Several pharmaceutical companies in the United States and abroad have developed a COVID-19 vaccine. Each has a very high efficacy rate (around 90-97 percent). The United Kingdom has already begun vaccinating its most vulnerable citizens. Vaccines are expected to be available in the United States soon.
While the vaccines that have been developed so far have been successful during trials, it is the willingness of the American public to actually get the vaccine that will determine if these vaccines are effective in reducing COVID-19 infections, hospitalizations, and deaths. Sadly, the vaccination rate in the United States for other vaccine-preventable diseases is already low.
According to the Centers for Disease Control and Prevention, only 45.3 percent of American adults received their flu shots in the 2018-2019 flu season, which is significantly below the public health target rate of 70 percent. A higher rate of vaccinations is desirable because the higher the rate, the more protection is offered to those who cannot (for health reasons), receive the vaccine.
This is what’s called “herd immunity”, which happens when a significant number of people are vaccinated leaving a disease unable to find a host and spread throughout the population. Yet, suspicions about a vaccine’s safety, or the process by which it came into use, could lead to significant resistance to getting the vaccine.
It is happening already. Some in the public square have suggested the vaccine’s development, and its eventual approval, was rushed and therefore the American public is taking a grave risk by getting the COVID-19 vaccine. According to a recent Gallup poll, only 58 percent say they are now willing to get a COVID-19 vaccine.
A recent Pew Poll found that 60 percent of respondents said that they would get the vaccine. Pew also found that a whopping 77 percent of Americans think it is very or somewhat likely that a COVID-19 vaccine will be approved before its safety and effectiveness are fully understood. 78 percent said that they think the vaccine was developed “too fast.”
So, is this true? In developing a COVID-19 vaccine, were pharmaceutical companies allowed to “skip steps” on safety in order to have the vaccine ready quickly?
-Presidential Nominee Joe Biden, talking about the COVID-19 vaccine approval process
False. Completely make believe.
While it’s certainly true that the COVID-19 vaccine was produced with unprecedented speed, its rapid development was due to many factors that do not affect the vaccine’s safety.
No Skipping Steps
Some worry that steps to ensure a safe vaccine were skipped or that certain regulatory measures were circumvented.
Steps were not skipped in the development of the COVID-19 vaccine but many of the steps were completed concurrently with other steps instead of being done sequentially. According to the Department of Health and Human Services (emphasis added), “Protocols for the demonstration of safety and efficacy are being aligned, which will allow the trials to proceed more quickly, and the protocols for the trials will be overseen by the federal government, as opposed to traditional public-private partnerships, in which pharmaceutical companies decide on their own protocols. Rather than eliminating steps from traditional development timelines, steps will proceed simultaneously, such as starting manufacturing of the vaccine at industrial scale well before the demonstration of vaccine efficacy and safety as happens normally. This increases the financial risk, but not the product risk.”
One way to think of this is to imagine two different kinds of races on a track. The typical vaccine protocol is a relay race with stacked runners each waiting to have the baton passed to them before running the race. Now imagine the a-typical COVID-19 vaccine process, which is more like a 50-yard sprint with several runners each running the race at the same time in their own lane. All of the runners—both relay racers and sprinters–complete the race on the same track. They just complete the distance in a slightly different way.
Operation Warp Speed Gives Companies Legal Protections and Financial Help
Another reason the process went so quickly is because in the spring of 2020, the Trump Administration launched Operation Warp Speed to provide funding, support, and certain legal protections to pharmaceutical companies interested in developing a COVID-19 vaccine. This public-private partnership allowed companies to align protocol steps and reduced delays related to funding shortfalls. Starting in the Spring of 2020, the Department of Health and Human Services awarded billions of dollars to pharmaceutical companies developing COVID-19 vaccines.
Human Trials Have Been Conducted
Some have also suggested that trials on humans have not been conducted. That too is false. Hundreds of thousands of individuals have participated in multiple trials. Most vaccine manufacturers are in or have completed their Phase 3 and final trials. For example:
- Johnson & Johnson’s Phase 3 clinical trial began on September 22, 2020 with 60,000 volunteers.
- Moderna’s Phase 3 clinical trial began on October 22, 2020 with 25,000 volunteers.
- Peer reviewed analysis of AstraZeneca’s Phase 3 clinical trial shows no severe coronavirus disease or hospitalizations among the 11,000 participants.
- Novavax’s Phase 3 clinical trials began on October 27 with 15,000 participants.
Other Countries Moving Faster
Some worry that the United States is moving quicker than other countries in developing a COVID-19 vaccine. That too is false. On December 2, 2020, regulators in the United Kingdom approved Pfizer’s COVID-19 vaccine for use on frontline health workers and some vulnerable citizens. China and Russia have also approved vaccines.
Emergency Use Authorization
In the United States, the process for approving a COVID-19 vaccine is still moving forward. Before a vaccine is released for public use, the Food and Drug Administration (FDA) will need to approve it.
In order to expedite this process, the FDA will likely invoke the emergency use authorization process, which is authorized by the Pandemic and All-Hazard Preparedness Reauthorization Act of 2013. According to the FDA, this faster approval process allows “unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions … when there are no adequate, approved, and available alternatives.”
Yet this type of approval doesn’t allow the FDA to ignore safety information nor does it permit pharmaceutical companies to provide incomplete safety information to government agencies and medical panels. Under this process, the FDA still needs to see the final analysis of any phase 3 clinical efficacy trials that have been conducted by pharmaceutical companies and the trial’s data must meet the pre-specified success criteria established prior to the trial being conducted. In other words, the safety criteria can’t be altered to suit the results of the trial.
According to the FDA, when phase 3 of a human clinical trial reaches a predetermined point, an independent panel of medical and scientific processionals reviews the data and informs the manufacturer of the results. Based on this panel’s review, manufacturers decide whether and when to submit an EUA request to FDA, taking into consideration input from FDA and the panel. After the FDA receives an EUA request, FDA scientists and physicians will evaluate all of the information included in the manufacturer’s submission. FDA will then host public meetings of another panel called the Vaccines and Related Biological Products Advisory Committee, at which experts, who are screened for conflicts of interest, review and discuss the safety and effectiveness data. Following that advisory committee meeting, FDA staff will consider all of the input of the advisory committee members as well as the pharmaceutical company’s submitted information to determine whether the available data support an emergency use authorization.
Americans should feel relieved that there are many safety checks along the regulatory route to getting approval for a vaccine and that multiple layers of government, industry, and independent experts are part of the process to ensure that only safe vaccines are provided to the American public.
Politics Does Not Matter!
It is important for Americans to understand that those who develop vaccines aren’t politically motivated. They, as individuals, may have their own political beliefs, but as career scientists and physicians, they know their role is to be experts in infectious diseases and immunology and to assess the vaccines that are being considered for approval. These officials work to ensure vaccine safety no matter who holds political office.