COVID-19 vaccines were not developed hastily

Disease and treatment 5. jun 2022 2 min Professor of Medicine Aaron S. Kesselheim Written by Kristian Sjøgren

When the COVID-19 pandemic struck, the vaccines soon followed. Many people were therefore concerned that the technologies might have been approved too rapidly. New research shows, however, that developing and patenting the COVID-19 vaccines took about the same time as other vaccines.

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When you say COVID-19, you say vaccine.

Nevertheless, many people have been hesitant because they have felt that the COVID-19 vaccine technologies – especially the new messenger RNA (mRNA) technologies – transitioned too quickly from the laboratory to market authorisation.

New research, however, does not confirm this assumption.

Most of the technologies behind the new vaccines were already developed and patented more than a decade ago, which is similar to the time needed to develop new vaccines in the past.

“Our review of the patents on which the new vaccines were developed shows that the original patents date back more than 10 years. The vaccines and technology are therefore not new and untested, as many have otherwise been concerned about. Scientists had been working on the technology for a very long time and then exploited it when the new virus struck,” explains a researcher behind the study, Aaron S. Kesselheim, Professor of Medicine, Harvard Medical School and Brigham and Women’s Hospital, Boston, United States.

The research has been published in Clinical Infectious Diseases.

The vaccines were not designed from scratch

The starting-point for the study was the time in 2021 when the new mRNA vaccines from BioNTech/Pfizer and Moderna came on the market.

The vaccines were mass-produced so that as many people as possible could be protected from severe COVID-19.

At that time, Aaron S. Kesselheim was already collaborating with the Centre for Advanced Studies in Biomedical Innovation and Law (CeBIL) at the University of Copenhagen on the interface between innovation and infectious diseases. Aaron S. Kesselheim and colleagues therefore threw themselves into the question of whether the new vaccines emerged from idea to market authorisation more rapidly than other previous vaccines.

The researchers reviewed all the patent filings on which the development of the vaccines was based.

Some cover the mRNA technology, which is used to make the mRNA fragments on which the vaccine is based. Others relate to DNA fragments.

A third group covers the encapsulation of the mRNA in lipid nanoparticles to create a strong immune response.

The researchers found that the vast majority of the patents had many years behind them. On average, the patent filing occurred 10.0 years before regulatory authorisation, and this is similar to previous vaccine development.

“The same thing applies to vaccine patents that are less controversial, such as vaccines for preventing pneumonia or shingles. One could say that SARS-CoV-2 was new, but the technology to defeat it was not new. These were not vaccines that were designed from scratch and then launched on the market, as many might think,” says Aaron S. Kesselheim.

Busting the myth surrounding new vaccines

The researchers also examined the historical context of the development of the mRNA vaccines. They looked at the time elapsed between filing a patent and the commercial authorisation of vaccines since 1980, when the Prevnar® vaccine to prevent infection with Streptococcus pneumoniae was first developed.

This part of the research shows that, over the decades, the development timelines for innovative vaccines from patent filing to commercial authorisation have been shortening.

For example, Prevnar® took about 20 years to arrive on the market. The human papillomavirus vaccine Gardasil® took about 15 years from when the first patents were filed in the early 1990s. The Shingrix® vaccine against shingles took about 12 years to navigate the approval process from 2005 onwards.

According to Aaron S. Kesselheim, the whole process is becoming more and more efficient. In addition, the new mRNA vaccines comfortably fit within a development pattern that has been going on for decades.

“The fact that the vaccines have been under development for much longer than some might think is interesting but not entirely surprising. This knowledge may help to bust some of the existing myths that COVID-19 vaccines have been developed more rapidly than other vaccines and are therefore less safe, which is not true,” concludes Aaron S. Kesselheim.

Premarket development times for innovative vaccines – to what extent are the coronavirus disease 2019 (COVID-19) vaccines outliers?” has been published in Clinical Infectious Diseases. Aaron S. Kesselheim’s research has been funded by Arnold Ventures and a grant from the Collaborative Research Program in Biomedical Innovation Law at the University of Copenhagen, which is funded by a grant from the Novo Nordisk Foundation.

Aaron S. Kesselheim MD JD MPH is a Professor of Medicine at Harvard Medical School and a faculty member in the Division of Pharmacoepidemiology and Ph...

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