COVID-19 Vaccines FAQs
Patient safety is central to the research and development of every vaccine. Vaccine makers must follow very strict scientific and health authority processes to bring a new vaccine to the public, even during the current pandemic.
With vaccine development moving so quickly, it is understandable why some people are asking whether a vaccine for COVID-19 will be safe and effective (work well).
Like all vaccines, the COVID-19 vaccines go through many stages of approval, including:
- Exploratory "proof of concept" stage.
- Pre-clinical stage (often include animal studies).
- Clinical development (which include human clinical trial phases 1-3).
- Health authority review, authorization or approval.
- Manufacturing and quality control.
Like with all other vaccines and medicines, COVID-19 vaccines are only authorized or approved for use with the general public after:
- Clinical trials thoroughly test them with tens of thousands of people.
- An independent group of experts with health authorities carefully review all the scientific and clinical trial data results and authorize it for use with the general public only if the benefits of the vaccine outweigh the known and possible risks of getting a COVID-19 infection.
Clinical trials also help find serious medical problems (called serious adverse events) that may happen shortly after getting a vaccine. However, rare medical problems, and problems that only become apparent long-term, are likely to be spotted only after large groups of people get the vaccine. This is why researchers and health authorities will continually monitor that use to check that no safety concerns surface and the vaccines continue to work well in different groups of people over time. The health authorities also check for very rare side-effects or side-effects that may become apparent only after long-term use.
Due to the public health emergency, the authorization and manufacturing of COVID-19 vaccines has been quicker than with previous vaccines. There has been a unique level of preparation and collaboration among researchers, vaccine makers, governments, and health authorities, as well as unprecedented funding for the vaccine development and manufacturing. These partnerships accelerated the safe and effective development and authorization of COVID-19 vaccines, without compromising on any of the safety or authorization processes.
Other factors that shortened the development timeline include:
- Vaccine makers carried out clinical trials and making vaccines in parallel instead of doing one after the other. This avoided long wait times between trials. Given the high spread of the virus, it has been easier to recruit clinical trial volunteers and easier to test the efficacy (how well it works to prevent infection) of vaccines.
- Vaccine makers gave health authorities access to the clinical trial results throughout the process (“a rolling review”), rather than waiting until the end, to help them carry out ongoing reviews of results. Even before final authorization, vaccine makers started manufacturing to shorten the time it would take to distribute vaccines.
- Vaccine makers have worked around the clock to update facilities and hire and train more staff to make the huge number of vaccines needed. Suppliers making vials, syringes, and stoppers are working overtime and in close partnership with the vaccine makers.
- Health authorities set up dedicated task forces made up of independent experts and rapid review processes to evaluate high-quality applications from vaccine makers. This allows the shortest possible timeframes while ensuring robust scientific opinions.
- Financial support from governments has, in some cases, allowed the above to happen more quickly than with other vaccines.
Tens of thousands of participants worldwide have volunteered to take part in COVID-19 vaccine clinical trials. Clinical trials are designed to test vaccines in people of all races and genders, different ages, and those with underlying health problems, including those with a higher risk of severe illness from COVID-19. This helps increase the understanding of safety and the efficacy (how well it works) of COVID-19 vaccines across different groups of people in different parts of the world. The more people who can get an authorized or approved vaccine, the more successful we will be in helping to stop the spread of the COVID-19 virus and ending the pandemic.
Vaccine makers support independent expert review of clinical trial data for all COVID-19 vaccines. They are also committed to transparently publishing clinical trial results that supported the approval of the vaccines by health authorities. Many of the vaccine makers have published their clinical trial results online and in peer reviewed medical journals such as The Lancet and The New England Journal of Medicine.
Transparency is one of the most important ways to inform the public about – and build greater confidence in – the process to develop a vaccine for COVID-19. Government agencies, like the FDA, EMA and CDC, have routinely released key information and held open meetings so that public feedback can help inform their decision-making.
Vaccine manufacturers have also taken steps to provide greater transparency within the COVID-19 vaccine development process. For example, it is common to pause a clinical trial if there are any safety questions which emerge, but they are rarely reported publicly. Several companies decided to publicly share any clinical pauses of COVID-19 vaccine clinical trials which occurred. This has helped keep the public informed of any bumps in the road to develop a vaccine and shows the vaccine clinical trial and development process of checks and balances is working appropriately.
Like with any other vaccine, such as the flu vaccine, some people can have a reaction or side effect. In some ways, these mild to moderate reactions are a sign that your immune system is responding to the vaccine. Most reactions happen shortly after getting the vaccine. This is why healthcare workers often ask you to stay in their office after you get a vaccine so that they can watch for immediate reactions to administration of the vaccine.
For the COVID-19 vaccines that are currently being used broadly, clinical trials have shown that side effects are similar to those of other vaccines and include:
- A sore arm where you got the shot.
- Feeling tired.
- A headache.
- Feeling achy.
If you have any of these side effects, they are likely to last no longer than a week. But if they do get worse or you are concerned, call your doctor. More information can be found in patient leaflets.
People are much more likely to get sick from the SARS-CoV-2 virus than from getting the vaccine. Severe side effects are extremely rare and happen in only 1-2 out of every million doses given (your chance of having one is 0.00005%). In comparison, studies show that 1 in 5 people with COVID-19 (20%) have a chance of having severe COVID-19.
Remember, COVID-19 vaccines are only authorized or approved for use with the general public after:
- Clinical trials thoroughly test them with tens of thousands of people
- An independent group of experts with health authorities carefully review all the scientific and clinical trial data results and authorize it for use with the general public only if the benefits of the vaccine outweigh the known and possible risks of getting a COVID-19 infection.
Clinical trials help find serious medical problems (called serious adverse events) that can happen shortly after getting a vaccine. However, rare medical problems, and problems that happen in the long-term, are only likely to be spotted after large groups of people get the vaccine. This is why researchers and health authorities, just like with other vaccines, will continue to closely watch people who have received a COVID-19 vaccine. This allows them to quickly identify any possible long-term side effects. Health authorities and vaccine makers are gathering extra resources to monitor safety and manage risk in the pandemic.
After health authorities authorize a vaccine for use with the public, the same health authorities monitor the vaccine’s safety over time. Like with all other vaccines, they continue to review and assess all COVID-19 vaccines even after they are made available to the public.
To help end the COVID-19 pandemic, millions of people will get vaccines over a short amount of time. Even though severe side effects are extremely rare and happen in only 1-2 out of every million doses given (your chance of having one is 0.00005%), there is the possibility that some people will have a serious reaction.
No, genetic vaccines for COVID-19 do not affect or interact with your DNA in any way. mRNA is not the same as DNA, and it cannot combine or interfere with your DNA to change your genetic code. mRNA vaccines never reach a cell’s nucleus, where your DNA is housed inside the cell.
mRNA COVID-19 vaccines contain a small part of the virus’s genetic code (RNA) to trigger an immune response. While mRNA vaccines are a newer type of vaccine, they have been studied for the past two decades.
COVID-19 mRNA vaccines tell your cells to make a harmless piece of what is called the “spike protein.” The spike protein is found on the surface of the virus that causes COVID-19. Your immune system makes antibodies in response to the spike protein. It also creates a memory for this response, so your body can fight off SARS-CoV-2 in the future. The mRNA is destroyed shortly after being “read” by your cells and does not linger in your body.
No. You cannot get the COVID-19 illness from the COVID-19 vaccine. Just like you will not get measles from a measles vaccine.
When a virus is used to make a vaccine, it will not make you sick. It prompts your immune system to “learn” to recognize the virus and teaches it to build defenses to help protect you from getting the disease in the future.
We need COVID-19 vaccines to help make the world safer for our families and for yours.
People who work within the biopharmaceutical industry have been affected by the global pandemic in many of the same ways that everyone else has. They’ve had to deal with loss, balancing work and homeschooling while also supporting family members, parents and friends in unexpected ways. All the while working to help advance science and bring COVID-19 vaccines into the world.
Hear their stories
