FS-ISAC Coronavirus Breaking News, Jan. 29, 2021

Johnson & Johnson releases vaccine candidate trial results

Johnson & Johnson said Friday that its single-dose coronavirus vaccine was 72% effective in protecting against moderate and severe Covid-19 in the US, but was less potent in other regions.

• The trial results puts a third vaccine on the horizon in the US - one with logistical advantages that could simplify distribution and expand access to shots in the country and worldwide.

• The highly anticipated findings were based on 468 confirmed Covid-19 infections among the Phase Three trial’s more than 43,000 volunteers, and included those infected with B.1.351, the new, highly contagious strain found in South Africa.
• The results came with a significant cautionary note, with the vaccine’s efficacy rate dropping to 57% in South Africa, where a highly contagious variant is driving most cases and studies suggest the new strain also blunts the effectiveness of other vaccines.
• Though less effective in its 44,000-person trial than 90-percent-plus effective vaccines made by Pfizer-BioNTech and Moderna, it was noted that the Johnson & Johnson shot was tested at the height of the pandemic, in areas of the world where the virus had changed in ways that can elude parts of the immune response.
• Johnson & Johnson said the vaccine was overall 85% effective in preventing severe disease four weeks after vaccination in all adults, and offered complete protection against Covid-related hospitalizations four weeks after vaccination.
• Effectiveness against severe disease increased over time with no cases in vaccinated participants reported after day 49, according to the company, with protection was consistent across race and age, including those over the age of 60.
• The vaccine was said to be well tolerated, with no significant safety concerns related to the vaccine reported, mild reactions and less than 10% of people experiencing fever and there were no reports of anaphylaxis.
• The company said it was working to file for emergency use authorization from the US Food and Drug Administration "inside of a week," potentially becoming the third company to seek EUA from the FDA for a coronavirus vaccine.
• Unlike the Pfizer and Moderna vaccines, Johnson’s candidate does not have to be stored in freezers, and can be kept for three months at refrigerator temperatures of 36 degrees to 46 degrees Fahrenheit.
• Pfizer and Moderna both use genetic technology called messenger RNA, or mRNA technology, while Johnson & Johnson uses a weakened common cold virus, known as adenovirus, to carry genetic instructions into the body to prompt an immune response.
• The US federal government has contracted to buy 100 million doses of the vaccine and the company has been manufacturing doses for months in anticipation that it would work and would win EUA from the FDA.

References

• Johnson & Johnson Covid-19 vaccine is 66% effective in global trial, but 85% effective against severe disease, company says - CNN
• Covid vaccine: J&J is 66% effective, but single shot may fall short against variants (cnbc.com)
• JJ vaccine: Single-shot Johnson & Johnson covid vaccine 66 percent effective against moderate and severe illness - The Washington Post
• Johnson & Johnson’s Vaccine Offers Strong Protection but Fuels Concern About Variants - The New York Times (nytimes.com)
• Johnson & Johnson single-shot vaccine 85% effective against severe COVID-19 disease - ABC News (go.com)
• Africa Variant in U.S.; Biden Reopens Obamacare: Virus Update - Bloomberg
• J&J says vaccine effective against Covid, though weaker against South Africa variant (nbcnews.com)
• J&J vaccine adds to COVID-19 armoury, includes South African variant | Reuters