Oct 17 (Reuters) - The plan to roll out Merck & Co's
promising antiviral pill to treat COVID-19 risks repeating the
inequities of vaccine distribution, potentially leaving the
nations with the greatest need once again at the back of the
line, international health groups say.
For example, only about 5% of Africas population is
immunized, creating an urgent need for therapeutics that could
keep people out of hospitals. That compares with more than a 70%
inoculation rate in most wealthy nations.
Merck on Oct 11 applied for U.S. emergency clearance of the
first pill for COVID-19 after it cut hospitalizations and deaths
by 50% in a large clinical trial. The medicine, made with
Ridgeback Biotherapeutics, could gain authorization as soon as
The U.S. drugmaker has taken the unusual pandemic step of
licensing several generics of its antiviral molnupiravir before
its branded version was even authorized for marketing.
But international health officials said even that is not
enough for the medicine to reach many in low- and middle-income
countries in large enough numbers, while noting shortcomings and
red tape among global organizations that could further slow
Merck this year plans to produce 10 million treatment
courses of the pill, which is taken twice a day for five days,
and another 20 million next year.
In addition, its licensing deals with eight Indian
drugmakers will allow cheaper generic versions for 109 low- and
middle-income countries including in Africa, a move
international groups acknowledge is a positive concession.
But as wealthy nations secure molnupiravir supply deals -
the United States has already locked up 1.7 million courses with
an option for 3.5 million more by January of 2023 at about $700
per course - concerns grow over who might be left out.
NOT MOVING QUICKLY ENOUGH
Merck said it has worked on the technology transfer needed
to start generic manufacturing, in contrast to vaccine makers
who continue to resist calls to waive patents or allow for
generic versions to boost supplies.
But a recent report prepared for the United Nations' Access
to COVID-19 Tools Accelerator program tasked with buying
COVID-19 therapeutics for poor countries cited concerns that
U.N. agencies were not moving quickly enough to secure adequate
volumes of potential new treatments ahead of time, including
Medicines Patent Pool (MPP), a United Nations-backed public
health organization, has 24 companies signed up and willing to
make the drug if Merck agrees to expand the licenses.
If you're not in the license, you're relying on Merck, and
it looks to us that that could mean a potential supply shortfall
as well as overpricing," said Peter Maybarduk of Public Citizen,
who sits on the MPP governance board. He suggested that could
lead to wealthy countries outbidding poor nations for the
It is unclear how many generic pills will be available or
when. The licensed Indian manufacturers including Aurobindo
Pharma, Cipla Ltd, Dr. Reddys Labs
, Emcure Pharmaceuticals, Hetero Labs, Sun
Pharmaceuticals, and Torrent Pharmaceuticals
declined to provide details on production plans.
In addition, manufacturing for low-income countries in many
nations also requires World Health Organization (WHO) approval,
a regulatory process that typically takes months.
Merck said it is committed to providing timely access to its
drug globally with plans for tiered pricing aligned with a
countrys ability to pay. A spokesperson confirmed it is in
discussions about expanding licenses for generic molnupiravir
"to build sufficient global supply of quality-assured product to
meet orders globally."
But middle-income countries will be hard pressed to
negotiate against the richest nations, another MPP official
The governments of Australia, South Korea, Thailand, Taiwan,
Singapore and Malaysia said they already had deals or were
negotiating supply contracts with Merck. The EU is
considering buying the pill after Merck applies for
authorization in Europe.
The eight generic manufacturers chosen by Merck all have WHO
pre-qualified facilities to allow them to supply buyers like the
Global Fund, according to Paul Schaper, Merck's executive
director of global public policy. They will set their pricing
and decide how much they plan to manufacture.
What we are anticipating and hoping for is that they will
compete with each other on pricing, Schaper said.
(Reporting by Francesco Guarascio in Brussels and Michael Erman
in New Jersey; Editing by Caroline Humer and Bill Berkrot)