The COVID-19 pandemic is continuing to rage unabated. Just as countries across the globe were coming online from a protracted lockdown, the second and third wave of the pandemic is threatening to derail hopes of a return to a more normal way of life.
It's against this backdrop that vaccines and treatments options have taken center stage.
The COVID-19 Vaccine Landscape: In the U.S., three vaccines have received authorization for emergency use. Pfizer Inc. PFE-BioNTech SE BNTX were the first to get the nod for emergency use, followed by Moderna, Inc. MRNA and Johnson & Johnson JNJ.
AstraZeneca PLC's AZN adenovirus vaccine — AZD1222 — has been approved for emergency use in several countries, although the FDA has yet to give its blessings.
Some of the other vaccines approved internationally include Russia's Sputnik V, India's indigenously developed COVAXIN and a trio of vaccines developed by Chinese companies.
The coronavirus vaccines have not received full approval. Pfizer and its German partner BioNTech announced Friday the initiation of a rolling submission for af biologic license application for full FDA approval of the companies' mRNA vaccine, BNT162b2.
The aim of governments is to make these vaccines as widely available as possible, especially to developing and underdeveloped countries, and vaccinate as many people as possible so that herd immunity may be achieved.
One aspect that could come in the way of this objective are patents related to the vaccines.
How Patents Influence Vaccine Availability: A patent, in layman's terms, is the protection vested on an innovation that will allow the developer or the inventor to take advantage of the fruits of their labor, which could be in the form of time, effort and money.
When COVID-19 vaccines are covered by patents, only the developer of the vaccine can manufacture them.
This would limit the availability of the vaccine, given the limitations with respect to scaling up of manufacturing to meet a need that seems gargantuan in light of available manufacturing capacity.
Pfizer said in its first-quarter report that it targets supplying 1.6 billion doses of vaccine in 2021. Moderna expects to supply 800 million to 1 billion doses of vaccine in 2021 and increase this figure to 3 billion doses in 2022.
Vaccine developers such as AstraZeneca and Novavax, Inc. NVAX have struck licensing partnerships with local companies such as the Serum Institute of India to increase the doses that are made available.
Nevertheless, there is a paucity of supply. In countries such as India, the second wave of the pandemic is creating havoc. Infections and deaths are spiraling, and to make matters worse, these countries are facing severe shortages of vaccine supplies.
The clamor for taking vaccine technology and intellectual property off patent is getting louder. If the original developers can share the vaccines with local companies, there is every possibility of increasing vaccine supplies and improving affordability.
Incidentally, Moderna announced as early as October that it will not enforce its COVID-19-related patents against those making vaccines intended to combat the pandemic.
"Further, to eliminate any perceived IP barriers to vaccine development during the pandemic period, upon request we are also willing to license our intellectual property for COVID-19 vaccines to others for the post pandemic period," the company said at the time.
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Countries Divided Over Patents: India and South Africa, which are hit hard by the pandemic, have suggested that COVID-19 vaccine patents be given a broad waiver from Trade-Related Intellectual Property Rights, aka TRIPS.
TRIPS are enforced by the World Trade Organization for safeguarding trademarks, designs, inventions and other intangible goods in global trade.
After objecting to the proposal initially, the Biden administration said earlier this week it will advocate the waiving of vaccine patents and related intellectual property.
On the other hand, Germany has been very vocal in supporting the upholding of patents related to vaccines.
Other WTO members such as the EU, Japan, Australia, Canada and Switzerland have lined up behind Germany.
Patent Waiver Proponents Lay Out Case: Much of the vaccine doses distributed now are going to high- and upper-middle-income countries. Relatively less supply is going to poorer nations that house about 80% of the world's population.
This is one principal reason world organizations and some countries are backing the proposal for making vaccines off-patent.
Why The Opposition? Opponents argue that such a move will disincentivize drug development. Vaccine developers that spent billions of dollars on R&D and manufacturing may now find themselves shortchanged, as they will have to hand out the technology literally for free.
There is also the fear of China and Russia getting access to the mRNA technology, a relatively new-age vaccine technology, and exploiting it.
Pharma companies have raised this issue in meetings with U.S. trade and White House officials, according to the Financial Times.
Germany has expressed concerns about the potential for severe complications in vaccine production.
"The limiting factor for the production of vaccines are manufacturing capacities and high-quality standards, not the patents," a German government spokeswoman said.
A Middle-Of-The-Road Approach Explored: An alternative now being discussed is private companies entering into licensing agreements with nations to share some, but not all, of the knowledge and designs needed to produce vaccines in the developing world.
How far this approach would help the broadening of vaccine availability is in question.
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