The news came as the regulator was set to convene an
independent panel Friday that will likely vote to authorize the vaccine, making
it the third available in the country hit hardest by the coronavirus pandemic.
In large clinical trials, the J&J vaccine’s efficacy
against severe disease was 85.9 percent in the United States, 81.7 percent in
South Africa, and 87.6 percent in Brazil.
Overall, among 39,321 participants across all regions, the
efficacy against severe Covid-19 was 85.4 percent, but it fell to 66.1 percent
when including moderate forms of the disease.
Crucially, analyses of different demographic groups revealed
no marked differences across age, race, or people with underlying conditions.
The vaccine was generally well-tolerated, with no reports of
severe allergic reactions (anaphylaxis), which have been seen in rare cases for
the Pfizer and Moderna shots.
Mild to moderate reactions, like injection-site pain,
headache, fatigue and muscle pains were more likely to occur in younger
participants than older.
There were no reported deaths in the vaccine group, but five
in the placebo group.
“The analysis supported a favorable safety profile with no
specific safety concerns identified that would preclude issuance of an EUA
(emergency use authorization),” the FDA wrote.
White House Coronavirus Response Coordinator Jeff Zients
told reporters that if authorized, the federal government would seek to
distribute three to four million doses next week.
“Johnson and Johnson has announced it aims to deliver a
total of 20 million doses by the end of March,” he continued, adding the
government was trying to speed up the delivery of the contracted 100 million
doses, which the company has promised by the end of June.
One dose, fridge storage
A third vaccine is seen as a vital means to ramp up the
immunization rate in the United States, where more than 500,000 people have
lost their lives to the coronavirus.
Some 65 million people in America have so far received at
least one shot of either the Pfizer or Moderna vaccines — but unlike those, the
J&J vaccine requires just one dose, and is stored at fridge temperatures.
The trade-off is slightly less protection against mild or
moderate forms of Covid-19.
“The vaccine was effective in preventing COVID-19 using a
less restrictive definition of the disease and for more severe disease,
including COVID-19 requiring medical intervention, considering all cases
starting 14 days after vaccination,” the FDA wrote in its briefing document.
“Although a lower efficacy overall was observed in South
Africa, where there was a predominance of B.1.3.5 lineage during the time
period of this study, vaccine efficacy against severe/critical COVID-19 was
similarly high across the United States, South Africa, and Brazil,” it added.
There was a hint, based on preliminary data, that the
vaccine might be effective against asymptomatic infection.
But “this finding needs to be further investigated with
additional data,” wrote the company in a separate document made available by
the FDA.
The J&J vaccine uses a common-cold causing adenovirus,
which has been modified so that it can’t replicate, to carry the DNA for a key
protein of the coronavirus into human cells.
This makes those cells 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.
AFP
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