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HEALTH-VIRUS-VACCINE-FDA-J&J
US expert panel to vote on Johnson & Johnson Covid vaccine
WASHINGTON, Feb 26, 2021 (BSS/AFP) – A US panel of independent experts was
set to vote Friday on whether to recommend emergency approval of Johnson &
Johnson’s single-shot Covid-19 vaccine, potentially paving the way for at
least three million doses to ship next week.
The committee’s 22 members, who were convened by the Food and Drug
Administration and include leading scientists as well consumer and industry
representatives, will hold a daylong virtual meeting to decide if the known
benefits of the drug outweigh its risks.
It is an exercise in transparency without parallel among other advanced
countries, giving the public access to the nitty gritty details of the
scientific debate.
Though the panel’s recommendations aren’t binding, they are usually
followed, and the members are widely expected to vote in favor.
An emergency use authorization (EUA) would soon follow, making the J&J
vaccine the third to be greenlighted in the United States after Pfizer’s and
Moderna’s were provisionally approved in December.
“If the FDA approves the use of this new vaccine, we have a plan to roll it
out as quickly as Johnson & Johnson can make it,” US President Joe Biden said
Thursday.
Administration officials said earlier this week they hoped to deliver three
to four million doses next week, pending emergency authorization.
– An invaluable tool –
The FDA released its own analysis ahead of the meeting that showed the
vaccine was highly effective in preventing severe Covid-19, including newer
variants.
In a global trial of almost 40,000 people, the efficacy against severe
disease was 85.4 percent, but it fell to 66.1 percent when including moderate
forms of the disease.
This makes it slightly less protective than the Pfizer and Moderna’s two-
shot regimens, which both have an efficacy of around 95 percent against all
forms of Covid-19 from the classic coronavirus strain.
Nevertheless, experts say J&J’s shot will be another invaluable tool in
bringing the outbreak to a close in the United States, where more than
500,000 people have died.
Crucially, it requires just one dose, while both Pfizer and Moderna’s need
two, and it can be stored at normal fridge temperatures rather than in
freezers, easing the logistical burden.
Analyses of different demographic groups, meanwhile, revealed no marked
differences in the J&J vaccine’s effects across age, race or people with
underlying conditions.
It was also generally well-tolerated, with no reports of severe allergic
reactions (anaphylaxis), which have been seen in rare cases for the Pfizer
and Moderna shots.
There was a hint, based on preliminary data, that the vaccine might be
effective against asymptomatic infection — though J&J said they need to do
more research to confirm this.
The company has announced it aims to deliver a total of 20 million doses by
the end of March, with 100 million by June — though the US is pushing to
expedite that timeline.
The J&J vaccine uses a common-cold causing adenovirus, which has been
genetically modified so that it can’t replicate, to carry the gene for a key
protein of the coronavirus into human cells.
Those cells then produce that protein, which in turn trains the human
immune system should it encounter the real virus.
Other adenovirus vector vaccines against Covid-19 include those made by
AstraZeneca-Oxford and Russia’s Sputnik V.
BSS/AFP/GMR/0912 hrs