[ 2021-02-25 ]

US set to approve Johnson & Johnson’s single dose Covid vaccine
A single-dose Covid-19 vaccine is set to receive
approval in the US as soon as Friday after proving
safe and effective in trials, showing complete
protection against hospitalisation and death.

The Johnson & Johnson vaccine is 85 per cent
effective at preventing severe illness and 66 per
cent protective overall against moderate cases,
experts from the US Food and Drug Administration
confirmed today.

The vaccine produced by the US pharmaceutical
giant has advantages over its rivals because it
can be kept in a fridge for three months, making
it easier to store and distribute than
alternatives made by Pfizer and Moderna which must
be kept frozen until use. The single-jab regime
means there is no need for follow-up
appointments.

American regulators have so far authorised two
double-dose vaccines, made by Pfizer-BioNTech and
Moderna. AstraZeneca, which is approved in Europe
and Israel, said this week that it expects its
two-jab vaccine to receive US authorisation at the
start of April once it has completed and analysed
a large-scale trial involving 30,000 people.

The FDA’s panel of independent experts meets on
Friday to decide on approving the Johnson &
Johnson product.

“We know this vaccine prevents 85 per cent of
the severe disease. It was 100 per cent effective
in preventing hospitalisation and deaths, and
that’s really what’s important,” Nancy
Bennett, a professor of medicine and public health
sciences at the University of Rochester School of
Medicine and Dentistry, told The Washington Post.

Crucially J&J reported to the FDA that its data
suggested its vaccine was effective at preventing
asymptomatic infections. In a preliminary analysis
of its trial it found 16 cases of asymptomatic
cases in the placebo group versus just two in the
vaccine group, or an 88 per cent efficacy rate.
The reduction of asymptomatic cases implies that
the vaccine can cut transmission of the disease.

J&J’s vaccine was 66 per cent effective in
preventing Covid-19 against several main variants
in a global trial involving nearly 44,000 people,
the company said last month.

Its effectiveness varied from 72 per cent in the
United States to 66 per cent in Latin America and
57 per cent in South Africa. Overall the vaccine
was 85 per cent effective in stopping severe cases
of the disease and not one vaccinated person in
the trial died from Covid-19.

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Fourteen days after injection two vaccine
recipients developed Covid-19 severe enough to
require medical treatment, compared with 14 in the
placebo group. After 28 days no vaccine recipients
developed Covid-19 severe enough to require
medical intervention.

Three vaccine recipients had severe side effects
in the trial that were probably related to the
vaccine but the FDA said its analysis did not
raise any specific safety concerns that would rule
out an emergency use authorisation.

The vaccine was less effective in a group of
adults older than 60 who also had risk factors for
severe illness but regulators said that there were
no deaths or cases requiring medical intervention
a month after those older adults received
vaccines. There were seven deaths in the trial,
all in the group that received a placebo.

Trials showed that a full course of the
Pfizer-BioNTech vaccine was 95 per cent effective
in protecting against Covid-19 and Moderna 92 per
cent.

J&J was on track to become the world’s first
one-dose option until Mexico announced this month
it would use a one-dose version from China’s
CanSino. That vaccine is made with similar
technology as J&J’s but was initially developed
as a two-dose option.

If the FDA clears the J&J vaccine for US use only
a few million doses are expected to be ready for
shipping in the first week after approval. J&J
told Congress this week that it expected to
provide 20 million doses by the end of March and
100 million by summer.

European regulators and the World Health
Organisation are considering J&J’s vaccine.
Worldwide, the company aims to produce around a
billion doses by the end of the year.

Source - The Times, UK

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