Single Dose Janssen COVID-19 Vaccine has been approved!
And will it work against variants?
Finally, a single dose vaccine! COVID-19 has not let up, and why should we? The Janssen vaccine was just approved on February 27th, by the Food Drug Administration (FDA) and will be given to anyone 18 years and older.
The FDA indicated that the Janssen COVID-19 Vaccine has met all the necessary criteria for issuance because the trial data has provided clear evidence in being effective against COVID-19.
The FDA said the benefits far outweigh the risk, and they have conducted a thorough evaluation of safety, effectiveness, and manufacturing quality. The most common side effects were pain at the injection area, fatigue, muscle aches, headache, and nausea. None of which were severe and only lasted 1–2 days.
Peter Marks, M.D., Ph.D., 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.
Janssen's Vaccine Effectiveness
The participants in the United States were not sick with the virus before receiving the vaccine.
The vaccine was 67% effective in preventing severe sickness with COVID-19 after 14 days and 85% effective after 28 days of vaccination with severe cases.
Janssen Biotech Inc. will be required to go through the Vaccine Adverse Event Reporting System (VAERS) as other manufacturers to report the vaccine administration as well as any serious adverse cases that could result in hospitalization and death.
Distribution Expectation
A webinar announcement by Mathai Mammen, M.D., Ph.D., Global Head, of Janssen Research & Development at Johnson & Johnson said, “The ability to avoid hospitalizations and deaths would change the game in combating the pandemic”.
100 million doses available by June 2021.
As well as, meeting its commitment, globally with one billion doses by the end of 2021.
Will the vaccine work against the three variants?
1) U.K. Variant — B.1.1.7
2) South African Variant — B.1.351
3) Brazilian Variant — P.1
Study Demographics Include 45% female and 55% male.
Johnson & Johnson’s Phase III data was based on 43,783 participants from different geographies in the age range of 18 years to 100 years.
The trial was conducted in eight countries and three continents. The sample also included those who were infected with the COVID-19 virus as well as, the South African, B.1.351 emerging variant.
1) Participants (43,783 with 34%, 14,672 over the age of 60)
2) United States (19,302 = 44%)
3) Central & South America (17,908 = 41% in countries: Argentina, Brazil, Chile, Colombia, Mexico, and Peru)
4) South Africa (6,576 = 15%)
Results show 100% protection against hospitalization and death.
Results show an 85% effectiveness across all geographies with efficacy increasing after 49 days.
The vaccine showed a complete 100% protection against COVID-19 related hospitalization and death.
The vaccine was given to cases requiring medical intervention that is, hospitalization, ICU admission, mechanical ventilation, extracorporeal membrane oxygenation (ECMO) with no reported deaths after 28 days of receiving the COVID-19 Vaccine.
Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, said “A one-shot vaccine is considered by the World Health Organization to be the best option in pandemic settings”.
How did Johnson & Johnson get to this stage?
Johnson & Johnson, a New Brunswick, New Jersey company began a year ago to develop a single-dose vaccine. Their goal has been to develop an effective solution for the largest number of people. The Janssen COVID-19 Vaccine.
Alex Gorsky, Board of Directors and Chief Executive Officer of Johnson & Johnson said, “We’re proud to have reached this critical milestone, and our commitment to address this global health crisis continues with urgency for everyone, everywhere”.
Janssen’s Viral Vector Vaccine Technology.
The company uses its AdVac® vaccine platform to develop and manufacturer its European Commission-approved Ebola vaccine regime as well as, the construct for Zika, RSV, and HIV investigational vaccine candidates.
In February 2020 they began on the COVID-19 vaccine using their technology platform.
Together, they entered into a collaboration with the Beth Israel Deaconess Medical Center (BIDMC) to support the development of the Janssen COVID-19 Vaccine. (jnj.com/coronavirus).
BIDMC is located in Boston, Massachusetts. It is a teaching hospital of Harvard Medical School. A merger in 1996 of Beth Israel Hospital and the New England Deaconess Hospital formed BIDMC.
To date, more than 44 million people have received at least one dose of the Moderna and Pfizer vaccines, and approximately 20 million have received a second dose.
However, we still need 75–80% of our population to be vaccinated for Herd Immunity.
The good news is there is light streaming through those tunnels after all.
