“How soon will a COVID-19 vaccine come out?” That’s one of the top questions I’ve been asked over the last several months. It’s usually followed with “Is it being rushed?” Unfortunately, the answer to the first question is still unclear. However, there are real, evidence-based reasons why and how scientists are achieving the seemingly-impossible: developing a vaccine against COVID-19 within months of the first identified cases. This post will discuss those reasons and whether the vaccine is being rushed.
You may have heard that it takes 10 or more years to develop a new vaccine. That’s true in most cases, but scientists have several advantages right now that are helping them to develop COVID-19 vaccines on a much faster timeline.
- They aren’t starting from scratch. You may have heard people say that COVID-19 is related to the common cold, we’ve never been able to develop a vaccine against the common cold, and therefore it shouldn’t be possible to develop a vaccine against COVID-19 either. That’s true and it’s not true. The common coronavirus is one of several viruses that can cause the common cold. While SARS-CoV-2, the virus that causes COVID-19, is related to the common coronavirus, it is a novel (new and different) form of coronavirus that causes much more severe illness than the common cold.
In fact, vaccine researchers had previously developed potential vaccines against two other novel coronaviruses: SARS-CoV-1, which caused the 2003 SARS outbreak, and MERS-CoV, which caused an outbreak of Middle East Respiratory Syndrome in Saudi Arabia in 2012. SARS-CoV-2 is much more similar to SARS-CoV-1 and MERS-CoV than it is to common coronaviruses. Therefore, the years of basic research and development usually needed for a new vaccine or drug had already been done by the time the COVID-19 pandemic began, and researchers only needed to modify the SARS-CoV-1 and MERS-CoV vaccines to work against COVID-19. That gave them a several-year head start compared to researchers developing a vaccine against a brand new disease.
- More COVID-19 cases means more opportunities to test COVID-19 vaccines. Scientists measure vaccine effectiveness by comparing the risk of infection in people who got a vaccine vs. people who did not get the vaccine. However, if no one or very few people in the unvaccinated group get the infection, then it will be very difficult or even impossible to measure the vaccine’s effectiveness, as you can see in the vaccine effectiveness equation below.
When researchers develop a vaccine against a rare disease, then they usually need vaccine studies lasting many years before they have enough data to measure whether the vaccine is effective. However, right now COVID-19 is not a rare disease. While the rising number of COVID-19 cases is bad on the whole, it means that it will probably take much less time than usual for researchers to measure COVID-19 vaccine effectiveness.
- Money. Applying for grants and completing grant reports are some of the biggest parts of the research process. Research and development is expensive, and so are large studies like the ones being run for COVID-19 vaccines. Unfortunately, a lot of very promising vaccines and medicines never get enough money to complete basic research and clinical studies. That’s also why a lot of vaccines and medicines come from large pharmaceutical companies – because they have the money to sponsor research that independent scientists don’t have.
Operation Warp Speed has taken away much of the need to apply for funding – and the time associated with finding and reporting on grants – by awarding billions of dollars for eight COVID-19 vaccine candidates. The companies that were awarded these funds can act a lot faster now that they have the money to support their research and vaccine studies.
- Up-front investment in manufacturing. Operation Warp Speed isn’t only funding vaccine research and clinical studies; it’s also investing in factories and companies to make large amounts of vaccines and other supplies needed for vaccines. Critically, they started the work of ramping up manufacturing before any of the vaccines had finished their clinical studies.
Under ordinary circumstances, vaccine manufacturers wouldn’t start building factories and making large amounts of a vaccine or medicine until after it had been approved by the Food and Drug Administration (FDA). It would be too much of a gamble to spend a lot of money before they even know whether it works. In this case, Operation Warp Speed is the one taking the gamble with their money. If one or more of the vaccines is approved, then the companies will be able to begin making it much more quickly than usual because they started manufacturing early.
I want to be clear on this point: Operation Warp Speed is absolutely taking a risk. A financial risk. They have spent a huge amount of taxpayer dollars in the hopes that one or more COVID-19 vaccine will be safe and effective, approved and recommended, and manufactured and available to the public quickly. However, they aren’t taking risks with vaccine safety.
- Combined studies. Finally, several of the COVID-19 vaccines are combining several steps of clinical studies. Typically, there are 3 phases of clinical studies, conveniently called Phase 1, Phase 2 and Phase 3. Right now, some vaccines are doing combined Phase 1/2 clinical studies followed by a separate Phase 3 clinical study and others are doing Phase 1 clinical studies followed by combined Phase 2/3 clinical studies.
Essentially, they are doing two studies simultaneously or back-to-back. They aren’t cutting corners or skipping parts of the process. In fact, the FDA issued guidance to COVID-19 vaccine manufacturers in June 2020 that stated that research into the safety of COVID-19 vaccines “should be no different than for other preventive vaccines for infectious diseases“. The FDA followed this up with additional guidance in October 2020 requiring that COVID-19 vaccine studies follow up with participants for at least two months after the last dose of vaccine in order to collect enough data on safety and effectiveness.
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) also met on October 22, 2020 and in my opinion they addressed vaccine approval and emergency authorization very thoughtfully. Of note, VRBPAC members widely agreed that if an Emergency Use Authorization is issued for a COVID-19 vaccine before full approval, then the vaccine must meet the full safety and effectiveness criteria needed for approval.
TL;DR: Are COVID-19 vaccines being rushed? As recently as a month ago, there was a lot of debate and uncertainty about this in the medical and public health community. However, the FDA’s October 2020 guidance and the discussions at the October 22, 2020 VRBPAC meeting gave me confidence that the most important parts of vaccine development – ensuring a safe and effective vaccine – will not be rushed.