Covid Vaccine Testing And Approval
Many people are astonished by the unprecedented speed of COVID vaccine testing.
The vaccine development process for COVID and any vaccine involves many layers of study, testing and review. According to The College of Physicians of Philadelphia, vaccines usually take an average of 10-15 years to create.
And yet, the COVID vaccines were developed in less than a year.
The vaccines for the novel coronavirus went through the same layers of review and testing as other vaccines. Due to the dire nature of the pandemic, certain barriers to development, related to funding and manufacturing, were removed.
To understand how this is possible, it is important to know how the vaccine development process typically works and how the COVID vaccine was created.
Still deciding about the vaccine or know someone who is? See these 7 reasons to get the vaccine.
New Vaccine Development Technologies
There are many different ways to develop a vaccine, but in the last decade, scientists have made significant advancements in this area.
For example, older vaccines were typically created by using weakened or inactivated viruses. Today, companies can simply read a virus’s genetic code and synthesize it in a lab, significantly shortening development times.
Other recent advances in immunology, genetics and other fields have enhanced scientists’ understanding of how to create an effective vaccine quickly.
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In This Section:
Enhanced Vaccine Certificates With Qr Codes
You can now get an enhanced vaccine certificate with a QR code that businesses and organizations can scan using the Verify Ontario app. The enhanced vaccine certificate is a more secure and convenient way to have your proof of vaccination verified.
You do not need to download an app. You only need the QR code certificate from the provincial vaccine portal.
You can also call the Provincial Vaccine Contact Centre at to have your enhanced vaccine certificate emailed or mailed to you.
You can save the electronic version of your enhanced vaccine certificate with a QR code to your phone or print a paper copy. Businesses must accept both electronic and paper versions.
As of January 4, 2022, the enhanced vaccine certificate with official QR code will be required to access certain businesses and organizations. Vaccine receipts without a QR code will no longer be accepted as valid proof of vaccination.
You will need to continue to show a piece of identification with your name and date of birth along with your proof of vaccination when visiting select businesses and organizations.
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Myth: The Ingredients In Covid
FACT: Nearly all the ingredients in COVID-19 vaccines are also ingredients in many foods fats, sugars, and salts.
Exact vaccine ingredients vary by manufacturer. Pfizer-BioNTech and Moderna COVID-19 vaccines also contain messenger RNA and the Johnson & Johnson/Janssen COVID-19 vaccine contains a harmless version of a virus unrelated to the virus that causes COVID-19. These give instructions to cells in your body to create an immune response. This response helps protect you from getting sick with COVID-19 in the future. After the body produces an immune response, it discards all the vaccine ingredients just as it would discard any information that cells no longer need. This process is a part of normal body functioning.
COVID-19 vaccines do NOT contain ingredients like preservatives, tissues , antibiotics, food proteins, medicines, latex, or metals.
Providing Proof Of Your Result
When you arrive at the border, you must present an accepted negative molecular test result or proof of a previous positive molecular test result taken between 14 and 180 days that includes:
- Traveller name and date of birth
- Name and civic address of the laboratory/clinic/facility that administered the test
- The date on which the test was taken
- The type of test taken
- The test result
Keep proof of your test results with you for the 14-day period that begins on the day you enter Canada.
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What Data Have To Be Provided For Special Populations And Age Groups
Vaccine studies focus on adults, including older adults, as well as people with underlying diseases that put them at particular risk of severe COVID-19 disease. Some studies may also include adolescents from 16 years of age.
People above 65 years of age should represent at least a quarter of the total number of participants in studies. This group is at greatest risk of severe COVID-19 disease.
Results from earlier safety and immunogenicity testing determine whether these people should be included in large clinical studies.
Studies should also include people from ethnic minorities.
Investigations into the use of COVID-19 vaccines in children are planned for once there is sufficient information from studies in adults and adolescents.
For more information, see
How Are Clinical Studies Carried Out In Other Parts Of The World
Since the COVID-19 pandemic affects people worldwide, it is important for companies developing COVID-19 vaccines to generate robust evidence that meets the needs of regulators around the globe. This is why EMA and other medicines regulators have agreed key principles on how to carry out clinical trials for COVID-19 vaccines.
Companies applying for approval of a vaccine in the EU must ensure that clinical studies meet stringent EU requirements no matter where in the world they took place.
For more information, see:
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Vaccines Can Keep Us Healthy By Preventing Infection Transmission Symptomatic Disease Hospitalization And Even Death
COVID-19 vaccines teach our immune system to recognize SARS-CoV-2, the virus that causes COVID-19, so that if we are exposed to the virus, our immune system can leap into action and keep us healthy.
Vaccines can protect us from COVID-19 by preventing us from getting infected at all, and by preventing us from getting sick, ending up in the hospital, or dying even if we are infected. Vaccines can also prevent us from transmitting the virus to others.
In clinical trials, there are many outcomes that researchers can assess to determine how a given vaccine candidate works. COVID-19 vaccines can prevent some or all of these health outcomes and the evidence from clinical trials helps us understand how vaccines keep us healthy.
Most phase 3 clinical trials report the vaccine efficacy for symptomatic disease as the primary outcome. That tells us how well the vaccine prevents us from getting sick. Or, in other words, the vaccine efficacy tells us how much less likely a vaccinated person is to get sick compared to an unvaccinated person.
For example, if a COVID-19 vaccines efficacy is reported to be 95% against symptomatic disease, participants who received the vaccine were 95% less likely to experience symptoms of COVID-19, compared to participants in the control group . A vaccine clinical trial can report a different outcome, or multiple outcomes, so it’s important to ask what outcome the vaccine efficacy estimate refers to.
Myth: Receiving A Covid
FACT: Receiving a COVID-19 vaccine will not make you magnetic, including at the site of vaccination which is usually your arm.
COVID-19 vaccines do not contain ingredients that can produce an electromagnetic field at the site of your injection. All COVID-19 vaccines are free from metals.
Learn more about the ingredients in the COVID-19 vaccinations authorized for use in the United States.
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What Types Of Covid Testing Does Intermed Offer
InterMed offers PCR COVID-19 testing, which is the most sensitive test for the detection of COVID-19. This test is appropriate for both symptomatic and asymptomatic patients. The sample is collected via nasal swab.
InterMed also offers Abbott ID NOW rapid testing, a test that provides reliable results in 15-30 minutes in appropriately selected patients with symptoms. This is a viral RNA detection test, which is less sensitive than the PCR test. When used in symptomatic patients this test is very effective in rapidly determining a patient’s COVID-19 status. The sample is collected via nasal swab.
If your provider has a high suspicion that you may have COVID-19 but results from the Abbott ID NOW rapid test are negative, the provider may request repeating the nasal swab and testing with the more sensitive PCR.
What This Means For You
As cities and countries begin to require proof of vaccination for entry, you’ll need to find a way to keep your information secure but easily available. Experts advise due diligence before choosing an app for this purpose. When considering apps, find out where your information will be stored and who will have access to it. As a failsafe, keeping a photo of your vaccination card on your phone is a low-tech but secure option.
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Will Testing For Covid Stop As Time Goes On
It is unlikely our approach to COVID testing will change in the immediate future. However, as COVID vaccines are rolled out and since COVID is likely to become endemic and stay with us for a long time, the acute response phase to the pandemic will end.
So COVID testing may become part of managing other infectious diseases and part of how we respond to other ongoing health priorities.
Test And Documentation Requirements
You must be tested with a viral test to look for current infection these include an antigen test or a nucleic acid amplification test .
Phrases indicating a test is an antigen test could include, but not are not limited to:
- Rapid antigen test
- Viral antigen test
- Also, could be noted as Antigen Chromatographic Digital Immunoassay, Antigen Chemiluminescence Immunoassay, or Antigen Lateral Flow Fluorescence
Examples of available NAATs for SARS-CoV-2 include but are not restricted to:
- Reverse transcription polymerase chain reaction
- Isothermal amplification including:
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If You Received One Or More Of Your Doses Outside Of Ontario
If you received one or more doses of the COVID-19 covid 19vaccine out of province, contact your local public health unit to register your information and receive proper documentation. They will verify and record your vaccination records in COVaxON. If you do not have an Ontario health card, they can provide you with a unique pass code called a COVID ID.
Once recorded, you will be able to obtain an enhanced vaccine certificate through the provincial portal at COVID-19 vaccination provincial portal or by calling the Provincial Vaccine Contact Centre at . The contact center agent can email you a secure URL so you can access your vaccine certificate.
Proof of vaccination may also include a vaccination receipt from another jurisdiction that shows the holder is fully vaccinated against COVID-19 covid 19.
What Studies Are Needed After Approval
Data from long-term clinical studies on safety and efficacy are important for a number of reasons. These data allow the assessment of how protection against COVID-19 evolves over time, such as if the level of antibodies in the blood might go down after some time.
Long-term data are also important to assess whether there is any risk of vaccine-associated enhanced disease . VAED is a condition that would occur when a vaccinated person subsequently infected with a virus develops a more severe disease than they would have had if they were not vaccinated.
This has been seen in animal models given vaccines against SARS or MERS and never with humans given such SARS or MERS vaccines. VAED has not been seen with COVID-19 vaccines in any studies done so far.
For more information, see:
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New Codes For Immunizations
CPT codes have been created for reporting of immunizations for the novel coronavirus . These CPT codes are unique for each coronavirus vaccine as well as administration codes unique to each such vaccine. The new CPT codes clinically distinguish each coronavirus vaccine for better tracking, reporting and analysis that supports data-driven planning and allocation.
More information can be found at the COVID-19 CPT vaccine and immunization codes page.
Air Travellers: Register In Advance For Arrival Testing
You may be required to get tested before exiting the airport. To speed you through the process, register in advance with the testing provider for the airport you will arrive at.
When you register, use the same email address you used for your ArriveCAN account.
Requirements for children accompanying parents:
- children accompanying a parent selected for a test must follow the same rules as children of all vaccinated travellers
- children selected for a test must quarantine, whether or not their parent are not required to do so if they weren’t selected
Fully vaccinated travellers are not exempt from mandatory randomized arrival testing.
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Should Patients With Autoimmune Conditions Or Immunocompromised Patients Receive The Vaccine
Individuals with autoimmune conditions or patients who are immunocompromised may receive COVID-19 vaccination if they have no contraindications to vaccination. Patients should contact their primary care provider to discuss their specific situation ahead of receiving the vaccine. Visit our Vaccine page for details, including third dose and booster eligibility. Patients should continue to follow all guidelines to protect themselves against COVID-19, which includes wearing a mask, washing your hands frequently and staying at least 6 feet away from others.
Check With Your Doctor’s Office
Did you get vaccinated at a doctor’s office, clinic or health care facility? If so, they may have a record of your shot. If not, they’ll be able to point you in the right direction.
Your doctor’s office or clinic may use an app, like MyChart, that stores your proof of vaccination. Some physicians put vaccine documents and test results in the app, so it’s easy to grab. But keep in mind that even if your information is available from the app, you may not be able to get a replacement card with the CDC’s seal if your doctor’s office doesn’t offer one. However, you may be able to ask for a printed version of your vaccine record.
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More Information About Covid
Australians are encouraged to rely on reputable sources of information to help them make informed choices and stay up to date.
Information will be communicated through government channels, as well as states and territories and the health sector.
Reputable information about vaccines is available from:
Red Flag: It’s Illegal To Falsify Your Vaccine Card
Selling or purchasing a fake vaccine card — or filling in false information — is committing fraud. Even if you’ve had the vaccine, buying a fake card is considered fraud and is punishable by fines and up to five years in jail.
The US Customs and Border Protection agency regularly seizes thousands of fake vaccine cards across the country — a good reminder to retrieve your proof of vaccination the right way.
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Get Your Nova Scotia Covid
If you provide an email when you book your vaccination appointment, you receive a digital copy of your Nova Scotia COVID-19 Proof of Vaccination by email . You can also get your Nova Scotia COVID-19 Proof of Vaccination online. Make sure you have your Health Card and the email address or phone number you used to book your vaccination appointment.
If you dont provide an email when you book your vaccination appointment or you didnt receive a digital copy of your Nova Scotia COVID-19 Proof of Vaccination by email, call to provide an email or request a copy of your proof of vaccination. You need to call from a Canadian phone number and be in Canada when you call.
Ways To Prove Your Covid
Angela Underwood’s extensive local, state, and federal healthcare and environmental news coverage includes 911 first-responder compensation policy to the Ciba-Geigy water contamination case in Toms River, NJ. Her additional health-related coverage includes death and dying, skin care, and autism spectrum disorder.
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What Is Known About The Vaccine’s Side Effects
Common side effects include pain, swelling, or redness in the arm where you got the shot. You may experience chills, tiredness, or headache. These side effects usually start within a day or two of getting the vaccine. They might feel like flu symptoms and might even affect your ability to do daily activities, but will go away in a few days. For more safety information, refer to the federal CDC’s Pfizer or Moderna, or Johnson & Johnson COVID-19 vaccine resources.
How Much Time Should L Allow Between A Mammogram And Covid Vaccine
Try to schedule your screening mammogram before your first COVID-19 vaccine dose or at least 4 weeks after your second vaccine dose. This reduces the chance that swollen lymph nodes from the vaccine will appear on your mammogram. If you have already scheduled a vaccine within this timeframe, keep your appointment. Regular screening mammograms ensure that breast cancer can be detected as early as possible.
It is especially important to keep your mammogram appointment if you are significantly overdue for screening.
If you have a mammogram after your COVID vaccine, let your mammography technologist know which dose, the date you received it, and in which arm. This information will help the breast radiologist interpreting your screening mammogram. Learn more
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Should Patients Who Are Pregnant Or Breastfeeding Receive The Vaccine
The American College of Gynecologists recommends COVID-19 vaccination for pregnant and breastfeeding women. Getting a vaccine could help both you and your fetus. Remember that pregnant women have a higher risk of severe illness from COVID-19 than nonpregnant women. The vaccines are very effective at preventing COVID-19 infection, severe illness, and death. A growing amount of data confirms that COVID-19 vaccines are safe during pregnancy. Scientists have compared the pregnancies of women who have received COVID-19 vaccines and women who have not. The reports show that these women have had similar pregnancy outcomes. Data do not show any safety concerns. For breastfeeding women, there is no need to stop breastfeeding if you want to get a vaccine. When you get vaccinated, the antibodies made by your body may be passed through breastmilk and may help protect your child from the virus.