Vaccines falling through the cracks in the regulatory mosaic

Geneva Health Files
7 min readJul 11, 2021

Newsletter Edition #69 [The Weekly Primer]

Originally published July 6th, 2021 on Geneva Health Files.


The ongoing goof-up around European Union’s prized vaccine certificates which do not recognize some WHO-approved vaccines, has brought back to life memories on governmental dysfunctions.

Having spent a substantial part of my life in India, I am long used to bureaucratic delays, inexplicable and convoluted ways in which red tape eats into productive hours. It is a fact of life. Indians mostly account for unanticipated surprises from unimaginative public servants who put the letter of the law above the spirit of it, and are often, averse to common sense.

Watching vaccine barriers go up in the EU, on the back of export restrictions and vaccines hoarding, has illustrated the total lack of not only empathy but also the lack of imagination in bureaucracies.

Professionals and students from different parts of the world are struggling to travel and meet contractual obligations, simply because they have received a vaccine not approved by the European Medicines Agency (although approved by WHO EUL). The costs for families are a mounting toll, in a world already torn asunder by uncertainty.

This also speaks to the relevance of WHO’s shrinking remit in persuading member states to make coordinated policy decisions, not only for equitable access for medical products but also facilitating coherent travel rules.

If certain vaccines fall through the cracks in the regulatory mosaic, the burden will disproportionately affect some countries more than others. The state of affairs is a cocktail of political, economic and, commercial considerations bulldozing human rights considerations.

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First Meeting of the Task Force on COVID-19 Vaccines, Therapeutics and Diagnostics for Developing Countries: WHO, WTO, WB, IMF

As an urgent first step, we are calling on G20 countries to (1) embrace the target of at least 40 percent in every country by end-2021, and at least 60 percent by the first half of 2022, (2) share more vaccine doses now, including by ensuring at least 1 billion doses are shared with developing countries in 2021 starting immediately, (3) provide financing, including grants and concessional financing, to close the residual gaps, including for the ACT-Accelerator, and (4) remove all barriers to export of inputs and finished vaccines, and other barriers to supply chain operations.

In addition, to enhance transparency we agreed to compile data on dose requests (by type and quantity), contracts, deliveries (including through donations), and deployments of COVID-19 vaccines to low and middle-income countries — and make it available as part of a shared country-level dashboard. We also agreed to take steps to address hesitancy, and to coordinate efforts to address gaps in readiness, so countries are positioned to receive, deploy and administer vaccines.”

The new Bureau for a potential Pandemic Treaty, first meeting next week: WHO

  • The WHO Resolution WHA74.7 recommended that the Member States Working Group on Strengthening WHO Preparedness and Response to Health Emergencies shall have a Bureau comprising six officers (two Co-Chairs and four Vice-Chairs, to be appointed at the first meeting), one from each WHO region. Politico reported “the countries chosen to chair new bureau that will lead on a report about a potential pandemic treaty are France, the U.S., Botswana, Singapore, Iraq and Indonesia, according to multiple diplomats.”
  • Discussions begin next week on exploring the need for a new legal international instrument to address future pandemics.

WHO calls for lower prices on Gilead drug for Covid-linked black fungus: Financial Times

“The World Health Organization has called for prices of a Gilead Sciences drug to treat black fungus infections to be cut and supplies boosted amid a sharp rise in cases among Covid-19 patients in India and Nepal.

The California-based drugmaker produces AmBisome, a lipid-based amphotericin, which is used to treat the condition, also known as mucormycosis. Cases of black fungus, which starts in the nose and quickly spreads to the eyes and brain, are normally rare, but have soared during the coronavirus crisis in south Asia. Many patients require surgery to scrape out the dead tissue killed by the infection and at least 50 per cent of people die.

Mariângela Simão, the WHO’s assistant director-general for access to medicines, told the Financial Times that Gilead should adjust an existing agreement to supply AmBisome at lower prices to poorer nations so that it includes the treatment of black fungus cases linked to coronavirus.”

The Financial Times

WTO DG tasks DDGs to deliver on controversial, non-mandated issues: Third World Network


“The DDG from the United States is also being asked to deliver on “trade and health”, which is being promoted by the DG based on her “third way” approach.

The non-inclusion of the TRIPS waiver as proposed by the developing countries in the list of “deliverables” remains a proverbial eyesore, said people who asked not to be quoted.

Coincidentally, a day before the finalization of the “deliverable” on trade and health, the Ottawa Group of countries led by Canada and a few other countries issued a third revised draft text on “COVID-19 and Beyond: Trade and Health” that includes issues such as export restrictions, customs and services, technical regulations, tariff liberalization, and cooperation with other international organizations to be delivered at the 12th ministerial conference (MC12).”

Third World Network

Europe has created a two-tier vaccination system that will hit poorer countries: The Guardian

Russia Pushes Ahead with Open License Approach to Sputnik V – Despite WHO Concerns Over Manufacturing Practices: Health Policy Watch

  • Fascinating story. Have a read. This is an evolving picture. Extremely complex.

W.H.O. officials, concerned about the Delta variant, urge vaccinated people to keep wearing masks: The New York Times

Technical considerations for implementing a risk-based approach to international travel in the context of COVID-19 : WHO

Novartis weighs entry into mRNA technology, chairman tells paper: Reuters

  • A decisive shift underway.

There’s now a Delta Plus variant of COVID-19 – what does this mean? GAVI

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: Knowledge Ecology International

“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.”


Image Credit: Photo by Pixabay from Pexels



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