Making Vaccines During A Public Health Emergency
Obviously, during a public health emergency, we cannot wait for 10 to 20 years, so how does the process change?
First, in an emergency, it is likely that more resources will be put toward the project, so more scientists are able to work on developing a vaccine. For example, more than 70 companies are working on a COVID-19 vaccine, whereas under normal circumstances, fewer than five and, often only one or two companies are working on developing any particular vaccine. This means that all of those working on vaccine development can benefit from the findings of their competitors. This builds the knowledge base more quickly.
Second, researchers are able to work together with fewer barriers. For example, in the current COVID-19 pandemic, the World Health Organization is overseeing an international randomized controlled trial in which candidate vaccines can be compared with a single placebo, or control, group. The plan is also written in a way that candidate vaccines can start being tested at different times, and data can be compared. In this way, the trial can help increase scientific rigor and efficient use of resources.
Third, normal processes are likely to be altered as well. This can include eliminating animal model studies, reducing the number of study participants at each phase, and shortening the timeline for monitoring results.
The Steps That Produced The Most Rapid Vaccine Rollout In History
Vaccine development is typically measured in years, not months. But as the COVID-19 pandemic rages on, scientists are racing the clockand breaking recordsto develop an immunization that provides protection against the virus.
The nations scientific community also faces another obstacle: convincing the public that the COVID-19 vaccine is safe, and how important it is to get a COVID-19 vaccination in the first place.
Even the most effective vaccine cant protect us or our loved ones if people are afraid to take it or will not take it, said Kathleen Mullane, director of infectious disease clinical trials at University of Chicago Medicine. We know things are moving faster than ever, but the nations scientific community has cooperated and collaborated in ways as never before and we are absolutely committed to making sure whatever is ultimately approved works and is safe. I am going to get vaccinated and am recommending vaccination for my family and friends because I believe in the safety and efficacy of these agents.
How Does Immunity From A Vaccine Compare To Immunity From Infection
Vaccine-induced immunity and natural immunity both provide protection against getting the infection in the future. Which one provides better immunity can depend on the type of infection it is.
We are still learning about COVID-19 and immunity, but a recent study showed that vaccine-induced immunity was better than natural immunity in protecting against COVID-19. Getting the vaccine also allowed the immune system to recognize other coronavirus strains, which could provide protection against new variants that develop.
An important advantage of any vaccine-induced immunity is that you can get immunity without actually getting sick. For COVID-19, this is especially important because even if you recover from it, many people continue to have debilitating symptoms for months.
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How Is Safety Assured When Vaccine Development Is So Fast
Safety is the first and foremost goal for a vaccine.
In my opinion, safety is not compromised by the speed of vaccine development and emergency use authorization. The reason that vaccines may be approved so quickly is that the large clinical trials to assess vaccine efficacy and safety are happening at the same time as the large-scale manufacturing preparation, funded by the federal governments Operation Warp Speed program.
Typically, large-scale manufacturing begins only once the vaccine has been tested in clinical trials. In the case of COVID-19, the U.S. government wanted to be ready to begin distributing the vaccine the moment the results of the phase 3 trials were known and the safety data had been analyzed.
To this end, the pharmaceutical companies launched at-risk manufacturing which means that the manufactured vaccine doses would be thrown away if the vaccine was ineffective or unsafe during the FDA-mandated two-month safety waiting period.
The upside is that if the vaccine is safe and effective, it can be distributed immediately, and vaccination can begin.
Birth Of A Vaccine: Chesterfield Missouri
Pfizer-BioNTech’s American vaccine is born in Chesterfield, not far from St. Louis, where the raw ingredients begin the process of becoming a vaccine.
It starts with circular snippets of DNA called plasmids. These carry the genetic material that codes for the notorious spike protein on the surface of SARS-CoV-2, the virus that causes COVID-19. The virus uses the spike to hook onto cells so it can infiltrate them and reproduce.
The DNA is made in large vats, said Christine Smith, vice president of Pfizer’s division of BioTherapeutics Pharmaceutical Sciences Medicinal Sciences. These hold hundreds of gallons of an amber-colored solution containing specially designed E. coli bacteria.
Using a process called biosynthesis, these bacteria churn out trillions of the DNA plasmids over the course of two weeks.
When completed, the solution goes through a purification process akin to straining spaghetti through a colander that removes everything but the microscopic loops of DNA.
Next, the loops are straightened out, or “linearized,” using enzymes to cut the circles. The lines of DNA in the now-clear solution are then packed into special high-tech bags about the size of a grocery bag and frozen to minus 112 F for storage.
Pfizer must vet the bag producer and check every lot that comes in, so it can verify they meet federal manufacturing guidelines. The bags cant fail, because each contains the building blocks of the COVID-19 vaccine.
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Add Fat Fill And Finish: Kalamazoo Michigan
This is where the frozen mRNA is turned into a vaccine and vials are filled for distribution.
The process happens in Building 41 at Pfizers enormous Kalamazoo plant.
The COVID-19 vaccine uses most of the 1 million-square-foot building as it goes from start to finish. Three shifts of 30 to 40 people work 24 hours a day, seven days a week. The lines are continuously staffed and didn’t stop for the holidays.
Just to get into the formulation portion of the plant, workers must first change into scrubs, then enter the facility and completely strip, donning an aseptic gown and finally gear that resembles spacesuits.
Very few people go in there. Theyre all monitored environmentally because were controlling those conditions very stringently, said Calitri, vice president of Operations for Sterile Injectables for the United States and the European Union.
This is all to protect the purity of the vaccine. Any impurity would render the whole batch worthless, setting back the company and leaving millions of people waiting for promised shots.
Duringthe encapsulation process, the fragile strands of mRNAare enclosed in tiny balls of fat known as lipid nanoparticles. This makes them stable enough to travel from the syringe into the bloodstream and then into cells before they dissolve.
Without the balls of fat, the vaccine woulddisintegrate before it could deliver its payload. It’s a bit like enclosing M& Ms in candy coating so they melt in your mouth, not in your hands.
What Does This Mean For Me And My Family
While people are anxious to resume regular activities, it is important that any vaccine against COVID-19 is safe and effective. Therefore, it is important to monitor what is happening with vaccine development, but it will be even more important for public health officials to clearly communicate what is known about any new COVID-19 vaccine in terms of how well it works and its possible side effects.
Likewise, other factors will also be important at that time. People will need to evaluate whether the disease is spreading in their area, whether they have immunity as a result of previous illness, what is known about how long immunity lasts, and whether a certain level of immunity is needed for protection.
With all of this information, public health officials will likely make vaccine recommendations, and families, in consultation with their healthcare providers, will need to decide the relative risks and benefits of being vaccinated.
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Next Steps: Clinical Studies With Human Subjects
Phase I Vaccine Trials
This first attempt to assess the candidate vaccine in humans involves a small group of adults, usually between 20-80 subjects. If the vaccine is intended for children, researchers will first test adults, and then gradually step down the age of the test subjects until they reach their target. Phase I trials may be non-blinded .
The goals of Phase 1 testing are to assess the safety of the candidate vaccine and to determine the type and extent of immune response that the vaccine provokes. In a small minority of Phase 1 vaccine trials, researchers may use the challenge model, attempting to infect participants with the pathogen after the experimental group has been vaccinated. The participants in these studies are carefully monitored and conditions are carefully controlled. In some cases, an attenuated, or modified, version of the pathogen is used for the challenge.
A promising Phase 1 trial will progress to the next stage.
Phase II Vaccine Trials
A larger group of several hundred individuals participates in Phase II testing. Some of the individuals may belong to groups at risk of acquiring the disease. These trials are randomized and well controlled, and include a placebo group.
The goals of Phase II testing are to study the candidate vaccines safety, immunogenicity, proposed doses, schedule of immunizations, and method of delivery.
Phase III Vaccine Trials
Phase Ii Clinical Trials To Assess Safety And Immune Responses
Phase II clinical trials continue to assess safety and immune responses but in a larger number and more diverse group of volunteers, typically one to several hundred people. Phase II trials may include target populations of a specific age or sex, or those with underlying medical conditions. Vaccines for children start with adult volunteers and move to progressively younger groups of children. Different types of immune responses are often measured, including antibodies and cell-mediated immunity, but phase II trials do not assess how well a vaccine actually works. Only in phase III trials is vaccine efficacy assessed.
Phase 2 trials can be completed in three to four months, allowing for longer follow-up to better assess safety and immunogenicity. This timeline is shortened when phase 1 and phase 2 trials are combined.
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Vaccine Product Approval Process
The U.S. Food and Drug Administrations Center for Biologics Evaluation and Researchexternal icon is responsible for regulating vaccines in the United States.
The sponsor of a new vaccine product follows a multi-step approval process, which typically includes
- An Investigational New Drug application
- Pre-licensure vaccine clinical trials
- Presentation of findings to FDAs Vaccines and Related Biological Products Advisory Committeeexternal icon
- Usability testing of product labeling
After approving a vaccine, FDA continues to oversee its production to ensure continuing safety. Monitoring of the vaccine and of production activities, including periodic facility inspections, must continue as long as the manufacturer holds a license for the vaccine product.
FDA can require a manufacturer submit the results of their own tests for potency, safety, and purity for each vaccine lot. FDA can require each manufacturer submit samples of each vaccine lot for testing.
To learn about FDAs role in the vaccine approval process, consult FDAs Vaccine Product Approval Processexternal icon web page.
Its A Tortuous Path With Regulatory Hurdles At Multiple Points Along The Way
Life cannot return to normal as long as the novel coronavirus circulates among us, and experts agree that a vaccine would be the best way to remove that threat.
So what takes so long?
President Trumps plan, announced Friday, to make hundreds of millions of vaccine doses available by the end of the year moves the timeline far earlier than scientists previous, most optimistic predictions. Most said a coronavirus vaccine wont be on the market for a year or two.
Thats because vaccine development normally follows a tortuous path intended to make sure the drug works and wont cause harm. The process wends from identifying a vaccine candidate, to testing it in the laboratory and in people, and then to manufacturing it, with regulatory hurdles at multiple points along the way. With the coronavirus, drug makers, researchers, and public-private partnerships are racing down that path as fast as they can.
Historically, vaccine development for a new virus not previously seen by the human species would take decades, said Dr. Dan Barouch, head of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, who is working on a coronavirus vaccine with Johnson & Johnson.
But humanity cannot wait decades now. The urgent demand for a COVID-19 vaccine is probably greater than the demand for any other vaccine in human history, he said. For COVID-19, there is extreme pressure to go as fast as possible.
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Vaccines For Adolescents: A New Generation Of Vaccines
Adolescents, like adults, were recommended to get tetanus boosters every 10 years most requiring their first booster dose around age 11. Other than this, however, most adolescents did not require additional vaccines unless they missed one in childhood. By 2005, vaccines specifically recommended for adolescents were only recommended for sub-groups based on where they lived or medical conditions that they had. However, a new group of vaccines became available in the latter part of the decade.
- New vaccines: Tdap, 2005, meningococcal conjugate , HPV , meningococcal serogroup B vaccine
- Additional recommendations for existing vaccines: HPV , intranasal influenza vaccine
- New versions of existing vaccines: HPV
- Discontinuation of vaccine: intranasal influenza vaccine
Do I Still Need To Take Precautions If Im Vaccinated
Yes, youll still need to take precautions but not as many as before. Remember, not everyone has been vaccinated and COVID-19 is still spreading in some areas.
If you are fully vaccinated meaning its been at least 2 weeks since your last COVID-19 dose you can now participate in some activities that you did prior to the pandemic.
The Centers for Disease Control and Prevention periodically updates their guidelines on what fully vaccinated people can do. For example:
If you are around other fully vaccinated people, you dont need to wear a mask or socially distance in small indoor or outdoor gatherings .
If you travel in the U.S., you dont need to get tested before or after travel.
You can eat at an indoor restaurant or bar.
You should still wear a mask when traveling on public transportation and watch out for COVID-19 symptoms if youve been around someone who is sick.
Vaccines work well but are not 100% effective, and people who have been vaccinated can still get sick. Fortunately, these COVID-19 breakthrough cases are very rare and the vaccine helps prevent more serious illness.
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Unlocking the coronavirus secrets
To back up a bit first, designing the vaccines began far earlier than the jabs-in-arms stage. It began with of SARS-CoV-2, the virus that causes COVID-19 . By early January 2020, that genetic blueprint was in hand and the first vaccines to test were ready just a few weeks later.
For some perspective, researchers first deciphered, or sequenced, the entire human genome over a span of almost 13 years, starting in 1990 and wrapping up in 2003 . Because of advances in computers, the same task now can take only hours.
Most crucially, researchers now had the genetic instructions for making the spike proteins that the virus uses to break into cells a key ingredient for making the vaccines. Jutting out from the virus surface, these spike proteins make an easy target for the immune system to recognize. Researchers knew to zero in on those proteins thanks to decades of work studying coronaviruses, including two that have caused other outbreaks of human diseases SARS and MERS. That work also identified the best form of the protein to use: a stable form just before the virus fuses with a cell its about to infect.
Finding a delivery system
See all our coverage of the coronavirus outbreak
Benefiting from past research
Getting fast results
Jumping the line
Phase Iii Clinical Trials To Assess Safety And Efficacy
Phase III clinical trials are critical to understanding whether vaccines are safe and effective. Phase III trials often include tens of thousands of volunteers. Participants are chosen at random to receive the vaccine or a placebo. In Phase III, participants and most of the study investigators do not know who has received the vaccine and who received the placebo. Participants are then followed to see how many in each group get the disease. Assessing short- and long-term safety is also a major goal of phase 3 trials.
Phase 3 trials may take six to nine months to allow early assessment of safety and efficacy, particularly if conducted in areas with a high risk of infection, but with follow-up continuing for two years or more to assess long-term safety and efficacy.
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Getting Back To Normal
Next comes the challenge of manufacturing and distributing a vaccine. The full rollout may take months to get enough batches for the general public in the interim, authorities will prioritize distribution to those most at risk of contracting COVID-19 or those who are at highest risk of suffering the most severe effects of the illness, such as health care workers, older adults, adults with pre-existing conditions and essential workers.
As a new vaccine is distributed, the clinical trials will go on and data will continue to flow in about its long-term effectiveness and any potential safety issues. This will allow researchers and healthcare providers to adapt distribution as necessary.
Realistically, the general public likely wont have access to a vaccine until sometime this summer. Thats far later than Operation Warp Speeds initial goal of having 300 million doses available by January, but significantly faster than any other vaccine development effort to date.
Individuals who are interested in participating in the ongoing COVID-19 vaccine trialsincluding potential new vaccine candidates in future trialsmay sign up for the UChicago Medicine COVID-19 Vaccine Registry at covidvaccinestudies.uchicago.edu.