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- A coronavirus vaccine developed by the healthcare giant Johnson & Johnson is safe and 66% effective at preventing COVID-19, results of a late-stage trial show.
- J&J expects to submit the data in early February to the US Food and Drug Administration for emergency use authorization.
- If the vaccine gets the green light from regulators, it would boost supplies for the US vaccination campaign.
- Visit Business Insider’s homepage for more stories.
The US effort to halt the coronavirus got some good news on Friday as another vaccine succeeded in the final stages of clinical research.
The single-dose vaccine, developed by healthcare giant Johnson & Johnson with US government funding, proved to be 66% effective at preventing people from developing COVID-19, J&J said in a statement. That’s significantly lower than the protection offered by shots from Pfizer and from Moderna, though both of those shots require two doses.
Still, J&J’s vaccine is likely poised to become the third authorized coronavirus vaccine in the US, further boosting available supply. The vaccine was tested in a trial of about 44,000 volunteers who randomly received either one shot or a placebo.
The success comes with a sobering caveat. J&J’s vaccine was less effective in South Africa, suggesting a variant of the virus first identified in that country called B.1.351 has drifted far enough away from the original strain to diminish the benefits of the shot.
J&J’s stock fell 4.1% in early trading, while Moderna soared 29% and Pfizer gained 4.5%. Novavax, which said yesterday that its coronavirus vaccine is effective, jumped 65%.
Overall, J&J's study found the shot to be 72% effective in the US, 66% effective in Latin America, and 57% effective in South Africa. J&J said 95% of the cases recorded in South Africa came from the B.1.351 variant. That raises the troubling prospect that B.1.351 and other variants could evade the vaccine, complicating a global immunization campaign.
J&J's results are the second piece of experimental evidence that coronavirus vaccine may be less effective against some new strains of the coronavirus. On Thursday, Novavax said its two-dose vaccine was 89% effective in a trial in the UK, but reported efficacy of just 49% in South Africa.
Even with the variant concerns, J&J's vaccine was 85% effective across all regions at preventing severe cases of COVID-19, J&J said.
"The potential to significantly reduce the burden of severe disease, by providing an effective and well-tolerated vaccine with just one immunization, is a critical component of the global public health response," Dr. Paul Stoffels, J&J's chief scientific officer, said in a statement.
Johnson & Johnson
The scientific success comes at a perilous moment in the pandemic, particularly in the US. The country is averaging about 155,000 cases a day, and more than 100,000 people are hospitalized, according to the COVID Tracking Project. About 3,300 deaths have been reported on average each day over the past week.
J&J said it will file in early February for emergency permission from US regulators to make the shot available more widely.
Single dose should simplify a difficult immunization campaign
A one-dose jab should simplify the task of immunizing hundreds of millions of people. J&J's vaccine can also be stored at typical refrigerator temperatures for several months, unlike Pfizer's vaccine, which requires extremely cold storage.
These logistical challenges have led to a slower-than-expected rollout in the US, though President Joe Biden has set a goal of giving at least 100 million shots in his first 100 days in office.
Read more: What's coming next for COVID-19 vaccines? Here's the latest on 11 leading programs.
The US Food and Drug Administration is expected to follow the same regulatory process used for Pfizer's and Moderna's vaccines, which includes convening an independent expert panel to vet the data. The FDA took 18 days to review Pfizer's and Moderna's applications and grant an emergency OK. Typically, agency reviews for new medicines take six to 10 months.
J&J hopes to produce 1 billion doses of its vaccine in 2021. The US government and J&J agreed in August to a $1 billion deal for 100 million doses. The healthcare giant has said it will supply the vaccine at nonprofit levels during the pandemic period.
J&J's vaccine was co-developed by a team led by virologist Dr. Dan Barouch at Boston's Beth Israel Deaconess Medical Center.
J&J's vaccine uses a modified adenovirus, a virus that causes the common cold, to carry and deliver DNA-based instructions to cells on how to produce the spike protein. The cells then produce the protein, generating an immune response in the body that helps fight off the coronavirus in the future. J&J's has engineered the adenovirus so that it can't replicate in the body.
Pfizer's and Moderna's vaccines are both messenger RNA-based shots, a new technology that uses the genetic information called mRNA to instruct cells to make the coronavirus' spike protein.
J&J's shot compared to Moderna's and Pfizer's
Moderna's and Pfizer's shots were overwhelmingly effective at preventing COVID-19. Large-scale studies for two-dose regimens found the vaccines were respectively 94% and 95% effective at preventing symptomatic cases of COVID-19 after people got both doses.
Both shots also showed promising evidence that they are highly effective at preventing severe disease.
Neither Moderna's or Pfizer's vaccines raised any major safety concerns after being studied in tens of thousands of volunteers. But both had high rates of short-term, expected reactions to the shots.
The most common side effects for both vaccines were injection site pain, fatigue, and headache. Volunteers aged 18-64 recorded more side effects after getting Moderna's shot, with nearly one in five recording a severe reaction after the second dose.
The most common severe side effects for this age group were fatigue (11%), muscle pain (10%), joint pain (6%), fever (2%), and chills (2%). These side effects were significant enough to impede on daily living activities but not life-threatening.
Pfizer's vaccine, by comparison, also had the highest rates of severe reactions in people under 55 years old after the second injection.
Among this group, 5% recorded severe fatigue, 3% had severe headaches, 2% had severe chills, and 2% had new or worsened muscle pain.
Both mRNA-based vaccines have also led to severe allergic reactions in a handful of individuals. While these have been exceedingly rare cases, the CDC has said they are occurring at a rate about 10 times higher than the flu shot. J&J said that there were no cases of these severe allergic reactions, known as anaphylaxis, in its trial.
The company said that its shot was generally tolerated, and fevers developed up in 9% of those who took part in the trial. More serious fevers were reported in 0.2% of trial participants, J&J said.
The company hasn't yet provided the detailed information on side effects and safety that Pfizer and Moderna have published.