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Johnson & johnson JNJ announced that the ENSEMBLE phase III study, which is evaluating its investigational single-dose COVID-19 vaccine candidate, has met all key primary and secondary endpoints.
The primary safety and efficacy data from the above study was based on 43,783 participants with a total of 468 symptomatic cases of COVID-19.
According to the company, the ENSEMBLE study evaluated the safety and effectiveness of the COVID-19 vaccine candidate in protecting moderate to severe COVID-19, with primary endpoints of 14 days and 28 days after the vaccination. The candidate was found to be 66% effective in preventing moderate to severe COVID-19 28 days after vaccination, including participants infected with an emerging viral variant of the virus.
A single injection of the COVID-19 vaccine candidate has been shown 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 serious illness from COVID-19 in adults aged 18 years and older, 28 days after vaccination. Importantly, the single-dose vaccine candidate has demonstrated complete protection against COVID-related deaths and hospitalizations, 28 days after vaccination.
Importantly, protection against serious disease has been observed in all geographic areas and against several variants of rapidly emerging infectious virus, including the South African variant. No significant safety concerns were reported and the vaccine was well tolerated. J&J will apply for emergency use authorization from the FDA in early February.
Notably, the vaccine should remain stable for two years at -20 ° C, of which at least three months can be at temperatures of 2 to 8 ° C.
J&J shares have risen 3.6% so far this year compared to the industry’s 0.8% gain.
We note that several companies have already launched vaccines to fight against the COVID-19 virus.
Pfizer PFE / BioNTech’s COVID-19 mRNA vaccine, BNT162b2, is approved for emergency / temporary / conditional use in several countries, including the United States and 27 EU member countries. Another mRNA-based COVID-19 vaccine candidate, mRNA-1273, developed by Moderna, Inc. MRNA has been approved for emergency / temporary use in the US, Europe and a few other countries.
Meanwhile, AstraZenecaThe AZN adenovirus-based coronavirus vaccine candidate, AZD1222, developed in partnership with the University of Oxford, is also approved for emergency use in the European Union, United Kingdom, India and in a few other countries.
Notably, protecting against COVID-19 with a single vaccination could be a major breakthrough for J&J and could help the company gain an advantage over its competitors, as all currently licensed COVID-19 vaccines that are approved for use in emergency should be taken as two blows.
According to the press release, a single-dose vaccine is considered the best option in a pandemic by the World Health Organization.
Zacks Rank
J&J currently has a Zacks # 3 (Hold) rank. You can see The full list of current Zacks # 1 Rank (Strong Buy) stocks here.
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