishing the rising COVID-19 cases in the U.S.

The FDA’s Acting Commissioner, Janet Woodcock, M.D. stated that “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” during last week’s press announcement.

To date, according to the CDC’s COVID Data Tracker, over 78.6 million coronavirus vaccine doses have been administered to Americans across the country. Over 51.7 million have received one or more doses and 26.1 million have received two doses and are now considered fully vaccinated against COVID-19. These numbers represent about 15.6% of the population receiving one or more doses and 7.9% receiving two doses.

The rollout of the third approved coronavirus vaccine will only help in fast tracking vaccinations and protecting the population from the novel virus.

The Janssen Pharmaceutical Companies’ COVID-19 Vaccine

Johnson & Johnson’s coronavirus vaccine falls under the Non-Replicating Viral Vector vaccine category. Unlike the Pfizer-BioNTech and Moderna vaccines, which are both RNA-based vaccine types, the Janssen vaccine is a single-shot vaccine.

The phase III trial interim analysis results were announced January 29 and were submitted for emergency use authorization to the U.S. FDA on February 4, 2021. So far, it has only been authorized for use in the United States and is recommended for individuals who are 18 years of age or older.

Interestingly, the Johnson & Johnson coronavirus vaccine uses the same platform as vaccine candidates for Ebola, HIV and RSV. The vaccine is manufactured using a specific type of virus called adenovirus type 26 (Ad26). The adenovirus has been modified for the COVID-19 vaccine as to not have the capability of replicating in the human body to cause illness.

Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research said of the Janssen COVID-19 vaccine: “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.”

The FDA’s evaluation of available effectiveness data rested on the analysis of 39,321 participants who did not have evidence of SARS-CoV-2 infection before receiving the vaccine. The study was conducted in the U.S., South Africa, Mexico, and certain countries in South America.

The study showed that the vaccine was around 67% effective in preventing moderate to severe/critical COVID-19 and 77% effective in preventing severe/critical COVID-19 occurring at least 14 days after vaccination. It also showed a 66% effective rate in preventing moderate to severe/critical COVID-19 and an 85% effective rate in preventing severe/critical COVID-19 occurring at least 28 days after vaccination.

The FDA concludes that there currently is not enough data to establish how long the Janssen vaccine will provide protection against the virus nor if it will prevent transmission of COVID-19.

Johnson & Johnson is currently seeking authorization for emergency use of its newly developed COVID-19 vaccine in Europe and from the World Health Organization (WHO). The company aims to produce one billion doses of the vaccine by the end of the year, to be delivered globally.

In order to do so, Johnson & Johnson is partnering with Merck & Co. to boost the production of the new vaccine. Although a leading vaccine player themselves, Merck & Co. have agreed to provide Johnson & Johnson with two U.S. manufacturing sites for the making, packaging and shipping of the newly authorized vaccine, which would double their expected vaccine capacity. This news follows Merck’s exit from the COVID-19 vaccine race after disappointing results during early trial stages.

“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.” – Peter Marks, M.D., Ph.D.

COVID-19 Vaccine Progression

To date, there are 251 vaccines in development in the fight against COVID-19. Of these, 59 are in clinical testing and 11 are currently in use around the world.

The latest vaccines that have entered the race, without mentioning the Moderna, Pfizer-BioNTech and Janssen COVID-19 vaccines are:

  • Oxford/AstraZeneca

    • In use in Argentina, Brazil, Dominican Republic, El Salvador, India, Mexico, Morocco, Pakistan, and the U.K.

  • Gamaleya Research Institute

    • In use in Algeria, Argentina, Bolivia, Hungary, Palestine, Paraguay, Serbia, Turkmenistan, UAE, and Venezuela, and “registered” in Belarus and Russia.

  • CanSino Biologics

    • Approved for use for “the military” by China’s Central Military Commission.

  • Wuhan Institute/Sinopharm

    • Approved for “emergency use” in China and the UAE.

  • Sinovac/Instituto Butantan

    • Approved for “emergency use” in Brazil, China, and Indonesia.

  • Beijing Institute/Sinopharm

    • In use in Bahrain, China, Pakistan, and the UAE.

  • Bharat Biotech

    • Approved for “emergency use” in India.

  • Research Institute for Biological Safety Problems

    • Approved through “temporary registration” in Kazakhstan.

Johnson & Johnson’s FDA approval will allow Americans more access to coronavirus vaccines. Dr. Richard Nettles, Vice-President of U.S. Medical Affairs at Janssen Pharmaceuticals said that a total of 4 million doses are currently set to be shipped across the United States, with an additional 16 million doses ready by the end of March. Thankfully, the continuing research, development and administering of coronavirus vaccines is edging the world closer and closer to a COVID-19-free future.