Johnson & Johnson JNJ announced that the phase III ENSEMBLE study, which is evaluating its experimental single-dose COVID-19 vaccine candidate, has met all primary and key secondary endpoints.
The top-line safety and efficacy data from the above study were based on 43,783 participants accruing 468 symptomatic cases of COVID-19.
Per the company, the ENSEMBLE study evaluated the safety and efficacy of the COVID-19 vaccine candidate in protecting moderate-to-severe COVID-19, with co-primary endpoints of 14 days and 28 days after vaccination. The candidate was found to 66% effective in preventing moderate-to-severe COVID-19 after 28 days following vaccination including participants who were infected with an emerging viral variant of the virus.
A single shot of the COVID-19 vaccine candidate was found to 72% effective in the United States, 66% in Latin America and 57% in South Africa.
Moreover, the vaccine candidate was 85% effective in preventing severe COVID-19 disease in adults aged 18 years and above, 28 days post vaccination. Importantly, the single-shot vaccine candidate demonstrated complete protection against COVID-related death and hospitalization, 28 days after vaccination.
Importantly, the protection against severe disease was observed across geographies and against multiple rapidly emerging infectious virus variants including the South African variant. No significant safety concerns were reported, and the vaccine was well-tolerated. J&J will seek Emergency Use Authorization from the FDA in early February.
Notably, the vaccine is expected to remain stable for two years at -20°C, at least three months of which can be at temperatures of 2-8°C.
Shares of J&J have increased 3.6% so far this year compared with the industry’s rise of 0.8%.
We note that several companies have already launched vaccines for fighting the COVID-19 virus.
Pfizer PFE / BioNTech’s mRNA-based COVID-19 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 United States, Europe and a few other countries.
Meanwhile, AstraZeneca’s AZN adenovirus-based coronavirus vaccine candidate, AZD1222, developed in partnership with the University of Oxford, is also approved for emergency use in in the European Union, the United Kingdom, India and a few other countries.
Notably, protection against COVID-19 with just one immunization might be a major breakthrough for J&J and might help the company gain an edge over its competitors, as all the currently authorized COVID-19 vaccines that are approved for emergency use are to be taken as two shots.
Per the press release, a one-shot vaccine is considered to be the best option in pandemic settings by the World Health Organization.
J&J currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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Originally published February 1, 2021, 4:50 PM