How Long Was The Flu Vaccine Tested Before Release

Caring For Yourself And Others

If you are unwell, stay at home and rest ideally/preferably in a separate, well ventilated room away from other people.

It is important to drink small amounts of fluids often.

Antibiotics only work against bacterial infections, not the viral infections that cause influenza.

Carefully read and follow the labels on any medication and contact your doctor or pharmacist if you have any questions

You can also:

• reduce fever by using a damp cloth on your forehead, washing the arms and body with a cool cloth, bathing in slightly warm water
• take appropriate medicines to relieve discomfort and fever if necessary.
• It is especially important to reduce fever if you are pregnant.
• gargle a glass of warm water and/or suck sugarless hard sweets or lozenges to help with sore throats
• shower or bathe regularly and keep bedding and nightwear clean and dry
• use skin balm or moisturiser to stop your lips from cracking.

Know the danger signs that mean you should seek urgent medical attention .

Any child younger than 3 months who has a fever should see a doctor

Annual Updates To The Immunization Schedule 1995 To 2010

As more vaccines became available, an annual update to the schedule was important because of changes that providers needed to know, such as detailed information about who should receive each vaccine, age of receipt, number of doses, time between doses, or use of combination vaccines. New vaccines were also added.

Important changes to the schedule between 1995 and 2010 included:

• New vaccines: Varicella , rotavirus hepatitis A pneumococcal vaccine
• Additional recommendations for existing vaccines: influenza hepatitis A
• New versions of existing vaccines: acellular pertussis vaccine intranasal influenza
• Discontinuation of vaccine: Oral polio vaccine

2000 | Recommended Vaccines

* Given in combination as DTaP** Given in combination as MMR

A Brief History Of The Flu Vaccine

Every year, three to five million people catch the seasonal flu, according to the World Health Organization , and between 290,000 and 650,000 people die from it worldwide. Still, thanks to the flu vaccine, this is only a fraction of how many people it used to kill. During the last major flu pandemic of 1918-1919, it killed between 50 and 100 million people around the world.

For a long time, scientists had thought that the flu was caused by a bacteria called Haemophilus influenzae, but after the 1918-19 pandemic, they started to suspect it was caused by a virus instead. However, it wouldnt be until the 1930s that they would confirm that. In 1933, three scientists isolated the Influenza A virus in ferrets one of the three types of flu and in 1936, it was discovered that the virus could be grown inside embryonated chicken eggs, a key step towards making a vaccine.

Just two years later, in 1938, Jonas Salk and Thomas Francis developed the first vaccine using fertilized chicken eggs and an inactivated strain of the Influenza A virus.

This new vaccine was first used to help protect soldiers fighting in World War II it wouldnt be approved for civilians until 1946. According to a 1944 study of the new vaccine, it helped reduce illness that was accompanied by a temperature above 99 degrees Fahrenheit.

Know your flu risk. Check out the Flu Tracker on The Weather Channel App.

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Early Polio Vaccine Projects

Unfortunately, initial trials were poorly executed and caused great harm to those involved. Teams of researchers in New York and Philadelphia both administered vaccines containing active poliovirus to tens of thousands of living subjects, including children and chimpanzees. Many subjects became severely ill or paralyzed, experienced allergic reactions, and even died of polio.

Regulating Vaccines In Canada

The Food and Drugs Act and its Regulations categorize vaccines as biologic drugs. Biologic drugs differ from chemical drugs because they come from living organisms, which means they are more variable than chemical drugs. Therefore, biologic drugs require more regulatory oversight than chemical drugs, as well as special expertise and procedures for their:

• manufacture

For more in-depth information on regulating biologics, refer to our regulatory roadmap for biologic drugs in Canada page.

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Licensing Of Seasonal Influenza Vaccines

The Food and Drug Administration is responsible for regulating vaccines in the United States. Licensure of seasonal influenza vaccines follows the same general approach as licensure of other vaccines and has been described previously.3 Licensure may be obtained either through a traditional approval pathway or by the accelerated approval mechanism. Both pathways share similar requirements for demonstration of product safety and consistency of vaccine manufacturing. Traditional approval provides prelicensure evidence of efficacy from clinical trials in which influenza illness is assessed as the primary endpoint. Recent examples of influenza vaccines that have been approved by the traditional pathway include Flucelvax® in 2012, an inactivated trivalent vaccine produced in cell culture by Novartis Vaccines and Diagnostics, Inc. , and Flublok® in 2013, a recombinant protein vaccine manufactured by Protein Sciences Corporation.

Evaluation of the vaccineinduced immune response in the clinical disease endpoint efficacy studies is important to potentially extrapolate vaccine effectiveness to populations not included in the efficacy trial. For example, persons 659 months of age and those 65 years of age and older may not have been included in efficacy studies because of ethical concerns related to conducting placebocontrolled efficacy studies in populations for which influenza vaccines are recommended. In such populations, effectiveness can be based on immunogenicity endpoints.3

Groups Who Should Especially Get The Vaccine

The flu shot can protect you against the flu. Because of this, it can reduce your chances of being infected with COVID-19 and the flu at the same time. This can lead to serious complications. You should especially receive the flu vaccine this season if youre:

• at high risk of severe COVID-19 related illness
• capable of spreading the flu to those at high risk of severe illness related to COVID-19

The flu vaccine is especially important for the following groups.

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Pandemic 2009 Briefing Note 7

It takes approximately five to six months for the first supplies of approved vaccine to become available once a new strain of influenza virus with pandemic potential is identified and isolated. These months are needed because the process of producing a new vaccine involves many sequential steps, and each of these steps requires a certain amount of time to complete. The vaccine development process from start to end is summarized below.

Activities at WHO Collaborating Centers

1. Identification of a new virus: As part of a network set up for surveillance, laboratories around the world routinely collect samples of circulating influenza viruses and submit these to WHO Collaborating Centres for Reference and Research on Influenza for analysis. The first step towards the production of a pandemic vaccine starts when a Centre detects a novel influenza virus that differs significantly from circulating strains and reports this finding to WHO.

Vaccine virus is grown in eggs because the flu virus grows well in them, and eggs are readily available.

3. Verification of the vaccine strain: After its preparation, the hybrid virus needs to be tested to make sure that it truly produces the outer proteins of the pandemic strain, is safe and grows in eggs. Upon completion of this process, which takes roughly another three weeks, the vaccine strain is distributed to vaccine manufacturers.

Activities at vaccine manufacturers

This process takes two weeks.

Koprowski Polio Vaccine Tests

So when was the polio vaccine invented?

In the late 1940s, Dr. Hilary Koprowski of Lederle Laboratories in Philadelphia successfully administered a vaccine for type 2 poliovirus. He chose to test it on himself and his assistant after trying it on chimpanzees. They both drank the vaccine and observed no adverse effects.

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How Influenza Vaccines Are Made

For the United States there are three different influenza vaccine production technologies approved by the U.S. Food and Drug Administration external icon:

• egg-based flu vaccine,
• cell-based flu vaccine, and
• recombinant flu vaccine.

All commercially available flu vaccines in the United States are made by private sector manufacturers. Different manufacturers use different production technologies, but all flu vaccines meet FDA safety and effectiveness requirements. Different vaccines have different indications. See Different Types of Flu Vaccines for more information.

Compliance And Enforcement Activities

To protect the safety of the public and prevent deception in relation to vaccines, Health Canada:

• monitors compliance
• undertakes enforcement activities
• addresses non-compliance

Inspectors in Health Canada’s Regulatory Operations and Enforcement Branch deliver the national compliance and enforcement program for vaccines authorized for sale in Canada. We may inspect any party conducting a regulated activity. Regulated parties have mandatory responsibilities under the Food and Drugs Act.

Foreign establishments that conduct regulated activities in Canada, or in relation to a vaccine sold, imported or advertised in Canada, are also subject to Canadian law. Regulated activities for a vaccine under the Food and Drugs Act include:

• selling

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Measles Mumps And Rubella

Measles, Mumps, and Rubella are viral infections that have each caused widespread, deadly disease outbreaks. Throughout the 1960s, individual vaccines were developed for each of them, but a decade later, they were combined into one.

Measles was the first of the three to receive its own vaccine in 1963, followed by mumps in 1967, and rubella in 1969. Two years later, in 1971, Maurice Hilleman of the Merck Institute of Therapeutic Research developed a combined vaccination that would provide immunity for all three viruses.

Hilleman was credited with creating the first measles and mumps vaccine, and began researching ways to incorporate a system of immunity for each virus. Using his previous research and a rubella vaccine developed by Stanley Plotkin in 1969, he created the first successful MMR vaccine in just two years.

According to the CDC, “One dose of MMR vaccine is 93% effective against measles, 78% effective against mumps, and 97% effective against rubella.”

“Two doses of MMR vaccine are 97% effective against measles and 88% effective against mumps.”

The Schedule From 2011 To Present

Annual updates to both the childhood and adult immunization schedules offer guidance to healthcare providers in the form of new recommendations, changes to existing recommendations, or clarifications to assist with interpretation of the schedule in certain circumstances. The schedules are reviewed by committees of experts from the Centers for Disease Control and Prevention, the American Academy of Pediatrics, and the American Academy of Family Physicians.

Important changes to the schedule:

• New vaccines: meningococcal serogroup B vaccine
• Additional recommendations for existing vaccines: HPV , intranasal influenza vaccine
• Discontinuation of vaccine: intranasal influenza vaccine

2020 | Recommended Vaccines

* Given in combination as DTaP** Given in combination as MMR

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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.

People At High Risk Of Complications From The Flu

• people with health conditions, such as:
• cancer and other immune compromising conditions
• diabetes
• kidney disease
• neurological or neurodevelopmental conditions
• children up to 18 years of age undergoing treatment for long periods with acetylsalicylic acid

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Does A Flu Vaccine Increase Your Risk Of Getting Covid

• There is no evidence that getting a flu vaccine increases your risk of getting sick from a coronavirus, like the one that causes COVID-19.

• You may have heard about a study published in January 2020 that reported an association between flu vaccination and the risk of four commonly circulating seasonal coronaviruses, but not the one that causes COVID-19. This report was later found to be incorrect.

• The results from that initial study led researchers in Canada to look at their data to see if they could find similar results in their population. The results from Canadas study showed that flu vaccination did not increase the risk for these seasonal coronaviruses. The Canadian findings highlighted the protective benefits of flu vaccination.

• The Canadian researchers also identified a flaw in the methods of the first study, noting that it violated the part of the study design that compares vaccination rates among patients with and without flu . This flaw led to the incorrect association between flu vaccination and seasonal coronavirus risk. When these researchers reexamined data from the first study using the correct methods, they found that flu vaccination did not increase the risk for infection with other respiratory viruses, including seasonal coronaviruses.

Who Should Get The Flu Shot Who Shouldnt

People over 6 months of age should receive the flu shot each year.

Its particularly important for people who are at an increased risk for flu-related complications to be vaccinated.

This includes:

• anyone living or working in a nursing home or chronic care facility
• caregivers of any of the above

Children under 6 months of age shouldnt receive the influenza vaccine. To protect these children from potential exposure to the virus, all family members or caregivers should be vaccinated.

This is called herd immunity and will help protect those who cant receive the vaccine.

Additionally, if youre currently sick with an acute illness, you may need to wait until youre better to receive the vaccine.

Before youre vaccinated, you should let your doctor know if youve had:

• a prior allergic reaction to the flu vaccine
• complications from vaccines
• Guillain-Barré syndrome

These factors may indicate that you should not get the flu shot. But check with your doctor to see what they recommend.

Many flu shots contain a small amount of egg protein. If you have a history of egg allergies, talk with your doctor about receiving the flu shot.

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Key Facts About Seasonal Flu Vaccine

On June 30, 2022, CDC announced that Director Rochelle P. Walensky adopted the Decision memo approving the ACIP vote for a preferential recommendation for the use of higher dose or adjuvanted flu vaccines over standard-dose unadjuvanted flu vaccines for adults 65 years and older. CDCs full recommendations for the use of flu vaccines during 2022-2023 will appear in a forthcoming Morbidity and Mortality Weekly Report. Edits to this page are also forthcoming. More information can be found online: CDC Director Adopts Preference for Specific Flu Vaccines for Seniors

Note: Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices United States, 2021-2022 Influenza Season has been . More information on the 2021-2022 season is also available.

What Side Effects Can Occur After Getting A Flu Vaccine

• While a flu vaccine cannot give you flu illness, there are different side effects that may be associated with getting a flu shot or a nasal spray flu vaccine. These side effects are mild and short-lasting, especially when compared to symptoms of a bad case of flu.

A flu shot: The viruses in a flu shot are killed , so you cannot get flu from a flu shot. Some minor side effects that may occur are:

• Soreness, redness, and/or swelling where the shot was given

• Headache

• Nausea

• Fatigue

The nasal spray: The viruses in the nasal spray vaccine are weakened and do not cause severe symptoms often associated with influenza illness. In children, side effects from the nasal spray may include:

• Runny nose

• In adults, side effects from the nasal spray vaccine may include:

• Runny nose

• Sore throat

• Cough

• If these problems occur, they begin soon after vaccination and usually are mild and short-lived. A flu shot, like other injections, can occasionally cause fainting. Tell your provider if you feel dizzy or have vision changes or ringing in the ears. As with any medicine, there is a very remote chance of a vaccine causing a severe allergic reaction, other serious injuries, or death.

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Why Do I Need A Flu Vaccine Every Year

• A flu vaccine is needed every season for two reasons. First, a persons immune protection from vaccination declines over time, so an annual vaccine is needed for optimal protection. Second, because flu viruses are constantly changing, flu vaccines may be updated from one season to the next to protect against the viruses that research suggests may be most common during the upcoming flu season. For the best protection, everyone 6 months and older should get vaccinated annually.

Other Methods Of Manufacture

Methods of vaccine generation that bypass the need for eggs include the construction of influenza virus-like particles . VLP resemble viruses, but there is no need for inactivation, as they do not include viral coding elements, but merely present antigens in a similar manner to a virion. Some methods of producing VLP include cultures of Spodoptera frugiperdaSf9 insect cells and plant-based vaccine production . There is evidence that some VLPs elicit antibodies that recognize a broader panel of antigenically distinct viral isolates compared to other vaccines in the hemagglutination-inhibition assay .

A gene-based DNA vaccine, used to prime the immune system after boosting with an inactivated H5N1 vaccine, underwent clinical trials in 2011.

On November 20, 2012, Novartis received FDA approval for the first cell-culture vaccine. In 2013, the recombinant influenza vaccine, Flublok, was approved for use in the United States.

On September 17, 2020, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for Supemtek, a quadrivalent influenza vaccine . The applicant for this medicinal product is Sanofi Pasteur. Supemtek was approved for medical use in the European Union in November 2020.

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