Johnson & Johnson The JNJ announced that the phase III ENSEMBLE study, which is evaluating its experimental single-dose vaccine candidate COVID-19, has met all primary and secondary endpoints.
The first-line safety and efficacy data from the study above were based on 43,783 participants accumulating 468 symptomatic cases of COVID-19.
By company, the ENSEMBLE study evaluated the safety and efficacy of the candidate vaccine COVID-19 in protecting moderate to severe COVID-19, with co-primary outcomes of 14 days and 28 days after vaccination. The candidate was found to be 66% effective in preventing moderate to severe COVID-19 28 days after vaccination, including participants who were infected with an emerging viral variant of the virus.
A single injection of the candidate vaccine COVID-19 was found to be 72% effective in the United States, 66% in Latin America and 57% in South Africa.
In addition, the vaccine candidate was 85% effective in preventing severe COVID-19 disease in adults 18 years and older, 28 days after vaccination. It is important to note that the candidate vaccine for a single dose demonstrated complete protection against death and hospitalization related to COVID, 28 days after vaccination.
It is important to note that protection against serious diseases was observed in all geographies and against several variants of infectious viruses emerging rapidly, including the South African variant. No significant safety concerns were reported and the vaccine was well tolerated. J&J will seek FDA Emergency Use Authorization in early February.
Notably, the vaccine must remain stable for two years at -20 ° C, at least three months of which may be at temperatures of 2-8 ° C.
J&J shares have risen 3.6% so far this year, compared to the sector’s 0.8% increase.
We note that several companies have already launched vaccines to combat the COVID-19 virus.
Pfizer The PFE / BioNTech mRNA-based COVID-19 vaccine, BNT162b2, has been approved for emergency / temporary / conditional use in several countries, including the United States and 27 EU member countries. Another mRNA-based vaccine candidate COVID-19, mRNA-1273, developed by Moderna, Inc. MRNA has been approved for emergency / temporary use in the United States, Europe and some other countries.
Meantime, AstraZenecaThe AZN adenovirus-based coronavirus candidate vaccine, AZD1222, developed in partnership with the University of Oxford, has also been approved for emergency use in the European Union, the United Kingdom, India and some other countries.
Notably, protection against COVID-19 with just one immunization can be a major breakthrough for J&J and can help the company gain an edge over its competitors, as all currently authorized COVID-19 vaccines that are approved for emergency use must be taken as two shots.
According to the press release, a single vaccine is considered the best option in pandemic settings by the World Health Organization.
Zacks Rank
J&J currently has a Zacks Rank # 3 (Hold). You can see today’s complete list of Zacks # 1 Rank (buy strong) shares here.
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Originally published