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 (Reuters) - A single dose of Johnson & Johnson's <JNJ.N>
experimental COVID-19 vaccine produced a strong immune response
against the novel coronavirus in an early-to-mid stage clinical
trial, according to interim results published on Friday.
The vaccine, called Ad26.COV2.S, was equally well-tolerated at two
different doses, the results showed. A single shot, versus a rival
two-dose approach being tested by Moderna Inc <MRNA.O> and Pfizer
Inc <PFE.N>, could simplify distribution of the vaccine.
However, it is unclear whether elderly people, one of the
populations most at risk from the virus, will be protected to the
same degree as younger people with the J&J vaccine.
The trial in close to 1,000 healthy adults, which is backed by the
U.S. government, began after the J&J vaccine was found in July to
offer strong protection in a single dose to monkeys.
Based on the current results, J&J on Wednesday kicked off a final
60,000-person trial, which could pave the way for an application for
regulatory approval. The company said it expects results of that
so-called Phase 3 trial by the end of the year or early next year.
The results, released on the medical website medRxiv, have not been
peer-reviewed. (https://www.medrxiv.
org/content/10.1101/2020.09.23.
20199604v1.full.pdf)
Researchers, including those from J&J's unit Janssen
Pharmaceuticals, said 98% of participants with data available for
the interim analysis had neutralizing antibodies, which defend cells
from pathogens, 29 days after vaccination.
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However, immune response results were available from only a small number of
people - 15 participants - over 65 years old, limiting the interpretation.
In participants older than 65, the rate of adverse reactions such as fatigue and
muscle aches was 36%, much lower than the 64% seen in younger participants, the
results showed, suggesting the immune response in older people may not be as
strong.
The researchers said more details on safety and effectiveness will follow when
the study is completed.
For now, the results justify why more studies are needed in larger numbers to
look for serious adverse effects, Dr. Barry Bloom, a professor at Harvard T.H.
Chan School of Public Health who was not involved in the J&J trial, told
Reuters.
"Overall, the vaccine is doing what you would expect it to do if you were to
move it to Phase 3 trials," Bloom said.
(Reporting by Vishwadha Chander and Manas Mishra in Bengaluru; Editing by Sriraj
Kalluvila, Nancy Lapid and Will Dunham)
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