Johnson & Johnson vaccine protects monkeys from COVID-19 with one dose, study says

By RILEY GRIFFIN AND MARTHE FOURCADE | Bloomberg | Published: July 30, 2020

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Johnson & Johnson's experimental coronavirus vaccine protected macaque monkeys with a single shot in a pre-clinical study, potentially gaining on other vaccines that are further along in testing but require two doses over time.

Five of six primates exposed to the pandemic-causing pathogen were immune after a single injection. The exception showed low levels of the virus, according to a study published in the medical journal Nature. Researchers evaluated a total of 52 macaques and seven different vaccine prototypes. The health care behemoth kick-started human trials on July 22 in Belgium and in the U.S. earlier this week.

Although other vaccine-makers have moved more quickly into development, with AstraZeneca having already administered its experimental vaccine to almost 10,000 people in the U.K., gaining protection with a single dose could prove an advantage in the logistical challenge of rolling out massive vaccination programs worldwide.

"The findings published today are a very important part of the profile that we can bring to the table over the next few weeks as we work with different countries on reaching advanced agreements" for supply of the still-experimental vaccine, Paul Stoffels, the drugmaker's chief scientific officer, said in an interview.

The primate data show that the coronavirus vaccine candidate generated a strong antibody response, and provided protection with only a single dose, Stoffels said.

J&J aims to embark on the last phase of tests in September, compressing the traditional timeline as it races against others including AstraZeneca, Moderna Inc., Pfizer Inc. and GlaxoSmithKline Plc for a shot to end the pandemic.

"This is clearly good news," Louise Chen, a Cantor Fitzgerald analyst said in a Thursday note to investors. "The positive data today is important since J&J has a vaccine platform that has been used before which could ease concerns about the safety of new vaccines being developed for Covid-19."

After slight pre-market gains, J&J fell 0.06% to $146.45 at 12:13 p.m. in New York.

The New Brunswick, N.J.-based drugmaker will test both a one-dose coronavirus shot and a shot coupled with a booster in its early-stage studies of more than 1,000 adults. As the vaccine candidate accelerates through later-stage trials, data will first report out from the one-dose arm of its trials, and Stoffels said J&J will likely seek an emergency use authorization from regulators for a single shot.

The shot-plus-booster regimen, however, poses better prospects for enduring immunity, Stoffels said. "That is the optimal approach for long-term protection. If you give a boost, you get 100-fold more neutralizing antibodies. The paper shows that the higher your neutralizing antibodies, the better for your protection."

Stoffels said vaccine-makers must rise to the challenge of protecting 70% of the world's population from Covid-19 through safe and effective inoculation. Should they achieve that goal, the virus could be "eliminated from the world entirely," he said.

But it's not clear how long coronavirus antibodies can protect people from the disease, and clinical trials haven't yielded proof that a shot could prevent infection for an extended period of time.

Albert Bourla, chief executive officer of Pfizer, said on Tuesday that he's preparing for the coronavirus to endure, leading to long-term demand for a seasonal shot to protect against covid-19.

"There is a likely scenario that either the vaccine's immunity will not be lasting forever," Bourla said, "or that the virus will mutate, or that the virus will find ways to come back again and again."

J&J's Stoffels offers a different perspective.

"I hope we can protect people for a long time with one, two, or even three boosters. Hopefully, by then, it will be done," and the world will achieve comprehensive heard immunity, he said.

J&J, which received a $456 million award from the Biomedical Advanced Research and Development Authority, has already entered discussions with the U.S., the European Union, and governments around the world about supplying its vaccine should it prove successful in the clinic. Stoffels said those negotiations will advance in light of the new data.

J&J's technology is based on the human adenovirus, a type of common cold virus. It's an approach that is perhaps best known for its use in an Ebola vaccine.

The company has not yet determined a price for its shot, though top executives suggest it will be offered on a not-for-profit basis for the duration of the pandemic.