Johnson & Johnson JNJ announced that the Phase III ENSEMBLE study, which evaluates the experimental single-dose COVID-19 vaccine candidate, meets all primary and important secondary endpoints.
The safety and efficacy data of the above study are based on 43 783 participants who had 468 symptomatic cases of COVID-19.
According to the company, the ENSEMBLE study evaluated the safety and efficacy of the candidate for the COVID-19 vaccine in the protection of moderate to severe COVID-19, with co-primary endpoints of 14 days and 28 days after vaccination. The candidate was found to be 66% effective in preventing moderate to severe COVID-19 after 28 days after vaccination, including participants infected with an emerging viral variant of the virus.
A single survey of the candidate for the COVID-19 vaccine 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. Importantly, the single-headed vaccine candidate showed complete protection against COVID-related death and hospitalization 28 days after vaccination.
What is important is that protection against serious diseases has been observed across the country and against multiple rapidly emerging infectious virus variants, including the South African variant. No significant safety concerns have been reported and the vaccine is well tolerated. J&J will apply for FDA approval for emergency use in early February.
In particular, the vaccine is expected to remain stable at -20 ° C for two years, of which at least three months may be between 2-8 ° C.
Shares of J&J have risen 3.6% so far this year compared to the 0.8% rise in the industry.
We note that several companies have already launched vaccines to combat the COVID-19 virus.
Pfizer PFE / BioNTech’s 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 States. Another mRNA-based COVID-19 vaccine candidate, mRNA-1273, developed by Modern, Inc. MRNA has been approved for emergency / temporary use in the United States, Europe and some other countries.
Meanwhile, it AstraZenecaThe AZN adenovirus-based coronavirus vaccine candidate, 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 a few other countries.
It is especially important that protection against COVID-19 with just one vaccination can be a major breakthrough for J&J and help the company gain an edge over its competitors, as all current COVID-19 vaccines have been approved for emergency use, should be taken as two shots.
According to the press release, a one-vaccine is considered by the World Health Organization to be the best option in pandemic conditions.
Zacks Rank
J&J currently has a Zacks Rank # 3 (Hold). You can see the complete list of today’s Zacks # 1 Rank (Strong Buy) shares.
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Originally published