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Johnson & Johnson became the third western biopharmaceutical company to start a new test of its Covid-19 vaccine this week, but with one difference: in a surprise announcement Thursday morning, the company said it would test its vaccine in a format single dose.
Moderna (MRNA) and Pfizer (PFE) began Phase 3 testing this week of Covid-19 vaccines that would have to be administered in two-dose regimens. Johnson & Johnson (JNJ) said Thursday that, after the publication of promising data from a trial of the drug in monkeys, it had begun a first phase1 / 2a human trial of the vaccine in the US and Belgium that would test both regimens of one and two doses of the vaccine, and would include more than 1,000 people.
A Covid-19 vaccine that could be effective as a single dose would have an advantage over competitors, as it could substantially decrease the complexity of the global inoculation program likely necessary to end the pandemic.
“We are excited to see these preclinical data because they show that our SARS-CoV-2 vaccine candidate generated a strong antibody response and provided protection with a single dose,” said Johnson & Johnson chief scientific officer Paul Stoffels, it’s a statement. “The results give us confidence as we move forward in the development of our vaccines and high-level manufacturing in parallel.”
Shares of Johnson & Johnson, the world’s largest pharmaceutical company, rose 1.8% in premarket trading on Thursday morning. The stock is up 0.5% so far this year, and is trading at 17.2 times the expected earnings over the next 12 months, according to FactSet, above its five-year average of 16.2 times earnings. .
“This is clearly good news,” Cantor Fitzgerald analyst Louise Chen wrote in a note Thursday morning.
An article to be published by Nature, and published online by the journal in unedited form on Thursday morning, described a study of a single-dose regimen of the Johnson & Johnson vaccine with 52 rhesus monkeys.
After six weeks, the monkeys were dosed with the virus that causes Covid-19. Several experimental versions of the Johnson & Johnson vaccine were tested; Among the six monkeys that received the version the company is moving forward with, none developed a detectable lower respiratory tract infection, while one showed a low amount of virus in a nasal swab.
“Ad26-S.PP induced robust [neutralizing antibody] responses after a single immunization and provided complete protection against SARS-CoV-2 challenge in 5 out of 6 animals, while one animal had low levels of virus in [nasal swab]”The Nature authors wrote.” These data suggest minimal or no replication of the virus in animals vaccinated with Ad26-S.PP after challenge with SARS-CoV-2. “
Johnson & Johnson says it plans to start a Phase 3 trial of a single-dose regimen in September. The timeline accelerates from its previous plan to begin Phase 1 testing in September and seek approval in the middle of next year. He has not yet said when he plans to seek approval for his vaccine.
The vaccine, a so-called non-replicating viral vector vaccine, uses an altered version of a cold virus called Ad26 to deliver viral genetic material to a cell. Although no Ad26-based vaccine was approved by US regulators in the past, the technology was used in the company’s Ebola vaccine, which was administered to 50,000 people and approved by European regulators on July 1.
Write to Josh Nathan-Kazis at [email protected]
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