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IP and breakthrough infections: Global Health Today

This is the third in a series of newsletters, offering the expert insight of Lalita Panicker – consulting editor, views, Hindustan Times, New Delhi – into some of the most pressing health issues of the day. This edition highlights vaccines – specifically, the IP debate and so-called breakthrough infections. To read the first, click here.

Vials containing the Moderna COVID-19 vaccine sit on a table in preparation for vaccinations at Kadena Air Base, Japan, Jan. 4, 2021. As part of the DoD strategy for prioritizing, distributing and administering the COVID-19 vaccine, those providing direct medical care and emergency services will be prioritized to receive the vaccine at units based in Japan, including Kadena AB. (U.S. Air Force photo by Airman 1st Class Anna Nolte) Photographer: Airman 1st Class Anna NoltePost-production: Zacharie Grossen, Public domain, via Wikimedia Commons. Moderna offered indemnity concept.
Vials containing the Moderna COVID-19 vaccine. Image credit:. (U.S. Air Force photo by Airman 1st Class Anna Nolte) Photographer: Airman 1st Class Anna Nolte. Post-production: Zacharie Grossen, Public domain, via Wikimedia Commons

COVID-19 has become a Great Leveller, perhaps because of the death and destruction it has caused over the last eighteen months. For example, the world’s richest country, the U.S. has been laid low with the largest number of cases and deaths globally, although it is by no means the most populous. And just as it seemed to be picking itself up, the U.S. has again been struck by the emergence of new COVID-19 variants; the virus moves in mysterious ways its wonders to perform. Could this have played a role in the US staging a 360-degree turn on intellectual property (IP) protections for anti-COVID-19 vaccines? No matter how much you vaccinate at home, there is always the chance of some nasty little variant coming up amongst the unvaccinated masses out there and coming home to roost!

Leaving aside the usual rich versus poor argument,  the pandemic has reignited a long-running debate about the right balance between private profit and public health. Some say that the World Trade Organization (WTO) rules on IP limit poor countries’ access to critical medicines. Others take the opposite view, that rules are needed to incentivise pharma companies. (See: “The Debate Over a Patent Waiver for COVID-19 Vaccines: What to Know.”)

In late 2020, developing countries led by India and South Africa floated a proposal to temporarily waive IP protections for vaccines and other products needed to fight the pandemic until most of the world’s population is immune. The last time the WTO altered its rules on the sale of patented medical products was in 2003

People queue for a COVID-19 shot in India. Image credit: Ganesh Dhamodkar, CC BY-SA 4.0 <>, via Wikimedia Commons

Wealthy countries, including the U.S., initially balked at the proposal. Then, in May 2021, the Joe Biden administration reversed course and announced its support for a vaccine IP waiver. Shortly thereafter, the developing countries submitted a revised proposal.  Largely the same as the first, it went into specifics however, stating that the waiver would apply to pandemic-related “health products and technologies,” including vaccines, diagnostics, therapeutics, and personal protective equipment (PPE) and would be in force for at least three years, with an opportunity for extension.

Proponents say the waiver could boost the production of vaccines and other life-saving products. The WTO rules, they say, are preventing companies other than the inventors from manufacturing critical medical products.

Waiver proponents point to the generous government funding that pharmaceutical companies received to support their development of COVID-19 vaccines and argue that the public is entitled to greater access even if that means fewer profits. Governments still have the authority to allow companies to produce a patented product without the rights-holder’s consent during public health emergencies—known as compulsory licensing. But those in support of a waiver say the process is too complicated and piecemeal. In addition, the U.S. and other wealthy countries have looked unfavourably on countries that grant compulsory licences. 

To opponents, the waiver will do little to improve global vaccine distribution while eliminating incentives for innovation. They hold that low manufacturing capacity, not patents, is the biggest impediment to global vaccination efforts. More importantly, IP rules—and the profits they allow—promote the development of breakthrough technologies such as the COVID-19 vaccines. 

Instead of an IP waiver, the US should stop hoarding vaccines and increase its exports, argue former US Food and Drug Administration (FDA) Commissioner Scott Gottlieb and former Acting FDA Chief Scientist and Council on Foreign Relations (CFR) Senior Fellow Luciana Borio. In addition, they say, vaccine-producing countries such as Australia, Belgium, France, Japan, and the United Kingdom should invest in a major manufacturing expansion. 

Some six billion doses out of the 8.6 billion confirmed purchases so far have been pre-ordered by governments in high- and middle-income countries. Seth Berkeley, chief executive of Gavi, estimates that rich countries have procured around 1.5 billion excess doses. They should immediately donate these to COVAX for urgent distribution to low- and middle-Income countries (LMICs).

These donations are the quickest way to get shots in arms right away. But they are not enough. Donations are a charity model and once the ‘‘giveaway’’ is over, the vaccine supply dilemma remains. Thus, what is also needed is a sustainable way for LMICs to be able to make their own vaccines to ensure population-wide vaccination by the end of 2021 (or early 2022 at the latest).

The number of vaccines given so far in Africa amounted to little more than one dose per person for some two percent of Africa’s 1.2 billion people. (See: “A patent waiver on COVID vaccines is right and fair”)

This is because the continent currently imports 99 per cent of its vaccines, and because African countries lack the pre-order purchasing capacity of richer nations. It is why the African Union has announced a plan for sixty per cent of Africa’s vaccines to be manufactured on the continent by 2040.


Confirmed cases of COVID-19 concept. a covid-19 blood test tube with result of positive on yellow background the X has clipping path and can be removed. COVID-19 testing concept. Antibody tests concept. Image credit: 罗 宏志 / 123rf. COVID-19 cases now number at one million: concept. Testing illustration. Symptomatic COVID-19 illustration. Cases of COVID-19 in India concept. COVID-19 clusters concept.. new covid-19 variant mutant strain long covid. COVID-19 cases concept. Even after recovery from COVID-19, long-COVID symptoms may persist. Image credit: 罗 宏志 / 123rf. B.1.617 concept. black fungus. Delta plus variant concern. Delta variant concept. Excess mortality illustration. Fresh COVID-19 cases illustration.
Breakthrough infections are an issue of mounting concern. Image credit: 罗 宏志 / 123rf

Every silver lining has a cloud attached to it so why should the battle against COVID-19 be any different? Yes, we have vaccines with more of them hitting the market regularly. But the viral response to that, the cloud that stops the sun from shining for a while, is “breakthrough” infections. 

study by University of Oxford scientists, awaiting peer review, has found that people who contract the Delta variant of COVID-19 after being fully vaccinated carry a similar amount of the coronavirus as those who catch the disease and have not been inoculated. The researchers stressed that vaccination still offers good protection against catching the disease in the first place, and protects against getting seriously ill with it.

The survey indicates, that vaccinated people with “breakthrough” infections could still pose a significant infection risk to those who have not been vaccinated.

The findings could have implications for policymakers who’ve banked for months on hopes of achieving “herd immunity”; that is, by vaccinating a large proportion of any given population, they will also protect people who cannot or will not get inoculated themselves by reducing transmissions overall.

“The fact that they [fully vaccinated people] can have high levels of virus suggests that people who aren’t yet vaccinated may not be as protected from the Delta variant as we hoped,” Oxford’s lead researcher, Dr Sarah Walker, told The Telegraph. 

Breakthrough cases accounted for about one in five newly diagnosed cases in six states of the U.S., according to The New York Times. The states in question are California, Colorado, Massachusetts, Oregon, Utah, Vermont, and Virginia. The trends in these states may not reflect the numbers throughout the country, the newspaper reported.

There’s basic arithmetic at play. As more people get vaccinated, even if breakthroughs are rare, a rising number of cases will be among the vaccinated.

“Even with a 95 per cent efficacious vaccine, you will have one in twenty vaccinees who are exposed [who] get the disease,” said Dr Kathleen Neuzil, director of the Centre for Vaccine Development and Global Health at the University of Maryland. 

Certainly, with the Delta variant taking over — which spreads about two to three times faster than the original strain — there will be more cases among everyone, vaccinated and unvaccinated, said John Moore, professor of microbiology and immunology at Weill Cornell Medicine.

Scientists stress more research is needed to understand this issue. In the meantime, “the safest thing to do is to avoid being infected altogether” according to virus expert Angela Rasmussen of the Vaccine and Infectious Disease Organization at the University of Saskatchewan in Canada.

That might mean — in addition to vaccination — breaking out masks again, re-upping good hand hygiene and getting more air circulating when gathering indoors.

“The mitigation measures that we have put in place previously will still work against the delta variant — it’s not being transmitted by some other route,” Rasmussen added. And that continues to be the silver lining.


Lalita Panicker is consulting editor, views, Hindustan Times, New Delhi

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