Johnson & Johnson announces disappointing results from its Phase 3 COVID-19 vaccine trials; only 66% effective

The last time we wrote about Johnson & Johnson was back in September 2020 when the world’s biggest pharmaceutical company launched the final phase of the human trial of its COVID-19 single-shot vaccine that includes 60,000 volunteers.

Four months later, Johnson & Johnson has just released the first round of the results from its Phase 3 COVID-19 vaccine trials, and they are disappointing. According to the announcement, the results showed that the vaccine is only 66% effective at preventing moderate and severe COVID-19 (and that’s excluding mild cases of the virus).

The effectiveness of Johnson & Johnson’s vaccine is less than those of Moderna, Pfizer, AstraZeneca, and others, which stand at about 95%. According to the announcement on the company’s website, the topline safety and efficacy data are based on 43,783 participants accruing 468 symptomatic cases of COVID-19. In a news release, Johnson & Johnson said:

The Phase 3 ENSEMBLE study is designed to evaluate the efficacy and safety of the Janssen COVID-19 vaccine candidate in protecting moderate to severe COVID-19, with co-primary endpoints of 14 days and 28 days following vaccination. Among all participants from different geographies and including those infected with an emerging viral variant, Janssen’s COVID-19 vaccine candidate was 66% effective overall in preventing moderate to severe COVID-19, 28 days after vaccination. The onset of protection was observed as early as day 14. The level of protection against moderate to severe COVID-19 infection was 72% in the United States, 66% in Latin America and 57% in South Africa, 28 days post-vaccination.

Meanwhile, mainstream media like the Financial Times tries to put a positive spin on the news saying that the vaccine is, at the very least, still 57% effective against the South African variant – which is…not exactly reassuring.

The vaccine showed some protection against the 501. V2 variant, which first emerged in South Africa, although efficacy was 57 per cent in trials conducted there. The jab showed an efficacy rate of 72 per cent in the US, and 66 per cent in Latin America. Alex Gorsky, J&J’s chief executive, called the results a “critical milestone”. The company intends to file for a US emergency use authorisation in early February and, if granted, will immediately be able to ship vaccines. “Our goal all along has been to create a simple, effective solution for the largest number of people possible, and to have maximum impact to help end the pandemic,” he said.

Alex Gorsky, Chairman, Board of Directors and Chief Executive Officer, Johnson & Johnson also said: “Johnson & Johnson embarked on the global effort to combat the COVID-19 pandemic a year ago, and has brought the full force of our capabilities, as well as tremendous public-private partnerships, to enable the development of a single-shot vaccine. Our goal all along has been to create a simple, effective solution for the largest number of people possible, and to have maximum impact to help end the pandemic.” Gorsky added: “We’re proud to have reached this critical milestone and our commitment to address this global health crisis continues with urgency for everyone, everywhere.”

According to the September 2020 announcement, the final phase (Phase III) includes 60,000 volunteers with each receiving a single-shot COVID-19 vaccine that potentially would simplify the distribution of millions of doses compared with leading rivals using two doses.