[Ip-health] ​Biden Administration asked to clarify scope of sanctions exceptions for Cuba’s vaccine program, and to support the evaluation and registration of its COVID-19 vaccines

James Love james.love at keionline.org
Thu Jul 1 05:57:42 PDT 2021


https://www.keionline.org/36381

Biden Administration asked to clarify scope of sanctions exceptions for
Cuba’s vaccine program, and to support the evaluation and registration of
its COVID-19 vaccines

July 1, 2021

On June 28, 2021, KEI sent a memorandum to Gayle E Smith (State), Eric
Lander (OSTP), Loyce Pace (HHS) and Samantha Power (USAID), asking the U.S.
government to clarify that its sanctions against Cuba do not extend to
activities and agreements related to the development, manufacturing,
distribution and sale of its COVID-19 vaccines. The KEI memo also asks that
the NIH, BARDA and other federal agencies directly engage with the Cuban
research institutes to fund expanded or additional clinical trials to
continue to test the efficacy of two or more of the Cuban vaccine
candidates. The U.S. government is also asked to support the Cuban research
institutes in achieving global regulatory approval for these vaccines. The
KEI memo cites Biden’s National Security Directive Number 1, and a June 13,
2016 Memorandum of Understanding between the Department of Health and Human
Services of the United States of America and the Ministry of Public Health
of the Republic of Cuba that called for deepening public health cooperation
on communicable diseases.

Memorandum

TO:
Gayle E. Smith, Coordinator for Global COVID-19 Response and Health
Security, Department of State
Dr. Eric Lander, Director, Office of Science and Technology Policy (OSTP)
Loyce Pace, Director, Office of Global Affairs, Department of Health and
Human Services (HHS)
Samantha Power, Administrator, U.S. Agency For International Development
(USAID)

FROM: James Love, Knowledge Ecology International (KEI)
RE: Cuban Vaccine Program
DATE: June 28, 2021

Cuba is in the late stages of development of several COVID-19 vaccines.
This development has been hindered by the perception and perhaps reality
that U.S. sanctions on Cuba extend to the interactions related to the
research, development, and manufacturing of Cuba’s vaccines.

On June 21, 2021, the government of Cuba announced that its three dose
Abdala vaccine was 92 percent effective. Earlier Cuba had announced that
its Soberana 2 vaccine was 62 percent effective with two doses, and its
efficacy is expected to be higher with the third dose. Cuba is expected to
disclose further data on these vaccines, and to file for regulatory
approval with the local authorities shortly.

These and other COVID-19 vaccines under development in Cuba are recombinant
protein subunit vaccines, the same technology platform as the Novavax
vaccine. It is our understanding that protein subunit vaccines have
advantages concerning scaling production, including from facilities now
used to manufacture small molecule drugs. Further, due to features like
favorable cold chain requirements and possible intranasal administration,
these vaccine candidates could be particularly important in
resource-constrained settings.

It is our understanding that the government of Cuba is in the process of
engaging the World Health Organization (WHO) in the evaluation of its
regulatory approval. Recently, during an international summit, Cuba
committed to open licensing their technology, including both the patents
and know-how. KEI has encouraged the government of Cuba to collaborate with
the WHO’s COVID-19 Technology Access Pool (C-TAP). KEI has also encouraged
the WHO to make it clear to vaccine or drug developers that they can
receive royalties or other remuneration when sharing technology through
C-TAP.

Over the past year and a half, U.S. sanctions against Cuba have cast a
cloud over the ability of companies and non-profit organizations to work
with Cuba on its vaccine program. The Biden administration needs to clear
the air and reassure the WHO, suppliers of inputs and others that none of
the U.S. sanctions against Cuba extend to activities to make, sell or
distribute its vaccines. This should extend to royalties or other payments
to the Cuban research institutions that have developed the vaccine and that
will be involved in the transfer of know-how.

A four page June 13, 2016 Memorandum of Understanding between the
Department of Health and Human Services of the United States of America and
the Ministry of Public Health of the Republic of Cuba is still in effect
and highly relevant to COVID-19. [link]

President Biden’s January 21, 2021 National Security Directive Number 1, on
United States Global Leadership to Strengthen the International COVID-19
Response and to Advance Global Health Security and Biological Preparedness,
is also relevant, including but not limited to Section 2 (c), on Sanctions
Relief:

=============
Section 2. United States Leadership in the Global Response to COVID-19.

(c) COVID-19 Sanctions Relief. The Secretary of State, the Secretary of the
Treasury, and the Secretary of Commerce, in consultation with the Secretary
of HHS and the Administrator of USAID, shall promptly review existing
United States and multilateral financial and economic sanctions to evaluate
whether they are unduly hindering responses to the COVID-19 pandemic, and
provide recommendations to the President, through the APNSA and the
COVID-19 Response Coordinator, for any changes in approach. [link]
=============

According to several news articles that have been published in the past few
months, Cuban scientists are facing challenges in the development and
scaling manufacture of their vaccine candidates due to restrictions imposed
by the United States sanctions. These challenges range from difficulties in
acquiring resources like scientific equipment and raw materials, to
challenges in making bank transactions with suppliers willing to work with
them. KEI has also talked with public health institutions that have been
unwilling to work with Cuba, due to the U.S. sanctions.

Recommendations

1. Pursuant to National Security Directive Number 1, clarify the scope of
exceptions to the sanctions for Cuba’s vaccine program.

2. Pursuant to the June 13, 2016 MoU between the US and Cuba to deepen
public health cooperation focusing on communicable diseases, the United
States government should also directly engage with the Cuban research
institutes to fund expanded or additional clinical trials to continue to
test the efficacy of two or more of the Cuban vaccine candidates.

3. The United States government should support the Cuban research
institutes in achieving global regulatory approval for these vaccines.
-- 
James Love.  Knowledge Ecology International
U.S. Mobile +1.202.361.3040
U.S. office phone +1.202.332.2670
http://www.keionline.org <http://www.keionline.org/donate.html>
twitter.com/jamie_love


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