Vaccination 1 shot to prevent COVID-19! Johnson and Johnson single dose of new crown vaccine EU application for market: prevention of moderate to severe COVID-19, total efficiency 66%!

February 18, 2021 // -- Johnson and Johnson (JNJ) recently announced that its Jansen-Cilag International Corporation has submitted a conditional marketing authorization application (MAA) to the European Medicines Agency (EMA) seeking approval for its single dose of Jassen COVID-19 vaccine.
maa based on top-line efficacy and safety data from Phase 3 ENSEMBLE clinical trials.
a conditional marketing authorization, Johnson and Johnson must meet certain obligations, including providing additional data, within a specified period of time.
Jassen COVID-19 vaccine is compatible with standard vaccine distribution channels.
if approved, the Jassen COVID-19 vaccine is expected to remain stable at -20C (-4F) for 2 years, with a temperature of 2-8C (36F-46F) for at least three months.
company will use cold-chain technology currently used to transport other innovative drugs to deliver vaccines.
regulatory approval, Johnson and Johnson is committed to providing an affordable COVID-19 vaccine in a non-profit manner for emergency pandemics. "There is still an urgent need for more COVID-19 vaccines across Europe, and today's submission is an important step in ensuring that the EU has another option to help reduce the impact of the epidemic in Europe and around the world," said Dr. Paul Stoffels, M.D., Vice Chairman and Chief Scientific Officer of the executive committee of
Johnson and Johnson.
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we are ready to start distributing vaccines in the EU in the second quarter of 2021.
" December 2020, Johnson and Johnson announced that it had begun rolling its Janssen COVID-19 vaccine application to the EMA, which would enable the EMA to review the data as it obtained it.
addition, Johnson and Johnson has begun rolling applications for single-dose COVID-19 vaccines in countries around the world and to the World Health Organization (WHO).
the United States, Johnson filed an emergency authorization (EUA) application on February 4, 2021.
the end of January 2021, Johnson and Johnson released top-line efficacy and safety data from the Phase 3 ENSEMBLE study, showing that the Janssen COVID-19 vaccine reached all major and critical secondary endpoints.
safety and ability data based on 43,783 participants, a total of 468 cases of COVID-19 symptoms occurred.
vaccine (photo source: nasdaq.com) Phase 3 ENSEMBLE study aims to assess the effectiveness and safety of Jansen COVID-19 candidate vaccines in protecting moderate to severe COVID-19, with the common primary endpoints being 14 and 28 days after vaccination.
among all participants from different regions, including those infected with emerging virus variants, the overall effectiveness of the Jansen COVID-19 vaccine candidate vaccine in the prevention of moderate to severe COVID-19 was 66% 28 days after vaccination.
note that protective effects were observed as early as the 14th day of vaccination.
28 days of vaccination, the protection rates for moderate to severe COVID-19 infections were 72%, 66% and 57%, respectively, in the United States, Latin America and South Africa.
results from a single dose of coVID-19 vaccine represent a promising moment.
by providing an effective and well-to-resistant vaccine, it is possible to significantly reduce the burden of serious diseases with just one immunization, which is a key component of the global public health response.
world health organization believes that a one-shot vaccine is the best option in a pandemic environment and enhances access, distribution and access.
85 per cent effectiveness in preventing serious COVID-19 diseases and preventing COVID-19-related medical interventions will have the potential to protect hundreds of millions of people from the serious and fatal consequences of COVID-19.
it also offers hope of helping to ease the enormous burden on the health care system and communities.
origin: Johnson and Johnson Announces Submission of European Conditional Marketing Authorisation application to the EMA for its Investigational-Single-Shot Janssen COVID-19 Vaccine Candidate