After regulatory nods, Johnson & Johnson says latest Ebola vaccine data could support prophylactic use

ebola
Merck was the first company to gain approval for an Ebola vaccine, getting nods from the European Union and FDA in 2019. With strong data from a phase 3 trial in Sierra Leone, Johnson & Johnson and Bavarian Nordic also are positioned for full approvals (Fierce Pharma)

After scoring a European approval and a prequalification from the World Health Organization, the Ebola regimen from Johnson & Johnson has turned in a significant trial win.

The two-shot vaccine, which combines J&J’s Zabdeno followed eight weeks later by Bavarian Nordic’s Mvabea, was safe, well tolerated and produced a strong immune response in the trial, according to two reports released Monday in The Lancet Infectious Diseases. 

The vaccines induced antibody responses to the Zaire ebolavirus 21 days after the second dose in 98% of recipients, with the immunity persisting in adults for two years. Additionally, a booster dose administered to adults two years after initial vaccination induced a strong response within seven days, investigators said.

The regimen was effective in both adults and children aged 1 to 17. It was the first study of the vaccine combo in kids.

The results "support the potential prophylactic use" of the shot to help prevent against outbreaks, J&J said in a statement. The vaccine has already been deployed in response to a 2021 outbreak in Guinea earlier this year, and in June, WHO vaccine advisors recommended the vaccine during an outbreak for people at some risk of an infection. Further, outside of an outbreak, the WHO advisors said it can be used preventatively among national or international first responders where outbreaks may crop up.

Merck was the first company to gain approval for an Ebola shot, getting nods from the European Union and FDA in 2019. Its vaccine was originally developed by Canada’s National Microbiology Laboratory and then licensed by NewLink Genetics. Merck took it over during the 2014 Ebola outbreak in West Africa, which killed more than 11,300 people.

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More recently, the vaccines produced by J&J and Bavarian Nordic gained approval in Europe in July 2020 and prequalification from the WHO in April of this year. 

“Recent and ongoing outbreaks in Africa underscore that the threat of Ebola is not going away, which is why we collaborated to develop a vaccine regimen capable of inducing long-term immunity,” J&J’s chief scientific officer Paul Stoffels said in statement.

The most recent outbreak occurred earlier this year in Guinea, with 12 deaths among 16 confirmed and seven probable cases. In May, J&J revealed that it was donating thousands of vaccine regimens to Guinea. On June 19, the outbreak was declared over. 

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Proving the effectiveness and safety of the vaccines in children was critical. Of the more than 28,000 cases reported during the 2014-to-2016 outbreak, 20% were in children age 15 and younger. Additionally, kids younger than age 5 are at a higher risk of death, said The Lancet.