The World Health Organization granted emergency authorization on Friday to Johnson & Johnson’s Covid-19 vaccine, adding the first one-dose option to the W.H.O.’s global arsenal against the pandemic.
The designation makes the vaccine eligible for distribution
through Covax, a global initiative to ensure that low- and middle-income
countries have access to vaccines. Many of those countries have barely begun
their vaccination campaigns.
The Johnson & Johnson vaccine has advantages for
countries in that program. Besides providing powerful protection against severe
Covid-19 and death with a single shot, the vaccine can be stored for three
months at refrigerator temperatures. This makes it well-suited for use in
countries and locations that may not have access to the freezers and ultra-cold
storage required by some other vaccines.
“As new vaccines become available, we must ensure they
become part of the global solution and not another reason some countries and
people are left further behind,” Dr. Tedros Adhanom Ghebreyesus, the director
general of the W.H.O., said in a briefing on Friday. “We hope that this new
vaccine will help to narrow vaccine inequalities and not deepen them.”
The W.H.O. will convene an advisory group next week to
develop formal guidelines for the vaccine’s use.
Covax has reserved 500 million doses of the vaccine, but
Johnson & Johnson has been working through production problems and has
contracts to provide the United States with 200 million doses. A new production
partnership with a rival pharmaceutical giant, Merck, is expected to help speed
up the manufacturing process.
“We’re hoping by at least July that we have access to doses
that we can be rolling out, if not even earlier,” said Dr. Bruce Aylward, a
senior adviser to the W.H.O., at the Friday briefing.
Data from the Phase 3 ENSEMBLE study showed that the Johnson
& Johnson COVID-19 vaccine was well tolerated and demonstrated a 67 percent
reduction in symptomatic COVID-19 disease in participants who received the
vaccine in comparison to participants given the placebo. The onset of
protection was observed from day 14 and was maintained 28 days
post-vaccination.
The data also demonstrated the vaccine was 85 percent
effective in preventing severe disease across all regions studied, and showed
protection against COVID-19 related hospitalization and death across countries
with different variants, beginning 28 days after vaccination.1 Variants observed
in an ongoing analysis in the ENSEMBLE study included the B.1.351 variant which
was identified in 95 percent of the COVID-19 cases in South Africa.
“From the beginning of the pandemic, we have worked to
develop and deliver a vaccine that could protect the health of people
everywhere, and today’s milestone represents significant progress toward
ensuring global access to our single-shot vaccine,” said Alex Gorsky, Chairman
and Chief Executive Officer at Johnson & Johnson. “We are moving forward
with urgency and purpose to meet our commitments to the global community as we
do all we can to help end the pandemic.”
The EUL procedure streamlines the process by which new or
unlicensed products can be assessed for use during public health emergencies by
governments and United Nations procurement agencies. The EUL process expedites
access to such products in many countries around the world and is also a
prerequisite to supply vaccines to the new COVAX Facility, a global mechanism
for pooled procurement and distribution of COVID-19 vaccines in 190
participating countries, including 92 lower-income countries.
“The WHO listing of our single-shot COVID-19 vaccine
advances our pledge to help stem this pandemic and our unwavering commitment to
equitable access,” said Paul Stoffels, M.D., Vice Chairman of the Executive
Committee and Chief Scientific Officer at Johnson & Johnson. “Achieving
this important prerequisite for distributing our vaccine through the COVAX
Facility which is co-led by Gavi is a major step forward in making our vaccine
accessible for all.”
.jpeg)
0 comments:
Post a Comment