Open source covid vaccine: a new hope

The swift development of effective vaccines against COVID-19 was an unprecedented scientific achievement. But production challenges, vaccine nationalism, and variants such as Omicron are the hurdles. The global efforts to develop and distribute an effective vaccine produced several safe and effective options. The accelerated development of multiple vaccines is unprecedented; the process typically takes eight to fifteen years.

However, the immunization of a critical mass of the world’s population, continues to confront challenges, including dangerous new strains of the virus, such as omicron; global competition over a limited supply of doses; and public hesitation about the vaccines.

Global vaccinations status

More than twenty vaccines have been approved for general or emergency use in countries including China, Russia, the United Kingdom, and the United States. As of late 2021, close to nine billion doses had been administered worldwide. Several countries, e.g. Portugal, Singapore, UAE etc. have made significant progress in immunizing their citizens.

The uneven rollout of vaccines was felt sharply in places such as India, where the spread of the delta variant and relaxed restrictions led to a devastating surge in mid-2021 that impeded vaccine shipments elsewhere. The country eventually ramped up its vaccination campaign, immunizing more than five hundred million people by the end of the year. Meanwhile, WHO has warned that the lack of access to vaccines in Africa, where less than 10% of the population has been fully vaccinated, will prolong the pandemic.

How it works?

Traditionally, vaccines are dead or weakened virus molecules, commonly known as “antigens”. They trigger defensive white blood cells in the immune system to create antibodies that bind to the virus and neutralize it. Sinopharm’s COVID-19 vaccine, which contains inactivated coronaviruses, is one example.

There are also several types of vaccines that use the virus’s genetic material — DNA or RNA — to prompt the body to create antibodies. The vaccines Pfizer and BioNTech from Germany Moderna are genetic-based. No vaccine of this kind had ever been approved for commercial use in humans before the COVID-19 pandemic. Additionally, some COVID-19 vaccines rely on viral vectors, or modified versions of a different virus, to prompt an immune response. Several approved COVID-19 vaccines use viral vectors, for example University of Oxford and British-Swedish company AstraZeneca.

When most of a population has been vaccinated and is immune to a particular disease, even those who are not immune are considered protected because the likelihood of an outbreak is small.

Vaccine development process

Vaccines are frequently collaborative efforts across sectors of society, with private pharmaceutical firms teaming up with public health agencies or university labs. There are many stages involved in the development and production of a vaccine, from initial academic research to distribution to hospitals. Clinical trials are crucial indicators of whether a vaccine is effective. Potential vaccines, as with other drugs, are commonly tested in animals first. Human trials are broken up into three phases, progressively increasing the number of volunteers. If a vaccine candidate appears to be ineffective, has harmful side effects, or is too similar to existing vaccines, they stop. If a vaccine candidate is considered successful in human trials, the developers can seek approval by a national or regional regulatory agency, such as the FDA.

How to accelerate the process?

In normal conditions, the stages of vaccine development occur sequentially. A vaccine takes eight to fifteen years on average to get from the lab to hospitals. The fastest a vaccine had ever been developed before this pandemic was four years. Following the emergence of COVID-19, however, researchers around the globe accelerated the process by carrying out stages of development simultaneously and by looking to new vaccine technologies.

  • 1st Generation Coronavirus Vaccine (SARS and MERS vaccines)

In 2011, CVD embarked on efforts to develop vaccines against coronaviruses, becoming one of the first major groups to recognize the potential pandemic threat of coronaviruses.  That coronavirus vaccine development program was initiated with support from the NIAID/NIH and in partnership with the New York Blood Center (NYBC), the University of Texas Medical Branch at Galveston (UTMB), Walter Reed Army Institute of Research (WRAIR) and Immune Design, a therapeutic vaccine product development company, to develop two recombinant subunit vaccines to protect against the coronaviruses that caused SARS and MERS outbreaks.

  • 2nd Generation Coronavirus (COVID-19) Vaccine

The strategy to combat this global public health crisis was to develop a safe, effective and low-cost vaccine against COVID-19 using recombinant protein-based vaccines, a previously well-established and proven technology that is used in many countries worldwide to produce other vaccines. This approach leveraged the extensive knowledge about the biology of coronaviruses that was acquired in the past decade during the development of vaccines against SARS and MERS. The COVID-19 vaccine was developed in a record timeframe of only 18 months.

  •       Universal Coronavirus Vaccines

In parallel to the development of the COVID-19 vaccine, the researchers are working to accelerate the development of a universal coronavirus vaccine. COVID-19 represents the third major coronavirus pandemic of the 21st century, beginning with SARS in 2003 and MERS in 2012.  The coronavirus vaccine program was launched at Texas Children’s CVD in 2012 following the emergence of MERS as the second major coronavirus causing serious illness and death. It is a known fact now that the COVID-19 will not be the last major coronavirus, we have to accelerate new coronavirus vaccines for each emerging new virus, an ideal situation would be to create a single vaccine that might simultaneously protect against multiple coronaviruses and we are actively involved in building such a vaccine.

CORBEVAX – the game changer

The story of CORBEVAX started almost twenty years ago. Dr. Peter Hotez and Dr. Maria Elena Bottazzi were medical researchers at George Washington University in Washington, D.C., where they worked on vaccines and treatments for what are called neglected tropical diseases, such as schistosomiasis and hookworm.

When a strain of coronavirus known as SARS broke out in 2003, they decided to tackle that disease. After moving to Houston to affiliate with Baylor College of Medicine and the Texas Children’s Center for Vaccine Development, they created a vaccine candidate using protein subunit technology. This involves using proteins from a virus or bacterium that can induce an immune response but not cause disease.

It uses old but proven vaccine technology and can be manufactured far more easily than most of the COVID-19 vaccines in use today. This going to be a game changer. It will enable countries around the world, particularly low-income countries, to be able to produce these vaccines and distribute them in a way that’s going to affordable, effective and safe. When a new strain of coronavirus triggered the COVID-19 pandemic, Dr. Hotez and Dr. Bottazzi figured they could dust off their old technology and modify it for use against COVID-19. After all, the virus causing COVID-19 and the virus causing SARS are quite similar.

The objective was to develop a low-cost, durable, easy-breezy vaccine that can vaccinate the whole world. In the beginning the US Government were not giving any heed to this as they were more focused on innovation. Dr. Bottazzi turned to private philanthropies. A major donor early on was the JPB Foundation in New York along with Texas philanthropies: the Kleberg Foundation, the Dunn Foundation, Tito’s Vodka, Anderson Foundation etc. Unlike the mRNA vaccines from Pfizer and Moderna, and the viral vector vaccine from Johnson & Johnson, protein sub-unit vaccines like CORBEVAX have a track record. And surprisingly the cost is one dollar and fifty per dose only.

Clinical trials showed they were right to be confident CORBEVAX would work. An unpublished study conducted in India involving 3,000 volunteers found the vaccine to be 90% effective in preventing disease cause by the original COVID-19 virus strain and 80% against the delta variant. It’s now being still being tested against omicron.

But CORBEVAX is already entering the real world. Last month, the vaccine received emergency use authorization from regulators in India. The Indian government granted emergency approval to a vaccine manufactured by the Hyderabad-based company Biological E.

Biological E. has said it has completed two Phase 3 clinical trials involving more than 3,000 people across India, with one finding that Corbevax is more than 80 percent effective against symptomatic disease, but the company has not publicly released the underlying data.

The company announced that it is producing 100 million doses per month and has already sold 300 million doses to the Indian government. Biological E. has ambitious plans to produce more than 1 billion doses of the vaccine in 2022. Hotez and Bottazzi won’t personally get a penny from it, but their employer Baylor College will get a fee.

Importantly Drs. Hotez and Bottazzi has made their intellectual property rights of this vaccine available to everybody. Now anybody across the globe can manufacture it. Whereas the makers of Pfizer and Moderna, for example, are not sharing their recipe.

One drawback to the CORBEVAX technology is that it can’t be modified as quickly as mRNA vaccines can to adjust to new variants.

Something which can be adapted the fastest versus something that can be adapted relatively quickly, but then more importantly can be manufactured at a large global capacity and at a cost of production which is much lower.

If everything goes according to plan, manufacturers all around the world could produce their own versions of the Texas Children’s Hospital vaccine, which uses older recombinant protein technology that many manufacturers already have experience with, rather than newer and potentially more complicated technology. Some advocates hope it could be a model for how vaccines should be developed and shared globally during a pandemic.

Drs. Hotez and Bottazzi hope that India is just a start. There are advanced talks to manufacture versions of the Texas Children’s Hospital vaccine in Indonesia, Bangladesh and Botswana. And while other vaccine developers have fiercely guarded their intellectual property during the pandemic, Hotez and Bottazzi are in talks to share the license for the vaccine with the WHO’s covid-19 technology access pool.

Simple calculation explained the need for more inexpensive vaccine doses. In terms of unvaccinated people as we have a billion people in sub-Saharan Africa, almost a billion in Latin America and the Caribbean, another billion in the smaller, low-income countries of Southeast Asia. This means we are going to need 6 to 9 billion doses of vaccine.

Is Pakistan going to take the advantage by boarding the bus or we are going to lose it, as usual?

The author, Nazir Ahmed Shaikh, is a freelance columnist. He is an academician by profession and writes articles on diversified topics. Mr. Shaikh could be reached at [email protected]

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