Vaccines for Children

November 5, 2016

The beginning of the school year marks a time period when parents and other caregivers are swamped with paperwork to complete from their children’s school, and many of them have concerns about their children’s vaccine schedule.

Dr. Marion Gruber, director of the office of Vaccines Research and Review for the Food and Drug Administration (FDA), states that, “Parents should know that vaccines protect children from many serious illnesses from infectious diseases. The risk of being harmed by vaccines is much smaller than the risk of serious illness from infectious diseases,” she says.

The biggest complaint most children experience from vaccination is soreness around the site where they were injected. Other than that, there are no serious effects; and if they are, the instances are very rare.

Benefit of Vaccination

Childhood diseases like measles, Hib (Haemophilus influenzae type b) and diphtheria have become rare occurrences thanks to vaccines. Vaccines have worked wonders to make childhood diseases like smallpox and polio nonexistent in United States. Thus, the use of vaccines has prevented many children in the United States from having to suffer and die from various diseases that were once commonplace in childhood.

According to Gruber, just because vaccination has made childhood diseases of the past a very rare phenomenon, parents cannot dismiss the possibility these diseases can still occur—especially if people elect not to have their children vaccinated.

Guidelines to Follow When Having Your Child Vaccinated

Review the vaccine information sheets

The following material contains information required by law that healthcare professionals have to provide on the pros and cons of using vaccines.

Discuss the pros and cons of having your child vaccinated with your child’s physician.

It’s important to know the risks taken when parents decide not to let their children have vaccines. For example, diseases that are preventable because of vaccines (i.e. pertussis, diphtheria and measles) are known to be fatal or cause lasting harm for some children.

Notify the doctor about your child’s medical history prior to getting them vaccines.

If your child has a medical history of previous illnesses or has had an allergic reaction to vaccines in the past, then your child’s healthcare provider needs to know that. Also, tell the doctor of any known allergies your child has. If your child is allergic to eggs, then a flu vaccine could prove to be harmful or fatal to your child since eggs are used to produce flu vaccines.

People sensitive to latex may have a problem taking vaccines that are packaged in latex material. Also, you should let your child’s doctor know about vaccines your child should avoid because of a weak immune system.

Report adverse reactions

The FDA and the Center for Disease Control and Prevention (CDC) recommend all parents report any adverse reactions or other problems from taking a vaccine to the Vaccine Adverse Event Reporting System.

Healthy Winter Season

October 22, 2016

Contagious viruses are actives year round, but in the fall and winter we are the most vulnerable to them. People spend more time indoors during this time with other people and there’s a lot of cold weather. To combat viruses we can use several FDA approved vaccines and medications.

Viruses

Most respiratory viruses are gone within a few days and have no lasting effects, but some of them can cause serious health problems. People that use tobacco or get secondhand smoke, are prone to respiratory illnesses and can have more complications than nonsmoker do when exposed.

Colds

A cold usually causes sneezing, stuffed, and runny noses. There may be a scratchy throat as well as watery eyes and coughing. There’s no vaccine for a cold and they start gradually and often come from contact with infected mucus.

Flu

The flu last longer than a cold and can come on suddenly. Headache, fever, chills, body aches, dry cough, general misery, and fatigue are all symptoms of the flu. The flue may also cause a stuffy or runny nose and there may be nausea or vomiting issues. The flu is spread when people talk, sneeze or talk and spread droplets in the air. You may also get the flu by touching an infected surface that has the flu virus.

Tips for Prevention

There are rare exceptions, but everyone over six months of age should get the flu vaccine. You can get the vaccine as a nasal spray or a shot. This reduces doctor’s visits, flu illness as well as missed school or work. The vaccine also prevents hospitalization due to flu complications as well as death from the flu.

You should get the vaccine before October, but vaccines through January and other months can still offer you protection. You need an annual vaccination as the flue always changes and the vaccine needs to be updated. A person’s immune protection from the virus will decline over time. For people at high risk, an annual flu vaccine is important. These individuals include:

  • Children under five years of age, and especially those younger than two
  • Women that are pregnant
  • People that have chronic illnesses like diabetes, asthma, lung, or heart disease
  • Anyone over the age of sixty-five

Wash Hands Often

You should wash your hands often and teach your children to do this also. Colds and flu can be passed through contaminated surfaces like your hands. Soap and water are best for hygiene according to the FDA, but you can also use alcohol based hand rubs. Make sure you clean the hands and remove dirt or blood as this will make the alcohol based rub ineffective at killing bacteria.

Limit Exposure to Those that are Sick

Try to keep small children like infants away from crowds during their first few months.

Heathy Habits for Prevention

  • Make sure you eat a healthy diet
  • Get plenty of sleep
  • Make sure you exercise
  • Keep tabs on your stress

Seasonal Flu Vaccines

December 20, 2014

Many of the projected 135-139 million doses of influenza vaccines being produced for this flu season for use in the U.S. are now available to consumers from six manufacturers licensed by the Food and Drug Administration (FDA).

A variety of flu vaccines, including some that were not available during past influenza seasons, are available this year. In addition to the availability of vaccines that protect against three strains of influenza virus (trivalent), vaccines that protect against four strains of the virus (quadrivalent) will also be available this year.

In addition, a vaccine that is produced by growing the virus in cells rather than in eggs will be available for use in people 18 years of age and older.

Unlike eggs, cells can be frozen for later use to grow large volumes of cells for the production of vaccine. This could provide a faster start-up time of the manufacturing process for any unexpected need.

“New technologies are providing additional and diverse influenza vaccines, which helps to ensure an adequate supply in the Unites States,” said Karen Midthun, M.D., director of FDA’s Center for Biologics Evaluation and Research.

“Influenza seasons are unpredictable and can be severe, even deadly,” she added. “Last year’s influenza season brought an increase in reported hospitalizations and deaths compared to recent years, and vaccination is the best defense to prevent influenza.”

All of the vaccines have been determined by FDA to be safe and effective. Getting vaccinated early, before flu season is in full swing, is key to prevention.

An Exacting Process

Manufacturing flu vaccines is an exacting and complex process. New vaccines must be produced each year because the viruses change from year to year and because the protection received the previous year diminishes over time.

Each February, before one flu season ends, the FDA, World Health Organization, the Centers for Disease Control and Prevention (CDC) and other public health experts collaborate on collecting and reviewing data to identify the virus strains likely to cause the most illnesses in the next flu season. Based on that information and the recommendations of an FDA advisory committee, FDA selects the strains for manufacturers to include in their vaccines for use in the United States.

Both egg-based flu vaccines and vaccines made with newer technologies work the same way; they trigger the immune system of the person receiving the vaccine to produce antibodies capable of attacking the virus.

Vaccines are available in a variety of delivery methods, as a needle into muscle, as a needle injected into skin (approved for ages 18 through 64), and as a nasal spray (approved for people ages 2 through 49). In addition, one vaccine made in a high dose formulation is approved for people 65 years of age and older.

The Procedure

Under traditional egg-based production methods, once the influenza viruses have been selected, they are adapted for use in manufacturing and provided to companies licensed by FDA. The manufacturers inject each virus strain into eggs, which are incubated for several days to allow the virus to multiply.

The virus-loaded fluid from the eggs is then harvested and purified.

Manufacturers grow each strain separately then test it, including for potency. Then the strains are mixed and tested again. Once divided into standard dosages, the vaccines are put into containers such as vials, syringes or sprayers.

Test results are submitted to FDA, along with samples from each batch, or lot. FDA reviews the test results and the samples before releasing the vaccine for distribution in the United States. Each lot, or batch, undergoes testing before release by FDA.

FDA also inspects the manufacturing facilities on a regular basis and continues to monitor the safety of the vaccines once they are in use by the public.

The level of effectiveness can depend on the health and immune system of individuals and how well a particular season’s vaccine strains match circulating flu strains.

There is a possibility of a less than optimal match between the virus strains predicted to circulate and the virus strains that end up causing the most illness. However, even if the vaccine and the circulating strains are not an exact match, the vaccine may reduce the severity of the illness and help prevent influenza-related complications.

CDC recommends that everyone six months of age and older get vaccinated soon after vaccine becomes available. Those people for whom vaccination is particularly important include young children, the elderly, pregnant women, and those who suffer from a variety of chronic illnesses, including asthma, diabetes and heart disease.

Although the winter months are usually the peak month for flu activity, influenza disease in people typically begins appearing in October.

FDA’s website has specific information about each flu vaccine, including the FDA-approved age range of use. The website also provides the names of the influenza viruses included in this season’s vaccines and an up-to-date list of the number of vaccine lots that have been released for each manufacturer.

Meant to get vaccinated in the fall to ward off the flu, but somehow didn’t get around to it? Think it’s too late to get vaccinated now?

Not so. According to the Food and Drug Administration (FDA), vaccinations can be protective as long as flu viruses are circulating. And while seasonal flu outbreaks can happen as early as October, flu activity usually peaks in January or February, and can last well into May.

FDA plays a key role in ensuring that safe and effective influenza vaccines are available every flu season. In fact, the task of producing a new vaccine for the next flu season starts well before the current flu season ends. For FDA, it’s a year-round initiative.

Why a new vaccine?

According to Marion Gruber, Ph.D., director of FDA’s Office of Vaccine Research and Review, there are several reasons that new vaccines must be manufactured each year.

“Influenza viruses can change from year to year, due to different subtypes and strains that circulate each year,” says Gruber. A vaccine is needed that includes virus strains that most closely match those in circulation, and the protection provided by the previous year’s vaccine will diminish over time.

Identifying Likely Virus Strains

Each February, before that year’s flu season ends, FDA, the World Health Organization, the Centers for Disease Control and Prevention (CDC) and other public health experts collaborate on collecting and reviewing data from around the world to identify the flu viruses likely to cause the most illnesses in the next flu season. Based on that information and the recommendations of an FDA advisory committee, the agency selects the virus strains for FDA-licensed manufacturers to include in their vaccines for use in the United States.

“The closer the match between the circulating strains causing disease and the virus strains in the vaccine, the better the protection against influenza,” Gruber says.

In addition, FDA inspects the manufacturing facilities on a regular basis, and prepares and provides reagents (necessary test components to standardize vaccines) that vaccine manufacturers need to make their vaccine and to verify its identity and strength. FDA also evaluates each manufacturer’s vaccine each year for approval purposes, conducts lot release (that is, performs certain tests and reviews the results of the manufacturers’ tests on each lot of vaccine prior to distribution), and continues to monitor the safety of the vaccines once they are approved for use and in distribution.

FDA and CDC scientists routinely evaluate reports to the Vaccine Adverse Event Reporting System (VAERS) of health problems that may be associated with a vaccine.

FDA conducts yearly surveillance for Guillain-Barre syndrome, a rare neurological condition associated with the 1976 flu vaccine, in collaboration with the Centers for Medicare and Medicaid Services. And the agency is now testing influenza surveillance in the new Mini-Sentinel Post Licensure Rapid Immunization Safety Monitoring (PRISM) system. If testing proves successful, FDA will be able to monitor rates of health problems after influenza vaccination among members of multiple health plans that serve the general U.S. population.

CDC also monitors the safety of annual influenza and other vaccines through the Vaccine Safety Datalink (VSD) by almost real-time observation of the health of people who are vaccinated, in collaboration with nine integrated health care organizations.

Who’s Most Affected So Far?

CDC tracks influenza activity year round in the U.S. and typically children and seniors are most at risk for influenza, but occasionally a flu virus will circulate that disproportionately affects young and middle-aged adults. So far, data reported by CDC suggest that 2013-2014 could be such a flu season.

CDC received an unusually high number of reports of severe respiratory illness among young and middle-aged adults in the last two months of 2013. Many of the cases were associated with the H1N1 strain of influenza that affected children and young adults compared to older adults during the 2009 influenza pandemic. The 2009 H1N1 virus has circulated each year since the pandemic. It is not known if those most severely affected received a vaccine, but this particular strain is included in this year’s vaccine and will help provide protection.

“Influenza seasons and severity are often unpredictable. Annual influenza vaccination is the best way to prevent influenza among people 6 months of age and older,” says Gruber. “However, taking such practical measures as washing hands, covering coughs and sneezes and staying home when sick can also help to decrease the spread and minimize the effects of flu.”

In addition, while antiviral drugs are not a substitute for vaccine, they can help to treat influenza. Tamiflu (oseltamivir phosphate) and Relenza (zanamivir) are the two FDA-approved influenza antiviral drugs recommended by CDC for use against recently circulating influenza viruses.

Flu Vaccines

August 30, 2013

The flu vaccine that you get at your doctor’s office or pharmacy is the work of highly skilled microbiologists, epidemiologists, physicians and other public health experts too numerous to mention. It also likely required a hen and a rooster monitored by a veterinarian inside a henhouse that met biosecurity requirements.

Sound complicated? It is. The manufacturing of flu vaccines is a highly-orchestrated and complex process.

Vaccine manufacturers each year use millions of fertilized eggs as a culture to grow influenza viruses that, after numerous steps requiring about six months of expert work, become that season’s flu vaccine. And while this tried-and-true method will continue to provide safe and effective vaccines for the foreseeable future, flu vaccines using new, more advanced technologies are arriving on the scene. Some don’t require eggs at all.

The Food and Drug Administration (FDA) and its parent, the U.S. Department of Health and Human Services, have long encouraged the development of new technologies for producing flu vaccines. For example, cell culture technology is used to make vaccines to prevent other infectious diseases, and FDA has been working for a number of years, both on the research and regulatory fronts, to facilitate this for flu vaccines. A major push for cell-based flu vaccines occurred in 2006 as part of a plan to be ready in case of a world-wide epidemic.

In 2010, FDA issued final guidance to assist manufacturers working to develop safe and effective viral vaccines that grow in specially prepared cell lines. In the last two months, FDA has approved two new flu vaccines that, instead of using eggs to grow the influenza virus, use cell lines from either a mammal or insects.

“This is an important advance that will supplement current egg-based vaccines,” said Jerry P. Weir, Ph.D., director of the Division of Viral Products in FDA’s Center for Biologics Evaluation and Research. “The more manufacturing alternatives there are available, the better we can respond to public health emergencies in a timely manner.”

Although egg-based production remains vital, cell technology has some advantages. Unlike eggs, cells can be frozen for later use to grow large volumes of cells. That advantage offers the potential for faster start-up of the vaccine manufacturing process for any unexpected need. This would also be critical if egg supplies were compromised. In addition, some flu virus strains don’t grow that well in eggs at first and may grow better and faster in cells, helping speed vaccine production and availability. Moreover, alternatives to egg-based products provide an option for people with egg allergies.